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This medicine usually begins to work for erectile dysfunction within 30 minutes after taking it. It continues to work for up to 4 hours, although its action is usually less after 2 hours.

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

Alcohol: Avoid. Very serious interactions can occur

Dizziness, headache, flushing, or stomach upset may occur. Vision changes such as increased sensitivity to light, blurred vision, or trouble telling blue and green colors apart may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Generic Viagra Cost Dropping

There is good news for men who routinely use Viagra to treat erection problems: Since Viagra came off patent, the generic form, sildenafil, made by legitimate drug manufactures, has been becoming widely available at lower and lower prices.

This is a godsend, because Viagra originally cost $60 a pill, making it unaffordable for huge numbers of men who could have been helped by it.

Medicare used to allow only four pills a month. So if you weren’t rolling in money, Medicare essentially was rationing sex for couples in which an older man was suffering with ED.

For many years, Viagra has been the most counterfeited drug in the world. But many of the phony versions available online were adulterated with dangerous substances such rat poison or blue ink, so it was dangerous to be taking them. Now you can buy legitimate sildenafil for much less.

Even when the original patent expired, drug manufactures kept the prices for the little blue pill high — around $30 a pill in December of 2017.

But now that many respected manufacturers are making sildenafil, the prices have gone down dramatically.

If you take sildenafil, do some investigation of costs through different pharmacies and services. For instance, getting the drug through your regular pharmacy.

The lowest WEMAILMD.COM price for the most common version of sildenafil 100 mg is 300 pills for around $120.

Sildenafil citrate (Viagra) may help protect the cardiovascular health of the offspring.

An estimated six to 15 million people in the U.S. are children born of a pregnancy complicated by preeclampsia. New research performed in rats reveals that treating preeclampsia with sildenafil citrate (Viagra) may help protect the cardiovascular health of the offspring.

Preeclampsia occurs when women with otherwise normal blood pressure experience elevated blood pressure during pregnancy. Children of women with preeclampsia during pregnancy have higher blood pressure during childhood and almost double the risk of stroke later in life.

“The ultimate goal of our work is to improve the long-term health of women and children affected by preeclampsia,” said Hannah Turbeville, a doctoral student at the University of Mississippi Medical Center, who conducted the new study. “There are limited guidelines for addressing the health risks to these groups, and we hope not only to bring attention to these risks but also to propel research forward that will inform preventative interventions.”

Turbeville will present the new research at the American Physiological Society’s annual meeting during the 2019 Experimental Biology meeting to be held April 6-9 in Orlando, Fla.

In previous work, the researchers found that sildenafil citrate, which lowers blood pressure by acting on the nitric oxide pathway, can treat preeclampsia in a rat model of the condition while also decreasing blood pressure in offspring. In the new work, they wanted to determine how sildenafil citrate affects the offspring’s response to stressors that normally increase blood pressure.

To mimic human preeclampsia as much as possible, the researchers used a rat model that develops the condition without a procedure or drug. They then exposed the offspring to a stressor that increases blood pressure. The researchers observed smaller increases in blood pressure for male offspring of rats treated with sildenafil citrate compared to those that did not no receive treatment or received a more commonly used blood pressure medication. The protective effect was not apparent in female offspring.

“Our studies demonstrate the potential for targeted therapy of the nitric oxide pathway to improve the body’s response to stressors in the later lives of children of women who experienced preeclampsia,” said Turbeville. “This pathway plays an important role in improving blood flow and lowering blood pressure.”

The researchers are working to better understand the gender-specific response to sildenafil citrate. They are also exploring whether the improved response to stressors leads to decreased risk of chronic diseases such as high blood pressure and chronic kidney disease when these offspring become adults.

Story Source:

Materials provided by Experimental Biology.

Know how Sildenafil Drug Market is Demanding

The Research Insights has as of late declared the addition of another research report to its developing repository. The exploration report, titled “Global Sildenafil Drug Market Report,” offers an unmistakable understanding of the subject matter. Understood from the title of the publication, the 2019–2025 forecast period considered here has been kept in view to foresee the overall revenue, price, consumption by country, and sales by type and application of the market.

Sildenafil, sold as the brand name Viagra among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is unclear if it is effective for treating sexual dysfunction in women. It is taken by mouth or injection into a vein. The Sildenafil drug market is predictable to grow exponentially during the estimated period due to increasing prevalence as well as incidence of erectile dysfunction and rising aging population globally. The petition for the treatment of erectile dysfunction is increasing due to more incidences of severe disease, rising awareness, and patient education.

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Top Companies

Pfizer, Lupin Laboratories, Unichem Laboratories, Torrent Pharmaceuticals, Alembic Chemical, Sandoz, Osho Pharma, and Atlas Laboratories Pvt Ltd.

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Buy Apcalis jelly is available in doses of 100 mg Tadalafil and is the maximum recommended dose, for 36 hours. Take the desired amount (not to exceed 100mg) 15 to 30 minutes before sex. Open the package and remove the contents of the package in a spoon or directly in the mouth. The contents of the package should dissolve in your mouth before you have to swallow it. When consuming it will have an approximate action time of 24-36 hours and will have time to have sexual relations.

Buy Apcalis that integrates exactly the same active component as Cialis pills. As such, the effectiveness of this powerful medicine is that it can last up to 36 hours. During this stage of action it is possible to have multiple erections. Because of its long period of efficiency, circumstantial sex will again be possible.

Apcalis oral jelly is prescribed during the treatment of sexual impossibility in men. It is determined when there are problems with carrying out an erection and its maintenance for a necessary time. It consists of a generic form of the well-known drug called Cialis.

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The top 5 medications that are popular amongst men

Erectile dysfunction is a prevalent condition that continues to affect men globally. The inability to “rise to the occasion” often leads to severe esteem issues that are sometimes difficult to overcome. A significant chunk of men aged 40 and above experience erectile dysfunction. However, there are certain drugs that help alleviate ED by improving blood flow to the genitals. These performance-enhancing medications are often used by most men suffering from this unfortunate condition.

Here are the top 5 medications that are popular among men:

 

  • Kamagra Oral Jelly

 

If you’re tired of swallowing those large male tablets that are difficult to swallow, Kamagra Oral Jelly might just be what you need. This liquid jelly gets absorbed swiftly (within 20 minutes of ingestion) and works effectively for about 4 to 6 hours. Sildenafil Citrate, the active compound found in this performance-enhancing medication, efficiently dilates the body’s blood vessels – especially those located in your genitals. Consequently, you experience a sturdier blood flow that supports long-lasting erections. Kamagra Oral Jelly comes in a variety of flavours such as banana, mango, chocolate, mint and strawberry. These different flavours are sent to you upon ordering.

 

  • Avanafil

 

Popularly known as Spedra/Stendra (the trademark names), Avanafil is an active chemical inhibitor used to treat erectile dysfunction. This drug is approved by the FDA, making it safe to use. Depending on body composition, it takes around 20 to 30 minutes for this ED drug to start working. Elevated erectile performance can last for 8 hours on average. However, it’s crucial to follow the correct dosage prescribed by your physician.

