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Tadact 10mg/20mg tab Tadalafil Review: Erectile Dysfunction Treatment from US FDA-Approved IPSA Laboratories

by Jacob Thompson 2017-03-01

Tadact 10mg/20mg is one of the products indicated for the use of patients diagnosed with the condition Erectile Dysfunction (ED), which affects a significant number of the male population. The patients affected with ED typically lose control over their erectile function and find it difficult to get an erection and maintain the response even with the presence of sexual stimuli and ED is usually due to a large number of physiological and psychological causes [1].

Medications usually given by doctors to patients suffering from the disease usually fall into the category of the drug classification of phosphodiesterase inhibitors and specifically, those medications dealing with the type-5 phosphodiesterase [2]. Well-known treatments from the PDE5 inhibitor drug family are Sildenafil Citrate, Tadalafil and Vardenafil [2]. Patients prescribed with the PDE5I drugs such as Tadalafil have improvements in their ED, although the effects are temporary. Medical science has yet to discover a cure for erectile dysfunction and for now, the PDE5Is should suffice.

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The product Tadact 10mg/20mg is made available by the company IPCA Laboratories Limited, which belongs to one of the generic manufacturers in India [3]. India is well known to be one of the largest countries in terms of generic manufacturing and IPCA Laboratories contribute to the annual pharmaceutical output of the country. As for the available dosage forms for Tadact, it is sold in 10 and 20 mg variants [3], but in oral tablet form only. Tadalafil products like Tadact are known to keep its effects for up to 36 hours [4], that’s why Tadalafil is usually preferred over Sildenafil or Vardenafil treatments.

About IPCA Laboratories Ltd

Belonging to the roster of the renowned international pharmaceutical companies in India is Tadact’s manufacturer, IPCA Laboratories Ltd, which has been existing for more than 60 years in the pharmaceutical/healthcare business [5], as it was founded in the year 1949 [6]. The company, being an international company, has its products distributed to 110 of the world’s countries in Asia, Africa, Europe, the United States, and Australia [5].

IPCA is specialized in the manufacture of active pharmaceutical ingredients (APIs) and sells them to companies worldwide [6]. It is famous for its production of anti-malarial agents and distributes 34% of the world’s anti-malarial products [5]. Aside from that, the company is also a leader in the production of Disease Modifying Anti-Rheumatic Drugs or DMARDs for rheumatoid arthritis [5].

IPCA Laboratory

IPCA Laboratory

IPCA also has partnerships with various renowned pharmaceutical companies including GSK (GlaxoSmithKline), Merck, Roche, AstaZeneca, and Sanofi-Aventis and has established its partnerships with these companies for years [5].

The company IPCA currently is home to 350 product formulations and 80 APIs [6] which the company manufactured in high-quality, international standards for manufacturing. As for IPCA’s accreditations, it currently holds the coveted approvals of the drug regulators such as the US FDA, Europe EDQM, Geneva WHO, UK MHRA, and a number of other agencies [5].

