- 1 About Mesmer Pharmaceuticals/Icon Life Sciences
- 2 Clinical Research on Tadalafil
- 3 Description of Tadalafil Action
- 4 T-Fil Benefits for Erectile Dysfunction
- 5 Doses Recommendations and Duration of Therapy
- 6 Adverse Effects and Warnings
- 7 Contraindications
- 8 Customer Reviews
- 9 Price, Existing Forms, and T-Fil Dosage
- 10 Reference List
- 11 Editor's Rating
T-Fil 10mg/20mg tablets are Tadalafil tablets from yet another Indian manufacturer of pharmaceutical products, Mesmer (Icon Life Services).
Tadalafil is effective in the improvement of the patients’ erectile function diminished by age, underlying disease, psychological state, medications, or other reasons.
Aside from the use of Tadalafil in the management of Erectile Dysfunction, Tadalafil is also indicated for patients with Pulmonary Arterial Hypertension (PAH) and Benign Prostatic Hyperplasia (BPH)  but there are specific products/brands intended for the treatment of these two conditions.
There is no actual cure for Erectile Dysfunction, but Tadalafil products and other similar medications that belong to the category of Phosphodiesterase Type 5 Inhibitors are helpful in temporarily restoring a patient’s erectile function. The patients are allowed to have several hours of control for their erectile function with the use of Tadalafil products like T-Fil.
As for the available dosage forms, T-Fil is sold in 10 mg and 20 mg dosages, although the manufacturer only has the products in oral tablet form and none else.
About Mesmer Pharmaceuticals/Icon Life Sciences
The company Mesmer Pharmaceuticals is the maker of T-Fil Tadalafil product. The company was founded on 2004 and is located in Hyderabad, Telangana in India . Mesmer is known to manufacture products found in the anti-epileptic, anti-ulcer, hypertension, hepatoprotective, and protein supplement ranges .
Icon Life Sciences is the alternate name for Mesmer Pharmaceuticals . Aside from the mentioned areas of focus in manufacturing, Icon/Mesmer is also concerned with research and development in the area of Neuropsychiatry . According to Mesmer Pharmaceuticals, it will also venture into other areas of concern like pain management, diabetes, and cardiology in the future.
Icon/Mesmer currently has a reach limited to 16 states in India, but its goal is to saturate the nation in the coming years . One of the developments that the company is proud of is its gabapentin brand, PROGABA, which is the first pregabalin tablet formulation in India .
According to the company information, its facilities are accredited by the WHO and is also GMP certified. Since the company is able to operate locally in India, we can assume that it is also accredited by the country’s own FDA.
Clinical Research on Tadalafil
Erectile Dysfunction in men has various etiologies and treatments are often tailored depending on the source of the ED in patients. PDE5 (Phosphodiesterase Type 5) inhibitor treatments like Tadalafil, Sildenafil Citrate, and Vardenafil, however, are effective in treating ED conditions of various etiologies in patients diagnosed with the disease. The study of de Tejada et al in 2002, “Effects of Tadalafil on Erectile Dysfunction in Men With Diabetes” is one study which evaluated the effect of the PDE5I Tadalafil in the case of ED in patients with diabetes . Diabetic patients (with either type 1 or type 2) with a history of erectile dysfunction for more than 3 months were grouped into 3 and administered with placebo (71 patients), Tadalafil 10 mg (73 patients), or Tadalafil 20 mg (72 patients) for 12 weeks with a daily dose of each treatments . The patients were then evaluated using the IIEF (International Index of Erectile Function) and were asked SEP2 (Sexual Encounter Profile 2) and SEP3 (Sexual Encounter Profile 3) questions which pertain to penetration and the completion of the intercourse . Of the 88% patients who completed the study, the results of the above-mentioned study favored the use of Tadalafil for erectile dysfunction, as the drug was observed to significantly improve the parameters for effectiveness and also caused improved scores in IIEF and SEP responses . All in all, Tadalafil was well-tolerated by patients and only caused minimal side effects such as headache and dyspepsia among the patients . De Tejada et al concluded that Tadalafil is very effective in enhancing the patients’ erectile function and was generally well-tolerated by patients diagnosed with both ED and diabetes .
