Sildenafil Teva 100mg/50mg Tablets Reviews: Alcohol-Restricted Viagra Generic Version

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Sildenafil Teva, the product of Teva (an Israel-based pharmaceutical company) is currently the first US FDA-approved generic drug for Sildenafil Citrate and used mainly for erectile dysfunction [1]. Sildenafil Teva and Viagra are presently the only Sildenafil drugs with the blessing of the FDA to be dispersed in the USA. However, the drug is not yet ready to be disseminated in the United States due to Pfizer’s hold. According to the reports, although Sildenafil Teva is US-market ready, it can be bought freely in December 2017 [2]. Teva paid a royalty to Pfizer before being allowed to market by the end of 2017, as Pfizer has the patent protection for its iconic erectile dysfunction drug, Viagra, until 2020 [2].

The drug, Sildenafil Teva, contains the same active pharmaceutical ingredient found in Viagra (Sildenafil Citrate). This active content is the one responsible for the success of these drugs for erectile dysfunction, although impotence is not the only indication for Sildenafil Citrate use. Sildenafil Citrate, which belongs to the category of phosphodiesterase PDE5-suppressors (along with Tadalafil (Cialis) and Vardenafil (Levitra)) is also approved by the FDA to be utilized for hypertension of the pulmonary kind and also for the urinary symptoms of BPH [3]. Besides those applications, though, there are a number of off-label uses being considered for Sildenafil Citrate, which we may expect in the coming years.

Teva’s Sildenafil exists in 100 mg, 25 mg and 50 mg [2], however, in the orthodox tablet form alone. Sildenafil Teva is actually available in other countries such as the United Kingdom and European countries (nations where Pfizer’s patent has already expired) even if the United States still prohibits its marketing [1].

About Teva

Teva Pharmaceuticals is one multinational company which has its headquarters stationed in Israel [4]. The company has its arms worldwide, including the United States, Canada, and 60 other countries [4]. Teva has been operating since its inception in 1901 and has since innovated largely to supply the world with top-class generic drugs.

Teva Pharmaceuticals ain Office

Teva Pharmaceuticals ain Office

According to the Internet sources, what’s significant to Teva is that it is, at present, the world’s largest generic drug manufacturer [5]. Besides that, it also is included in the roster of the fifteen biggest drug companies worldwide [5]. The company statistics states that Teva is capable of producing 64 billion tablets/capsules in a year. The massive production can be credited to the company’s 58,000 employees across the globe.

Teva features state-of-the-art facilities which have acquired various certifications worldwide. As mentioned on Teva’s company information, it is adherent to GLP, GCP and GMP (Good Laboratory/Manufacturing/Clinical Practice) and as a proof of its commitment to quality, Teva is FDA approved for its 26 manufacturing plants and also is EMA-certified for its 31 facilities [6].

Scientific Studies on Sildenafil

To establish the optimum dose of Viagra/Sildenafil in patients with erectile dysfunction, earlier studies were about dose optimization of Sildenafil. The study of Meuleman et al in 2001, “A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction” assessed how effective was Sildenafil in patients when administered to men with the impotence of various origins [7]. There were 315 men included in the study with various concomitant diseases/probable etiologies for impotence (pelvic surgery, hypertension, diabetes, heart disease) who were given with a starting dose of 25 mg to 100 mg of Sildenafil [7]. The treatment lasted for 12 weeks and the results indicated that 26% responded to 25 mg, 32% responded to 50 mg, and 42% responded to the 100 mg dose [7]. All of the doses were able to improve the patients’ orgasmic and erectile functions, and also causing the patients to have ameliorated satisfaction with their intercourse activity [7]. Overall, Sildenafil once again proved that it is both safe and efficacious for erectile dysfunction [7].

