Each f/c tablet contains : Sildenafil citrate equivalent to Sildenafil 25 mg & 50 mg.
Supra(Sildenafil) is a therapeutic drug for erectile dysfunction. It acts by selectively inhibiting phosphodiesterase type 5 , causing increased levels of guanosine monophosphate in the corpus cavernosum and resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil is rapidly absorbed and it reaches the maximum plasma concentrations within 30 - 120 min. (average 60 minutes) after oral dosing in the fasted state. The absorption is reduced when taken with a high fat meal . It is about 96 % bound to plasma proteins. It is metabolized by CYP3A4 and CYP2C9 hepatic microsomal isoenzymes to an N-desmethyl active metabolite. Excretion occurs predominantly in the feces and to a lesser extent in the urine. The elimination half life of both Sildenafil and its metabolites are 4 hours.
Supra is indicated for the treatment of erectile dysfunction.
DOSAGE & ADMINISTRATION :
- The recommended dose is 50mg (one Supra 50 tablet) taken once daily approximately 1hour before sexual activity. The dose may be reduced to 25 mg (one Supra 25 tablet) but should not exceed 100 mg.
- A starting dose of 25 mg (one Supra 25 tablet) should be considered in healthy elderly people ( > 65 years ) due to reduction in the clearance of Sildenafil.
RESTRICTIONS ON USE :
Sildenafil is contraindicated in patients who are using organic nitrates.
- Patients with preexisting cardiovascular diseases may have a potential for cardiac risk of sexual activity .
- Patients should be carefully screened against cardiovascular diseases to determine their liability to the systemic
vasodilatory effects of Sildenafil especially in combination with sexual activity .
- Use with caution in patients who have suffered a myocardial infarction , stroke , or life threatening arrythmia
within the last 6 months , patients with resting hypotension , cardiac failure or coronary artery disease causing
unstable angina and patients with retinitis pigmentosa.
- In event of an erection that persists longer than 4 hours and priapism , the patients should seek immediate medical
assistance to avoid the risk of penile tissue damage and permanent loss of potency .
Use in Pregnancy and lactation
There are no adequate and well - controlled studies of the use of Sildenafil during pregnancy and lactation.
Sildenafil is not indicated for use in nursing women.
DRUG INTERACTIONS :
- Inhibitors of cytochrome P- 450 isoforms 3A4 and 2C9 may reduce Sildenafil clearance resulting in increased
plasma concentration and / or the amount of Sildenafil absorbed. These include cimetidine, erythromycin,
ketoconazole and HIV protease inhibitors as saquinavir and ritonavir.
- Single doses of antacids (magnesium hydroxide / aluminum hydroxide) do not affect the bioavailability of
- Rifampicin will decrease plasma levels of Sildenafil.
ADVERSE EFFECTS :
Headache, flushing, dyspepsia, nasal congestion, urinary tract infections, abnormal vision, diarrhoea ,dizziness and rash.
STORAGE INSTRUCTIONS :
Store below 30° C, in a dry place .
Supra 50 : Pack of 2 tablets, 4 tablets and 10 tablets.
Supra 25 : Pack of 10 tablets.