Concise Prescribing Info
Contents
Sildenafil citrate
Indications/Uses
Dosage/Direction for Use
Adult 50 mg approx 1 hr before sexual activity. May be increased to a max 100 mg or decreased to 25 mg. Max recommended dosing frequency: Once daily. Hepatic impairment & severe renal impairment 25 mg should be considered.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. CV disorders eg, unstable angina or severe cardiac failure. Loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION). Severe hepatic impairment, hypotension (BP <90/50 mmHg), recent history of stroke or MI & hereditary degenerative retinal disorders eg, retinitis pigmentosa. Co-administration w/ nitric oxide donors or nitrates. Women. Childn <18 yr.
Special Precautions
Increased susceptibility to vasodilators including left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy) or rare syndrome of multiple system atrophy manifesting as severely impaired autonomic BP control. Serious CV events including MI, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, HTN & hypotension. Anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease) or hematological disorders predisposing to priapism (eg, sickle cell anemia, multiple myeloma or leukemia). Discontinue if sudden visual/hearing defect occurs. Co-administration w/ α-blocker. In vitro potentiation of Na nitroprusside antiaggregatory effect. Hepatic or severe renal impairment. May affect ability to drive or operate machinery.
Adverse Reactions
Headache. Dizziness; visual disorders & color distortion; flushing; nasal congestion; dyspepsia.
Drug Interactions
Potentiate hypotensive effects of organic nitrates. Enhanced hypotensive effect of nicorandil & amlodipine. Symptomatic hypotension may occur w/ α-blockers. Reduced clearance by drugs that inhibit CYP450 isoenzyme CYP3A4 eg, cimetidine, delavirdine, erythromycin, itraconazole & ketoconazole. Increased plasma conc by HIV-PIs; grapefruit juice; clarithromycin, telithromycin & erythromycin; cimetidine. Decreased plasma conc by CYP3A4 inducers eg, rifampicin; bosentan.
ATC Classification
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Iqnyde FC tab 100 mg
Packing/Price
4's
Form
Iqnyde FC tab 50 mg
Packing/Price
4's
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