 

  • Sildenafil (Viagra)

 

The sheer mention of Viagra sparks tremendous interest among most people. Four in five men who experience erectile dysfunction normally report having healthy, long-lasting erections during sex after taking Viagra. The effects of Viagra usually manifest after around 30 minutes to an hour after ingestion. According to Viagra.com, this drug only works when you’re sexually stimulated. Overall, it’s important to consult a physician before getting an over-the-counter dose of Sildenafil.

 

  • Tadalafil (Cialis)

 

This ED drug helps to treat erectile dysfunction by accelerating the flow of blood to the penis. It comes in pill format and its effects kick off after less than 45 minutes. Erectile prowess can proceed to 24 hours or more, depending on your dose. However, there are a few side effects associated with Cialis. These include dizziness, indigestion and migraines. Unless you have a heart condition or rare allergy, using this drug should be perfectly safe.

 

  • Vardenafil (Levitra)

 

Vardenafil is a highly potent compound used to treat erectile dysfunction. By increasing blood flow to your genitals, this ED drug effectively causes blood vessels within your penis to expand, stiffening it for prolonged sexual activity. It takes around 30 to 60 minutes for Vardenafil to start working. Delightfully, the optimal erectile function can continue for around 5 hours. It’s wise to avoid alcohol when using this drug – alcohol inhibits the effectiveness of this drug, reducing your ability to achieve an erection.

These 5 medications usually help men combat erectile dysfunction.

The drug Cialis is popular because you can take it every day. But should you?

Tadalafil (Cialis) is one of the most popular erectile dysfunction (ED) drugs. Its major appeal? The drug comes in low-dose versions that can be taken daily. This means you can have sex at any time, rather than needing to take a pill from time to time as needed like other ED brands.

The starting dose for daily-use Cialis is 2.5 milligrams (mg). If that doesn’t work, you can increase your daily dose up to 5 mg. But is this the right approach for you—or are you better off with traditional ED drugs like Viagra, Levitra, or even the nondaily version of Cialis? If you are contemplating Cialis for daily use, consider these questions and then discuss it with your doctor:

  • How often do you have sex? If it’s two or more times a week, a daily pill might be a reasonable choice, since the drug continually circulates in your bloodstream.
  • How important is spontaneity? A daily pill clears the path for sex at any time—if the drug works for you. (Remember, just like other ED drugs, it may not work for everyone). On the other hand, the 36-hour window offered by the nondaily version of Cialis might offer enough spontaneity.
  • Have side effects of your current ED pill been bothering you? Taking a daily low-dose pill may reduce side effects, though it may reduce effectiveness as well. In studies, the most common daily pill side effects were headache, muscle pain, indigestion, and back pain.
  • How much alcohol do you drink? Men taking Cialis for daily use can experience a worrisome drop in blood pressure if they drink too much.
  • What other medications do you take? Ask your doctor if any medications or supplements you take might interact with a daily erectile dysfunction pill, including blood pressure drugs, antifungal drugs, and HIV drugs. Also, men taking nitrate medications are advised not to take any ED drugs.
  • How important is cost? While the manufacturer suggests that a 30-day supply of daily Cialis should cost about the same as eight pills of 36-hour Cialis a month, there’s no way to enforce this. Check your insurance policy and local pharmacies for price information.

– By Matthew Solan
Executive Editor, Harvard Men’s Health Watch

FDA Action Alert: Theravance's Approval, Mallinckrodt and Aquestive

he Food and Drug Administration (FDA) is taking care of a few approvals and committee meetings ahead of the Thanksgiving holiday week. They include drugs for chronic obstructive pulmonary disease, a pain drug, and a sublingual film formulation of a well-known drug for erectile dysfunction. Here’s a look.

Theravance’s Revefenacin for COPD

Theravance Biopharma, based in Dublin, Hertfordshire, England, and Pittsburgh, along with Mylan, have a target action date of November 13 for their New Drug Application (NDA) for Yupelri (revefenacin). The drug is a long-acting muscarinic antagonist (LAMA) being evaluated for chronic obstructive pulmonary disease (COPD).

The agency indicated it didn’t plan on holding an advisory committee hearing about the NDA.

At the company’s third-quarter financial report on November 6, Rick E. Winningham, company chairman and chief executive officer, noted that the company had recently sold its Vibativ to Cumberland Pharmaceuticals, which “allows our commercial organization to concentrate exclusively on the potential launch of Yupelri, which if approved will be the first once-daily nebulized LAMA for the treatment of COPD.”

The FDA jumped ahead and approved the drug on Friday, November 9.

FDA Adcom to Meet on Mallinckrodt’s Roxicodone

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee will have a joint meeting on November 14. The two committees will evaluate the 505(b)2 new drug application submission for Mallinckrodt Pharmaceuticals‘ MNK-812, the company’s abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for the management of pain severe enough to require an opioid analgesic.

The target action date for the drug is November 16. “We look forward to engaging with the Advisory Committees to discuss the potential benefits our new abuse-deterrent formulation technology can bring in helping to mitigate opioid abuse and misuse,” stated Matt Harbaugh, Mallinckrodt’s executive vice president, chief financial officer and president of Specialty Generics in October.

Aquestive Therapeutics’s AQST-119 for Erectile Dysfunction

Aquestive Therapeutics (Formerly known as MonoSolRx), headquartered in Warren, New Jersey, has a target action date of November 18 for its AQST-119, an oral film formulation of tadalafil, for erectile dysfunction. The company focuses on developing and delivering medications by way of its PharmFilm technology, which allows patients to take medications by placing the film under their tongue.

Tadalafil is a PD35 inhibitor marketed by Eli Lilly and Company as Cialis for erectile dysfunction and for treatment of pulmonary arterial hypertension under the name Adcirca.

At the company’s third-quarter financial statement on November 6, Keith J. Kendall, company chief executive officer, emphasized the commercial launch of a compound from its central nervous system franchise, rather than the upcoming tadalafil formulation. “Aquestive is the worldwide leader in delivering therapeutics on oral film with our PharmFilm technology. Over the past quarter, we have met a number of key business milestones that position us well to achieve our long-term vision for growth. We are excited to continue advancing our pipeline and building our CNS commercial franchise with the launch of Sympazan. Late stage development of Libervant is also advancing with the recent completion of the adult EMU study.”

Sympazan’s oral film was approved for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years or older.

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New Erectile Dysfunction Treatment Likely to Face Stiff Competition If Approved

The treatment of erectile dysfunction (ED) has helped literally tens of millions of men in America alone. The number of drugs treating ED has grown substantially over the years, and each drug tends to have a different target market within the community of those suffering from ED.

Now that Viagra and Cialis are facing generic competition, the total pool of dollars spent on treating ED after the Big Pharma patent cliffs expired is expected to drop ahead. Still, there are many newer and upcoming drugs that targeting subsets of patients with new issues around ED.