Like the first study, there were other studies who investigated Sildenafil’s effect in patients with inherent medical considerations. For instance, Blonde, in his 2006 paper, “Sildenafil citrate for erectile dysfunction in men with diabetes and cardiovascular risk factors: a retrospective analysis of pooled data from placebo-controlled trials” analyzed the efficacy of Sildenafil in patients with both diabetes and cardiovascular risks such as hypertension, smoking, and dyslipidemia [8]. The author studied clinical trial outcomes for the administration of 25mg, 50mg, and 100mg of Sildenafil in patients with the said concomitant diseases [8]. All in all, 11 trials were included (total of 974 men with impotence) which randomized the patients to either Sildenafil or placebo [8]. Based on the results from these trials, Blonde ascertained that Sildenafil Citrate even used in patients with the risk factors is beneficial for the patients (more than the action of placebo for the same patient groups) [8]. Although there were consistent side effects such as headaches, flushing, and dyspepsia, the rate of occurrence was low (7% is the greatest for any of these side effects), Sildenafil was tolerated properly by the patients and was deemed efficacious for impotence treatment regardless of the medical risks [8].

Novel routes of delivery for Sildenafil Citrate as a treatment for impotence are explored by the researchers. In 2004, Deveci et al conducted their study “Sublingual sildenafil in the treatment of erectile dysfunction: faster onset of action with less dose”, which presented the benefits of the sublingual Sildenafil preparation in patients with erectile dysfunction [9]. There were 40 male recruits suffering from impotence who were subjected to either 20mg of sublingual Sildenafil or placebo [9]. Based on the outcome of the study, 65% or 13 out of 20 patients taking sublingual Sildenafil showed excellent erectile response and coital success. Also, the sublingual preparation functioned at the rate of 15.5 minutes only after drug consumption [9]. The results of the study can benefit the patients in the future, as sublingual Sildenafil has a faster action onset and is also more economical due to the less dose needed for a substantial erectile response [9].

How Sildenafil Acts

Sildenafil Citrate is a drug which enables the males to have the appropriate erectile response whenever there is a sexual stimulus. However, that is only a summary of what the drug can actually do. The mechanism of Sildenafil Citrate in patients actually involves the inhibition of the PDE5 enzyme in order to propagate the blood flow to the penile tissues.

Patients with impotence are having trouble getting erections because their PDE5 enzyme has the precipitate action of destroying the erectile response before it actually occurs. Sildenafil merely ensures that an erection takes place and it does so by preventing PDE5 from destroying the de rigueur chemical signal for the instigation of the erectile response in male patients. By halting the effect of PDE5, Sildenafil is able to restore the balance needed for the instigation of an erection in patients with a disability of the erectile response.

Sildenafil Teva Effects for Erectile Dysfunction

We are informed by numerous studies and resources that Sildenafil does not have a singular effect. Due to its characteristic selectivity to PDE5 (which is located all over the body in specific tissues), the drug is also necessitous and invaluable to other medical conditions. However, its exertion on impotence is the one most recognized by the patients all over the world.

Sildenafil is effective in treating ED of various causes [7,8], that’s why patients who are given the drug can expect better erectile function from any Sildenafil product (such as Sildenafil Teva), regardless of their ED origin. The main benefit of Sildenafil Teva is the apparent appropriate erections when the males are stimulated, which lasts for about 4 hours in the patients’ system.

Recommended Doses and Continuation of Therapy

Males diagnosed with ED are usually bequeathed with a starting strength of 50 mg of Sildenafil. The dose may be upgraded to 100mg when the effect seems inadequate or relegated to 25mg when 50mg seems too strong for the patients. Regardless of the needed dose by the patients, the patients should let their physician decide on the dose adjustment and not do the optimization themselves. The doctors may also advise persisting in the current dose until the patents are well-acquainted with the dosage.

How long does it last? Sildenafil drugs such as Sildenafil Teva only stay for about 4 hours, so you may be tempted to take another dose to compensate for the loss of effect. However, this is not advised, as Sildenafil Citrate is restricted to only a single dose per day. If you want lasting effects, you may just want to consider other PDE5 drugs (the ones with Tadalafil in particular) as there are PDE5 inhibitor treatments which are able to last more than Sildenafil’s 4-hour effect.

Side Effects and Warnings

As described by the studies by Blonde and Deveci [7][8], side effects common to the use of Sildenafil Citrate in males with impotence are headaches, dyspepsia, and flushing. These three, although can be expected by the patients, does not really occur in great incidences. In one of the studies above [7], the greatest incidence of the side effects in clinical trials was 7%. However, the patients should still be made aware of the possibility of side effects or adverse events related to Sildenafil Citrate use.

