Canada - Tiếng Anh - Health Canada

pharmascience inc - sildenafil (sildenafil citrate) - tablet - 50mg - sildenafil (sildenafil citrate) 50mg - phosphodiesterase type 5 inhibitors

Canada - Tiếng Anh - Health Canada

pharmascience inc - sildenafil (sildenafil citrate) - tablet - 100mg - sildenafil (sildenafil citrate) 100mg - phosphodiesterase type 5 inhibitors

Canada - Tiếng Anh - Health Canada

laboratoire riva inc. - sildenafil (sildenafil citrate) - tablet - 25mg - sildenafil (sildenafil citrate) 25mg - phosphodiesterase type 5 inhibitors

Canada - Tiếng Anh - Health Canada

laboratoire riva inc. - sildenafil (sildenafil citrate) - tablet - 50mg - sildenafil (sildenafil citrate) 50mg - phosphodiesterase type 5 inhibitors

Canada - Tiếng Anh - Health Canada

laboratoire riva inc. - sildenafil (sildenafil citrate) - tablet - 100mg - sildenafil (sildenafil citrate) 100mg - phosphodiesterase type 5 inhibitors

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

apotex nz ltd - sildenafil citrate 28.1mg equivalent to sildenafil 20mg - film coated tablet - 20 mg - active: sildenafil citrate 28.1mg equivalent to sildenafil 20mg excipient: colloidal silicon dioxide croscarmellose sodium hyprolose hypromellose macrogol 8000 magnesium stearate microcrystalline cellulose titanium dioxide - apo-sildenafil 20 mg is used to treat patients with symptom-limited pulmonary arterial hypertension (group i of the who classification of pulmonary hypertension) to improve exercise capacity. the efficacy of apo-sildenafil has not been evaluated in patients currently on bosentan therapy.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

camber 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 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 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. 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 considerations     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/m 2 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/m 2 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 to an infant during lactation. the safety and effectiveness of sildenafil 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 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)].

Úc - Tiếng Anh - 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.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

ix biopharma pty ltd - sildenafil citrate, quantity: 70.24 mg (equivalent: sildenafil, qty 50 mg) - capsule - excipient ingredients: croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; tartrazine; sunset yellow fcf; 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.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

ix biopharma pty ltd - sildenafil citrate, quantity: 35.12 mg (equivalent: sildenafil, qty 25 mg) - capsule - excipient ingredients: croscarmellose sodium; lactose monohydrate; magnesium stearate; 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.