A relatively new and unheard of company called Aquestive Therapeutics Inc. (NASDAQ: AQST) has a decision on the U.S. approval of AQST-119 (tadalafil oral film) for ED coming up shortly. This company just came public in the summer of 2018. Wedbush Securities, which rates Aquestive with an Outperform rating and $34 target (versus a $17.91 prior close) sees it receiving FDA approval on or before the PDUFA date of November 18, 2018.

The question now is just how much a new ED treatment is needed for the market, as well as how much a new entrant can really make off of a new ED treatment now that Viagra is over 20 years old and with generics and lower-priced competition on the market. Wedbush posted a 90:10 probability of approval on Aquestive’s ED treatment, and it listed the following data sets in its report:

  • 1,800,000 estimated eligible patients
  • Price per patient of $3,726
  • Gross peak sales of $62.9 million
  • Peak sales year of 2024

These numbers may be great for a company with a mere $450 million market cap like Aquestive. Unfortunately, it’s a small subset of the ED market as a whole, and the total global pie treating ED is still worth hundreds of millions to billions of dollars as a whole.

The demand for drugs to treat ED has risen to meet the needs of an aging population and to help combat disease-related ED from issues around kidney disease, hypertension-related issues, chronic disorders, hormonal issues, diabetes complications and neurological disorders. Again, the dollar amounts being generated around ED is dropping due to stiff competition from generics.

Some other broader news has been around in the larger ED treatments in 2018 and in 2017 shown below.

In September of 2018, Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced the exclusive first-to-file launch of a generic version of Cialis tablets in the United States. Eli Lilly and Co. (NYSE: LLY) tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. The Teva release showed that Cialis had annual sales of more than $1.9 billion in the United States as of July 2018. That said, due to generics and competition, Cialis sales may drip under $1 billion in 2019 or shortly thereafter.

Pfizer Inc. (NYSE: PFE) enjoyed billions of dollars in sales of its Viagra for ED, but Viagra went generic in late 2017. Pfizer makes its own generic version, as do companies like Teva, Aurobindo and Cambia.

Bayer also had Levitra, but this was a distant number-three drug behind leader Viagra and then behind Cialis.

A site called Sharecare suggests that more than 30 million men in America have a form of ED. Now think about how many more millions of men have had it who have died, and how many millions of men will have it in the future but do not yet. Does the market need yet another treatment for ED? Maybe the answer really depends on whom you ask.

Vidalista: What is it and who can use it?

Here are some key points about Cialis. More detail is in the main article.

  • Under the name Cialis, tadalafil is used to treat erectile dysfunction.
  • As Adcirca, the same drug treats pulmonary arterial hypertension and benign prostatic hyperplasia.
  • Cialis increases blood flow to the penis, enabling an erection to occur when a man is sexually stimulated.
  • Anyone with a heart condition should seek medical advice before using Cialis.
  • Cialis is a medication, with potentially serious adverse effects. It should only be obtained from a reputable source and used under medical supervision.
Cialis is the brand name for tadalafil, a drug used to treat erectile dysfunction. It is similar to Viagra and Levitra. Under the brand name Adcirca, tadalafil is used for pulmonary arterial hypertension.

Cialis increases blood flow to the penis, and this enables a man to achieve an erection. It does not lead to sexual arousal. It should be used with caution, and only under medical supervision.

Tadalafil was approved by the United States (U.S.) Food and Drug Administration (FDA) in 2003 for the treatment of erectile dysfunction (ED). It is also used to treat pulmonary arterial hypertension and benign prostatic hyperplasia, a condition in which the prostate gland becomes enlarged, causing problems with urination.

Daily Tadalafil May Be Effective for Peyronie’s Disease

Daily tadalafil has the potential to be a treatment option for Peyronie’s disease (PD), according to data presented at the Sexual Medicine Society of North America 18th Annual Fall Scientific Meeting in San Antonio, Texas.

In a small study of PD patients, treatment with the drug, a phosphodiesterase type 5 (PDE5) inhibitor that is FDA approved for treating erectile dysfunction, was associated with decreased pain on erection and degree of penile curvature and improved erectile function.

PAE Is a Promising BPH Treatment Alternative
In a study, men with Peyronie’s disease who tadalafil 5 mg per day had decreased pain on erection and degree of penile curvature.

Daily tadalafil has the potential to be a treatment option for Peyronie’s disease (PD), according to data presented at the Sexual Medicine Society of North America 18th Annual Fall Scientific Meeting in San Antonio, Texas.

In a small study of PD patients, treatment with the drug, a phosphodiesterase type 5 (PDE5) inhibitor that is FDA approved for treating erectile dysfunction, was associated with decreased pain on erection and degree of penile curvature and improved erectile function.

Pain resolution was achieved in 55%, 70%, and 78.3% of groups 1, 2, and 3, respectively, after 12 weeks, the researchers reported in a poster presentation. The changes in the mean degree of penile curvature were -4.6, -6.2, and -7.2 degrees, respectively. The changes in mean plaque size were 0.2, 0.2, and 0.3 cm2. Further, groups 2 and 3 showed a greater increase in International Index of Erectile Function (IIEF)-Erectile Function domain score compared with group 1 (3.8 and 3.8 vs 0.4, respectively). Commonly reported adverse events (AEs) included hematoma at the injection site (4 cases), myalgia (3 cases), and dyspepsia, headache, and flushing (1 case each). No patient discontinued treatment due to AEs, the investigators reported.

The new study is not the first investigation to demonstrate the potential usefulness of tadalafil in treating PD. In a paper published in Urology Annals (2015;7:345-349) Lucio Dell’Atti, MD, of University Hospital S. Anna, Ferrara, Italy, reported that combined treatment with tadalafil and IVI was associated with better pain control and reduced penile curvature and improved erectile function than IVI or tadalafil alone. The study included 59 PD patients, who were divided into 3 groups. Group A had 23 patients treated with IVI, group B had 19 patients treated with tadalafil 5 mg once daily for 12 weeks, and group C had 17 patients treated with IVI and tadalafil 5 mg once daily for 12 weeks. At baseline, groups A, B, and C had mean IIEF-5 scores of 12.90, 12.51, and 11.58, respectively.

At 12 weeks, pain resolved completely in 57%, 61%, and 76% of groups A, B, and C, respectively. The final mean curvature degree decreased in all groups, with not significant difference among the groups. Mean plaque size did not decrease significantly in group A (1.57 vs 1.59 cm2 at baseline) and group B (1.51 vs 1.52 cm2 at baseline), but decreased significantly in group C (1.46 vs 1.58 cm2 at baseline). The mean IIEF-5 score improved significantly in group C compared with groups A and B (23.1 vs 14.4 and 18.2, respectively).

Reference

Park HJ, Park NC. Daily tadalafil therapy: A new treatment option for Peyronie’s disease? Presented in poster format at the Sexual Medical Society of North American 18th Annual Fall Scientific Meeting in San Antonio, Texas. Poster 134.