Tadalafil is also used in the treatment of other medical conditions aside from ED. Patients having LUTS or lower urinary tract symptoms secondary to the condition Benign Prostatic Hyperplasia (BPH) are also treated with PDE5 inhibitors like Tadalafil. Roehrborn et al in 2008 in their study “Tadalafil Administered Once Daily for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Dose Finding Study” studied the effectiveness of various doses of Tadalafil for the treatment of LUTS secondary to BPH . 1,058 patients with BPH were included in the study (placebo-treated 4 weeks prior to Tadalafil administration) were given varied doses of Tadalafil (2.5 mg, 5 mg, 10 mg, or 20 mg) or placebo once a day for 12 weeks and observed for the effect on the LUTS . The results of this study indicated that the improvement of the symptoms was dose-dependent, although the patients were able to respond even to the least (2.5 mg) dose of Tadalafil administration . There were improvements for the parameters (for doses 5 mg up) such as the International Prostate Symptom Score (IPSS) for irritative and obstructive symptoms, IPSS Quality of Life, BPH Impact Index (although the result was nonsignificant for 10 mg), Global Assessment Question, and IEEF (International Index of Erectile Function-Erectile Function) domain . Side effects were present although they were transient and manageable in patients treated with Tadalafil . Overall, the daily administration proved effective in the management of LUT symptoms and also improved function parameters in patients treated with Tadalafil, although the most beneficial results (with the least risk profile) proved to be for the 5 mg dose .
Description of Tadalafil Action
The main action of Tadalafil lies on its nature as a PDE5 (Phosphodiesterase Type 5) inhibitor, which inhibits the enzyme PDE5 in the penile tissue. PDE5 inhibitors like Tadalafil help maintain the cGMP (cyclic guanosine monophosphate) levels in patients. cGMP is the mediator of the smooth muscle relaxation leading to penile erection in males.
PDE5, the enzyme, immediately acts to degrade cGMP which causes the failure of the erection in patients affected with erectile dysfunction. PDE5 inhibitors block PDE5 from destroying cGMP in the penile tissue in order for patients to maintain their control over their erectile function. But as cGMP is only released upon sexual stimulation, patients may only expect Tadalafil to work on their erectile function upon the presence of sexual stimuli. Tadalafil does not cause standalone erections in patients treated with the drug.
T-Fil Benefits for Erectile Dysfunction
Tadalafil is effective in managing impotence in patients diagnosed with erectile dysfunction. Although the drug is not a cure for the condition, patients with erectile dysfunction are aided by the drug to regain control over the erectile function which may be lost due to age, disease, medication side effect, or psychological causes.
Tadalafil is proven effective in the treatment of erectile dysfunction with various causes and it is also well-tolerated by patients [5,6] given either the as-needed or daily doses of the medication.
Doses Recommendations and Duration of Therapy
Depending on the patient response and the doctor’s recommendation, the patients should be administered with 5/10/20/40 mg of Tadalafil on an as needed basis. The initial dose for Tadalafil though is 10 mg but the dose may be titrated to higher doses as per the need of the patients . PDE5 inhibitor treatments are only used prior to the intended sexual activity. The patients can also be prescribed the daily treatment (2.5 mg to 5 mg) depending on the recommendation of their doctors.
There is no universally prescribed duration of therapy for the administration of Tadalafil in patients, primarily because the drug is used only when needed. But for the daily dose of Tadalafil intake, there are still no recommendations for the appropriate length of treatment a patient can abide by. Since Tadalafil is not yet a cure for ED, the intake recommendation may remain indefinite or otherwise advised by the doctors.
Adverse Effects and Warnings
Like any prescription medication, there is always a risk of the presence of side effects upon the intake of Tadalafil in patients.
These side effects are common to the users of Tadalafil regardless of the indication it is used for.