Drug Interactions

Patients already taking other impotence drugs (may they be herbal or prescription) should not take their ED drugs with Sildenafil Citrate. The concomitant administration of two ED drugs may be harmful, toxic, or even detrimental to the patients.

Other drugs to avoid are Nitrates, which are drugs with the prime indication for blood pressure and heart disease. These Nitrate drugs can induce myocardial infarction or critical hypotension in patients. Besides those, patients should also avoid drugs for Hepatitis, AIDS, fungal infections, bacterial infections, and other similar conditions, since these drugs can alter the mechanism of action of Sildenafil in the body.

In addition, although it’s not a drug, alcohol is also restricted to be administered with Sildenafil due to its possible adverse interaction with the active ingredient. Alcohol is reported to cause hypotension and can also render the drug useless or ineffective.

Customer Reviews

Although it is amazing that Sildenafil Teva is actually the first generic impotence medication approved by the prestigious US FDA, the drug is not yet too popular in the online community. There were no reviews uncovered for Sildenafil Teva; in fact, the Indian generic meds which are used off-label have a greater number of feedbacks than Sildenafil Teva.

Teva may have been not too lenient with the distribution of Sildenafil Teva online, thus the reason for the lack of independent reviews. But since it is actually a US FDA-accredited drug, patients can be assured that notwithstanding the dearth of reviews, the drug is efficacious, safe, and reliable for impotence treatment.

Price, Drug Forms, and Available Dosage

Sildenafil Teva is available in three dose formulations (25mg, 50mg, and 100mg) as it was able to win FDA’s approval for all three. The drug is sold in various online stores and although generic, its price is a little steep compared to its generic contemporaries (probably due to its US FDA-approved status).

Sildenafil Teva Pricing

Sildenafil Teva Pricing

To prove the point, Sildenafil Teva is sold at about $7.50 each pill, when other generic brands are sold around $0.5-$3. However, when buyers are capable of purchasing more of the item, the patients can have discounts for Sildenafil Teva and can have the drug for as low as $3.75 each.

Sildenafil Teva Shipping Cost

Sildenafil Teva Shipping Cost

For shipping concerns, Sildenafil Teva is available to ship worldwide, courtesy of Pharmacy2home.com and other online drug-vending sites. The shipping rate is actually reasonable (Pharmacy2home.com at least) and is set at $16 flat rate.

Although the drug is not yet for release until December 2017, patients are considering online options such as this store for their Sildenafil Teva products. Patients from the USA can avail of the product online, although there is still a restriction on the sale of generic products in the area. Somehow, there is a backdoor. However, it is ideal to follow the laws concerning the importation of generic pharmaceuticals, as it is a more difficult situation to get caught and legally reprimanded for importing generic Viagra products.

Conclusion and Rating

Sildenafil Teva is actually impressive as it is the first generic product to be approved by the US FDA as a treatment for erectile dysfunction. Teva going against the giant Pfizer is remarkable, and that is actually good because the patients are going to have a more cost-effective option for their erectile dysfunction treatment. Pfizer has been asking for a lot for its Viagra product, and Teva stepping up against the company is good news for the patients who are unable to afford Viagra for impotence due to exorbitant cost. Sildenafil Teva, though it does not have reviews, can be given 5 out of 5 for being the first US FDA approved generic drug for impotence.

Reference List

  1. https://www.law360.com/articles/769742/fda-approves-teva-s-generic-viagra-tablets
  2. http://www.raps.org/Regulatory-Focus/News/2016/03/10/24515/Teva-Wins-FDA-Approval-for-First-Viagra-Generic-Will-Not-Launch-Until-2017/
  3. https://en.wikipedia.org/wiki/PDE5_inhibitor
  4. http://www.tevausa.com/TevaGlobal.aspx
  5. https://en.wikipedia.org/wiki/Teva_Pharmaceutical_Industries
  6. http://www.tevapharm.com/about/profile/quality_assurance/
  7. https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~Bmzt7g:122:@[email protected]@/cgi-bin/sis/search2/d?./temp/~wWjrcw:[email protected]
  8. https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~Bmzt7g:126:@[email protected]@/cgi-bin/sis/search2/d?./temp/~wWjrcw:[email protected]
  9. https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~Bmzt7g:123:@[email protected]@/cgi-bin/sis/search2/d?./temp/~wWjrcw:[email protected]
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