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Which Drug for Erectile Dysfunction Is Better: Viagra or Cialis?

Q. Which is better: Viagra or Cialis?

A. The Food and Drug Administration has approved four similar drugs for erectile dysfunction, sold under such names as Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil) and Stendra (avanafil). They all work the same way, producing an erection by increasing blood flow to the penis. Which drug is best may depend on your preference for quick onset versus long duration and your individual medical needs.

The discovery of Viagra is one of the classic stories of serendipity in drug development. In the 1980s, the pharmaceutical company Pfizer began studying sildenafil, the generic name for Viagra, as a treatment for heart disease. It didn’t work, but the men in the study developed unusually strong, long-lasting erections. The rest is history.

All four of the currently approved drugs seem to be equally good at producing erections. But it is difficult to be more definitive in evaluating their efficacy, because few studies directly comparing them have been conducted, a common problem with many drugs.

Since all four drugs are similarly effective, the answer to which drug is best will depend on other attributes, such as side effects, drug interactions, speed of onset and duration of action.

ide effects are similar among the four drugs. Headache, flushing and upset stomach are the most common side effects. And, in rare cases, all can cause a persistent and sometimes painful erection that will not go down, a condition called priapism that can result in permanent damage if not treated promptly.

Drug interactions are largely similar, with the most important interaction being a contraindication to nitrate-containing drugs, such as nitroglycerin, commonly used to treat angina.

FDA: Vaping, erectile dysfunction drugs a bad combination

Consumers, especially men, should not purchase or use two e-cigarette liquids that contain popular erectile dysfunction drugs, the Food and Drug Administration warned Tuesday.

The two HelloCig e-liquids contain tadalafil and sildenafil, the main ingredients in two of the most popular male enhancement drugs on the market, the FDA said. “These FDA-approved prescription drugs are not approved for inclusion in e-liquid products sold over the counter and are therefore being sold illegally.”

By not properly labeling the e-liquids, the agency said, the company was not providing adequate warnings for the protection of users, specifically anyone with erectile dysfunction, high blood pressure, diabetes, high cholesterol or heart disease who take nitrates to manage their condition.

“These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels,”  the FDA said in its warning .

A lab analysis found both sildenafil and tadalafil in E-Cialis HelloCig E-Liquid and sildenafil in E-Rimonabant HelloCig E-Liquid, both sold by Shanghai-based HelloCig Electronic Technology Co. Ltd.

The company has not responded to a request for comment.

Although no adverse events have been reported to the agency, all consumers should stop using the products immediately, the FDA said, and anyone who experiences side effects  should report them  to the FDA’s MedWatch Adverse Event Reporting program.

The FDA says it sent a  warning letter  to HelloCig in October, citing a number of concerns about illegal marketing claims. HelloCig was misbranding and selling its products in the United States as an “FDA approved product with FDA,” in violation of federal rules.

“FDA recently warned HelloCig of these issues and contacted the company several times to recommend they recall these products due to the risks to consumers. However, HelloCig has not responded to the agency’s recommendation,” the agency said in its warning.

Bottles of E-Cialis HelloCig E-Liquid were sold with an image of a Cialis bottle and tablets, while advertisements on Twitter and Tumbir showed “a partially undressed couple embracing,” the FDA says. The caption states, “WOOOOW, Have you tried our E-Cialis? It is amazing LOL.”

Though E-Rimonabant HelloCig E-Liquid contains the same active ingredient as Viagra, the FDA said HelloCig was marketing it with an image of an Acomplia container and tablets.

“Acomplia is the tradename of the anti-obesity drug product in Europe,” the FDA warned. “Using the tradename of the drug product Acomplia and including an image of the Acomplia container and tablets next to the product on your website suggests that the product is intended to treat obesity.”

HelloCig did not respond to the initial warning, the FDA said.

The manufacturers of Cialis has not responded to requests for comment. The maker of Viagra had no comment.

Best in Class Erectile Dysfunction Drug

adalafil (Cialis®) was originally developed by Lilly ICOS, LLC –a longer lasting alternative to Sildenafil Citrate (Viagra®) and is indicated for the treatment of erectile dysfunction (ED) in adult males. Tadalafil is facing imminent patent expiration.

Whilst Cialis® is a long acting ED drug, its absorption shows extensive variability with Tmax values ranging from 0.5 h to 12 h for a single 20 mg tadalafil dose. Despite the recommendation on the label to take Cialis® 30 minutes before sexual activity, only a minority of the patients reported successful intercourse attempts 30 mins after taking the highest approved 20 mg dose of Cialis®. In the same study 10 mg Cialis® failed to achieve its end-point for successful intercourse attempts within 30 mins over the placebo group.

Following oral administration of DRGT-99 immediate release tablets, maximum drug concentration was achieved on average 4 times faster than with 20 mg Cialis®.

Administering the 10 mg or 15 mg DRGT-99 tablet, drug exposure was more than 3-fold greater and variability was lower than for 20 mg Cialis® in the first 30 mins.

Time to achieve therapeutically effective plasma levels was also significantly shorter for DRGT-99 than for 20 mg Cialis®. Around half of the subjects taking 10 mg DRGT-99 reached therapeutically effective plasma levels in 15 mins and 100% by 30 mins. This number for 15 mg DRGT-99 was 72% and 100% respectively. Even 5 mg DRGT-99 resulted in therapeutically effective plasma levels in 73% of the subjects at 30 mins.

As for 20 mg Cialis® none of the subjects reached therapeutically effective plasma levels in 15 mins and only half of them at 30 mins.

Furthermore, reported adverse events for DRGT-99 were less frequent and less severe for all the dosage strengths tested than for 20 mg Cialis®. A potential safety advantage for DRGT-99.

“Our objective with DRGT-99 has been to develop the Best in Class ED drug that combines reliable, fast onset, longevity and improved side effect profile at the lowest possible dose” – said Gabor Heltovics, CEO of DRGT. “These encouraging results indicate that we are on track to do just that. We are advancing DRGT-99 to pivotal studies”- he added.

About DRGT

DRGT is a specialty pharmaceutical company dedicated to the development and commercialization of high-value proprietary drugs that deliver measurable and meaningful improvements in clinical utility.

DRGT utilizes its proprietary Super-API drug development platform to carefully select and screen drugs and develop their Super-API compositions. The Company’s Super-API portfolio contains 30 compounds in indications such as oncology, pain and erectile dysfunction with multi-$ billion potential. Super-API drugs are protected by global composition of matter IP.

DRGT is incorporated in Ireland with R&D facilities in Budapest, Hungary.

The corporation was founded by Dr. Ferenc Darvas, Chairman of the oldest Hungarian upstream-technology network.

Cialis and Viagra are registered trademarks of their respective owners.