Scientific Studies on Tadalafil

Phosphodiesterase 5 inhibitors (PDE5I) are all effective in the treatment of erectile dysfunction and are approved in countries for the effective treatment of the condition. Although the effects of these drugs are comparably similar, there are studies which actually note the preference of patients of Tadalafil over the other PDE5 inhibitors such as Sildenafil Citrate or Vardenafil. The study of Govier et al in 2003, “A multicenter, randomized, double-blind, crossover study of patient preference for tadalafil 20 mg or sildenafil citrate 50 mg during initiation of treatment for erectile dysfunction” is one of the studies which determined the preference of the patients for Tadalafil or sildenafil for the treatment of erectile dysfunction [7]. Aside from determining the user preference for either Tadalafil in 20 mg and Sildenafil in 50 mg for ED primary treatment, the study also determined both drugs’ tolerability in the patients for the mentioned doses [7]. There were 215 patients previously diagnosed with ED and randomized to Sildenafil-Tadalafil(109) and Sildenafil-Tadalafil (106) for 4 weeks for the initial medication and an additional 4 weeks for the other [7]. Although 215 were enrolled, only 190 were able to complete the treatment [7]. Based on the results received from the study, patients preferred Tadalafil treatment over the Sildenafil treatment, as 66.3% of the patients were in favor of Tadalafil compared to the 33.7% who preferred Sildenafil [7]. In general, both medications were well-tolerated, although there were incidences of side effects in a fraction of the patient population [7]. Headaches appeared in 11.2% of the Tadalafil-treated patients and 8.8% in Sildenafil-treated ones, dyspepsia (6.0% and 4.2% for Tadalafil and Sildenafil respectively), nasopharyngitis (4.7% and 2.8%), and flushing (2.8% and 4.7%) [7]. The authors of the study concluded that both medications were effective in the treatment of erectile dysfunction and were generally well-tolerated, although patients preferred Tadalafil (20 mg) over Sildenafil (50 mg) as a treatment for erectile dysfunction [7].

Erectile dysfunction in patients comes from diverse etiologies and underlying diseases play a great role in the disease’s pathophysiology. Diabetes in patients with ED is prevalent and studies were conducted in the past years to determine the disease’s effect on the patients’ response to erectile dysfunction treatment. Fonseca et al in 2004 in their study, “Impact of diabetes mellitus on the severity of erectile dysfunction and response to treatment: analysis of data from tadalafil clinical trials” characterized the safety and effectiveness of using Tadalafil as a treatment of ED patients with diabetes [8]. The study involved 637 patients with ED and with diabetes and randomized them to varied doses of Tadalafil (10 mg or 20 mg) or placebo, and the results were compared with 1681 men with ED but with diabetes [8]. The baseline values determined that diabetic patients were suffering from more severe cases of ED than those participants without diabetes as reflected by their IEEF (International Index of Erectile Function) scores [8]. The results of the study reflected that Tadalafil in both doses (10 mg and 20 mg) was effective in improving the erectile function of both patient groups and that the response of the male patients to Tadalafil was similar in nature despite the existence of current diabetic treatment of the ED-diabetic group [8]. The researchers concluded that Tadalafil is also effective in the treatment of patients with comorbid ED and diabetes although their diagnosis was more severe than those ED patients without diabetes [8]. Authors also noted that Tadalafil elicited a more positive response in the diabetic population as compared to the lack of effectiveness of other PDE5 inhibitors lie Sildenafil in patients with ED and diabetes [8].

How Tadalafil Acts

Inhibitors of the enzyme PDE5 (Phosphodiesterase 5), like Sildenafil Citrate, Tadalafil and Vardenafil, all function in patient with ED by blocking the enzyme’s action in instantly metabolizing the cGMP (cyclic guanosine monophosphate) released in patients during sexual stimulation. This immediate degradation of the cGMP in patients results to the inability to attain or maintain an erection, as cGMP is the moderator for the patient erectile response.

As PDE5 inhibitors block the PDE5 enzyme’s action in destroying cGMP present in the penile tissue, the high cGMP level is maintained. Since this is so, cGMP is able to command the relaxation of the smooth muscles in the penile walls and encourage the blood flow increase in the spongy tissue of the penile corpus cavernosum, which equates to erection in patients. Since the half-life of Tadalafil is longer than Sildenafil Citrate or Vardenafil, patients experience a prolonged effect for Tadalafil as opposed to the mean 4 hours duration of the other two PDE5 inhibitors.

Tadact Benefits for Erectile Dysfunction

Tadalafil benefits patients with symptoms of erectile dysfunction (ED) in every use by helping them restore their lost erectile function due to failed PDE5/cGMP/nitric oxide mechanisms mediated by a number of health factors. Every time the patients use Tadalafil, the patients should expect improvements in their erectile function, as the drug is able to restore the normal pathway of nitric oxide-cGMP in patients with ED.

