Tadalista Centurion Laboratories is an example of the internet-sold generic medications for erectile dysfunction in men. The brand “Tadalista” by Centurion Laboratories coincides with another Tadalafil brand “Tadalista” but by Fortune Healthcare . There were mentions of the Centurion Laboratories’ product in forum websites, and there are also internet photos of the pills. It is unusual, though, that two separate manufacturers are able to have the same name for their products. There was no news of the dispute and the settlements, but Centurion Laboratories seems to make Vidalista for its Tadalafil-containing goods and Fortune Healthcare continues to bear the Tadalista name for its Tadalafil medicines.
Generic products for impotence are popular over the internet due to their low costs . But there is a big issue regarding the safety and the regulatory approvals of these drugs since currently, there is only a handful of US FDA approved generic treatments for erectile dysfunction (Teva, Sandoz) and marketed in a handful of areas alone .
The product Tadalalista by Centurion Laboratories is only one of the numerous generic products manufactured by the country India annually. India is known to be one of the major players in the global pharmaceutical industry, as it is the 3rd largest producer of meds globally in terms of volume . India is home to numerous multinational pharmaceutical companies due to low production costs and low manpower costs.
In the recent years, the Indian Pharmaceutical industry has been a subject of public scrutiny, especially by the US Food and Drug Administration . Large pharmaceutical companies have been sanctioned and issued warning letters due to noncompliance or due to interfering with test results . Also, Indian pharmaceuticals have been tainted with reports of counterfeit, substandard, and ineffective medications. However, this does not mean that all of the medications coming from the country are of low quality; buyers and medical health professionals just have to screen their medications well and do their homework regarding the manufacturer integrity and the current regulatory approvals of the medicines they are unsure of.
About Centurion Laboratories
The company Centurion Laboratories is one of the few native Indian companies in the country. Centurion started in 2006 , although there are sources stating that the company was incepted in 1995. Its CEO is Ambalal Patel and Centurion currently employs “101-500” people under its care . According to the company’s mission, it aims to serve its clients with high-quality medicines but at low and affordable prices.
There are little-known certifications for Centurion Laboratories. Centurion’s website mentions an “NSIC D&B D-U-N-S No.(65-056-7063)” certification, GMP approval for its 2500 square meter facility, and a WHO-GMP certification for its B-Lactum plant. Concerning the company’s products, Centurion creates products for various merchandises in the expanses of pharmaceutical and nutraceutical medicine, cold and cough medicines, pain management, antibiotics, psychiatric medications, antiseptic ointments, allergy, cardiovascular, and men’s health.
Scientific Studies for Tadalafil
Clinical trials and investigations were piloted and organized in the previous years subsequent to the discovery of the Tadalafil brand-name treatment in 2003. There were studies which are targeted at verifying the efficacy of Tadalafil in treating patients with impotence, determining the ideal administration modalities, ascertaining the possible side effects, and others. One of the studies vested in verifying the effectiveness of Tadalafil in patients is the one performed by Seftel and his colleagues in 2004, “The efficacy and safety of Tadalafil in United States and Puerto Rican men with erectile dysfunction” . The study centered on gauging the safety and the effectiveness of Tadalafil when taken on an on-demand basis for the treatment of impotence/erectile dysfunction ranging from mild to moderate . 207 patients were randomized to either 20 mg of Tadalafil or placebo for 12 weeks and were assessed for their answers to the SEP (Sexual Encounter profile) diary Question 2 for successful penetration and Question 3 for successful intercourse; and their GAQ (Global Assessment Question) responses . Their IIEF-EF (International Index of Erectile Function erectile function) scores were also assessed pre and post the administration of the therapy . Based on the results of the study, the men treated with Tadalafil had greater mean changes in their IIEF-EF scores in comparison with the placebo results. 31.6% of the patients were also able to have successful penetrations, 43.5% were able to have successful intercourse attempts, and 67.6% had successful intercourse attempts per treatment group percentage compared to the low placebo patient scores . It was noted by the participants that their success in penetration attempts occurred mostly within 4 to 36 hours of Tadalafil intake . The success in the penetration and the intercourse attempts in the patients may be attributed to the patients’ improved erections (82.8% reported to have improved erectile response) based on the patients’ response to GAQ . During the study, treatment side effects which surfaced are headache, back pain, and dyspepsia, which all had higher incidence rates than placebo (highest incidence was 15% amongst all the patients) . Seftel et al concluded that Tadalafil is able to substantially improve the erectile response of the ED patients and was well-tolerated by the patient group treated with the medication .
