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unit dose services - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - 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: - 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

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

remedyrepack inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil tablets are 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 was shown to potentiate the hypotensive effects of nitrates, and its 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, 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 tablets is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets, 25 mg, 50 mg and 100 mg and sildenafil tablets, 20 mg, or any component of the tablet. hypersensitivity reactions have been reported, including rash and urticaria [ see adverse reactions (6.1) ]. do not use sildenafil tablets in patients who are using a gc stimulator, such as riociguat. pde5 inhibitors, including sildenafil citrate, may potentiate the hypotensive effects of gc stimulators. sildenafil citrate is not indicated for use in females. there are no data with the use of sildenafil citrate in pregnant women to inform any drug-associated risks for adverse developmental outcomes. animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human dose (mrhd) of 100 mg/day on a mg/m 2 basis (see data ). no evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received oral doses up to 200 mg/kg/day during organogenesis. these doses represent, respectively, about 16 and 32 times the mrhd on a mg/m 2 basis in a 50 kg subject. in the rat pre- and postnatal development study, the no observed adverse effect dose was 30 mg/kg/day given for 36 days, about 2 times the mrhd on a mg/m 2 basis in a 50 kg subject. sildenafil citrate is not indicated for use in females. limited data indicate that sildenafil and its active metabolite are present in human milk. there is no information on the effects on the breastfed child, or the effects on milk production. sildenafil citrate is not indicated for use in pediatric patients. safety and effectiveness have not been established in pediatric patients. healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil resulting in approximately 84% and 107% higher plasma auc values of sildenafil and its active n-desmethyl metabolite, respectively, compared to those seen in healthy young volunteers (18 to 45 years) [ see clinical pharmacology (12.3) ]. due to age-differences in plasma protein binding, the corresponding increase in the auc of free (unbound) sildenafil and its active n-desmethyl metabolite were 45% and 57%, respectively [ see clinical pharmacology (12.3) ]. of the total number of subjects in clinical studies of sildenafil citrate, 18% were 65 years and older, while 2% were 75 years and older. no overall differences in safety or efficacy were observed between older (≥ 65 years of age) and younger (< 65 years of age) subjects. however, since higher plasma levels may increase the incidence of adverse reactions, a starting dose of 25 mg should be considered in older subjects due to the higher systemic exposure [ see dosage and administration (2.5) ]. no dose adjustment is required for mild (clcr=50 to 80 ml/min) and moderate (clcr=30 to 49 ml/min) renal impairment. 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) ]. 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. a starting dose of 25 mg should be considered in patients with any degree of hepatic impairment [ see dosage and administration (2.5) and clinical pharmacology (12.3) ].

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

trupharma llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - 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

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

nucare pharmaceuticals,inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - 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

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

a-s medication solutions - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - 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: - 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

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

atlantic biologicals corp. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - 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

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

denton pharma, inc. dba northwind pharmaceuticals - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - 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

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

proficient rx lp - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - 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: 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

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

ascend laboratories, llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - adults sildenafil for oral suspension 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)].   additional information is approved for viatris specialty llc's revatio® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. 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 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 anaphylacti

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

denton pharma, inc. dba northwind pharmaceuticals - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - 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