COMPOSITION :

Each film coated tablet contains : Sildenafil Citrate equivalent to Sildenafil 25 mg or 50 mg.

Each chewable tablet contains : Sildenafil Citrate equivalent to Sildenafil 25 mg or 50 mg.

DESCRIPTION :

Supra (Sildenafil) is a therapeutic drug for erectile dysfunction. It acts by selectively inhibiting phosphodiesterase

type 5 (PDE5), resulting in smooth muscle relaxation and inflow of blood to the penis. 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 is 80% in the feces and 13% in the urine. The elimination half-life of both Sildenafil and its metabolites are

4 hours.

INDICATIONS :

Supra is indicated for the treatment of erectile dysfunction.

DOSAGE & ADMINISTRATION :

- Adults : The recommended dose is 50mg taken once daily approximately one hour before sexual activity. The dose

may be reduced to 25 mg but should not exceed 100 mg according to efficacy and toleration .

Note : The tablet should be chewed before swallowed in case of Supra F&S chewable tablet.

- Elderly people( > 65 years): A starting dose of 25mg should be considered due to reduction of Sildenafil clearance.

- Patients with impaired hepatic function or impaired renal function (creatinine clearance < 30 ml/min):

Dose of 25 mg should be considered.

RESTRICTIONS ON USE :

Contraindications

- Hypersensitivity to Sildenafil ,contraindicated in patients who are using organic nitrate or nitric oxide donors .

- Patients with unstable angina , severe cardiac failure, , stroke or myocardial infarction within the last 6 months,

severe hepatic impairment, hypotension.

- Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION),

retinitis pigmentosa .

Precautions

- Patients with sickle cell anaemia , leukaemia, multiple myeloma , deformity of penis

- Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of the

patients, since there is a degree of cardiac risk associated with sexual activity.

- Sildenafil should not be given to persons with no erectile dysfunction, individuals under the age of 18 or woman.

- 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 .

Effects on ability to drive and use machines

Sildenafil may cause dizziness and can affect vision, so caution should be taken .

DRUG INTERACTIONS :

- Sildenafil clearance is reduced resulting in increased plasma concentration when co- administered with inhibitors

of cytochrome P- 450 (CYP) (such as cimetidine, erythromycin , ketoconazole and HIV protease as saquinavir and

ritonavir).

- Single doses of antacids (magnesium hydroxide or aluminum hydroxide) do not affect the bioavailability of

Sildenafil.

- Co-administration of Sildenafil with alpha blockers may lead to hypotension.

- Rifampicin will decrease plasma levels of Sildenafil.

ADVERSE EFFECTS :

Common adverse effects : Headache, dizziness ,visual disorders , flushing , dyspepsia, nasal congestion.

Uncommon effects : Tinnitus, vomiting, nausea and skin rash.

STORAGE INSTRUCTIONS :

Store below 30°C, in a dry place .

PRESENTATIONS :

Supra 50 : Pack of 2 tablets, 4 tablets and 10 tablets and hospital packs of different sizes.

Supra F&S 50 chewable : Pack of 4 tablets and hospital packs of different sizes.

Supra 25 : Pack of 10 tablets and hospital packs of different sizes.

Supra F&S 25 chewable : Pack of 10 tablets and hospital packs of different sizes