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Pharma companies do 40% of US generics

Pharma companies & US generics


The volume share of Indian pharma companies in the US generic market has grown to nearly 40% in August despite regulatory woes and pricing pressures. A steady increase in drug approvals and portfolio rationalisation by MNCs resulted in India’s volume share rising by 5% over the last few months, though value is still impacted due to price erosion.

The US, the most lucrative generics market valued at around $60 billion, accounts for 40-60% of revenues of most domestic companies — including Sun PharmaNSE 2.02 %, CiplaNSE 1.96 %, LupinNSE 4.23 % and Aurobindo — with an overall share of around $10 billion.

Over the last couple of years, channel consolidation and deep pricing pressure has hit generic companies, leading to biggies like Teva, Mylan and Sandoz recently rationalising their portfolio. This has given ground for Indian companies to increase their hold in the US market and it can continue to rise as the portfolio rationalisation is far from over since new (domestic) companies are still awaiting approvals in base products, according to an analyst from DSP Merrill Lynch India.

Planned portfolio exits from large MNC firms have taken India’s volume share up 4 percentage points in the last six months. Around 100 generic drug discontinuations have already been registered with the American regulator USFDA till now, largely from these MNCs, with their share in the US market plummeting to all-time lows — dropping to the level of Indian generic makers. For example, Mylan’s latest rolling four-week marketshare at 6.1% is already neck and neck with Lupin and Aurobindo, while market leader Teva is at 12.6% share — down 140 basis points y-o-y (100bps = 1 percentage point).
The volume-led upside in certain companies is not well reflected as yet, but will soon drive growth in the near and mid-term, and drive earnings 5-7% higher in FY19-20, the analyst adds. Not only have drug approvals of ‘plain-vanilla’ generics surged in the US, but an increasing number of domestic companies are manufacturing ‘complex first generic’ products.

AT Kearney partner (healthcare and pharma) Abhishek Malhotra says, “The first stage of growth was based on leveraging India’s high-quality and low-cost manufacturing base, and primarily focused on generic drugs. Given the pressure on pricing, increased competition and higher regulatory scrutiny, many leading Indian companies have embarked on the second leg of the growth journey. This includes moving up the value chain and developing more complex and specialty drugs and acquiring US companies to have manufacturing and R&D assets in the US.”

PwC India leader (pharmaceutical & life sciences) Sujay Shetty says complex generics and speciality products, which are difficult to manufacture, and niche drugs could add value for domestic companies in the near to mid-term as they are more resilient to pricing pressure.

Viagra is set to get cheaper, thanks to Indian pharma companies

Viagra is set to get cheaper, thanks to Indian pharma companies


Pfizer’s Viagra patent is up for grabs and Indian pharmaceutical companies are on the prowl.

Viagra — equal parts erectile dysfunction treatment and dubious subject line starter in your spam folder — is set to get a lot less expensive. That is if Indian pharmaceutical corporations have their way. Pfizer, the American Pharma giant that manufactures the drug, is set to lose its patent.  Although sildenafil, the drug sold under the Viagra brand name, was originally intended to help people with hypertension and cardiovascular disease, it was discovered that the drug could induce strong penile erections. To treat erectile dysfunction, Pfizer filed a patent for the drug that was later marketed as Viagra in 1994.

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The Pfizer patent which allows the formulation of Viagra, a drug used to treat erectile dysfunction (ED) among men, ends by 2020. Since America is India’s largest market for medicines, this move will open new avenues for Indian pharma companies. They will look to target the almost five crore American men who suffer from ED. Seven Indian companies have already secured permission and are a part of the 15 company group that has been granted approval by US health authority, Food and Drug Administration (FDA), to produce sildenafil citrate — the primary drug of Viagra.

The Indian companies currently in the fray to sell the Blue Pill are Rubicon Research, Hetero Drugs, Macleods Pharma, Dr Reddy’s, Aurobindo Pharma, Torrent Pharmaceuticals and Ajanta Pharma. The Indian companies are also working on plans to lower the price of Viagra by almost 99 per cent. According to a report in The Hindustan Times, The pill that cost around $65 (a little over 4,400 ruppes) currently in the US will see a huge drop in the prices once the Indian companies are allowed. The Mumbai-based Macleods Pharmaceuticals, which started exporting its products to the US in 2012, sells their version of Viagra in India called the Macsutra for just ruppes 58 per tablet. Even Ajanta Pharma, a publicly-listed form sells its version in India for just ruppes 32 per tablet.

The Indian company’s entry to the American markets will definitely leave a dent on Pfizer’s profits. The company earned over $1.68 billion (ruppes 11,535 crore) thanks to Viagra sales in 2014. In a research conducted by Transparency Market Research, the global erectile dysfunction drug market itself was valued at $4.35 billion (ruppes 29,876 crore) in 2016. But the Indian firms entering the US markets will have to contend with the rising FDA license fees. The FDA had earlier increased the fee by over 65 ruppes lakh from ruppes 45 lakh to 1.1 ruppes crore for the 2018 fiscal year.

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Insomnia, or poor sleep, is fairly common but it does not usually last for long. It may mean that you have difficulty getting off to sleep, or you may wake up for long periods during the night, or you may wake up too early in the morning. ‘Sleeping tablets’ like zopiclone are considered to be a last resort, but they are sometimes prescribed for a short period of time to help with a particularly bad patch of insomnia.


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Zopiclone is a type of sleeping pill that can be taken to treat bad bouts of insomnia. It helps you fall asleep more quickly, and also helps stop you waking up during the night.

Zopiclone comes as tablets. It also comes as a liquid for people who find it hard to swallow tablets, but this has to be ordered specially by your doctor.

Zopiclone belongs to a class of medicines commonly called Z drugs. It works by acting on the way messages are sent in your brain, which help you to sleep. It reduces the time it takes for you to fall asleep and increases the length of time you spend sleeping.

Zopiclone will often work well in the short term, but it is not normally prescribed for more than two to four weeks. This is because your body gets used to it within a short period of time and after this it is unlikely to have the same effect. Your body may also become dependent on it when it is taken for longer periods of time than this.

  • Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about zopiclone and will provide you with a full list of the side-effects which you may experience from taking it.
  • It is usual to be prescribed one tablet (7.5 mg) to be taken just before going to bed. Do not take more than one dose during a single night. If you are over 65 years of age, your doctor may consider the 3.75 mg strength tablets more suitable for you.
  • Take zopiclone exactly as your doctor tells you to. You could be advised to take a tablet on only two or three nights per week, rather than on every night.
  • Zopiclone takes around 1 hour to work.
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Sildenafil (Viagra) May Cut Colorectal Cancer Risk

Could a daily dose of Viagra prevent cancer? New study says it’s possible


The little blue pill that has famously changed the sex lives of countless men around the globe may have an even more powerful effect that could save people’s lives, new research reveals. Viagra may help in reducing the risk of colorectal cancer, which is the third leading cause of cancer-related deaths among both men and women in the United States, according to the American Cancer Society. A study published in February 2018 in the Journal Cancer Prevention Research found that when researchers gave a small, daily dose of sildenafil, also known as Viagra, to male and female mice that had been genetically modified to develop a large number of intestinal polyps, their risk of developing colorectal cancer dropped by 50 percent. (source)

Taking Viagra with the flu vaccine could prevent cancer and stop it spreading, according to new research.The uncoventional combination works by boosting the immune system – helping it mop up tumour cells left behind after surgery.
Experiments found they reduced spread of the disease by more than 90 percent in mice.

The results were so successful two dozen stomach cancer patients are to be given the unconventional therapy.Cancer kills because it migrates to other organs. And surgery makes this process easier, by weakening the immune system.

Viagra may help repair it.

Dr Rebecca Auer, surgical oncologist and head of cancer research at The Ottawa Hospital, Ontario , said: “Surgery is very effective in removing solid tumours.”However we’re now realising that, tragically, surgery can also suppress the immune system in a way that makes it easier for any remaining cancer cells to persist and spread to other organs.

“Our research suggests combining erectile dysfunction drugs with the flu vaccine may be able to block this phenomenon and help prevent cancer from coming back after surgery.”Viagra is widely used to treat impotence. It relaxes muscle cells around vessels so they can fill with blood much more easily.This is how it helps men with erectile dysfunction. But evidence is growing it can be used to treat a host of other disorders.

These include diabetes, lung problems, stroke, infertility, heart failure – and even premature births. Earlier this year US scientists found a daily dose dramatically reduced the risk of bowel cancer in mice genetically engineered to develop the disease. It prevented the formation of polyps – clumps of cells on the intestines which may become cancerous.

The latest study published in OncoImmunology analysed the effect of Viagra, another erectile disfunction drug Cialis and the flu vaccine Agriflu in mice with lung cancer. After surgery cases of tumour spread soared almost fourfold in the lab rodents. But this was more than five times less likely after treatment with Viagra or Cialis. And it was about 12 times less likely when the animals were given the flu vaccine as well as one of the impotence drugs.

Dr Auer is now leading the world’s first clinical trial of an impotence drug and the flu vaccine in cancer patients. It will involve 24 patients at The Ottawa Hospital undergoing surgery for abdominal tumours. Afterwards they will be given Cialis , with Agriflu.

The study is designed to evaluate safety and look for changes in the immune system. If successful, larger trials could look at possible benefits to patients. Dr Auer said: “We are really excited about this research because it suggests that two safe and relatively inexpensive therapies may be able to solve a big problem in cancer. “If confirmed in clinical trials, this could become the first therapy to address the immune problems caused by cancer surgery.”

Using a variety of mouse and human models, Dr Auer’s team has also made progress in understanding how impotence drugs and the flu vaccine affect cancer after surgery. Normally, immune cells called natural killer (NK) cells play a major role in killing cancer cells that have spread to other organs. But surgery causes another kind of immune cell called MDSC (myeloid derived suppressor cell) to block the NK cells. Dr Auer and colleagues found impotence drugs block these MDSCs, which allows the NK cells to do their job fighting cancer. The flu vaccine further stimulates the NK cells.(source)

US President may hit India

US President Donald Trump’s new drug plan may hit India


WASHINGTON: US President Donald Trump on Saturday denounced foreign countries for “extorting unreasonably low prices from US drugmakers” to enable their citizens to pay much less than American consumers for the same drugs. Trump made the comments while unveiling his drug price policy which he said would “end the global freeloading” on US drug-making expertise “once and for all”.

