Contents: Sildenafil citrate

Management of erectile dysfunction.

Initially 50 mg approx 1 hr before sexual activity. May be increased to 100 mg once daily or decreased to 25 mg once daily.

May be taken with or without food.

: Hypersensitivity. Concomitant use w/ organic nitrates.

Special Precautions: CV risks, anatomical or hematological disorders predisposing to priapism, bleeding disorders or active peptic ulceration, hypotension, recent history of stroke or MI, retinal disorders eg rhinitis pigmentosa. May impair ability to drive or operate machinery.

Adverse Drug Reactions
: Headache, flushing & dyspepsia; visual disturbances, dizziness & nasal congestion. Diarrhea, muscle pain, skin rashes, UTI & resp tract infection.

Drug Interactions
: Reduced clearance w/ CYP3A4 inhibitor eg cimetidine. Hypotensive effects potentiated by organic nitrates.

Pregnancy Category (US FDA):
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

MIMS Class:
Drugs for Erectile Dysfunction and Ejaculatory Disorders

ATC Classification
: G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.

Regulatory Classification: Rx
Reference: mims

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