Sildenafil Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
Sildenafil is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [ see Clinical Studies (14) ]. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise.
What should I know before taking it?
Sildenafil tablets are contraindicated in patients with: • Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [ see Warnings and Precautions (5.2) ]. • Concomitant use of riociguat, a guanylate cyclase stimulator. PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. • Known hypersensitivity to sildenafil or any component of the tablet. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.
What important warnings are listed?
5 WARNINGS AND PRECAUTIONS • Increased mortality with increasing doses in pediatric patients. Not recommended for use in pediatric patients. ( 5.1 ) • Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ( 5.2 ) • Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. ( 5.3 ) • Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. ( 5.5 , 5.6 ) • Pulmonary hypertension secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. ( 5.9 ) 5.1 Mortality with Pediatric Use In a long-term trial in pediatric patients with PAH, an.
How is this medication usually taken?
Sildenafil Tablets, USP Sildenafil tablets, USP are supplied as white to white-off, film-coated, round tablets debossed with "C 89" on one side and plain on the other side containing sildenafil citrate equivalent to 20 mg of sildenafil.
What side effects are listed?
The following serious adverse events are discussed elsewhere in the labeling: • Mortality with pediatric use[ see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] • Hypotension [ see Warnings and Precautions (5.2) ] • Vision loss [ see Warnings and Precautions (5.5) ] • Hearing loss [ see Warnings and Precautions (5.6) ] • Priapism [ see Warnings and Precautions (5.8) ] • Vaso-occlusive crisis [ see Warnings and Precautions (5.9) ]
What interactions are listed?
Nitrates Concomitant use of sildenafil with nitrates in any form is contraindicated [ see Contraindications (4) ]. Ritonavir and other Potent CYP3A Inhibitors Concomitant use of sildenafil with ritonavir and other potent CYP3A inhibitors is not recommended [ see Clinical Pharmacology (12.3) ]. Other drugs that reduce blood pressure Alpha blockers. In drug-drug interaction studies, sildenafil (25 mg, 50 mg, or 100 mg) and the alpha-blocker doxazosin (4 mg or 8 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06571775-b651-4e23-a35b-88392aae7e13
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.