The US President directed his top trade negotiator, Bob Lighthizer, to strongly take up with all countries the fixing of prices of American pharmaceuticals and medical devices, extending his ‘America First’ policy to put ‘American Patients First’ and vowing to “bring soaring drug prices down to earth”.

Trump’s new policy action could have an impact on India-US bilateral trade relations given that the American industry has been fighting with the recent move by the Indian government to fix prices of certain highly expensive pharmaceuticals and medical devices – like stents, for example.

Just last month, the US in its annual report card on the protection of intellectual property rights around the world had criticised the drug pricing and reimbursement policies of India and several other countries like Canada, South Korea, Japan, New Zealand and a number of European nations, saying that they did not adequately recognise the value of innovative medicines.

“America will not be cheated any longer, and especially will not be cheated by foreign countries,” Trump said at the White House Rose Gardens on Saturday. “As we demand fairness for American patients at home, we will also demand fairness overseas. When foreign governments extort unreasonably low prices from US drugmakers, Americans have to pay more to subsidise the enormous cost of research and development,” he said.

China’s Plan To Import Indian Medicines

China’s Plan To Import Indian Medicines Receives Cold Response From Pharma Firms


On May 4, China, the second largest market for pharmaceuticals after the US, said it has removed import duties on as many as 28 medicines, including all cancer drugs, from May 1, a move which would help India to export these pharmaceuticals to the neighbouring country.


BEIJING:  China’s much-publicised announcement to slash tariffs on 28 medicines, including cancer drugs from India, has failed to create any buzz among the Indian pharmaceutical firms as exports to China are possible only after lengthy field trials and approvals, which could take years, an official at an Indian firm has said.

On May 4, China, the second largest market for pharmaceuticals after the US, said it has removed import duties on as many as 28 medicines, including all cancer drugs, from May 1, a move which would help India to export these pharmaceuticals to the neighbouring country.

“China has exempted import tariffs (duties) for 28 drugs, including all cancer drugs, from May 1. Good news for India’s pharmaceutical industry and medicine export to China. I believe this will help reduce trade imbalance between China and India in the future,” Chinese Ambassador to India Luo Zhaohui said in a tweet.

Mr Luo’s announcement generated optimism that India’s persistent demand from China to provide opening for Indian pharmaceutical firms to market their economically priced drugs compared to the multinational firms may be realised.

However, the official with the Indian pharmaceutical company said it is surprising to see the reports from the Indian media that the move to reduce tariffs will pave the way for exports of Indian pharmaceutical firms.

 “For Indian pharmaceutical companies, it is not going to be much different as imports of Indian drugs both generic and anti-cancer is possible only with the approval of China Food and Drug Administration (CFDA),” the official told news agency PTI on the condition of anonymity.

The announcement has not created any enthusiasm among the Indian firms as for both oral and injectable drugs a lengthy process of clearances is required in China which may take anywhere between two and half years to three years.

India has been lobbying actively with China to ensure quick clearances but it has not worked so far, he said. Any exports to China at this point of time is possible only if Beijing accepts certification by US Food and Drug Administration, which has approved a whole host of Indian drugs.

“As regards India benefiting because China has lifted import tariffs, I do not see it as a measure that is specifically favouring the Indian pharmaceutical products alone,” V Viswanath, a Beijing based senior consultant for Indian, Chinese as well as multi-national pharmaceutical firms told news agency PTI.

“This will benefit all imported products irrespective of which the country of origin is,” he said, highlighting the long drawn out struggle by Indian pharmaceutical firms to enter Chinese markets despite persistent campaign.

India has been asking China for long to open up its IT and pharmaceutical firms to reduce the trade deficit which has claimed to over $50 billion.

But ahead of Mr Luo’s announcement, China’s Cabinet or State Council on April 12 has approved a proposal that China will exempt import tariffs on all cancer drugs and encourage the import of more innovative drugs.

From May 1, import tariffs on all common drugs including cancer drugs, cancer alkaloid-based drugs, and imported traditional Chinese medicine will be exempted, state-run Xinhua news agency quoted an official statement as saying.


Beijing, May 13 (PTI) Chinas much-publicised announcement to slash tariffs on 28 medicines, including cancer drugs from India, has failed to create any buzz among the Indian pharmaceutical firms here as exports to China are possible only after lengthy field trials and approvals, which could take years, an official at an Indian firm has said.

On May 4, China, the second largest market for pharmaceuticals after the US, said it has removed import duties on as many as 28 medicines, including all cancer drugs, from May 1, a move which would help India to export these pharmaceuticals to the neighbouring country.

“China has exempted import tariffs (duties) for 28 drugs, including all cancer drugs, from May 1. Good news for Indias pharmaceutical industry and medicine export to China. I believe this will help reduce trade imbalance between China and India in the future,” Chinese Ambassador to India Luo Zhaohui said in a tweet.

Luo?s announcement generated optimism that Indias persistent demand from China to provide opening for Indian pharmaceutical firms to market their economically priced drugs compared to the multinational firms may be realised.

However, the official with the Indian pharmaceutical company said it is surprising to see the reports from the Indian media that the move to reduce tariffs will pave the way for exports of Indian pharmaceutical firms.

“For Indian pharmaceutical companies, it is not going to be much different as imports of Indian drugs both generic and anti-cancer is possible only with the approval of China Food and Drug Administration (CFDA),” the official told PTI on the condition of anonymity.

The announcement has not created any enthusiasm among the Indian firms as for both oral and injectable drugs a lengthy process of clearances is required in China which may take anywhere between two and half years to three years.

India has been lobbying actively with China to ensure quick clearances but it has not worked so far, he said. Any exports to China at this point of time is possible only if Beijing accepts certification by US Food and Drug Administration, which has approved a whole host of Indian drugs.

“As regards India benefiting because China has lifted import tariffs, I do not see it as a measure that is specifically favouring the Indian pharmaceutical products alone,” V Viswanath, a Beijing based senior consultant for Indian, Chinese as well as multi-national pharmaceutical firms told PTI.

“This will benefit all imported products irrespective of which the country of origin is,” he said, highlighting the long drawn out struggle by Indian pharmaceutical firms to enter Chinese markets despite persistent campaign.

India has been asking China for long to open up its IT and pharmaceutical firms to reduce the trade deficit which has claimed to over USD 50 billion.

But ahead of Luo?s announcement, China?s Cabinet or State Council on April 12 has approved a proposal that China will exempt import tariffs on all cancer drugs and encourage the import of more innovative drugs.

From May 1, import tariffs on all common drugs including cancer drugs, cancer alkaloid-based drugs, and imported traditional Chinese medicine will be exempted, state-run Xinhua news agency quoted an official statement as saying.

Value Added Tax in the production and import of drugs will drop by a large margin, it said.

The authorities will reduce the prices of cancer drugs through centralised government procurement and eliminate premium prices for drugs by means of cross-border e-commerce, it said.

Imported innovative drugs, especially much-needed cancer drugs, will be incorporated into the catalogue of medical insurance reimbursement, the statement said.

So as of now there is nothing specific for Indian pharmaceutical industry as such, the Indian pharma firm, the Indian pharma firm official said.

The move is aimed at reducing exorbitant costs of medicines in general and cancer drugs in particular by the multinational firms in China, he said.

The tariff reduction is also not going to amount much as it accounts to only about three to four percent, which is negligible, he said.

In fact, the reimbursement for cancer drugs by the provincial and central governments is aimed at prevailing on the innovator multinational companies to reduce their prices, which they will considering the size of the Chinese market, he said.

With reimbursement on cards the multinational companies are going to bring down their prices to cash in on the scheme, he said adding that this may even stop the rampant smuggling of Indian cancer drugs to China as prices will come down.

“Pharma companies in general and Indian Pharma companies in particular have struggled to get their products approved by the China Food and Drug Administration (CFDA) which is the first step in commercialisation of products. Pharmaceuticals can only be imported and sold in China if they are registered with CFDA,” Viswanath said.

The announcement by China to import Indian drugs need to be “followed up with a more specific bilateral arrangement between China and India”, he said.

This is necessary as quality pharmaceutical products which are at very affordable prices are given fast-track approvals in CFDA.

India plans measures to facilitate drug exports to abroad

India plans measures to facilitate drug exports


The Central Drugs Standard Control Organisation (CDSCO), the apex regulatory authority that oversees the manufacture and sale of medicines in the country, has proposed a self declaration mechanism for pharmaceutical manufacturers for updation of information about the products they manufacture from their registered production centres. This information will then be verified by the State Licensing Authority.

The move is part of a series of industry friendly measures being planned by the apex regulator.

According to the proposal, the drug manufacturers licensed to manufacture in the country will be asked to upload the details of their manufacturing licences along with the list of the products permitted under such licences on an online data base developed by the government. The comprehensive database, termed “SUGAM”, will have the details of all the licenses issued by various state food and drug authorities (FDA) including the details of manufacturing sites, and approved products.

The CDSCO has created accounts on SUGAM for each state and is in the process of getting such accounts activated to facilitate the updation of the information.

The regulator is also exploring the possibility of relaxing the need for a no-objection-certificate (NOC) from CDSCO to manufacture and export drugs that are otherwise not approved for domestic use. At the moment, India’s drug law – the Drugs and Cosmetics Rules, 1945 – does not allow states to give manufacturing licenses for export of medicines that are not allowed to be sold in the country, without an NOC from CDSCO. The industry has been complaining that the need for such limited, export specific permissions, for manufacture of such drugs cause delay in executing export orders.

An apex drug advisory committee called “the Drugs Consultative Committee”, which draws members from the Centre and all the State Governments, is currently looking at these proposals to bring in uniformity in the administration of India’s drug regulations.