If Seftel et al’s study assessed the effectiveness of Tadalafil in patients suffering from impotence in the United States and Puerto Rico, the study Eardley et al in 2004, “Efficacy and safety of tadalafil in a Western European population of men with erectile dysfunction” verified the safety and the effectiveness of Tadalafil in patients with erectile dysfunction treated with the drug . The randomized, double-blind, placebo-controlled, multicenter trial evaluated the safety and the response of the patients to the then newly introduced PDE5 (phosphodiesterase type-5) inhibitor drug, Tadalafil in patients from Western Europe who were diagnosed with mild to severe impotence severities . The participants in the study were randomized to either Tadalafil 20 mg or placebo for 12 weeks (randomized to corresponding ED severity and 3:1 to Tadalafil and placebo) . The patients were evaluated for the changes in the baseline values for their IIEF (International Index of Erectile Function) scores, their responses to the SEP (Sexual Encounter Profile) Question 2 regarding successful penetration, and Question 3 for effective/successful intercourse, and their GAQ (Global Assessment Questions) responses . 40.5% of the patients included in the study were with severe impotence and 80% of them have erectile dysfunction for more than a year . The outcome data from the study indicated that the Tadalafil can enhance the erectile function of the patients (reflected by their domain IIEF scores; added a mean of 11.1) . The participants treated with Tadalafil were also able to have successful sexual intercourse attempts (73.9%), and also were able to experience increased intercourse satisfaction. As for the GAQs, the responses of the patients indicated that Tadalafil is better than placebo in terms of bettering erections and sexual activity . Tadalafil, overall, was well received by the patients with mild to severe ED, although there were adverse events noted such as back pain, limb pain, headaches, myalgia, dyspepsia, and headache; however, these side effects were manageable (mild to moderate) .
Not only were studies for the efficacy of Tadalafil were conducted; there were also papers which investigated the differences of the results of the clinical trials conducted for Tadalafil, Sildenafil Citrate, and Vardenafil, like the study of Doggrell in 2005, “Comparison of clinical trials with sildenafil, vardenafil, and tadalafil in erectile dysfunction” . The study evaluated the salient points in the effectiveness of the three PDE5 inhibitors intended for the management of impotence in patients . According to Doggrell, Sildenafil, the 1st PDE5 inhibiting drug is reportedly effective in treating erectile failure in patients, as shown by the 77% and 84% effectiveness of the drug (50 mg and 100 mg, respectively) among men diagnosed with ED . Not only was Sildenafil effective in managing ED in patients with comorbid diseases such as prostate cancer, coronary artery disease, and psychogenic diseases. Vardenafil HCl, on the other hand, is a tweaked version of Sildenafil and is a more potent and more selective inhibitor of PDE5, as unlike Sildenafil, it does not inhibit PDE6, which is associated with color perception . Tadalafil is the latest PDE5 inhibitor made available in the market. Tadalafil, according to Doggrell, lasts longer and can take up to 36 hours in patients. Due to this, the drug is preferred by most of the patients able to try out both Sildenafil and Tadalafil medication . The author concluded that in the long run, Tadalafil may supersede the sale of Sildenafil in the market , due to the patient preference towards the drug and its lasting action, which equates to more value for the patients’ money.
Mechanism of Action of Tadalafil
Tadalafil’s effect is notably efficient in assuaging impotence symptoms in patients, predominantly due to its nature as a PDE5 inhibitor. Although there are 3 different types of PDE5 drugs, the effect of these are still the same; PDE5 inhibitors are selective inhibitors to the enzyme PDE5, which instigates the early destruction of the cyclic GMP (guanosine monophosphate). This premature destruction cGMP is the cause of the insufficient erectile response in patients. So Tadalafil’s suppression of the PDE5 enzyme facilitates the maintenance of the proper cGMP levels crucial for the initiation of the erectile response. Proper cGMP levels in the penile tissue allow the smooth muscle cell relaxation in the corpus cavernosum, which then potentiates vasodilation and commences the greater blood flowing to the penile tissues. Since PDE5 inhibitors like Tadalafil is able to block PDE5 enzyme function for a long time, patients can expect the restoration of their erectile response in several hours (in Tadalafil’s case, more than 24 hours).
Tadalista Effects for Erectile Dysfunction
Tadalafil is one of the first treatments doctors consider for their patients when it comes to impotence management. PDE5 inhibitors like Tadalafil are effective in mitigating the effects of erectile dysfunction in patients. Often males suffering from erectile failure are not able to have their erections naturally; with the help of Tadalafil, the patients are able to respond amply to sexual stimulation, which they are not able to do on their own.
Recommended Dosage and Length of Treatment
There is very little information on the web regarding Tadalista Centurion Laboratories. Even in Centurion Laboratories’ website, Tadalista is not searchable. There are fragments of information scattered on the Internet regarding Tadalista Centurion Laboratories, but there was no explanation why the product coincided with the name of Fortune Healthcare’s Tadalista for Tadalafil.
The product is manufactured in the traditional pill form (2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg) and in soft/chewable tablets and sublingual tablets, which are also similar to the dosage formulations available for Tadalista Fortune Healthcare. Concerning the intake, Tadalista (Centurion) may be consumed as needed, with or without food, as desired by the patients. Since Tadalafil products are effective for up to 36 hours, there is a restriction for the consumption of the next Tadalafil dose; patients should take their subsequent Tadalafil dose in 36-48 hours post the initial dose to prevent adverse interactions or the upsurge of the side effects.
