Composition

Each film coated tablet contains:
Sildenafil citrate ............................................................................. 35, 70, 140 mg
Equivalent to Sildenafil .................................................................. 25, 50, 100 mg
Inactive ingredients: Lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, talc purified.

Therapeutic Indications

Silden is indicated for the treatment of erectile dysfunction.

Dosage and Administration

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, Silden may be taken anywhere from 4 hours to 0.5 hour before sexual activity.
Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.
The following factors are associated with increased plasma levels of sildenafil:
Age > 65 (40% increase in AUC), hepatic impairment (e.g. cirrhosis, 80%), severe renal impairment (creatinine clearance < 30 mL/min, 100%), and concomitant use of potent cytochrome P450 3A4 inhibitors [ketoconazole, itraconazole, erythromycin (182%), saquinavir (210%)].
Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered in these patients.
Ritonavir greatly increased the systemic level of sildenafil in a study of healthy, non-HIV infected volunteers (11-fold increase in AUC, see Drug Interactions). Based on these pharmacokinetic data, it is recommended not to exceed a maximum single dose of 25 mg of Silden in a 48 hour period.
Silden was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated.
When Silden is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating Silden treatment and Silden should be initiated at the lowest dose (see Drug Interactions).

Contraindications

Consistent with its known effects on the nitric oxide/cGMP pathway (see Pharmacological Properties), Silden was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form, is therefore contraindicated.
Silden is contraindicated in patients with a known hypersensitivity to any component of the tablet.