The suggestions of CDSCO are expected to streamline the process and facilitate the ease of doing business in the pharmaceutical sector, one of the most promising sectors where India has immense export growth potential.

According to the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL), India’s pharmaceutical exports stood at $16.8 billion in 2016-17 and are expected to grow by 30 per cent, over the next three years, to reach US$ 20 billion by 2020. During April 2017- January 2018, India exported pharmaceutical items worth $10.76 billion.

India Brand Equity Foundation estimates that India accounts for 3.1-3.6 per cent of the global pharmaceutical industry in value terms and 10 per cent in volume terms. It is expected to grow to $100 billion by 2025. The market is expected to grow to $55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size. Branded generics dominate the pharmaceuticals market, constituting nearly 80 per cent of the market share (in terms of revenues). (link)

‘ISIS drug’ Tramadol

‘ISIS drug’ Tramadol comes under narcotics law regulation


NEW DELHI: Tramadol, a painkiller pharma drug, has been declared a “psychotropic substance” by the Union government and its sale in the country will now be strictly monitored after the NCB said it was being internationally smuggled, and had possible supply links to the global terror group ISIS.

The Union Finance Ministry, as per data accessed by PTI, has brought the drug under the control of the Narcotic Drugs and Psychotropic Substances (NDPS) Act and a gazette notification to this effect was issued on April 26  2018.

The Finance Ministry regulates certain sections of the NDPS Act like categorisation of pharma drugs as narcotic substances.
The synthetic opiate is known to be abused on a wide scale by terrorists of the so-called ISIS to suppress pain and boost strength during injury and hence, is also known as the ‘fighter drug’ among international anti-narcotics authorities.

The Narcotics Control Bureau (NCB), a national agency to coordinate drug law enforcement action by involving various state agencies, police and central departments, had asked the government in July last year to bring this drug under its “regulation and control” so that it could only be used for medicinal purposes and its abuse be checked.

“Tramadol, after the notification issued by the Department of Revenue under the Union Finance Ministry, will no longer be available freely over the counter in India.

“It will be regulated under the NDPS Act, which will empower the NCB and other law enforcement agencies to raid and prosecute those who prepare it without permission,” a senior official in the anti-narcotics establishment said.

The latest notification will ensure that the availability of Tramadol is substantially reduced and regulated, and agencies like the NCB and police are able to keep a tab on its movement. PTI had first reported on March 26 that the NCB has sought bringing Tramadol under the NDPS Act after it detected that it was being “diverted” illegally.
“Tramadol is used like codeine (another pharma drug). It is not covered under the NDPS Act, 1985. It is a schedule ‘H’ drug under the Drugs and Cosmetics Act, 1940 and can only be dispensed under the prescription of a registered medical practitioner.

“lt is also not included in any of the schedules of the 1971 UN convention on psychotropic substances. Internationally, it is banned in many countries and hence is often smuggled through India,” the NCB had said in its latest report released in March.

The drug, the NCB had said, “is trafficked via courier and manual means to countries like the US and Canada among others.”
The NCB gave out these details on Tramadol while reporting on the ongoing and emerging trends of drug abuse in the country in the last year by “diversion” of pharma drugs and hence sought its regulation.
Official records state that huge quantities of Tramadol were seized in the country last year, including in July when over 30,000 tablets of Tramadol Hydrochloride were seized from the cargo terminal of the Indira Gandhi lnternational Airport (IGI) along with other pharma drugs.

In another instance, in October last year, the NCB seized 710 tablets of Tramadol from the house of a Lucknow-based medicine supplier. These were supposed to be illegally dispatched to the United States of America (USA).  source


 

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Mesterolone is a synthetic anabolic-androgenic steroid (AAS) and derivative of dihydrotestosterone (DHT). It is inactivated by 3α-hydroxysteroid dehydrogenase in skeleta muscules so it is considered a weak androgen. It is not a substrate for aromatase so it is not converted into estrogen. Mesterolone demonstrated to have minimal effect on sperm counts and levels of FSH or LH. Experiments of mesterolone serving as a potential treatment of depression are still undergoing. 


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Unlike many other steroids, this one is taken orally and is commonly used to treat deficiency of male sex hormones. We’ll go into the uses for Mesterolone below. Before that though, let’s take a quick look at how it works.

The belief that the weak anabolic nature of this compound indicates a tendency to block the androgen receptor in muscle tissue, thereby reducing the gains of other more potent muscle-building steroids, should likewise not be taken seriously. In fact, due to its extremely high affinity for plasma binding proteins such as SHBG, mesterolone may actually work to potentate the activity of other steroids by displacing a higher percentage into a free, unbound state. Among athletes, mesterolone is primarily used to increase androgen levels when dieting or preparing for a contest, and as an anti-estrogen due to its intrinsic ability to antagonize the aromatase enzyme.

Dosage can vary between 50 to 150 mg depending on need and goals. Since it is more androgenic rather than anabolic, this steroid works by increasing androgen receptors in the body. What this means is that it won’t actively increase or affect production or testosterone levels but it will help with male sex traits and to a large extent reduce the production in estrogen which often causes the main side effects of many steroids.

 

Some negative side effects of Generic Proviron 25mg include:

  • Suppression of testosterone
  • Increased levels of bad cholesterol – this means increased risk of heart problems
  • Acne
  • Excessive growth of hair
  • Issues with high blood pressure

 

 

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In the late 80’s, steroid guru Dan Duchaine speculated that nolvadex could be used to help with gynecomastia (bitch tits). Since that time, it has become popular as anti-gynecomastia treatmentand for on-cycle use in guys who are gyno prone.


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When gyno prone anabolic steroid users run aromatising compounds, such as testosterone or dianabol, they convert to estrogen. This can lead to puffy nipples, bloating, blood pressure, erectile dysfunction (ED) and other estrogen related sides. Nolvadex can prevent some estrogen-related side effects from occurring, and it can halt the growth of gynecomastia. However, in my opinion, using an AI is much more effective for overall estrogen control.

In practice, tamoxifen is best used to help boost LH and total testosterone. This will help you recover from a cycle, which makes it a popular choice for post cycle therapy (PCT). A clomiphene, tamoxifen combination is one of the best recovery options for most PCT regiments.

 

Dosages for PCT: 10-40mgs ED or EOD

Dosages for gynecomastia treatment: 20-80mgs ED

*ED = every day *EOD = every other day

Some users swear by nolvadex, others prefer clomid during pct. Some users complain about reduced libido, others say it increases libido. I believe the negativity with tamoxifen is due to improper dosing protocols – mainly over-dosing with high dosages.

You should start with 10-20mg every other day at the most, and see how the dosage works for you. Make sure to run it as a part of a complete post cycle therapy.

There is evidence that Nolvadex up-regulates progestin receptors. This means if you run tamoxifen along with a progestin, such as any type of nandrolone or trenbolone, you run a higher chance of developing progestin related side effects. This has some ongoing debate in both the medical and bodybuilding community. Therefore, to be on the safe side, don’t use it with progestins.

 

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Clomid (Clomiphene Citrate) is a powerfully effective anti-estrogen officially classified as a Selective Estrogen Receptor Modulator (SERM). In many ways, it is very similar to another popular SERM in Nolvadex(Tamoxifen Citrate). Clomid first gained worldwide attention in the early 1970’s as a strong fertility aid and is still used for that purpose today. It is also one of the most commonly used SERM’s by anabolic steroid users. No, it is not an anabolic steroid but can be used to combat estrogenic side effects sometimes caused by anabolic steroids. It can also be used as a Post Cycle Therapy (PCT) medication in order to stimulate suppressed testosterone production due to anabolic steroid use. PCT use of Clomid is the most common purpose and most beneficial point of use for the anabolic steroid user.

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To understand how Clomid can aid this process, let’s look at how natural testosterone production is regulated.

Testosterone production is regulated by a feedback loop which senses not only testosterone or other androgen levels, but also estrogen levels. This feedback loop includes the hypothalamus, the pituitary, and the testes (often referred to as the HPTA, or hypothalamic-pituitary-testicular axis.)

When the hypothalamus senses low estrogen levels and does not sense high androgen levels, it’s stimulated to signal the pituitary by producing more LHRH, which stands for LH releasing hormone. On receiving this signal, the pituitary produces more LH (luteinizing hormone) which in turn signals the testes to produce more testosterone.

The common dosage for Clomid is 300mg for day 1; 100mg per day for days 2-11; and 50mg/day for days 12-21. However for nonmedical purposes, the suggested dose of the drug is 50-100 mg/day for 4-6 weeks.

Clomid ordinarily is dosed at 50 mg/day. However, it’s important to note that clomiphene has a long half life. Where this has relevance is that when a daily dose is taken, the body will have not only that dose in it, but also an accumulated amount of about five days’ worth of previous doses as well. That’s fine: it results in correct blood levels. Where there can be a problem is when first starting use. If simply taking 50 mg/day from the beginning, there is no such buildup and levels will be low.

To account for this, 300 mg is taken on the first day, as three doses of 100 mg, or optionally six doses of 50 mg. This immediately gets levels to where they should be. Ongoing 50 mg/day dosing will maintain this level.

After day 1, doses of more than 50 mg are not needed and are not recommended. They will not improve results, but may increase adverse side effects.

 

Clomid is one of the most well-tolerated SERM’s and anti-estrogens on the market, and this applies to both men and women. While it carries a very high threshold of toleration, side effects of Clomid do exist and are possible. However, “possible” is the key word and a very important one. Anytime anabolic steroids are discussed as well as non-steroidal items used by anabolic steroid users, many seem to enjoy implying side effects are assured. This is not the case; in fact, most should be able to use Clomid side effect free.

When it comes to the possible side effects of Clomid, we will find most are fairly rare. Some women who have used the SERM as a fertility aid have experienced ovarian enlargement, but again this is very rare. Other possible side effects of Clomid use include:

  • Headaches
  • Nausea
  • Hot Flashes
  • Uterine Bleeding (extremely rare)
  • Breast Discomfort

 

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Active substance Testosterone Undecanoate
US Brand Nebido
IN Brand Cernos Depot
Made by Sunpharma
Strength 1000mg/4ml per one vial
Form release 1 ampoule
Shipping time 7 – 18 days
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DescriptionDosageSide Effects

Each mL solution for injection contains testosterone undecanoate 250 mg corresponding to testosterone 157.9 mg.
Each ampoule with 4 mL solution for injection contains testosterone undecanoate 1000 mg.
It also contains benzyl benzoate and refined castor oil as excipients.


