Estados Unidos - inglês - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 25 mg - 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 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 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 coadministered at this time point [see dosage and administration (2.3), drug interactions (7.1), and clinical pharmacology (12.2) ]. sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and revatio® , 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 tablets, may potentiate the hypotensive effects of gc stimulators. risk summary sildenafil is not indicated for use in females. there are no data with the use of sildenafil 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/m2 basis (see data ). data animal 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/m2 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/m2 basis in a 50 kg subject. risk summary sildenafil 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 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, 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 cmax 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 cmax 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) ].

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - sildenafil citrate -

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - sildenafil citrate -

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sildenafil citrate, quantity: 28.1 mg (equivalent: sildenafil, qty 20 mg) - tablet, film coated - excipient ingredients: macrogol 8000; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; hypromellose; titanium dioxide; hyprolose - sildenafil is 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 has not been evaluated in patients currently on bosentan therapy.

Estados Unidos - inglês - NLM (National Library of Medicine)

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

Estados Unidos - inglês - 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

Estados Unidos - inglês - 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.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - sildenafil citrate, quantity: 28.096 mg (equivalent: sildenafil, qty 20 mg) - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; microcrystalline cellulose; calcium hydrogen phosphate dihydrate; hyprolose; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake - ? 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 has not been evaluated in patients currently on bosentan therapy.

Estados Unidos - inglês - 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

Estados Unidos - inglês - NLM (National Library of Medicine)

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 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