Patients treated with Tadalafil or any PDE5 inhibitor treatment should expect to experience better erectile function and for prolonged periods. Patients suffering from impotence are able to find relief with the use of Tadalafil, although the drug is not yet a cure for ED.

Doses and Therapy Length Recommendations

Initially, the patients are recommended 10 mg of Tadalafil to be used at least 30 minutes before intercourse or any sexual activity, as the drug works in about 15-30 minutes upon intake. When the response elicited by the drug is insufficient, the patients definitely can be given higher doses of Tadalafil (dose may be titrated up to 40 mg), depending on the patients’ need.

There is no actual length of therapy prescribed for Tadalafil use since it is only used on-demand. Several long-term studies for PDE5 use have been conducted and the long-term use of Tadalafil and other PDE5 inhibitors are generally safe. Patients, though, are recommended to take the medication only once in 24 hours regardless of the dose, to help the body to properly excrete the medication and prevent blood toxicity.

Daily doses of Tadalafil are also recommended for ED, pulmonary arterial hypertension, and benign prostatic hyperplasia (for urinary symptoms). Patients who were treated with the daily dose also show similar erectile responses as those who were treated with the as-needed/on-demand basis for Tadalafil.

Side Effects and Warnings

Common side effects experienced by patients prescribed with Tadalafil for erectile dysfunction include headaches, dyspepsia, facial flushing, and nasopharyngitis [7]. Aside from those side effects, patients also report back pain, muscle pain, and dizziness [9].

Although the side effects described for patients are generally manageable and are transient in nature, there are cases where the patients are able to experience more severe side effects. Patients with risks for cardiovascular diseases should be wary of symptoms pertaining to heart attacks and should report any signs of chest pain radiating to the jaw and the upper extremities [9].

Patients should also stop using the medication should they experience sudden vision loss (NAION) or vision changes, hearing loss, nausea, lightheadedness, tinnitus, allergic reactions, and painful erections that last for more than 4 hours [9]. Although not all the side effects of Tadalafil can be categorized in a single list, patients should be alert and aware of the unusual changes in their bodies which may be the result of Tadalafil use.

Drug Interactions

Since there are a couple of medications which are not recommended to be taken by patients planning to go on a Tadalafil treatment, the patients should be open regarding the medications which they are currently taking to prevent unwanted drug interactions as a result of the drug incompatibilities.

Tadalafil taken with nitrates, blood pressure medication, chest pain/angina medication, and recreational drugs (“poppers”) can cause a dangerously low blood pressure in patients [10]. Aside from these, patients are also contraindicated to take alpha-blockers for prostate hyperplasia [10].

There are also drugs which may interfere with the mechanism of action of Tadalafil like antifungal medications, macrolide antibiotics, protease inhibitors, hepatitis C protease inhibitors, and HIV protease inhibitors, so these medications are also generally prohibited to be consumed with Tadalafil [10].

Customer Reviews

Tadact Review
One review was available for IPCA Laboratories’ Tadact and the reviewer posted his 5/5 star comment for the product on Safegenericpharmacy.com. The user was generally happy with the product, as he stated that the drug is effective in helping him regain his erectile function. He even described the drug as “magic”, referring to the product’s effectiveness. The patient recommends the product for other patients to use too.

Although a single review does not represent all of the reviews for the overall population taking Tadact for erectile dysfunction, the review is encouraging to read, especially for patients looking for cheaper generic alternatives which are as effective as the more expensive brand-name products.

As for my recommendation, I think a single patient reference is better than none, so I think Tadact 10mg/20g is a good product to try. The recommendation is not baseless too, as I am recommending the purchase of the product on the account of the manufacturer’s good reputation due to its numerous accreditations.

Price, Available Forms and Dosage

Tadact is available for sale in a number of online pharmacies and it is also eligible for international shipping. It may be due to the maker’s international accreditations for its products which equate to being able to ship the product worldwide.