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Testosterone undecanoate is an ester of the naturally occurring androgen, testosterone. The active form, testosterone, is formed by cleavage of the side chain.
Testosterone is the most important androgen of the male, mainly synthesized in the testicles, and to a small extent in the adrenal cortex.
Testosterone is responsible for the expression of masculine characteristics during fetal, early childhood, and pubertal development and thereafter for maintaining the masculine phenotype and androgen-dependent functions (eg, spermatogenesis, accessory sexual glands). It also performs functions eg, in the skin, muscles, skeleton, kidney, liver, bone marrow and CNS.
Dependent on the target organ, the spectrum of activities of testosterone is mainly androgenic (eg, prostate, seminal vesicles, epididymis) or protein-anabolic (muscle, bone, hematopoiesis, kidney, liver).
The effects of testosterone in some organs arise after peripheral conversion of testosterone to estradiol, which then binds to estrogen receptors in the target cell nucleus eg, the pituitary, fat, brain, bone, and testicular Leydig cells.

One ampoule / vial of Cernos Depot or Generic Nebido (corresponding to 1000 mg testosterone undecanoate) is injected every 10 to 14 weeks. Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation.

Start of treatment

Serum testosterone levels should be measured before start and during initiation of treatment. Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance. With this loading dose, sufficient steady state testosterone levels may be achieved more rapidly.

Maintenance and individualisation of treatment

The injection interval should be within the recommended range of 10 to 14 weeks. Careful monitoring of serum testosterone levels is required during maintenance of treatment. It is advisable to measure testosterone serum levels regularly. Measurements should be performed at the end of an injection interval and clinical symptoms considered. These serum levels should be within the lower third of the normal range. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered.

For intramuscular use.

The injections must be administered very slowly (over two minutes). Nebido is strictly for intramuscular injection. Care should be taken to inject Nebido deeply into the gluteal muscle following the usual precautions for intramuscular administration. Special care must be taken to avoid intravasal injection (see section 4.4 under “Application”). The contents of an ampoule / vial are to be injected intramuscularly immediately after opening. (For the ampoule see section 6.6 for instructions on opening the ampoule safely).

 

The most frequently observed adverse reaction was injection site pain (10%).

The following adverse reactions were reported in clinical trials with a suspected relationship to Nebido (according to the HARTS Body System and Dictionary Term system):

Common* (>1/100, <1/10): Digestive: Diarrhea. Musculoskeletal System: Leg pain, arthralgia. Nervous System: Dizziness, increased sweating, headache. Respiratory System: Respiratory disorder. Skin and Appendages: Acne, breast pain, gynecomastia, pruritus, skin disorder. Urogenital:Testicular pain, prostate disorder. General

Disorders and Administration Site Conditions:

Subcutaneous hematoma at the injection site.
*Due to the small sample size of the studies, the frequency of each reported adverse event with a suggested causal relationship falls at least into the category common (>1/100).
In the literature, the following adverse reactions from testosterone-containing preparations have been reported:
Blood and the Lymphatic System Disorders: Rare cases of polycythemia (erythrocytosis).

Metabolism and Nutrition Disorders:

Weight gain, electrolyte changes (retention of sodium, chloride, potassium, calcium, inorganic phosphate and water) during high dose and/or prolonged treatment.

Musculoskeletal System: 

  • Muscle cramps.

Nervous System: 

  • Nervousness,
  • Hostility,
  • Depression.
  • Sleep apnea.

Hepatobiliary Disorders: 

In very rare cases, jaundice and liver function test abnormalities.

Skin and Appendages: 

Various skin reactions may occur including acne, seborrhea and balding (alopecia).

Reproductive System and Breast Disorders: 

Libido changes, increased frequency of erections; therapy with high doses of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles; testosterone replacement therapy of hypogonadism can, in rare cases, cause persistent, painful erections (priapism), prostate abnormalities, prostate cancer**, urinary obstruction.

General Disorders and Administration Site Conditions: 

High-dose or long-term administration of testosterone occasionally increases the occurrences of water retention and edema; hypersensitivity reactions may occur.

 

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Active substance Testosterone Enanthate
US Brand Delatestryl
IN Brand Testenate Depot
Made by Searle
Strength 250mg per one vial
Form release 1 ampoule with syringle
Shipping time 7 – 18 days
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DescriptionDosageSide Effects

Testosterone Enanthate Injection, USP is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.

Primary hypogonadism (congenital or acquired) – Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.

Hypogonadotropic hypogonadism (congenital or acquired) – Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.)

If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.

Testosterone Enanthate Injection, USP may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date.

Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers.

It is popular for testosterone enanthate to be injected bi-weekly (twice a week) in order to keep concentrations as stable as possible. Common dose of 500mg enables a user to split 250mg injections on, for example, a Monday and a Thursday, with the common concentration products being 250mg/ml, therefore 1ml injected each time.

Testosterone enanthate anabolic steroid cycles
Novice user’s cycle

250mg-500mg of testosterone enanthate per week for 10 weeks. Start PCT 14 days after last injection

Most products will be 250mg/ml. If taking 250mg per week this will result in one ml injection once a week. If taking 500mg per week we will want to inject on a bi-weekly basis, so one injection on Monday and another on the Thursday, for example.

Intermediate user’s cycle

500mg-1000mg of testosterone enanthate per week for 10+ weeks. Likely to be stacked with other anabolic steroids, and is often used as the base compound.

Advanced user’s cycle

750mg + of testosterone enanthate per week for 10+ weeks. Likely to be stacked with many other anabolic steroids, such as dianabol, trenbolone, deca etc.

For males only

  • Blistering of skin under patch (especially when the nonscrotal patch is applied to bony areas of the skin)
  • breast soreness or enlargement
  • frequent or continuing erection of penis lasting up to 4 hours or painful penile erections lasting longer than 4 hours
  • frequent urge to urinate
  • itching or redness of skin under patch (less likely with nonscrotal patch) or at site of implants, mild to severe

For prepubertal boys only

  • Acne
  • early growth of pubic hair
  • enlargement of penis
  • frequent or continuing erections

 

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Active substance Testosterone USP 1%
US Brand Androgel
IN Brand Cernos Gel | TestoHeal
Made by Sun Pharma | Healing Pharma
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DescriptionDosageSide Effects

Cernos Gel or TestoHeal, is a containing testosterone. It is administered through the skin for treatment of low testosterone levels. It belongs to a class of drugs called androgens.  Testosterone is the major male sex hormone responsible for the normal growth and development of the male sex organs and secondary sex characteristics.

These effects include development of the prostate, penis, and scrotum; distribution of facial, pubic, chest and axillary hair; development of a deep voice and alterations in muscle mass and fat distribution.

Low production of testosterone leads to erectile dysfunction, reduced sexual desire, fatigue and loss of energy, depression, regression of secondary sexual characteristics, and weakening of bones (osteoporosis).

Androgel and other testosterone replacement products supplement or replace natural production of testosterone and reverse symptoms of low testosterone levels.

Testosterone Gel, is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

  • Primary Hypogonadism (Congenital or Acquired) – testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range.
  • Hypogonadotropic Hypogonadism (Congenital or Acquired) – idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.
DOSAGE AND ADMINISTRATION
  • Recommended starting dose: 5 g for adult males, applied topically once daily.
  • Apply to clean, dry, intact skin of shoulders and upper arms and/or abdomen. Do NOT apply AndroGel to the genitals.
  • Dose adjustment for adult males: If serum testosterone level is below the normal range, adjust dose from 5 g to 7.5 g and from 7.5 g to 10 g.

DOSAGE FORMS AND STRENGTHS

India Testosterone gel 1% for topical use is available as:

  •  5 g packet

CONTRAINDICATIONS
  • Men with carcinoma of the breast or known or suspected prostate cancer.
  • Pregnant or breast feeding women. Testosterone may cause fetal harm.

Most common adverse reactions (incidence ≥ 5%) are acne, application site reaction, abnormal lab tests, and prostatic disorders.

Cases of testosterone secondary exposure resulting in virilization of children have been reported. Reported signs and symptoms have included enlargement of the penis or clitoris, premature development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the exposure to testosterone gel. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size and bone age remained modestly greater than chronological age.

 

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Active substance Armodafinil
US Brand Nuvigil
IN Brand Waklert
Made by Sun Pharma
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DescriptionDosageSide Effects

GENERIC NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy and shift work disorder.


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Armodafinil is used to help people who have narcolepsy, obstructive sleep apnea (also called hypopnea syndrome), or shift work sleep disorders to stay awake during the day. This medicine does not cure these conditions and will only work as long as you continue to take it.

Armodafinil is the R-enantiomer of the racemic synthetic agent modafinil with central nervous system (CNS) stimulant and wakefulness-promoting activities. Although the exact mechanism of action has yet to be fully elucidated, armodafinil appears to inhibit the reuptake of dopamine by binding to the dopamine-reuptake pump, which leads to an increase in extracellular dopamine levels in some brain regions. This agent does not bind to or inhibit several receptors and enzymes that may be involved in sleep/wake regulation and is not a direct- or indirect-acting dopamine receptor agonist. Armodafinil has a longer half-life than modafinil.


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Armodafinil is not a direct- or indirect-acting dopamine receptor agonist. However, in vitro,both armodafinil and modafinil bind to the dopamine transporter and inhibit dopamine reuptake.For modafinil, this activity has been associated in vivo with increased extracellular dopamine levels in some brain regions of animals. In genetically engineered mice lacking the dopaminetransporter (DAT), modafinil lacked wake-promoting activity, suggesting that this activity was DAT-dependent. However, the wake-promoting effects of modafinil, unlike those of amphetamine, were not antagonized by the dopamine receptor antagonist haloperidol in rats. In addition, alpha-methyl-p-tyrosine, a dopamine synthesis inhibitor, blocks the action of amphetamine, but does not block locomotor activity induced by modafinil.