Minor side effects related to the use of Tadalista by Centurion Laboratories are the adverse events common to Tadalafil intake headaches, back pain, facial flushing, and dyspepsia. These side effects are observable in some patients; while common, these side effects are not experienced by all the patients taking Tadalafil drugs, although patients should watch out for these treatment-emergent side effects when taking Tadalista.
Tadalafil interacts with nitrate-containing medication, so any Tadalafil-containing product is not recommended to be taken by any patient on nitrate meds. Nitrates are commonly used for hypertension, heart disease management, recreational drugs, and others. The consumption of Tadalafil and nitrates may cause a critical lowering of the blood pressure in patients. Aside from the nitrate meds, patients should also avoid anti-fungal meds, antibiotics, Hepatitis C medication, and others. Patients should adhere to taking Tadalista or any Tadalafil drug under the direct supervision of the doctors to evade harm.
It is quite hard to find references to Tadalista from Centurion Laboratories as most of the user comments for Tadalista were for Tadalista made by Fortune Healthcare. Feedback for Centurion’s Tadalafil products was for Vidalista mostly. There was one mention for Tadalista Centurion Laboratories, though:
The user who posted February 2016 on one of the threads on Pharmacyreviewer.com mentioned that he was able to try out Tadalista 10 mg from Centurion but he did not have any luck with the results, although he mentioned that he was able to respond well to the brand-name Tadalafil counterpart of Tadalista (Cialis).
Pricing, Existing Forms, and Dosage
Unlike the other Tadalafil medications, there are only a few vendors selling Tadalista by Centurion Laboratories. Here are the available product pricings for the drug:
Alldaygeneric.com has Tadalista 40 mg available and has $74 as the cheapest product listing (60 pills plus 30 free). The store is one of the few selling Tadalista Centurion Laboratories online.
As for the 20 mg Tadalista Centurion Laboratories product, the item is charged at least $37.92 for the 10 pill pack. Aside from these suppliers, it is challenging to find other sellers with Tadalista Centurion Laboratories products available.
There is no clear reason why Tadalista Centurion Laboratories has an identical name with Tadalista Fortune Healthcare. But it is distinct that Fortune Healthcare is still manufacturing the brand and the current Tadalafil product Centurion Laboratories is known for is its Vidalista products. Also, no information about the current status of the awardee of the product name is available on the internet. There is a suspicion that Tadalista Centurion Laboratories may have been discontinued, but there is no copious proof that the production for the medicine has been suspended or ceased. It is still available in the market, though, so buyers can still try out the product when available. The rating for Tadalista Centurion Laboratories is just 2 out of 5, due to its confusing status.
- Fortunehealthcare.in: Tadalafil. Available at: http://fortunehealthcare.in/tadalafil.html
- Webmd.com: Buying ED Drugs Online: What’s the Risk?. Available at: http://www.webmd.com/men/buying-ed-drugs-online#1
- Fda.gov: First-Time Generic Drug Approvals – March 2016. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/ucm489688.htm
- Es.sandoz.com: SANDOZ BRAZIL LAUNCHES TADALAFIL, FIRST GENERIC VERSION OF CIALIS® TO TREAT ERECTILE DYSFUNCTION. Available at: http://www.es.sandoz.com/media_center/press_releases_news/global_news/2014_12_18_Sandoz_Brazil_launches_Tadalafil_first_generic_version_of_Cialis_to_treat_erectile_dysfunction.shtml
- En.wikipedia.org: Pharmaceutical industry in India. Available at: https://en.wikipedia.org/wiki/Pharmaceutical_industry_in_India
- Peoplespharmacy.com: How Reliable Are Your Generic Drugs From India?. Available at: https://www.peoplespharmacy.com/2016/02/15/how-reliable-are-your-generic-drugs-from-india/
- Seftel AD, Wilson SK, Knapp PM, Shin J, Wang WC, Ahuja S. The efficacy and safety of tadalafil in United States and Puerto Rican men with erectile dysfunction. The Journal of urology. 2004 Aug 31;172(2):652-7. Available at: http://www.sciencedirect.com/science/article/pii/S0022534705617107
- Eardley I, Gentile V, Austoni E, Hackett G, Lembo D, Wang C, Beardsworth A. Efficacy and safety of tadalafil in a Western European population of men with erectile dysfunction. BJU international. 2004 Oct 1;94(6):871-7. Available at: http://onlinelibrary.wiley.com/doi/10.1111/j.1464-410X.2004.05049.x/full
- Doggrell SA. Comparison of clinical trials with sildenafil, vardenafil and tadalafil in erectile dysfunction. Expert opinion on pharmacotherapy. 2005 Jan 1;6(1):75-84. Available at: http://www.tandfonline.com/doi/abs/10.1517/14656518.104.22.168