Gábor Heltovics, CEO
E-mail: info@drgtco.com
Phone: +36-1-5779-300
http://www.drgtco.com

tadacip

Active substance: Tadalafil
U.S. Brand: Cialis / Adcirca
Indian Brand: Tadacip
Mfd by:
Strength: 20mg
Form release: blister with 4/10 tablets
Shipping time: 7 – 21 days
Best price: 0.78 USD
Order: through request form


Descriptiondesigner image

Tadacip is a medication primarily used to treat erectile dysfunction (ED) in men. It contains the active ingredient Tadalafil, which belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors. Tadalafil works by increasing blood flow to the penis during sexual stimulation, helping men achieve and maintain an erection.

Here are some key points about Tadacip:

  1. Usage: Tadacip is typically taken orally, as directed by a healthcare professional, usually before anticipated sexual activity. It should not be taken more than once a day.
  2. Effectiveness: Tadacip is known for its relatively long duration of action, with effects lasting up to 36 hours in some individuals. This allows for greater flexibility in timing sexual activity compared to other ED medications.
  3. Onset of Action: Tadacip typically starts working within 30 minutes to an hour after ingestion, although individual response times may vary.
  4. Safety: While Tadacip is generally considered safe and effective for most men, it may not be suitable for individuals with certain medical conditions or those taking certain medications. It’s important to consult with a healthcare provider before starting Tadacip or any other ED medication.
  5. Side Effects: Common side effects of Tadacip may include headache, dizziness, flushing, nasal congestion, indigestion, and muscle pain. Serious side effects are rare but may include sudden vision loss or hearing loss, chest pain, and prolonged erections (priapism). Seek medical attention if you experience any severe or persistent side effects.
  6. Precautions: Tadacip should not be taken by individuals who are allergic to Tadalafil or any of the other ingredients in the medication. It should also be used with caution in individuals with certain pre-existing medical conditions, such as heart disease or low blood pressure.
  7. Interactions: Tadacip may interact with certain medications, including nitrates used to treat chest pain (angina) and alpha-blockers used to treat high blood pressure or prostate enlargement. It’s important to inform your healthcare provider about all medications you are taking before starting Tadacip.

As with any medication, it’s important to follow your healthcare provider’s instructions and dosage recommendations when using Tadacip.

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tadarise

Active substance: Tadalafil
U.S. Brand: Cialis / Adcirca
Indian Brand: Tadarise
Mfd by:
Strength: 20mg/40mg
Form release: blister with 10 tablets
Shipping time: 7 – 21 days
Best price: 0.40 USD
Order: through request form


DescriptionPhoto's

Tadarise by Sun Pharma: A Solution for Erectile Dysfunction

Overview: Tadarise is a medication manufactured by Sun Pharma, containing the active ingredient Tadalafil. Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor, and it is commonly prescribed for the treatment of erectile dysfunction (ED) in men.

Mechanism of Action: Tadalafil works by inhibiting the enzyme PDE5, leading to increased blood flow to the penis during sexual stimulation. This improved blood flow helps in achieving and maintaining an erection.

Indications: Tadarise is primarily prescribed to men experiencing difficulties in achieving or sustaining an erection, a condition known as erectile dysfunction. It is not intended for use by women.

Dosage: The recommended dosage can vary, and it is essential to follow the prescribing physician’s guidance. Tadarise is typically taken orally before anticipated sexual activity, with or without food. The onset of action is usually within 30 minutes to an hour.

Precautions:

  • Tadarise should not be taken more than once a day.
  • Individuals with cardiovascular issues or taking nitrates should consult their healthcare provider before using Tadarise.
  • It does not protect against sexually transmitted infections, and additional precautions are advised.

Side Effects: Common side effects may include headache, indigestion, back pain, and muscle aches. Serious side effects are rare but can include priapism (a prolonged and sometimes painful erection) and sudden vision loss. Seek medical attention if any unusual or severe side effects occur.

Conclusion: Tadarise, containing Tadalafil from Sun Pharma, is a medication designed to help men overcome erectile dysfunction. As with any prescription medication, it is crucial to follow medical advice, dosage instructions, and notify healthcare providers of any pre-existing conditions or medications.

Please note that this is a general description, and specific details about Tadarise may vary. Always consult with a healthcare professional for personalized advice and information.

jalyn

Generic Jalyn for ordering

It can treat an enlarged prostate.


Active substance: Tamsulosin / Dutasteride
U.S. Brand: Jalyn
Indian Brand: Urimax D
Mfd by:
Strength: 0.4 mg + 0.5mg
Form release: blister with 15 capsules
Shipping time: 7 – 21 days
Best price: 0.61 USD
Order: through request form


DescriptionHow to take?Common Side EffectsLatest New'sPhoto's

Generic Jalyn contains a combination of dutasteride and tamsulosin. Dutasteride prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH). Tamsulosin is in a group of drugs called alpha-adrenergic blockers. Tamsulosin relaxes the muscles in the prostate and bladder neck, making it easier to urinate. also relaxes the muscles of the bladder neck.

Buy Generic Jalyn online without a prescription, not required. Our generic pharmacy provides a range of generic prescription drugs from India and over the counter medications at highly competitive prices and shipping rate to any country. For any other questions / clarifications please feel free to contact page.

The lowest GoodRx price for the most common version of generic Jalyn is around $58.03, 67% off the average retail price of $179.64.

Buy WMMD pharmacy supplier prices is around $ 20 for 30 capsules if your order will more than 100 tablets.

Take this medicine by mouth about 30 minutes after the same meal every day. Follow the directions on the prescription label. Swallow the capsules whole with a glass of water. Do not crush, chew, or open capsules.

As with any drug, there may be side effects from taking Jalyn including decreased libido, decreased amount of semen production during sex, impotence, breast tenderness or enlargement, mild dizziness and runny nose. More serious side effects may include feeling faint and a penis erection that is painful or that lasts 4 hours or more. If you experience any side effects you must seek immediate medical attention for safety.

 

 

 

flomax

Buy Urimax (Generic Flomax)

Tamsulosin is used by men to treat the symptoms of an enlarged prostate


Active substance: Tamsulosin
U.S. Brand: Flomax
Indian Brand: Urimax
Mfd by:
Strength: 0.4 mg
Form release: blister with 15 capsules
Shipping time: 7 – 21 days
Best price: 0.28 USD
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DescriptionHow to take?Common Side EffectsLatest New'sPhoto's

The drug tamsulosin was first approved and used in the U.S. in 1996.

The medications marketed as Flomax and its generics are based on the active substance called Tamsulosin. It is a selective alpha-adrenergic blocker.

Generic Flomax (tamsulosin) is an alpha-blocker that relaxes the muscles in the prostate and bladder neck, making it easier to urinate. Urimax is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate). Flomax is not approved for use in women or children.

Urimax capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. Please, note,  capsules should not be crushed, chewed or opened.

1 capsule with the dosage of the active substance 0.4 mg is taken one time a day at the same time around 30 minutes after a meal. The pill should be swallowed entirely without being crushed and washed down with sufficient amount of water.