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Armodafinil and modafinil have wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although their pharmacologic profile is not identical to that of the sympathomimetic amines. In addition to its wake-promoting effects and ability to increase locomotor activity in animals, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants in humans. Modafinil has reinforcing properties, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine; modafinil was also partially discriminated as stimulant-like. Based on nonclinical studies, two major metabolites, acid and sulfone, of modafinil or armodafinil, do not appear to contribute to the CNS-activating properties of the parent compounds.


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The recommended dose of NUVIGIL for patients with OSA or narcolepsy is 150 mg or 250 mg given as a single dose in the morning. In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent
evidence that this dose confers additional benefit beyond that of the 150 mg/day dose.

Shift Work Disorder (SWD)

The recommended dose of NUVIGIL for patients with SWD is 150 mg given daily approximately 1 hour prior to the start of their work shift. Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4/5, such as steroidal contraceptives, triazolam, and cyclosporine.
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, and phenytoin may have prolonged elimination upon coadministration with

 

Less common

  1. Blistering, burning, crusting, dryness, or flaking of the skin
  2. burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  3. difficult or labored breathing
  4. fast, irregular, pounding, or racing heartbeat or pulse
  5. fever
  6. frequent urination
  7. headache, severe and throbbing
  8. increased volume of pale, dilute urine
  9. itching, scaling, severe redness, soreness, or swelling of the skin
  10. rash
  11. shakiness in the legs, arms, hands, or feet
  12. shortness of breath
  13. tightness in the chest
  14. trembling or shaking of the hands or feet
  15. wheezing

 

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Active substance Modafinil
US Brand Provigil
IN Brand Modalert | Modvigil
Made by Sun Pharma | HAB Pharma
Strength 200mg
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DescriptionDosageSide Effects

Generic Modafinil 200mg used to treat narcolepsy are targeted toward alleviating symptoms such as excessive sleepiness and cataplexy. The cause of this neurological sleep disorder is still not completely clear, though a destruction of hypocretin/orexin neurons has been implicated. The destruction of these neurons is linked to inactivity of neurotransmitters including histamine, norepinephrine, acetylcholine, and serotonin, causing a disturbance in the sleep/wake cycles of narcoleptic patients. Buy Generic Modafinil, from our company wich based in India, Generic Provigil, can be shipped to UK, USA, AU, under generic brands names Modalert, Modvigil it’s bestsellers, with different prices. You can receive prices via contact form.


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Modafinil is a stimulant drug marketed as a ‘wakefulness promoting agent’ and is one of the stimulants used in the treatment of narcolepsy. Narcolepsy is caused by dysfunction of a family of wakefulness-promoting and sleep-suppressing peptides, the orexins, whose neurons are activated by modafinil. The prexin neuron activation is associated with psychoactivation and euphoria. The exact mechanism of action is unclear, although in vitro studies have shown it to inhibit the reuptake of dopamine by binding to the dopamine reuptake pump, and lead to an increase in extracellular dopamine. Modafinil activates glutamatergic circuits while inhibiting GABA.


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 Modafinil is a synthetic molecule of the benzhydryl class. Benzhydryl compounds are comprised of two benzene rings attached to a single carbon molecule. Modafinil is classified as a sulphinyl benzhydryl molecule, as it also contains a sulphinyl group, a sulphur molecule double-bonded to an oxygen molecule, attached to the carbon of the benzhydryl group. From this sulphur group at R2, an acetamide group is bound at its free carbon through a carbonyl group to a terminal amine group. Modafinil is structurally analogous to fluorafinil, another benzhydryl stimulant.

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For narcolepsy or obstructive sleep apnea/hypopnea syndrome:
      • Adults and teenagers 17 years of age and older—200 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed.
      • Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor.
    • For shift work sleep disorder:
      • Adults and teenagers 17 years of age and older—200 milligrams (mg) one hour before you begin working.
      • Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of modafinil and you remember it before 12:00 noon the same day, take the missed dose as soon as possible.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Less common

  1. Black, tarry stools
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  3. chest pain
  4. chills or fever
  5. clumsiness or unsteadiness
  6. confusion
  7. dizziness or fainting
  8. increased thirst and urination
  9. mental depression
  10. problems with memory
  11. rapidly changing moods
  12. shortness of breath
  13. sore throat
  14. trembling or shaking
  15. trouble in urinating
  16. uncontrolled movements of the face, mouth, or tongue
  17. unusual bleeding or bruising
  18. unusual tiredness or weakness

 

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Active substance Sumatriptan
US Brand Imitrex
IN Brand Suminat
Made by Sun Pharma
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DescriptionDosageSide Effects

Sumatriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea or sensitivity to sound and light). Sumatriptan is in a class of medications called selective serotonin receptor agonists.

 

It works by narrowing blood vessels in the head, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Sumatriptan does not prevent migraine attacks or reduce the number of headaches you have.


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Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Sumatriptan Tablets are believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound.

 

Migraine Headache

Tablet

  • 25 mg, 50 mg, or 100 mg orally (taken with fluids)
  • Not to exceed 100 mg/dose; additional doses every 2 hours as needed
  • Recommended maximum dose: 200 mg/day

Sumatriptan comes as a tablet to take by mouth. It is usually taken at the first sign of a migraine headache.If your symptoms improve after you take sumatriptan but return after 2 hours or longer, you may take a second tablet. However, if your symptoms do not improve after you take sumitriptan, do not take a second tablet without calling your doctor. Your doctor will tell you the maximum number of tablets you may take in a 24-hour period.Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sumatriptan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Sumatriptan tablets: The maximum single recommended adult dose is 100 mg. The maximum recommended adult dose that may be given in 24 hours is 200 mg, given in two doses separated by at least two hours.

The safety of treating an average of more than 4 migraine headaches in a 30-day period with Sumatriptan has not been established. Most people using these medications for migraine treatment do not need quantities in amounts exceeding that necessary to treat a maximum of 4 migraine attacks in a 30-day period. For this reason, the benefit plan provides coverage only for amounts up to those listed. Members may obtain a combination of dosage forms, although quantity limits apply and total mg amount per 30 days may not exceed 900 mg of tablet equivalent.

 

  • flushing
  • tingling feeling
  • feeling warm or cold
  • drowsiness
  • tiredness
  • weakness
  • dizziness
  • upset stomach
  • diarrhea
  • nausea
  • muscle cramps

 

 

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Active substance Tizanidine
US Brand Zanaflex
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DescriptionDosageSide Effects

Tizanidine (tye zan’ i deen) is an imidazoline derivative and is a centrally acting muscle relaxant used for therapy of acute muscle spasms and chronic spasticity.  The mechanism by which tizanidine causes skeletal muscle relaxation is not well known; it appears to act at the level of spinal cord pain reflexes, most likely through activity as a central alpha-adrenergic agonist which results in an decrease in activity of motor neurons.  Tizanidine was approved for use in the United States in 1996 and currently several million prescriptions are filled yearly.


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Tizanidine is a commonly used muscle relaxant that has been linked to rare instances of acute liver injury, a few of which have been fatal.

Tizanidine is a short-acting muscle relaxer. It works by blocking nerve impulses (pain sensations) that are sent to your brain.

Tizanidine is used to treat spasticity by temporarily relaxing muscle tone.

Tizanidine may also be used for purposes other than those listed in this medication guide.

Tizanidine is used to help relax certain muscles in your body. It relieves spasms, cramping, and tightness of the muscles caused by medical problems, such as multiple sclerosis or certain injuries to the spine.

Generic Zanaflex does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.

Generic Tizanidine acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of the medicine’s side effects.

 

Muscle Spasticity

Spasticity associated with multiple sclerosis and spinal cord injury

Initial: 2 mg PO q6-8hr PRN; no more than 3 doses q24hr

Maintenance: Titrate in 2-4 mg/day increments to optimum effect with minimum 1-4 days between dose increments

Not to exceed 36 mg/day; single doses >16 mg not studied

To discontinue taper gradually; decrease by 2-4 mg daily

 

  • feeling light-headed, fainting, slow heart rate;
  • hallucinations, confusion, unusual thoughts or behavior;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • burning or pain when you urinate.

 

 

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Active substance Agomelatine
US Brand Valdoxan
IN Brand Noveltin
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DescriptionDosageSide EffectsHealth Benefits of Agomelatine

Depression is common. Symptoms can affect day-to-day life and can become very distressing. Treatments include talking (psychological) treatments and antidepressant medicines.

Our bodies have a number of important physical and behavioural processes which are controlled by the cycling of day and night. These are called circadian rhythms and, if disrupted, can result in depression. Agomelatine relieves depression by helping to restore the balance of these biological rhythms.

Agomelatine (Valdoxan) is an atypical antidepressant drug developed on the basis that abnormal circadian rhythm causes depression.


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While most other (typical) antidepressant drugs are selective serotonin reuptake inhibitors (SSRIs) that seek to increase serotonin in the brain, agomelatine activates melatonin (MT1 and MT2) receptors and blocks the 5-HT2C serotonin receptors.

Presently, agomelatine is approved in the European Union for the treatment of major depression.

In the United States, it is presently under a phase 3 trial for regulatory approval by the FDA, so it is considered a dietary supplement and doctors in the US do not prescribe agomelatine.

Depression is a disorder of the limbic system (part of the brain that controls emotions and memory) that is categorized by abnormalities in:

  • The stress responses or HPA Axis Dysfunction. Many depressed patients have elevated CRH and cortisol, but are cortisol resistant because they have reduced cortisol receptors in the brain.
  • Circadian rhythm. Many depressed patients have a phase shift in their circadian rhythms, so they stay up later and wake up later.
  • Sleep habits and sleep cycles. Depression has a high correlation with sleep disorders such as insomnia.
  • Inflammation in the brain and the gut. This causes sickness behavior (like chronic fatigue in humans) and also affects tryptophan and serotonin energy production.
  • Reduced BDNF levels.

