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

pharmacor pty ltd - sildenafil citrate, quantity: 28.1 mg (equivalent: sildenafil, qty 20 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; hypromellose; calcium hydrogen phosphate; purified water; croscarmellose sodium; magnesium stearate; 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.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

avkare, 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: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 . concomitant use of organic nitrates in a

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

ix biopharma pty ltd - sildenafil citrate, quantity: 70.24 mg (equivalent: sildenafil, qty 50 mg) - capsule - excipient ingredients: magnesium stearate; croscarmellose sodium; sunset yellow fcf; lactose monohydrate; tartrazine; titanium dioxide; gelatin; silicon dioxide; sodium lauryl sulfate - sildenafil is indicated for the treatment of erectile dysfunction in adult males. ,sildenafil is not indicated for use by women.

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

ix biopharma pty ltd - sildenafil citrate, quantity: 35.12 mg (equivalent: sildenafil, qty 25 mg) - capsule - excipient ingredients: magnesium stearate; lactose monohydrate; croscarmellose sodium; titanium dioxide; gelatin; silicon dioxide; sodium lauryl sulfate - sildenafil is indicated for the treatment of erectile dysfunction in adult males. ,sildenafil is not indicated for use by women.

Australia - angielski - 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: microcrystalline cellulose; hyprolose; croscarmellose sodium; calcium hydrogen phosphate dihydrate; 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.

Australia - angielski - 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: croscarmellose sodium; hyprolose; microcrystalline cellulose; calcium hydrogen phosphate dihydrate; 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.

Australia - angielski - 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: microcrystalline cellulose; hyprolose; croscarmellose sodium; magnesium stearate; 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 - angielski - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - sildenafil citrate, quantity: 70.2 mg (equivalent: sildenafil, qty 50 mg) - tablet, uncoated - excipient ingredients: indigo carmine aluminium lake; croscarmellose sodium; microcrystalline cellulose; calcium hydrogen phosphate; magnesium stearate; copovidone; saccharin sodium - tigerfil sandoz pharma is indicated for the treatment of erectile dysfunction in adult males. tigerfil sandoz pharma is not indicated for use by women.

Stany Zjednoczone - angielski - 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) ] .

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

alphapharm pty ltd - sildenafil citrate, quantity: 35.121 mg (equivalent: sildenafil, qty 25 mg) - tablet, film coated - excipient ingredients: purified water; croscarmellose sodium; calcium hydrogen phosphate; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake - vedafil is indicated for the treatment of erectile dysfunction in adult males. . vedafil is not indicated for use by women.