États-Unis - anglais - NLM (National Library of Medicine)

lake erie medical dba quality c - 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 to 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. pde5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. - known hypersensitivity to sildenafil or any component

États-Unis - anglais - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - 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 to 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 warnings and precautions (5.2)] . - concomitant use of riociguat, a guanylate cyclase stim

États-Unis - anglais - NLM (National Library of Medicine)

pd-rx pharmaceuticals, 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: - concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see

États-Unis - anglais - NLM (National Library of Medicine)

proficient rx lp - 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 to iii symptoms and idiopathic etiology (71%) or associated with connective tissue disease (ctd) (25%). sildenafil tablets are contraindicated in patients with: teratogenic effects : 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/m2  basis, 32- and 68-times, respectively, the recommended hum

États-Unis - anglais - NLM (National Library of Medicine)

rebel distributors corp - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil citrate 50 mg - consistent with its known effects on the nitric oxide/cgmp pathway (see clinical pharmacology ), viagra was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated. after patients have taken viagra, it is unknown when nitrates, if necessary, can be safely administered. based on the pharmacokinetic profile of a single 100 mg oral dose given to healthy normal volunteers, the plasma levels of sildenafil at 24 hours post dose are approximately 2 ng/ml (compared to peak plasma levels of approximately 440 ng/ml) (see clinical pharmacology: pharmacokinetics and metabolism ). in the following patients: age >65, hepatic impairment (e.g., cirrhosis), severe renal impairment (e.g., creatinine clearance less than 30 ml/min), and concomitant use of potent cytochrome p450 3a4 inhibitors (erythromycin), plasma levels of sildenafil at 24 hours post dose have been found to be

États-Unis - anglais - 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)].

États-Unis - anglais - NLM (National Library of Medicine)

aurobindo pharma limited - 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 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, injection, or oral suspension. 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/m2 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/m2 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)] .

Malte - anglais - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sildenafil citrate - film-coated tablet - sildenafil citrate 25 mg - urologicals

Malte - anglais - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sildenafil citrate - film-coated tablet - sildenafil citrate 50 mg - urologicals

Malte - anglais - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sildenafil citrate - film-coated tablet - sildenafil citrate 100 mg - urologicals