We think agomelatine is relevant for many SelfHacked readers and clients because, even though you are not diagnosed with depression, you likely suffer from one or a few such abnormalities.

How Agomelatine Works

Mode of action of agomelatine. Source: http://onlinelibrary.wiley.com/doi/10.1002/pnp.123/full

Unlike other antidepressants, agomelatine helps with several aspects of depression physiology as listed above, including:

  • Restoring normal circadian rhythm, just as melatonin would
  • Reducing cortisol
  • Increasing BDNF
  • Improving sleep quality
  • Reducing inflammation in the brain due to lipopolysaccharides (a model of leaky gut) in rats

Although agomelatine is molecularly very similar to melatonin, it is more potent than melatonin because of the longer half-life.


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Agomelatine has a half-life of 2.3 hours, while melatonin has a half-life of 50 minutes. Agomelatine also binds more strongly to melatonin receptors than does melatonin itself.

By blocking 5-HT2c receptors on dopaminergic and noradrenergic neurons, agomelatine elevates dopamine and norepinephrine levels in the brain (prefrontal cortex, but not limbic system), proving beneficial to both nootropic cognitive enhancement and treatment of depression.

Pharmaceutical agomelatine is prescribed (as Valdoxan) in 25 mg tablets, typically taken once daily at bedtime. Dosage may be adjusted to 50 mg (2 x 25 mg tablets) taken at bedtime, if agomelatine treatment has no effect after two weeks.

Antidepressant treatment using agomelatine typically lasts at least six months.

Agomelatine should not be used by elderly people (75+ years).

Common agomelatine side-effects (these affect less than 1 in 10 people)
What can I do if I experience this?
Feeling sick (nausea), diarrhoea Stick to simple foods (avoid fatty or spicy meals) and drink plenty of water
Feeling dizzy, tired or sleepy Do not drive or use tools or machines. Do not drink alcohol
Headache Ask your pharmacist to recommend a suitable painkiller. If the headache continues, speak with your doctor
Constipation, tummy (abdominal) pain Try to eat a well-balanced diet containing fresh fruit and vegetables. Drink plenty of water
Difficulty sleeping, feeling anxious, increased sweating, back pain These effects are usually mild and soon pass but if any become troublesome, speak with your doctor
Agomelatine Helps Treat Mood Disorders by Restoring Normal Circadian Rhythm

By stimulating melatonin receptors, agomelatine can resynchronize circadian rhythm with the external environment. In animal studies, agomelatine restored dysfunctional sleep/wake cycles, represented by enhanced duration of REM and slow-wave sleep after acute oral administration.

A combination of circadian rhythm restoration and selective serotonin blockers makes agomelatine a worthy treatment for mood and sleep disorders.

Agomelatine Protects the Brain by Increasing BDNF

Hippocampal BDNF enhances synaptic plasticity, which improves the brain’s ability to learn, store, and access new information.

Agomelatine increases BDNF levels in the hippocampus, thereby enhancing the survival of existing neurons and synapses, as well as the growth and production of newly generated ones.

Elevated BDNF helps prevent stress-induced impairment of visual memory and spatial learning. For this reason, agomelatine treatment may influence long-term behavioral response to stress, which can help mitigate symptoms of mood disorders and physiologically enhance the brain’s ability to cope with stressful situations.

Agomelatine also increases CREB (cAMP response element-binding protein), which helps prevent the degenerative effect of environmental stressors on the hippocampus. This neuroprotective property may contribute to agomelatine efficacy for treating mood disorders related to stress-induced deterioration of memory and mood.

Agomelatine Increases Neurotransmitter Release

By blocking the serotonergic receptor 5HT-2c, agomelatine increases norepinephrine and dopamine release, which enhances daytime motivation and helps combat the physical and mental effects of mood disorders.

Some aspects of agomelatine antidepressant characteristics may also be attributed to these pro-cognitive or nootropic benefits.

Agomelatine Reduces Anxiety Symptoms

Agomelatine may be used as an adjunctive treatment for depression-related anxiety symptoms. In clinical studies, agomelatine demonstrated the ability to improve anxiety symptoms within major depression, proving superior to both placebo and comparable depression medication.

Agomelatine may also treat generalized anxiety disorders (those not linked to depression).

In a study involving over 400 patients over the course of 12 weeks, agomelatine was shown to be as effective as escitalopram in mitigating anxiety symptoms and had less adverse effects as a result of its novel mechanism of action.

Agomelatine Helps with Neuropathic Pain

Due to the neurological causes of neuropathy, antidepressants (not painkillers) are among the go-to treatments for otherwise treatment-resistant neuropathic pain. Melatonin, serotonin, and norepinephrine play a major role in neuropathic pain disorders.

Melatonin reduces pain by simultaneously stimulating melatonin receptors and blocking specific serotonin receptors in rodents.

Agomelatine also reduced symptoms of pain hypersensitivity and abnormal pain sensation (from touch and temperature) in diabetic rats. Agomelatine ultimately restored pain sensitivity and response in the diabetic rats to the levels of non-diabetic control rats.

Agomelatine may even treat neuropathic pain in fibromyalgia cases that have previously been unresponsive to medical treatment, due to its blocking of serotonergic receptor 5HT-2C.

Agomelatine Improves Bone Health and Muscle Strength

Inflammatory cytokines are produced by cells to initiate localized inflammation and immune responses and maintain bone balance.

Uncontrolled amounts of inflammatory cytokines impair generation of important bone cells called osteoblasts and osteoclasts, which are involved in bone restoration and maintenance.

High amounts of IL-1β, IL-6, and TNF-α may even weaken bones and ultimately lead to osteoporosis, arthritis, bone erosion, cartilage degradation, and even gum disease.

Agomelatine reduces the levels of proinflammatory cytokines TNF-α, IL-1β, and IL-6.

By suppressing these potentially harmful cytokines, agomelatine helps keep bones healthy and prevents loss of bone density.

Agomelatine consistently raises both IGF-1 and growth hormone levels by stimulating melatonin receptors, which regulate hormone secretion during sleep. This is beneficial not only to healthy bone development, but also for prevention of bone loss and muscle atrophy.

By increasing IGF-1 and growth hormone secretion, while simultaneously reducing catabolic proinflammatory cytokines, agomelatine may even enhance muscle strength. Rodents treated with agomelatine showed an increase in muscle strength and density after five weeks of treatment.

Agomelatine Protects Mitochondria from Oxidative Stress

Agomelatine offers similar antioxidant and mitochondrial benefits due to its chemical similarity to melatonin. It also has a longer half-life, better oral bioavailability, and higher affinity for melatonergic receptors than melatonin itself.

Agomelatine’s potent antioxidant properties enhance natural elimination of 3-nitropropionic acid (3-NPA), a dangerous mitochondrial toxin that causes neuromuscular disorders.

3-NPA toxicity usually occurs as a result of prolonged ingestion of slightly moldy crops (like sugarcane or peanuts). 3-NPA causes health problems such as weight loss, motor impairment, and learning-memory deficits.

Agomelatine Reduces Inflammation from Leaky Gut

Lipopolysaccharides (LPS) is a bacterial toxin that can leak into the bloodstream when there is leaky gut. It can cause inflammation and metabolic problems like insulin resistance, obesity, diabetes, and heart diseases.

In rats, chronic treatment with agomelatine reduces the inflammatory cytokines IL-1beta and IL-6 induced by LPS. The same study also finds deactivation of NF-kB, the protein that turns on inflammatory responses in the immune system.

The study found that the inflammatory cytokines decreased both in the brain and throughout the body. Interestingly, Nattha also (unexpectedly) discovered that agomelatine helped with eczema during the day following agomelatine use.

 

 

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DescriptionDosageSide Effects

Amitriptyline belongs to a group of medicines known as tricyclic antidepressants. It has been traditionally prescribed for the treatment of depression, although it is rarely used for this nowadays as other medicines are usually prescribed in preference to it.


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Although amitriptyline is only licensed for use in depression, it is commonly prescribed ‘off-licence’ to help ease certain types of nerve pain, and also to help prevent migraines. Current medical practice supports the use of amitriptyline for these reasons, but if you have any questions about your treatment, it is important that you ask your doctor.


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An antidepressant medication. In some patients with depression, abnormal levels of brain chemicals called neurotransmitters may relate to the depression. Amitriptyline elevates mood by raising the level of neurotransmitters in brain tissue. Amitriptyline is also a sedative that is useful for depressed patients with insomnia, restlessness, and nervousness. It is sometimes used to treat fibromyalgia and symptoms related to chronic pain. Brand names are Elavil and Endep. A generic version is available.

Amitriptyline comes in a tablet form.

The recommended dose is 100-300 milligrams (mg) for most adults, and 25 mg for elderly patients. The initial dose is typically between 50-100 mg.

This medicine can be taken with or without food.

If you miss a dose of amitriptyline, take it as soon as you remember, unless it’s almost time for your next dose.

Then you should skip the missed dose and continue on your regular medication schedule.

Do not double up on doses to make up for a missed one.

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Carisoprodol, a muscle relaxant, is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries.

 It is typically prescribed to relieve pain caused by muscle injuries like strains and sprains. This drug comes in tablet form and is taken by mouth, often several times a day when treating an injury. This medication is typically combined with physical therapy and other treatments in order to treat muscle pain. However, some people become addicted to carisoprodol and use it other than how it is intended.

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The primary indications for cyclobenzaprine, metaxolone, methocarbamol, and carisoprodol are acute painful musculoskeletal conditions. Baclofen and tizanidine are indicated for spasticity associated with UMN disorders, but are frequently used off-label for painful musculoskeletal conditions. Diazepam is indicated for UMN muscle spasticity and local painful musculoskeletal spasm, as well as anxiety. Because the true mechanism of action on muscle spasm is unknown, the sedating side effects are often used to improve sleep. Muscle relaxants are mostly used for acute LBP or acute exacerbations of CLBP, rather than prolonged CLBP.