If the standard dosage is insufficient as observed by the doctor 2 weeks after the therapy start, it can be increased to 0.8 mg a day or two pills a day taken in a single intake in the same manner as the standard dosage.
If for some reason you stop taking the pills and then want to start taking them again, regardless of what dosage you used before the therapy discontinuation, i.e. 0.4 mg or 0.8 mg, you should re-start the therapy with 0.4 mg a day and increase the dosage only after 2 weeks of uninterrupted use if the standard daily dosage is insufficient.

Urimax capsules 0.4 mg are supplied in blisters with 15 hard gelatin capsules. The capsules are imprinted on one side with Urimax 0.4 mg.

Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].

  • low blood pressure
  • nasal congestion
  • swollen ankles
  • dry mouth
  • headaches and dizziness
  • fatigue
  • problems with ejaculation

Tamsulosin for Postoperative Urinary Retention

Response from Darren J. Hein, PharmD
Assistant Professor, Department of Pharmacy Practice, School of Pharmacy and Health Professions, Creighton University, Omaha, Nebraska

Postoperative urinary retention (POUR) refers to the inability to pass any urine despite a full bladder after surgery. It is a common complaint, occurring in up to 70% of surgical patients depending on the type of surgery. Individuals undergoing perineal, gynecologic, anorectal, inguinal, and lower urinary tract surgeries are at an increased risk for POUR. Additional risk factors include older age, male sex, prolonged surgery, spinal anesthesia, and early removal of urinary catheters.

The development of POUR has been associated with several negative outcomes, including pain, urinary tract infection (UTI), bladder dysfunction, kidney damage, increased length of hospital stays, elevated costs, and the need for additional surgeries. Urethral catheterization is the mainstay of management of POUR; however, catheterization alone can also increase the risk for UTI and extend hospital stays. For these reasons, pharmacotherapeutic approaches to prevention of POUR are needed.

At least eight clinical trials evaluating the safety and effectiveness of tamsulosin, a selective alpha-1 adrenergic receptor blocker, for prevention of POUR in male patients undergoing different types of surgery have been published to date. The results of these studies have been generally consistent, with six of the eight trials reporting a statistically significant reduction in the risk for POUR with tamsulosin versus placebo. The type of surgical patient and tamsulosin regimen studied in each of the identified trials are listed in the Table below. Three observational studies also have found positive outcomes associated with the use of tamsulosin in surgical settings.

Table. Characteristics of Clinical Research Assessing Tamsulosin Therapy for Prevention of POUR

Author (Year) Tamsulosin Regimen Surgery
Jang et al (2012)[2] 0.2 mg daily from day of operation to postop day 7 Rectal cancer surgery
Mohammadi-Fallah et al (2012)[3] 0.4 mg 6 hours before and 6-12 hours after surgery Inguinal herniorrhaphy
Ahmad et al (2014)[4] 0.4 mg 6 hours before and 6-8 hours after surgery Anorectal surgery
Bazzazi et al (2014)[9] 0.4 mg daily for 1 week before surgery Cataract surgery
Jeong et al (2014)[10] 0.4 mg daily from 1 day before operation to postop day 14 Robot-assisted laparoscopic radical prostatectomy
Madani et al (2014)[5] 0.4 mg 14 hours before, 2 hours before, and 10 hours after surgery Varicocelectomy, inguinal herniorrhaphy, or scrotal surgery
Akkoc et al (2016)[6] 0.4 mg 14 hours and 2 hours before surgery Urologic surgery
Basheer et al (2017)[7] 0.4 mg 48 hours before surgery and night before surgery Spinal surgery

Tamsulosin Ineffective for Small Ureteral Stones

Medical expulsive therapy using the alpha blocker tamsulosin does not aid passage of ureteral stones less than 9 mm in diameter, according to study findings published online in JAMA Internal Medicine.

In the double-blind STONE (Study of Tamsulosin for Urolithiasis in the Emergency Department) trial, investigators randomly assigned 512 emergency department patients (mean age 41; 27% female; 23% non-white) to 0.4 mg daily tamsulosin or placebo for 28 days. Stone passage rate did not differ significantly between groups (50% tamsulosin vs 47% placebo), Andrew Meltzer, MD, of George Washington University in Washington DC, and colleagues reported. In addition, the investigators observed no significant between-group differences with respect to time to stone passage, return to work time, analgesic use, hospitalization, need for surgery, or repeat visit to the emergency department.

For the study, patients could have stones in any part of the ureter. Stone size, location, and passage were confirmed by computed tomography.

Current guidelines by the American Urological Association recommend alpha blockers for ureteral stones 10 mm or less in diameter.

References

Meltzer AC, Katzen Burrows P, Wolfson AB, et al. Effect of tamsulosin on passage of symptomatic ureteral stones. JAMA Intern Med. doi:10.1001/jamainternmed.2018.2259 [Published online June 18, 2018]

Dahm P and Hollingsworth JM. Medical expulsive therapy for ureteral stones—Stone Age medicine. JAMA Intern Med. [Published online June 18, 2018]

Tamsulosin Associated With Dementia Risk in Older Patients With BPH

Treatment with an α1adrenoceptor antagonist, tamsulosin, is associated with increased dementia risk among patients with symptomatic benign prostatic hyperplasia (BPH) aged ≥65 years, according to a Medicare data analysis published in Pharmacoepidemiology Drug Safety.

Using Medicare data from 2006 to 2012, investigators obtained patient data for men ≥65 years who were actively taking tamsulosin (n=253,136). These patients were compared with propensity-score-matched patients who did not use BPH medications (n=180,926), as well as patients who used doxazosin (n=28,581), terazosin (n=23,858), alfuzosin (n=17,934), dutasteride (n=34,027), and finasteride (n=38,767). Investigators used International Classification of Diseases, Ninth Revision, diagnosis codes to determine and compare incident dementia rates between each group.

A greater number of men in the tamsulosin group had dementia at the median 19.8-month follow-up compared with men who were not taking BPH medications (31.3 vs 25.9 per 1000 person-years, respectively; hazard ratio [HR], 1.17; 95% CI, 1.14-1.21; <.001). In addition, patients taking tamsulosin had a significantly higher dementia risk than those taking doxazosin (HR, 1.20; 95% CI, 1.12-1.28; P<.001), terazosin (HR, 1.11; 95% CI, 1.04-1.19; =.002), alfuzosin (HR, 1.12; 95% CI, 1.03-1.22; =.010), dutasteride (HR, 1.26; 95% CI, 1.19-1.34; <.001), and finasteride (HR, 1.13; 95% CI, 1.07-1.19; <.001).

duprost

Order Duprost | Avodart 0.5 mg

Generic Dutasteride (Duprost) for ordering online


Active substance: Dutasteride
U.S. Brand: Avodart
Indian Brand: Duprost
Made by:
Strength: 0.5 mg
Form release: blister with 10 capsules
Shipping time: 7 – 21 days
Best price: 0.55 USD
Order:
through request form


DescriptionHow to take?Common Side EffectsLatest New'sPhoto's

Duprost 0.5 mg Capsule is used in the treatment of benign prostatic hypertrophy (prostate enlargement). This medicine should be used only by men. Women and children are advised not to handle this medicine since there is a chance of absorption through the skin.

