Austraalia - inglise - 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.

Austraalia - inglise - 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: croscarmellose sodium; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; magnesium stearate; 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.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - sildenafil citrate, quantity: 35.12 mg (equivalent: sildenafil, qty 25 mg) - tablet, film coated - excipient ingredients: magnesium stearate; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; croscarmellose sodium; hyprolose; titanium dioxide; indigo carmine aluminium lake; lactose monohydrate; hypromellose; triacetin - treatment of erectile dysfunction in adult males. it is not indicated for use by women.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - sildenafil citrate, quantity: 70.24 mg (equivalent: sildenafil, qty 50 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate dihydrate; hyprolose; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; indigo carmine aluminium lake; lactose monohydrate; hypromellose; triacetin - treatment of erectile dysfunction in adult males. it is not indicated for use by women.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

cardinal health 107, 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 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

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

novadoz pharmaceuticals llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil for oral suspension 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 for oral suspension 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: • 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

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

avpak - 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%). 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. pde-5 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. pregnancy category b there are no adequate and well-controlled studies of sildenafil in pregnant women. 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/m 2 basis, 32- and 68-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/m 2 basis). the safety and efficacy of sildenafil citrate during labor and delivery have not been studied. it is not known if sildenafil or its metabolites are excreted in human breast milk. because many drugs are excreted in human milk, caution should be exercised when sildenafil citrate is administered to a nursing woman. in a randomized, double-blind, multi-center, placebo-controlled, parallel-group, dose-ranging study, 234 patients with pah, aged 1 to 17 years, body weight greater than or equal to 8 kg, were randomized, on the basis of body weight, to three dose levels of sildenafil citrate, or placebo, for 16 weeks of treatment. most patients had mild to moderate symptoms at baseline: who functional class i (32%), ii (51%), iii (15%), or iv (0.4%). one-third of patients had primary pah; two-thirds had secondary pah (systemic-to-pulmonary shunt in 37%; surgical repair in 30%). sixty-two percent of patients were female. drug or placebo was administered three times a day. the primary objective of the study was to assess the effect of sildenafil citrate on exercise capacity as measured by cardiopulmonary exercise testing in pediatric patients developmentally able to perform the test (n = 115). administration of sildenafil citrate did not result in a statistically significant improvement in exercise capacity in those patients. no patients died during the 16-week controlled study. after completing the 16-week controlled study, a patient originally randomized to sildenafil citrate remained on his/her dose of sildenafil citrate or, if originally randomized to placebo, was randomized to low-, medium-, or high-dose sildenafil citrate. after all patients completed 16 weeks of follow-up in the controlled study, the blind was broken and doses were adjusted as clinically indicated. patients treated with sildenafil were followed for a median of 4.6 years (range 2 days to 8.6 years). mortality during the long-term study, by originally assigned dose, is shown in figure 6: figure 6: kaplan-meier plot of mortality by sildenafil citrate dose during the study, there were 42 reported deaths, with 37 of these deaths reported prior to a decision to titrate subjects to a lower dosage because of a finding of increased mortality with increasing sildenafil citrate doses. for the survival analysis which included 37 deaths, the hazard ratio for high dose compared to low dose was 3.9, p=0.007. causes of death were typical of patients with pah. use of sildenafil citrate, particularly chronic use, is not recommended in children. clinical studies of sildenafil citrate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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) ] .

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

h3 medical inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) -

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

proficient rx lp - 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 tablets 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 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

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

proficient rx lp - 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 tablets 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 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