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Patients with CLBP who are most likely to experience improvements with common analgesics are those without any contraindications or sensitivities to a specific medication, and without risk factors for chronicity such as psychological dysfunction, financial disincentives, or poor social support systems. Given that most of these medications are used only to address symptoms and do not affect any structural changes to the lumbosacral area, they are perhaps best used during acute exacerbations of CLBP rather than on an ongoing basis. The ideal CLBP patient for this type of intervention should also be willing to engage in an active intervention such as therapeutic exercise to address possible physical contributors to their condition.

  • The recommended dose of carisoprodol is 250 or 350 mg three times daily and at bedtime.
  • The recommended treatment duration is 2 to 3 weeks.
  • To avoid withdrawal symptoms, carisoprodol should be stopped gradually if it has been used for a long duration.
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Tramadol is a synthetic (man-made) pain reliever (analgesic). Researchers and doctors do not know the exact mechanism of action of tramadol, but it is similar to morphine. Like morphine, tramadol binds to receptors in the brain (narcotic or opioid receptors) that are important for transmitting the sensation of pain from throughout the body to the brain.


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Like other narcotics used to treat pain, patients taking tramadol may abuse the drug and become addicted to it.

Tramadol is not a nonsteroidal anti-inflammatory drug (NSAID), therefore, it does not have the increased risk of stomach ulcers and internal bleeding that can occur with NSAIDs.

Tramadol, a centrally acting synthetic opioid analgesic. Although its
mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to μ-opioid receptors and weak inhibition of re-uptake of norepinephrine and serotonin.

Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as  have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of ULTRAM®. Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours.


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Apart from analgesia, ULTRAM® administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. In contrast to morphine, tramadol has not been shown to cause histamine release. At therapeutic doses, ULTRAM® has no effect on heart rate, left-ventricular function or cardiac index. Orthostatic hypotension has been observed.

This is a typical dosing schedule for someone just starting to take tramadol regular-release tablets:

  • Your doctor will most likely start with 25 milligrams (mg) each morning.
  • That may increase by separate doses of 25 mg every three days to reach a maximum dose of 100 mg a day (25 mg, four times a day), depending on how much the medication is relieving your pain.
  • If necessary, your doctor may increase by separate doses of 50 mg every three days to reach a maximum of 200 mg a day (50 mg, four times a day).
  • A normal adult dose should not go above 400 mg a day.
  • For someone with cirrhosis (liver damage), the daily dose should not be above 100 mg in a 24-hour period.
  • For someone with kidney disease, the daily dose should not be above 200 mg.
  • For someone older than 75, the daily dose should not be above 200 mg.

 

Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

 

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Topiramate is used alone or with other medications to treat certain types of seizures including primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) and partial onset seizures (seizures that involve only one part of the brain). Topiramate is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Topiramate is also used to prevent migraine headaches but not to relieve the pain of migraine headaches when they occur. Topiramate is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.


According to the Topamax package insert, weight loss is one of the drug’s most common side effects. However, weight gain is also a side effect of TopamaxWeight loss in patients taking Topamax appears to be dose-dependent — that is, higher doses of Topamax cause more weight loss.


Psychiatrists have used topiramate to treat bipolar disorder, although the available evidence does not support its use in any phase of bipolar disorder treatment. A more recent review, published in 2010, suggested a benefit of topiramate in the treatment of symptoms of borderline personality disorder, however the authors note that this was based only on one randomized controlled trial and requires replication. Also the authors noted that the long-term effects have not been studied.

Topiramate has been used as a treatment for alcoholism. The VA/DoD 2015 guideline on substance use disorders lists topiramate as a “strong for” in its recommendations for alcohol use disorder.


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Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).


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Divalproex sodium is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.


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Divalproex sodium delayed-release tablets are intended for oral administration. Divalproex sodium delayed-release tablets should be swallowed whole and should not be crushed or chewed.

Patients should be informed to take divalproex sodium delayed-release tablets every day as prescribed. If a dose is missed it should be taken as soon as possible, unless it is almost time for the next dose. If a dose is skipped, the patient should not double the next dose.

Common side effects of divalproex include:

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This medication is used to treat pain caused by nerve damage due to diabetes or shingles(herpes zoster) infection.

Pregabalin belongs to a class of drugs called anticonvulsants. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

It isn’t known exactly how pregabalin works. It’s believed to work by calming the damaged or overactive nerves in your body that may cause pain or seizures.

The mechanism of action of pregabalin. Pregabalin modulates hyperexcited neurons via the following mechanism: Pregabalin binds to presynaptic neurons at the alpha2-delta (α 2-δ) subunit of voltage-gated calcium channels. Drug binding reduces calcium influx into presynaptic terminals. Decreased calcium influx reduces excessive release of excitatory neurotransmitters (e.g., glutamate, substance P, noradrenaline) from Shim, Hanyang Med Rev 2011 with permission.


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Dosage for shingles (nerve pain due to herpes zoster)

Adult dosage (ages 18–64 years)

  • Typical starting dosage: 75–150 mg taken two times per day, or 50–100 mg taken three times per day (for a total of 150–300 mg per day).
  • Dosage increases: Your doctor will adjust your dosage based on your response to this drug.
  • Maximum dosage: 300 mg taken two times per day, or 200 mg taken three times per day (for a total of 600 mg per day).

Drowsiness, dizziness, headache, dry mouth, nausea, constipation, and weight gain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: vision changes (such as blurred vision), unusual bleeding/bruising, muscle pain/tenderness/weakness (especially with fever or unusual tiredness), swelling hands/ankles/feet.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior such as signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

 

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Lenalidomide is a medicine used for the treatment of multiple myeloma, myelodysplastic syndromes and mantle cell lymphoma, which are conditions affecting blood cells and bone marrow.

In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide is used:

on its own, in adults who have had a stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced by stem cells from a donor) to stop the progression of the cancer;
in combination with dexamethasone (an anti-inflammatory medicine), for the treatment of adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have stem cell transplantation;
in combination with melphalan (a cancer medicine) and prednisone (an anti-inflammatory medicine) for the treatment of adults with previously untreated multiple myeloma, who cannot have stem cell transplantation;
in combination with dexamethasone, in adults whose disease has been treated at least once in the past.
In myelodysplastic syndromes, a group of bone marrow disorders that cause anaemia (low red blood cell counts), Lenalidomide is used for patients who need blood transfusions to manage their anaemia. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a type of cancer affecting white blood cells). Lenalidomide is used in patients who have a genetic abnormality (called deletion 5q) and are at a lower risk of AML, and it is used when other treatments are not adequate.

In mantle cell lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide is used in adults whose disease has come back after treatment, or does not improve with treatment.

Lenalidomide maintenance therapy after autologous stem-cell transplantation (ASCT) demonstrated prolonged progression-free survival (PFS) versus placebo or observation in several randomized controlled trials (RCTs) of patients with newly diagnosed multiple myeloma (NDMM). All studies had PFS as the primary end point, and none were powered for overall survival (OS) as a primary end point. Thus, a meta-analysis was conducted to better understand the impact of lenalidomide maintenance in this setting.

The meta-analysis was conducted using primary-source patient-level data and documentation from three RCTs (Cancer and Leukemia Group B 100104, Gruppo Italiano Malattie Ematologiche dell’Adulto RV-MM-PI-209, and Intergroupe Francophone du Myélome 2005-02) that met the following prespecified inclusion criteria: an RCT in patients with NDMM receiving ASCT followed by lenalidomide maintenance versus placebo or observation with patient-level data available and achieved database lock for primary efficacy analysis.

Overall, 1,208 patients were included in the meta-analysis (605 patients in the lenalidomide maintenance group and 603 in the placebo or observation group). The median PFS was 52.8 months for the lenalidomide group and 23.5 months for the placebo or observation group (hazard ratio, 0.48; 95% CI, 0.41 to 0.55). At a median follow-up time of 79.5 months for all surviving patients, the median OS had not been reached for the lenalidomide maintenance group, whereas it was 86.0 months for the placebo or observation group (hazard ratio, 0.75; 95% CI, 0.63 to 0.90; P = .001). The cumulative incidence rate of a second primary malignancy before disease progression was higher with lenalidomide maintenance versus placebo or observation, whereas the cumulative incidence rates of progression, death, or death as a result of myeloma were all higher with placebo or observation versus lenalidomide maintenance.

Lenalidomide is available as capsules (5 mg, 10 mg, 15 mg, and 25 mg) to be taken by mouth. The medicine can only be obtained with a prescription and treatment must be monitored by doctors who have experience in the use of cancer medicines.

Lenalidomide is taken in repeated 28-day cycles: the patient takes the medicine once a day on certain days over 28 days. Depending on the day, the patient may take one or more medicines or may not take any medicines.

The dose depends on the disease Lenalidomide is used to treat. The dose should be reduced or treatment interrupted depending on whether the disease has worsened, the severity of any side effects and the levels of platelets (components that help the blood to clot) and neutrophils (a type of white blood cell that helps fight infection). A lower dose should be used in patients who have moderate or more severe reduction in their kidney function.

 

Important things to remember about the side effects of Lenalidomide:

  • You will not get all of the side effects mentioned below.
  • Side effects are often predictable in terms of their onset, duration, and severity.
  • Side effects are almost always reversible and will go away after therapy is complete.
  • Side effects are quite manageable. There are many options to minimize or prevent them.

The following side effects are common (occurring in greater than 30%) for patients taking Lenalidomide:

 

  • Low blood counts . Your white blood cells and platelets may temporarily decrease. This can put you at increased risk for infection and/or bleeding.  Blood counts are monitored closely and dose adjustments may be necessary.
  • Diarrhea
  • Itching
  • Rash
  • Fatigue, tiredness

These are less common side effects for patients receiving Lenalidomide:

  • Constipation
  • Nausea
  • Sore throat
  • Generalized aches and pains
  • Fever
  • Back pain
  • Swelling of ankles or feet
  • Cough
  • Dizziness
  • Headache
  • Muscle cramps
  • Shortness of breath
  • Generalized weakness
  • Nose bleed
  • Infection
  • Dry skin
  • Anemia (low red blood cell count)
  • Pneumonia
  • Low potassium
  • Difficulty sleeping
  • Poor appetite
  • Vomiting

A rare, but serious side effect of Lenalidomide is blood clots, including deep vein thrombosis (DVT) and pulmonary embolus (PE).  You should seek emergency help and notify your health care provider immediately if you develop sudden chest pain and shortness of breath.  Notify your health care provider within 24 hours if you notice leg or arm swelling, redness, pain and/or skin warm to touch (signs and symptoms of possible blood clot)..