Duprost (Dutasteride) is to used to treat enlargement of prostate gland in BPH, reduce the problem of urinary blockage and the need for prostate surgery. Duprost is a medication designed for men only.

Duprost can lower the levels of the DHT hormone, which is the major cause of prostate growth. Duprost (Dutasteride) prevents the conversion of testosterone to dihydrotestosterone (DHT). DHT is involved in the development of benign prostatic hyperplasia and hair loss.

Duprost can also be used in the treatment of hair loss in mens. It may take 3-6 months to see any significant results after taking the medication.

The drug is available in the form of capsule under the following brand name and strength on our website:

  • Duprost – 0.5 mg Capsule

Buy Duprost – 0.5 mg online wemailmd.com.

The dosage depends upon the various factors such as age, weight, medical condition and your response to the treatment. Therefore, your doctor will decide the correct dose. Take the dose exactly as prescribed by the doctor. Never take two capsules at one time to double the doses.

Diarrhea, nausea, vomiting, dizziness and rash are the common side effects of Dutas. If any of these effects continues for a long time or deteriorate, contact your doctor immediately.

Beware ! Some medicines for prostate hypertrophy increase risk of Diabetes

Prescribed drugs to help them urinate are a third more at risk of type 2 diabetes- Research shows

Men who take medication to reduce their symptoms of prostate disease may be more likely to develop type 2 diabetes, research suggests.

Patients with enlarged prostates who are prescribed drugs called 5-alpha-reductase inhibitors are around a third more at risk of the condition.

They reduce the production of androgens, a hormone which help to boost urinary flow, a common problem among men with enlarged prostates.

But these drugs – which include finasteride and dutasteride – may slow metabolism and reduce the body’s insulin sensitivity, which can trigger type 2 diabetes.

The research was carried out by the University of Edinburgh and University College London. It was led by Professor Ruth Andrew, a personal chair of pharmaceutical endocrinology at Edinburgh.

‘We found that commonly prescribed medications for prostate disease can increase risk of type 2 diabetes,’ Professor Andrew said.

The 5-alpha-reductase inhibitors are often prescribed to treat benign prostatic hyperplasia (BPH), the medical term for an enlarged prostate.

This becomes more common with age, with an estimated prevalence of between eight and 60 per cent in men aged 90.

To determine the health effects of the drug, the researchers analysed the health records of 55,275 men in the UK who had been prescribed 5-alpha-reductase inhibitors for their BPH over 11 years.

Results – published in the British Medical Journal – revealed the drugs raise a man’s risk of developing type 2 diabetes by around one-third.

Dutasteride Market Rise

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The global Dutasteride market is valued at xx million US$ in 2018 is expected to reach xx million US$ by the end of 2025, growing at a CAGR of xx% during 2019-2025. This report focuses on Dutasteride volume and value at global level, regional level and company level. From a global perspective, this report represents overall Dutasteride market size by analyzing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, China and Japan. At company level, this report focuses on the production capacity, ex-factory price, revenue and market share for each manufacturer

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Browse 100+ market data Tables and Figures spread through Pages and in-depth TOC on ” Dutasteride Market by Type (, Avodart & Generic Avodart), by End-Users/Application (Hospital & Drug store), Organization Size, Industry, and Region – Forecast to 2023″. Early buyers will receive 10% customization on comprehensive study.

In order to get a deeper view of Market Size, competitive landscape is provided i.e. Revenue (Million USD) by Players (2013-2018), Revenue Market Share (%) by Players (2013-2018) and further a qualitative analysis is made towards market concentration rate, product/service differences, new entrants and the technological trends in future.

Generic copies of Avodart ready to hit market

Local pharmaceutical companies are preparing to release generic copies of Avodart (dutasteride), a treatment for enlarged prostate and hair loss, with reduced side effects.

The Ministry of Food and Drug Safety recently approved JW Pharmaceutical’s Jdart Tab., Dong-A ST’s Dutavan Plus Tab., Daehan New Pharm’s NPdart Tab., and JW Shinyak’s Neodart Tab.

These generics come in tablets, unlike Avodart and previous generics in soft capsules.

Soft capsules might be uncomfortable if they are stuck inside the mouth or the esophagus. The latest Avodart generics improved the patient convenience.

JW Pharm applied its technology called “self-micro emulsifying drug delivery system” (SMEDDS). SMEDDS converts insoluble agents to soluble ones, making body absorption quick.

The drugmaker unveiled the development of Jdart in March. It was the first in Korea to develop a dutasteride tablet.

JW Pharm completed the patent application for the dutasteride tablet in September last year. Dutasteride is effective in reducing urinary difficulties caused by enlarged prostate and acute cramps that make it difficult to release the urine. The agent is also known to prevent hair loss.

As Avodart’s patent expired in 2016, more than 30 generics have arrived in the market in severe competition.

GlaxoSmithKline, the supplier of Avodart, signed a contract with Teva-Handok to sell Avodart’s identical clone Zygard to counter attacks from generics.

To win the competition against the original treatment, Chong Kun Dang secured the generic exclusivity. Hanmi Pharmaceutical’s copy is only one-third of the size of Avodart.

With JW Pharm’s release of a similar tablet with minimized side effects, the competition in the Avodart-targeting market is likely to intensify.

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fincar

Buy Finasteride (Fincar) 5 mg

Order Generic Propecia 5mg – Fincar (Cipla)


Active substance: Finasteride
U.S. Brand: Propecia
Indian Brand: Fincar
Made by:
Strength: 5 mg
Form release: blister with 10 tablets
Shipping time: 7 – 21 days
Best price: 0.49 USD
Order:
through request form


DescriptionHow to take?Common Side EffectsLatest New'sPhoto's

Fincar 5mg tablets contain finasteride 5 mg, which is used to treat benign prostatic hyperplasia (BPH or enlarged prostate) and male pattern baldness. Fincar 5mg tablets inhibit the formation of the male hormone dihydrotestosterone (DHT), which causes enlarged prostate and hair loss.

Fincar 5 mg tablets known as the generic of Finasteride 5 mg, is mainly used to treat BPH (Benign prostatic hyperplasia or enlarged prostate) to minimize the prostate size and reduce the risk of urinary retention.

The tablets are also famous for treating male pattern hair loss (androgenetic alopecia). Androgenic alopecia is a very common type of hair loss in males that affects almost 70% of the men population. It helps in increasing the hair growth and prevents further hair loss from the scalp.

 

The dose of the medicine is fixed after taking into consideration several factors such as severity of condition, response to treatment, drug interaction and so on. Usually the dose that is prescribed is one tablet per day. It is recommended not to take more or less than the dose prescribed by your doctor as it may result in adverse effect in the body.

