United States - English - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a. inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - adults sildenafil for oral suspension is 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) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. sildenafil for oral suspension 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, 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/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) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of sildenafil for oral suspension 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)] . instructions for use sildenafil (sil den⸍ a fil) oral suspension read this instructions for use before you start taking sildenafil oral suspension and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important information: - ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of sildenafil oral suspension. - your pharmacist will mix (reconstitute) sildenafil oral suspension before it is given to you. do not take or give sildenafil oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. - always use the oral dosing syringe that comes with sildenafil oral suspension. if your carton does not come with an oral dosing syringe, contact your pharmacist. - do not take or give sildenafil oral suspension if the bottle adaptor is not in the bottle. if the bottle adaptor is not in the bottle, contact your pharmacist. - sildenafil oral suspension should not be mixed with any other medicine or flavoring. supplies you will need to take or give a dose of sildenafil oral suspension (see figure a): - 1 bottle of sildenafil oral suspension with pre-inserted bottle adaptor - 1 oral dosing syringe (provided in the carton) how should i store sildenafil oral suspension? - store mixed (reconstituted) sildenafil oral suspension below 86°f (30°c) or in a refrigerator between 36°f to 46°f (2°c to 8°c). - do not freeze mixed sildenafil oral suspension - throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. see the "discard after" date written on the bottle label. keep sildenafil oral suspension and all medicines out of the reach of children. pediatric use information is approved for viatris specialty llc's revatio ® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. mfd. by: taro pharmaceutical industries ltd. haifa bay, israel 2624761 dist. by: taro pharmaceuticals u.s.a., inc . hawthorne, ny 10532 this instruction for use has been approved by the u.s. food and drug administration. revised: december 2023

United States - English - 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

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

avallon pharmaceuticals pty ltd - sildenafil citrate, quantity: 35.1 mg (equivalent: sildenafil, qty 25 mg) - tablet, uncoated - excipient ingredients: indigo carmine aluminium lake; magnesium stearate; copovidone; microcrystalline cellulose; saccharin sodium; calcium hydrogen phosphate; croscarmellose sodium - noumed sildenafil is indicated for the treatment of erectile dysfunction in adult males. noumed sildenafil is not indicated for use by women.

Canada - English - Health Canada

jamp pharma corporation - sildenafil (sildenafil citrate) - tablet - 20mg - sildenafil (sildenafil citrate) 20mg - phosphodiesterase type 5 inhibitors

Canada - English - Health Canada

apotex inc - sildenafil (sildenafil citrate) - tablet - 20mg - sildenafil (sildenafil citrate) 20mg - phosphodiesterase type 5 inhibitors

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - 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  warnings and precautions (5.2) ].   • concomitant use of riociguat, a guanylat

United States - English - NLM (National Library of Medicine)

greenstone llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 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 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 cyclase stimulator. pde-5 inhibitors, including s

United States - English - 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

United States - English - NLM (National Library of Medicine)

tris pharma inc - 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 for oral suspension 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

United States - English - NLM (National Library of Medicine)

nucare 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%). 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 [ ]. •  riociguat. • known hypersensitivity to sildenafil or any component of the tablet. hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylac