Composition 
Each film coated tablet contains Sildenafil Citrate INN equivalent to Sildenafil 50 mg.

Pharmacology
The physiologic mechanism of erectile penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood which causes erection. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the copus cavernosum. Sildenafil at recommended doses has no effect in absence of sexual stimulation.

Indication
It is indicated in the treatment of erectile dysfunction. It is also recommended for relief symptom of pulmonary arterial hypertension.

Dosage And Administration
For Erectile Dysfunction: The recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. Based on effectiveness and tolerability, 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.
For Pulmonary Arterial Hypertension: 20 mg 3 times a day.

Use In Special Group
Renal insufficiency: In patients with severe renal impairment the clearance of Sildenafil is reduced which is associated with increased plasma levels of Sildenafil. Therefore, a starting oral dose of 25 mg should be considered in those patients.
Hepatic Insufficiency: In patients with hepatic impairment the clearance of Sildenafil is reduced which is associated with increased plasma levels of Sildenafil. Therefore, a starting oral dose of 25 mg should be considered in those patients.
Geriatric use:
Healthy elderly (65 years or over) has a reduced clearance of Sildenafil. Since higher plasma levels may increase both the efficiency and incidence of adverse events , a dose over 25mg should not be considered.

Contraindication
Sildenafil was shown to potentiate the hypotensive effects to nitrates and its administration to patients who are using organic nitrates, either regularly and or intermittently, in any form is therefore contraindicated. It is contraindicated in patients with a known hypersensitivity to Sildenafil.

Side Effects
The side effects of Sildenafil are usually mild to moderate and usually don’t last longer than a few hours. Some of these side effects are more likely to occur with higher doses. The most common side effects of Sildenafil are headache, flushing of the face, and upset stomach. Less common side effects that may occur are temporarily changes in color vision or blurred vision.

Precautions
Caution is advised when phosphodiesterase type 5 (PDE5) inhibitors are co-administered with alpha blockers. PDE5 inhibitors, including Sildenafil, and alpha adrenergic blocking agents are both vasodilators with blood pressure lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure leading to symptomatic hypotension (e.g. dizziness, lightheadedness, fainting). In order to reduce the likelihood of these symptoms in patients who are stable on alpha blocker therapy, Sildenafil inhibitors should be initiated at the lowest dose or who are already taking an optimized dose of a Sildenafil, alpha blocker therapy should be initiated at the lowest dose.

Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experienced symptoms (e.g. angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician. Sildenafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).

Drug Interactions
Effects of other drugs on Sildenafil
Sildenafil metabolism is principally mediated by cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes may reduce Sildenafil clearance and inducers of these isoenzymes may increase Sildenafil clearance such as ketoconazole, erythromycin, cimetidine, ritonavir.

Pharmaceutical Precautions
Store below 300c and protect from light and moisture. Keep out of reach of children.

Packing/Pack size
Each Box contain 1 x 10 tablets in blister pack.