Sildenafil Stada

Sildenafil Stada

sildenafil

Manufacturer:

Hemofarm

Distributor:

DCH Auriga

Marketer:

Stada
Concise Prescribing Info
Contents
Sildenafil
Indications/Uses
Dosage/Direction for Use
Adult 50 mg 1 hr before sexual activity. May be increased to 100 mg or decreased to 25 mg. Max: 100 mg once daily. Hepatic impairment, severe renal impairment & elderly Consider 25 mg as 1st dose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to sildenafil, soya, peanut, Ponceau 4R or to any of the excipients. Concurrent use of nitric oxide donors, organic nitrates or organic nitrites in any form. Non-arteritic anterior ischaemic optic neuropathy (NAION). Severe CV disorders (eg, unstable angina pectoris or established cardiac failure). Hypotension (BP <90/50 mmHg), recent history of stroke or MI; known hereditary degenerative retinal disorders (eg, retinitis pigmentosa). Severe hepatic impairment.
Special Precautions
Consider CV status prior to initiating treatment. Not to be used in men for whom sexual activity is inadvisable. Serious CV events including MI, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage & transient ischemic attack. Patients w/ increased susceptibility to vasodilators including those w/ left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy) or those w/ rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of BP. Patients w/ bleeding disorders or active peptic ulceration; anatomical derformation of the penis (eg, angulation, cavernosal fibrosis or Peyronie's disease) or in conditions that may predispose them to priapism (eg, sickle cell anemia, multiple myeloma or leukemia). Resting HTN (BP >170/110), arrhythmia w/in the last 6 mth, history of cardiac failure or CAD causing unstable angina. Co-administration w/ α-blockers. May potentiate the antiaggregatory effect of Na nitroprusside. Combinations w/ other PDE5 inhibitors, or other pulmonary arterial hypertension treatments containing sildenafil (REVATIO), or other treatments for erectile dysfunction is not recommended. Patients w/ risk factors for sudden decrease or loss of hearing. May affect the ability to drive or use machinery. Not indicated in women, childn & adolescent <18 yr.
Adverse Reactions
Headache. Dizziness; blurred vision, visual disturbances, cyanopsia; hot flush, flushing; nasal congestion; nausea, dyspepsia. Infrequently, prolonged erections (>4 hr), priapism.
Drug Interactions
Reduced clearance w/ CYP3A4 (eg, ketoconazole, erythromycin, cimetidine) inhibitors. Increased Cmax & plasma AUC w/ ritonavir & saquinavir. Increased systemic exposure w/ erythromycin. Increased plasma conc w/ cimetidine. Modest increased in plasma levels w/ grapefruit juice. Decreased AUC & Cmax w/ bosentan. Decreased plasma conc w/ rifampin. Potential serious interaction w/ nicorandil. May potentiate the hypotensive effects of nitrates. Concomitant administration w/ α-blockers (eg, doxazosin) may lead to symptomatic hypotension. Additional reduction on supine systolic BP w/ amlodipine.
ATC Classification
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Sildenafil Stada FC tab 100 mg
Packing/Price
4's
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