SILDENAFIL CITRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H)

Available from:

Torrent Pharmaceuticals Limited

INN (International Name):

SILDENAFIL CITRATE

Composition:

SILDENAFIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adults Sildenafil tablets are 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 use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Sildenafil citrate 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 (PDE5) 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. 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 to 4% and 15 to 20%, respectively. Clinical Consideratio ns 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/m2 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/m2 basis). Risk Summary Limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. There is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. Limited clinical data during lactation preclude a clear determination of the risk of sildenafil citrate to an infant during lactation. The safety and effectiveness of Sildenafil citrate have not been established in pediatric patients younger than 1 year of age. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Clinical studies of sildenafil citrate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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)] . No dose adjustment for mild to moderate impairment is required. Severe impairment has not been studied [see Clinical Pharmacology (12.3)] . No dose adjustment is required (including severe impairment CLcr <30 mL/min) [see Clinical Pharmacology (12.3)] .

Product summary:

Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side. Bottles of 30 with child-resistant closure            NDC 13668-185-30  Bottles of 90 with child-resistant closure           NDC 13668-185-90  Bottles of 500                                                  NDC 13668-185-05  Bottles of 5000                                                NDC 13668-185-51 Recommended Storage for Sildenafil Tablets USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SILDENAFIL CITRATE- SILDENAFIL CITRATE TABLET
TORRENT PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SILDENAFIL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SILDENAFIL TABLETS.
SILDENAFIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Indications and Usage (1) 1/2023
Dosage and Administration (2.1, 2.2) 1/2023
INDICATIONS AND USAGE
Adults
Sildenafil citrate 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. (1)
DOSAGE AND ADMINISTRATION
• Adults: 20 mg three times a day. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets_:_ 20 mg (3)
CONTRAINDICATIONS
Use with organic nitrates or riociguat. (4)
History of hypersensitivity reaction to sildenafil or any component of
the tablet. (4)
WARNINGS AND PRECAUTIONS
Vasodilation effects may be more common in patients with hypotension
or on antihypertensive
therapy. (5.1)
Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary
edema and is not
recommended. (5.2)
Hearing or visual impairment: Seek medical attention if sudden
decrease or loss of vision or hearing
occurs. (5.4, 5.5)
Pulmonary hypertension (PH) secondary to sickle cell disease:
Sildenafil citrate may cause serious
vaso-occlusive crises. (5.8)
ADVERSE REACTIONS
Adults: Headache, dyspepsia, flushing, pain in limb, myalgia, back
pain and diarrhea. (6.1, 6.2)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TORRENT PHARMA INC. AT
1-800-912-9561
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
• 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)
_Pediatric use information is approved for Viatris Specialty LLC's,
REVATIO (sildenafil) tablets. However,_
_due to Viatris Specialty LLC's marketing e