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

greenstone llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 25 mg - sildenafil citrate tablets is indicated for the treatment of erectile dysfunction. consistent with its known effects on the nitric oxide/cgmp pathway [see clinical pharmacology (12.1, 12.2) ], sildenafil citrate tablets were shown to potentiate the hypotensive effects of nitrates, and their administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. after patients have taken sildenafil citrate tablets, it is unknown when nitrates, if necessary, can be safely administered. although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [see dosage and administration (2.3), drug interactions (7.1), and clinical pharmacology (12.2) ]. sildenafil citrate tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil citrate

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

accord healthcare pty ltd - sildenafil citrate, quantity: 28.1 mg (equivalent: sildenafil, qty 20 mg) - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; hypromellose; croscarmellose sodium; calcium hydrogen phosphate; titanium dioxide; lactose monohydrate; triacetin - used to treat patients with pulmonary arterial hypertension classified as who functional classes ii and iii, to improve exercise capacity. efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. the efficacy of sildenafil citrate 20 mg has not been evaluated in patients currently on bosentan therapy.

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

accord healthcare pty ltd - sildenafil citrate, quantity: 28.1 mg (equivalent: sildenafil, qty 20 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; magnesium stearate; hypromellose; calcium hydrogen phosphate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; triacetin - used to treat patients with pulmonary arterial hypertension classified as who functional classes ii and iii, to improve exercise capacity. efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. the efficacy of sildenafil citrate 20 mg has not been evaluated in patients currently on bosentan therapy.

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

arrotex pharmaceuticals pty ltd - sildenafil citrate, quantity: 140.48 mg (equivalent: sildenafil, qty 100 mg) - tablet, film coated - excipient ingredients: macrogol 8000; titanium dioxide; hyprolose; hypromellose; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium - sildenafil is indicated for the treatment of erectile dysfunction in adult males. sildenafil is not indicated for use by women.

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

greenstone llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 20 mg - sildenafil is 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 was 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 capacity [see clinical studies (14)] . sildenafil is contraindicated in patients with: 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 d

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

vensun pharmaceuticals, inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 20 mg - 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 capacity [see clinical studies (14)]. 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.

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

major pharmaceuticals - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 20 mg - 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 capacity [ see clinical studies (14) ]. sildenafil citrate is contraindicated in patients with: risk summary limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear associati

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

arrotex pharmaceuticals pty ltd - sildenafil citrate, quantity: 70.24 mg (equivalent: sildenafil, qty 50 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; hyprolose; macrogol 8000; hypromellose; croscarmellose sodium; microcrystalline cellulose; titanium dioxide - sildenafil is indicated for the treatment of erectile dysfunction in adult males. sildenafil is not indicated for use by women.

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

arrotex pharmaceuticals pty ltd - sildenafil citrate, quantity: 35.12 mg (equivalent: sildenafil, qty 25 mg) - tablet, film coated - excipient ingredients: titanium dioxide; hyprolose; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; macrogol 8000; magnesium stearate; hypromellose - sildenafil is indicated for the treatment of erectile dysfunction in adult males. sildenafil is not indicated for use by women.

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)] .