Fincar may cause the following side effects: headache, runny nose, fainting feeling, skin rash, dizziness, weakness, swelling and tenderness in the breasts, abnormal ejaculations, loss of sex drive, swelling in feet and hands, difficulties reaching an orgasm.

Finasteride shows long-term safety for prostate cancer prevention

Finasteride safely prevented prostate cancer, despite previous findings that suggested the drug increased the risk for high-grade disease, according long-term data published in The New England Journal of Medicine.

The latest results report mortality over 2 decades among men in the Prostate Cancer Prevention Trial, which previously found that finasteride reduced risk for prostate cancer by 24.8% compared with placebo.

However, trial results also showed that the drug increased the number of high-grade prostate cancers, leading to a warning label from the FDA. Although additional data showed finasteride improved detection of prostate cancer and high-grade prostate cancer by improving the performance characteristics of PSA testing, digital rectal examination and the prostate biopsy — which could explain the conflicting original results — questions regarding the risk of the drug persisted.

Finasteride, a 5-alpha-reductase inhibitor, also is used to treat lower urinary tract problems and male pattern baldness.

“The men most likely to benefit are those we see in the study — they are 55 years or older and are undergoing PSA testing,” Ian M. Thompson Jr., MD, chair of the genitourinary cancer committee for SWOG Cancer Research Network and president of CHRISTUS Santa Rosa Hospital Medical Center, told HemOnc Today. “The magnitude of the benefit may be greater in men who are at higher risk for prostate cancer, that being a man with a family history or an African-American man. … But what we found in the original study is that all men — regardless of family history, race, ethnicity and so forth — have a risk reduction.”

Researchers of the trial randomly assigned 18,882 men — enrolled from 1993 to 1997 — to receive finasteride or a placebo for 7 years.

At median follow-up of 18.4 years, 42 men in the finasteride group and 56 men in the placebo group had died of prostate cancer.

The 25% lower risk for prostate cancer death with finasteride was not statistically significant (HR = 0.75; 95% CI, 0.5–1.12).

However, Thompson said the results eliminate concerns about the possible risk for more aggressive cancers with finasteride, which he described as an inexpensive and reliable prostate cancer prevention drug.

He said that he is unaware of a clear process that would take the warning label off the drug.

“But it’s not just changing the warning. It’s also putting in the label that this drug results in an unequivocal reduction in the risk for cancer,” Thompson told HemOnc Today. “This is really a big deal. … If we had known this at the time the study was originally published, my suspicion is that many or most men who are [aged] 55 years or older would be taking this medication. But because it had a stain on it … it’s kind of like a sticky fact. The trick will be helping the community get rid of that sticky fact and go back to this original discovery.

“This is the most common cancer in men,” Thompson added. “If men at risk for prostate cancer took this, we could eliminate 40,000 to 50,000 prostate cancer [diagnoses] a year, and that’s a huge deal from a cost and suffering standpoint.” – by John DeRosier

For more information:

Ian M. Thompson Jr., MD, can be reached at: ian.thompson2@christushealth.org.

Disclosures: The NCI and NIH funded this study. Thompson reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

What is the Role of the Pharmacological Use of Finasteride in Male Patients?

Look at the most common pharmacological use of finasteride in males

Finasteride is a popular drug known for its multiple uses. You can find finasteride in drug stores as Proscar and Propecia. The drug is used mainly as treatments for androgenetic alopecia popularly known as male pattern baldness and enlarged prostate. The most common pharmacological use of finasteride in male patients include:

Scalp hair loss

Treating male pattern baldness (a condition that develops in almost 80 percent of Caucasian men) is one of the most popular uses of finasteride. In the United States, finasteride is one of two drugs approved by the FDA for treatment of hair pattern loss.

Finasteride works by lowering the level of scalp and serum DHT. By doing this, finasteride can maintain or increase the number of terminal hairs in the anagen phase by inhibiting and sometimes reversing miniaturization of the hair follicle. Finasteride has shown to be most effective on the vertex but can reduce hair loss in all areas of the scalp.

The drug has been shown to provide up to 30 percent improvement in hair loss after six months of treatment. One thing to note is that the effectiveness of finasteride persists as long as the drug is taken. The drug should be taken regularly in order to get the most benefit from it.

Enlarged prostate

It is best to buy finasteride tablets online. The drug is known to improve BPH symptoms such as difficulty urinating, getting up during the night to urinate, hesitation at the start and end of urination, and decreased urinary flow.

In long-term studies, finasteride has been shown to reduce the risk of acute urinary retention (−57% at 4 years) and the need for surgery by about 54% over the same period. However, if the drug is discontinued, any therapeutic benefits are reversed within about 6–8 months.

Prostate cancer

In 2010, Cochrane reported that patients who take 5α-reductase inhibitor chemoprevention (like finasteride) have a 25 or 26 percent less chance of developing prostate cancer. An independent study carried out by Medicare claims of that the significant reduction in prostate cancer risk is also maintained even after discontinuation of treatment.

The downside to this is that 5α-reductase inhibitors have been found to increase the risk of developing certain rare but aggressive forms of prostate cancer (27% risk increase), although not all studies have observed this.

Side Effects of Taking Finasteride

Like every other drug, finasteride has its side effects. Some of the common side effects include, decreased sexual ability/desire, in some men, this medication can decrease the amount of semen released during sex.

However, there have been very few reports of serious allergic reaction to this drug. While this is unlikely, you should seek immediate medical attention if it occurs. To know if you have an allergic reaction to this drug: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

P.S: Finasteride is prescribed for only adult males, it should not be taken by women (pregnant women are not advised to handle it) and children.

Finasteride Not Tied to Increase in Prostate Cancer Mortality

(HealthDay News) — Finasteride is not associated with an increased risk for death due to prostate cancer, according to a research letter published in the New England Journal of Medicine.

Noting that a previous trial showed that finasteride was associated with a reduced risk for prostate cancer compared with placebo but a higher risk for high-grade cancer, Phyllis J. Goodman, from the Fred Hutchinson Cancer Research Center in Seattle, and colleagues examined whether finasteride would lead to an increase in prostate cancer mortality. To address this question, the authors calculated the cumulative incidence of death from prostate cancer among all participants who underwent randomization.

The researchers found that during 296,842 person-years of follow-up and a median follow-up of 18.4 years, there were 3048 deaths in 9423 men randomly assigned to finasteride (42 due to prostate cancer) and 2979 deaths in 9457 men randomly assigned to placebo (56 due to prostate cancer). The 25% lower risk for death from prostate cancer with finasteride was not statistically significant because of the small number of deaths from prostate cancer.

“The early concerns regarding an association between finasteride and an increased risk of high-grade prostate cancer have not been borne out,” the authors write.

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Reference

Goodman PJ. Long-Term Effects of Finasteride on Prostate Cancer Mortality. N Engl J Med 2019; 380:393-394. DOI:10.1056/NEJMc1809961

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