Sildenafil (PAH)
Other products: Sildenafil
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Patients with Renal Impairment No dose adjustment is required (including severe impairment CLcr < 30 mL/min) [see Clinical Pharmacology ] .
Dosing in liver impairment
Patients with Hepatic Impairment No dose adjustment for mild to moderate impairment is required. Severe impairment has not been studied [see Clinical Pharmacology ] .
Injection preparation card
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Preparation and administration
Reconstitution of the Powder for Oral Suspension Note: Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL) . Refer to the detailed instructions below. 1. Tap the bottle to loosen the powder. 2. Add 60 mL of water to the bottle. 3. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. 4.
Add another 30 mL of water to the bottle. 5. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. 6. Remove cap and press the bottle adaptor into the neck of the bottle. Replace the cap on the bottle. 7. Write the expiration date of the reconstituted oral suspension on the bottle label (the expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution).
Incompatibilities Do not mix with any other medication or additional flavoring agent.
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Sildenafil (PAH)
Plan dose times for sildenafil (pah) around meals and the rest of the list, from label timing statements.
Label text (2 paragraphs)
Nitrates Concomitant use of REVATIO with nitrates in any form is contraindicated [see Contraindications (4) ] . Strong CYP3A Inhibitors Concomitant use of REVATIO with strong CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3) ] . Moderate-to-Strong CYP3A Inducers Concomitant use of REVATIO with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. Dose up-titration of REVATIO may be needed when initiating treatment with moderate-to-strong CYP3A inducers. Reduce the dose of REVATIO to 20 mg three times a day when discontinuing treatment with moderate-to-strong CYP3A inducers [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] .
• Use with strong CYP3A inhibitors: Not recommended. ( 7 , 12.3 ) • Concomitant PDE-5 inhibitors: Avoid use with Viagra ® or other PDE-5 inhibitors. ( 5.6 )
Contraindications
4 CONTRAINDICATIONS REVATIO is 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 (5.1) ] . • Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. • Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.
• Use with organic nitrates or riociguat. ( 4 ) • History of hypersensitivity reaction to sildenafil or any component of the tablet, injection, or oral suspension. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for sildenafil (pah). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. There are risks to the mother and fetus from untreated pulmonary arterial hypertension (see Clinical Considerations ). Animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (RHD) of 20 mg three times a day in rats and rabbits, respectively (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.
Data Animal Data No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m 2 basis, 32- and 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day. In a rat pre- and postnatal development study, the no‑observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m 2 basis).
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Get label change alerts for sildenafil (pah).
Where labels differ
This page quotes Viatris Specialty LLC label (NDA203109, version 5, effective December 18, 2024). Compared with the reference listed drug label for Sildenafil Citrate (NDA020895, Mylan Pharmaceuticals Inc., effective August 29, 2024).
Indications
Only in this page's label (Viatris Specialty LLC)
- 1 INDICATIONS AND USAGE Adults REVATIO is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14) ] .
- Pediatric Patients (1 to 17 Years Old) REVATIO is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies (14) ] .
- Adults REVATIO is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.
- Pediatric Patients (1 to 17 years old) REVATIO is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise ( 1 , 14 )
Only in Reference listed drug: Sildenafil Citrate (Mylan Pharmaceuticals Inc.)
- 1 INDICATIONS AND USAGE Sildenafil citrate tablets are indicated for the treatment of erectile dysfunction.
- Sildenafil citrate tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 )
Contraindications
The two labels word this section differently throughout; compare the full labels.
Dosing
The two labels word this section differently throughout; compare the full labels.
Kidney dosing
Only in this page's label (Viatris Specialty LLC)
- In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3) ] .
Only in Reference listed drug: Sildenafil Citrate (Mylan Pharmaceuticals Inc.)
- 2.5 Dosage Adjustments in Special Populations Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil citrate tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations (8.5 , 8.6 , 8.7) and Clinical P…
- 8 USE IN SPECIFIC POPULATIONS • Geriatric use: Consider a starting dose of 25 mg ( 2.5 , 8.5 ) • Severe renal impairment: Consider a starting dose of 25 mg ( 2.5 , 8.6 ) • Hepatic impairment: Consider a starting dose of 25 mg ( 2.5 , 8.7 ) 8.1 Pregnancy Risk Summary Sildenafil citrate tablets are not indicated for use in females.
- In volunteers with severe renal impairment (Clcr<30 mL/min), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (~2 fold), approximately doubling of C max and AUC.
- A starting dose of 25 mg should be considered in patients with severe renal impairment [ see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ].
Liver dosing
Only in this page's label (Viatris Specialty LLC)
- 8.6 Patients with Hepatic Impairment No dose adjustment for mild to moderate impairment is required.
Only in Reference listed drug: Sildenafil Citrate (Mylan Pharmaceuticals Inc.)
- 2.5 Dosage Adjustments in Special Populations Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil citrate tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations (8.5 , 8.6 , 8.7) and Clinical P…
- 8 USE IN SPECIFIC POPULATIONS • Geriatric use: Consider a starting dose of 25 mg ( 2.5 , 8.5 ) • Severe renal impairment: Consider a starting dose of 25 mg ( 2.5 , 8.6 ) • Hepatic impairment: Consider a starting dose of 25 mg ( 2.5 , 8.7 ) 8.1 Pregnancy Risk Summary Sildenafil citrate tablets are not indicated for use in females.
- 8.7 Hepatic Impairment In volunteers with hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (47% for C max and 85% for AUC).
- The pharmacokinetics of sildenafil in patients with severely impaired hepatic function (Child-Pugh Class C) have not been studied.
Compared by label section text: statements in one label with no close counterpart in the other. Only this page's label is codified for dosing answers. Product labels can differ in indications (for example, uses carved out of generic labels), strengths, and wording; confirm against the label for the product you use.
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