But there are also more serious side effects caused by Tadalafil that patients should watch out for. If patients should experience any of the following conditions, they should contact their doctors immediately and stop the intake of Tadalafil: 4-hour or longer erections, vision loss, heart attack symptoms (chest pain spreading to the jaw and upper limbs, nausea, cold sweats), ringing in the ears, hearing loss, seizures, light-headed feeling, and irregular heartbeat .
Also if the common side effects of Tadalafil persist, patients should contact their doctor regarding their Tadalafil intake.
There are several drug interactions which are identified for Tadalafil and most of these drug interactions are between Tadalafil and blood pressure medication, as the patients may experience the extreme lowering of the blood pressure. Drugs included in the blood pressure-lowering category are Amyl Nitrate, Hypertension meds, Dapoxetine, Molsidomine, Sapropterin, vasodilators (organic nitrates), and angina medication .
Alcohol is also not to be taken with Tadalafil as it is also hypotensive. Meanwhile, there are also other drugs which are contraindicated with Tadalafil due to their risk of increasing the serum concentration of Tadalafil and CYP4A4 substrates and lead to toxicity. Some of these medications include other PDE5 inhibitor drugs, Simeprevir, Voriconazole, Telaprevir, Ritonavir, Posaconazole, Conivaptan, and other similar medications .
No patient reviews for the drug T-Fil 10mg/20mg were available online. It may be due to the increased competition of Tadalafil medications online—there are numerous generic medications containing Tadalafil and there are more famous generic drugs available containing Tadalafil.
Reviews are important to determine the actual patient effect of a certain medication. Even of generic drug manufacturers are claiming that their products have the identical active ingredient contents as the brand-name version for a certain drug, there are numerous factors affecting the actual effectiveness of the medication. There is this factor involving the inactive ingredient, the percentage of the actual API (active pharmaceutical ingredients) present in the medication, and the drug’s purity. These factors largely affect a drug’s effectiveness and also imply that generic medications are not 100% identical with each other or with the known brand-name medications existing for a certain API.
Price, Existing Forms, and T-Fil Dosage
T-Fil tablets are available for domestic online sale and Ndrugs.com gives us an overview of the product cost in India. The price for T-Fil is actually cheap—patients would only have to pay at least $1.54 for 4 tablets of the medication. That’s less than a dollar for each pill of T-Fil.
The online distribution of the product T-Fil is limited to domestic clients, as though there are sellers with T-Fil available in their drug lineup, international shipping is not yet possible. Domestic shipping in India is allowed and only costs a minimal fee for the patients. However, buyers interested in purchasing T-Fil from international locations like the US, Australia, and Canada, are not able to avail of the drug online due to (presumed) restrictions in the product distribution internationally. Mesmer/Icon may have yet to obtain its approvals for international online distribution of its products.
- 1mg.com: TFIL 10 MG TABLET. Accessible from: https://www.1mg.com/drugs/tfil-10-mg-tablet-233098
- Tabletwise.com: Tfil Tablet. Accessible from: http://www.tabletwise.com/tfil-tablet
- Indiamart.com: Mesmer Pharmaceuticals. Accessible from: http://www.indiamart.com/mesmer-pharmaceuticals/
- Iconlifesciences.in: Icon Life Science. Accessible from: http://www.iconlifesciences.in/about-icon.html
- De Tejada IS, Anglin G, Knight JR, Emmick JT. Effects of tadalafil on erectile dysfunction in men with diabetes. Diabetes Care. 2002 Dec 1;25(12):2159-64. Accessible from: http://care.diabetesjournals.org/content/25/12/2159.full
- Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. The Journal of urology. 2008 Oct 31;180(4):1228-34. Accessible from: http://www.sciencedirect.com/science/article/pii/S0022534708017151
- Drugs.com: Tadalafil. Accessible from: https://www.drugs.com/tadalafil.html
- Drugs.com: Tadalafil. Accessible from: https://www.drugs.com/ppa/tadalafil.html