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

 

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Gleevec is the trade name for the generic drug name Imatinib Mesylate. STI-571 is another name for Imatinib Mesylate. In some cases, health care professionals may use the trade name Gleevec or other name STI-571 when referring to the generic drug name Imatinib Mesylate.


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Imatinib Mesylate is a targeted therapy. Imatinib Mesylate is classified as a signal transduction inhibitor – protein-tyrosine kinase inhibitor.

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells.  To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that divide rapidly.  Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells.  Scientists look for specific differences in the cancer cells and the normal cells.  This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects.  Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.


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There are different types of targeted therapies, defined in three broad categories.  Some targeted therapies focus on the internal components and function of the cancer cell.  The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die.  There are several types of targeted therapy that focus on the inner parts of the cells.   Other targeted therapies target receptors that are on the outside of the cell.   Therapies that target receptors are also known as monoclonal antibodies.  Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Research continues to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.

Imatinib mesylate belongs to the signal transduction inhibitor category of targeted therapies.  It is particularly a protein-tyrosine kinase inhibitor.

  • Imatinib mesylate is a pill, taken by mouth, once or twice daily.
  • Imatinib mesylate should be taken with a large glass of water, after a meal.
  • The amount of Imatinib mesylate that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition being treated.  Your doctor will determine your dose and schedule.

Important things to remember about the side effects of Imatinib mesylate:

  • Most people do not experience all of the side effects listed.
  • Side effects are often predictable in terms of their onset and duration.
  • Side effects are almost always reversible and will go away after treatment is complete.
  • There are many options to help minimize or prevent side effects.
  • There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
  • The side effects of Imatinib mesylate and their severity depend on how much of the drug is given.  In other words, high doses may produce more severe side effects.

The following side effects are common (occurring in greater than 30%) for patients taking Imatinib mesylate:

  • Low blood counts.  Your white and red blood cells and platelets may temporarily decrease.  This can put you at increased risk for infection, anemia and/or bleeding.
  • Nausea and vomiting
  • Edema (swelling of the face, feet, hands)
  • Muscle cramps and bone pain
  • Diarrhea
  • Hemorrhage (see bleeding problems)
  • Skin rash (see skin reactions)
  • Fever

These side effects are less common side effects (occurring in about 10-29%) of patients receiving Imatinib mesylate:

  • Headache
  • Fatigue
  • Joint pain
  • Indigestion (see heartburn)
  • Abdominal pain
  • Cough
  • Shortness of breath
  • Poor appetite
  • Constipation
  • Night sweats (see skin reactions)
  • Nose bleeds (see bleeding problems)
  • Weakness
  • Your fertility, meaning your ability to conceive or father a child, may be affected by Imatinib mesylate.  Please discuss this issue with your health care provider.

rare, but potentially serious side effect of Imatinib mesylate is liver toxicity.  There may be elevations in transaminase, bilirubin, and lactate dehydrogenase.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here.  However, you should always inform your health care provider if you experience any unusual symptoms.

 

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Tadalafil is an oral drug that is used for treating impotence (the inability to attain or maintain a penile erection) and benign prostatic hyperplasia (BPH). It is in a class of drugs called phosphodiesterase-5 (PDE5) inhibitors that also includes sildenafil (Viagra) and vardenafil (Levitra).

Tadalista contains an active ingredient tadalafil, globally known as Generic Tadalafil. Tadalista (Generic Tadalafil 20 mg, 10 mg and 5 mg tablets) is an oral medication for the treatment of erectile dysfunction in men. We can ship generic Cialis, Tadalista in to USA, UK, AU, with traceable shipping.

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The mechanism whereby tadalafil improves the symptoms of BPH is not clear, but phosphodiesterase-5 also is present in the muscles of the bladder and the prostate, and it has been suggested that the relaxation of these muscles may make the passage of urine less difficult, for example, by reducing the pressure in the muscle surrounding the opening to the urethra that controls the flow of urine from the bladder. Tadalafil was approved by the FDA in November 2003.

The medication can start working in as little as 30 minutes, so it’s also possible to have spontaneous sexual encounters. Tadalista can treat mild, moderate, and severe erection problems. It can be taken with or without food, so it is easy to use Tadalista as a part of daily life.

The most common side effects with Tadalista:

  • headache,
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Tadarise is one of the best generic brands of Cialis – Tadalafil, is active ingredient a PDE5-inhibitor that assures that when a man is sexually aroused his penis receives a steady flow of blood to the cavernous tissue of the penis for as long as needed, i.e. until the ejaculation.

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Tadalafil relaxes muscles of the blood vessels and increases blood flow to particular areas of the body.

Tadalafil under the name of Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate). Another brand of tadalafil is Adcirca, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

You should take one Tadarise tablets 20mg with a glass of water approximately 25-60 minutes before sexual activity with or without food.  The effect of Tadarise tablets 20mg can last as long as 4-5 hours after taking your tablet.  You should take no more than one tablet a day and only if you plan to have sex.

The most common side effects with Tadarise:

  • headache,
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Vidalista is brand of Centurion laboratories manufactured in India. It contains Tadalafil as salt. which helps in relaxation of muscles and erectile dysfunction. Our company offer to delivery Vidalista ro your address in USA, AU, UK, Europe, just contact us for best india prices to Vidalista.

It’s the only medication proven to treat ED issues for as long as 36 hours.

Tadalafil is an orally adminstered drug used to treat male erectile dysfunction (impotence). It is marketed worldwide under the brand name Cialis. It is a phosphodiesterase 5 (PDE5) inhibitor. Tadalafil’s distinguishing pharmacologic feature is its longer half-life (17.5 hours) compared with Viagra and Levitra (4-5 hours). This longer half-life results in a longer duration of action and is, in part, responsible for the Cialis nickname of the “weekend pill.” This longer half-life also is the basis of current investigation for tadalafil’s use in pulmonary arterial hypertension as a once-daily therapy.

The maximum recommended dosing frequency is once per day. Vidalista may be taken between 30 minutes and 36 hours prior to anticipated sexual activity.

Take it 3 to 4 hours before. Once taken it, do not take it again within 48 hours. Its effectiveness lasts 36 hours. It can be taken with or without food.

The most common side effects:

  • headache,
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  • back pain,
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  • runny nose.

These side effects usually go away after a few hours.

 

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Tadacip 20mg Tablet is a phosphodiesterase (PDE-5) inhibitor. It works in erectile dysfunction by increasing blood flow to the penis by relaxing the muscles in penile blood vessels. It works in pulmonary hypertension by relaxing the blood vessels in the lungs to allow blood to flow more easily.

Tadacip is ideal for men who suffer from  impotence or who occasionally feel their sex life suffers because of their erection problems. Tadacip from Cipla is the strongest available dosage on the marker, fit to suit any man’s needs.

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The maximum recommended dosing frequency is once per day. Tadacip may be taken between 30 minutes and 36 hours prior to anticipated sexual activity.

Patients may initiate sexual activity at varying time points relative to dosing in order to determine their own optimal window of responsiveness. 

Tadacip 20 mg by Cipla may cause some unpleasant side effects.

The most common side effects with Tadacip by Cipla:

Headache,

Indigestion,

Back pain,

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Flushing,

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These side effects usually go away after a few hours.

 

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Malegra helps man to ocevercome the problem of frequent erectile failure problem.  Malegra made by Sunrise remedies Established in the year 1993 at Ahmadabad, Gujarat, India. Malegra made by trusted company.


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After being introduced in 1998, Malegra 100mg became the most popular treatment for erectile dysfunction issues. Malegra 100mg is a fast-acting medication that can last up to four hours. It works well for men at any age, regardless of how long the patient has been having issues getting and maintaining an erection.

Sildenafil relaxes muscles found in the walls of blood vessels and increases blood flow to particular areas of the body.

Sildenafil under the name Viagra is used to treat erectile dysfunction (impotence) in men.

Doctors usually recommend taking 100 mg  per day. Do not take more than one dose every 24 hours.

Typical side effects include headache, stomach upset, vision problems, dizziness, light sensitivity, flushed skin, and rashes.

 

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Suhagra is the old brand from Cipla, wich is fully compability with original brand, Suhagra is the first generic drand from India for US brand Viagra.

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Suhagra 100mg, is using by mans for treatment erectile disfunction. Its active ingredient is Sildenafil Citrate. It affects the response to sexual stimulation. Using a chemical called nitric oxide it enhances smooth muscle relaxation which allows increase blood flow into your penis to achieve and maintain erection.

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For problems related to erectile dysfunction, you should take them only when you need it, probably half an hour to one hour before any sexual activity. You should not take this medication more than once in a day in this regard.

The common side effects of Suhagra 100 MG Tablet are dizziness, headache, blurred vision, stuffy nose, pain in the back or in the muscles, stomach upset, trouble sleeping, etc.

 

 

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Sildenafil functions as a selective and competitive inhibitor of type 5 phosphodiesterases (PDE5) on smooth muscle cells in the penis and pulmonary vasculature, and is used extensively for erectile dysfunction and less commonly for pulmonary hypertension. Sildenafil has been associated with rare instances of clinically apparent liver injury.

Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction (ED); however, most men are later titrated to sildenafil 100 mg for improved efficacy.

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Aurogra is the 100% of Sildenafil, sold as the main brand name Viagra among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. Its effectiveness for treating sexual dysfunction for man’s.

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Dosage Information

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA may be taken anywhere from 30 minutes to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day.

Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.

Use With Food

VIAGRA may be taken with or without food.

The most common adverse reactions reported in clinical trials ( > 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.