Tadact Prices

Tadact Prices

As for the product price, Tadact 10 mg tablets are cheap; 10 tablets of the 10 mg costs $1.40 only, while the higher dose (20 mg) costs a mere $2.62 for 10 tablets. This product’s price is one of the cheapest in the market for Tadalafil treatment, which is great, as the product is made by a reputable company.

Tadact Shipping Options

Tadact Shipping Options

There are several shipping options offered by one Tadact vendor (Oms99.com) and the shipping options vary depending on the courier speed. India shipping fees range from $1.45 to $7.31, while international shipping costs are either $65.91 for the fast option and $29.29 for the slow shipping option.

Since these are the costs for the shipping of Tadact for one particular vendor, patients should look for vendors offering the right price for the medication while offering affordable shipping options too. If patients from the US, Australia, and Canada) are asked to pay $65 for the shipping, they can just look for Tadalafil alternatives in their area with the same price than pay for an enormous fee for the international shipping.

Tadact 10mg/20mg are also found in many countries too, like the United States, the UK, and Europe, so patients from those areas may locate Tadact domestically.

Reference List

  1. En.wikipedia.org: Erectile dysfunction. Accessible from: https://en.wikipedia.org/wiki/Erectile_dysfunction
  2. Medscape.com: Comparison of Phosphodiesterase Type 5 (PDE5) Inhibitors. Accessible from: http://www.medscape.com/viewarticle/542736_4
  3. 1mg.com: TADACT 20 MG TABLET. Accessible from: https://www.1mg.com/drugs/tadact-20-mg-tablet-137671
  4. Safegenericpharmacy.com: Tadact 20 mg. Accessible from: https://safegenericpharmacy.com/tadact-20mg.html
  5. Ipcalabs.com: Profile. Accessible from: http://www.ipcalabs.com/active-pharmaceutical-ingredients-manufacturers-about-us.html \
  6. En.wikipedia.org: Ipca Laboratories. Accessible from: https://en.wikipedia.org/wiki/Ipca_Laboratories
  7. Govier F, Kaufman J, Potempa AJ, Denne J, Ahuja S, Kovalenko P. A multicenter, randomized, double-blind, crossover study of patient preference for tadalafil 20 mg or sildenafil citrate 50 mg during initiation of treatment for erectile dysfunction. Clinical therapeutics. 2003 Nov 30;25(11):2709-23. Accessible from: http://www.sciencedirect.com/science/article/pii/S0149291803803284
  8. Fonseca V, Denne J, Seftel, Fredlund P. Impact of diabetes mellitus on the severity of erectile dysfunction and response to treatment: analysis of data from tadalafil clinical trials. Diabetologia. 2004 Nov 1;47(11):1914-23. Accessible from: https://www.researchgate.net/publication/8129626_Impact_of_diabetes_mellitus_on_the_severity_of_erectile_dysfunction_and_response_to_treatment_Analysis_of_data_from_tadalafil_clinical_trials
  9. Medicinenet.com: tadalafil (erectile dysfunction) – oral, Cialis. Accessible from: http://www.medicinenet.com/tadalafil-oral/page3.htm
  10. Medicinenet.com: tadalafil (erectile dysfunction) – oral, Cialis. Accessible from: http://www.medicinenet.com/tadalafil-oral/page5.htm

Editor's Rating

Overall Score
There is only one review available for Tadact 10mg/20mg tab, but it is positive, though. Tadact is not as popular as the other Tadalafil brands, but looking at its maker’s portfolio, one can be easily impressed; there are only a few local Indian companies having the US FDA’s seal of approval. Since the product did not have many reviews, I am just rating Tadact 4 out of 5. I highly recommend the product, though, given its company’s impressive portfolio. Not many domestic companies are accredited by the US FDA, and IPSA Laboratories being certified by the US FDA and other international regulatory speaks largely about the company’s quality manufacturing practices.
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