United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 20 mg - 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. new dosing regimen in adults with pulmonary arterial hypertension (pah) and treatment of pah in pediatric patients (ages 1 to 17) information are 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 these information. 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 (5.1)] . - 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.

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 20 mg - 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 patients (1 to 17 years old) sildenafil tablets are 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 underly improvements in exercise [see clinical studies (14)] . sildenafil tablets are contraindicated in patients with: click here to enter use in specific populations 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 mo

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 20 mg - 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 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 (5.1)] . - 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.   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 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/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 to an infant during lactation.   the safety and effectiveness of sildenafil 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 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)] .

United States - English - NLM (National Library of Medicine)

torrent pharmaceuticals limited - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 20 mg - 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)] .

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 20 mg - 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 patients (1 to 17 years old) sildenafil tablets are 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 underly improvements in exercise [see clinical studies ( 14 )] .  sildenafil 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 stimulat

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - sildenafil citrate -

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - sildenafil citrate, quantity: 140.48 mg (equivalent: sildenafil, qty 100 mg) - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; croscarmellose sodium; hyprolose; calcium hydrogen phosphate dihydrate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake - treatment of erectile dysfunction in adult males. it is not indicated for use by women.

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - sildenafil citrate -

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - sildenafil citrate -

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - sildenafil citrate -