United States - English - 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

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

dr reddys laboratories australia pty ltd - sildenafil citrate -

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

dr reddys laboratories australia pty ltd - sildenafil citrate -

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

advanced rx pharmacy of tennessee, llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - 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 citrate 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 (pde5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riocig

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

zydus pharmaceuticals (usa) 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, embryo toxicity, 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) product. 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)]. sildenafil (sil den' a fil) for oral suspension read this instructions for use before you start taking sildenafil for 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 prescribed dose of sildenafil for oral suspension. •   your pharmacist will mix (reconstitute) sildenafil for oral suspension before it is given to you. do not take or give sildenafil for 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 for oral suspension. if your carton does not come with an oral dosing syringe, contact your pharmacist. •   if the bottle adaptor is not in the bottle, contact your pharmacist. •   sildenafil for oral suspension should not be mixed with any other medicine or flavoring. supplies you will need to take or give a dose of sildenafil for oral suspension (see figure a): •   1 bottle of sildenafil for oral suspension with pre-inserted bottle adaptor •   1 oral dosing syringe (provided in the carton) step 1. shake the bottle of sildenafil for oral suspension for 10 seconds before each use. (see figure b)             step 2. remove the cap. open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise). (see figure c) step 3. fully push down (depress) the plunger of the oral dosing syringe. then insert the tip of the oral dosing syringe into the bottle adaptor while holding the bottle upright, on a flat surface. (see figure d) step 4. turn the bottle upside down while holding the oral dosing syringe in place. slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the ml marking on the syringe for your prescribed dose. (see figure e) if your dose of sildenafil for oral suspension is 1 ml (10 mg), measure 0.5 ml two times for a total of 1 ml of sildenafil for oral suspension. if your dose of sildenafil for oral suspension is more than 2 ml (20 mg), you will need to divide the dose. follow the instructions given to you by your healthcare provider or pharmacist about how to prepare the divided dose. if you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that sildenafil for oral suspension flows back into the bottle and repeat step 4. step 5. turn the bottle back upright with the oral dosing syringe still in place. place the bottle on a flat surface. remove the oral dosing syringe from the bottle adaptor by pulling straight up on the barrel of the oral dosing syringe. (see figure f) do not press on the plunger of the oral dosing syringe at this time. step 6. put the tip of the oral dosing syringe into your mouth and point it towards the inside of the cheek. slowly push the plunger of the oral dosing syringe all the way down to give the entire dose. do not squirt the medicine out quickly. (see figure g) if you are giving sildenafil for oral suspension to a child, make sure they are in an upright position before giving the medicine. step 7. replace the cap on the bottle, leaving the bottle adaptor in place. turn the cap in the direction of the arrow (clockwise) to close the bottle. (see figure h) step 8. wash the oral dosing syringe after each use. pull the plunger out of the barrel and rinse both parts with water. (see figure i) step 9. dry all parts with a clean paper towel. push the plunger back into the barrel. store the oral dosing syringe with the sildenafil for oral suspension bottle. how should i store sildenafil for oral suspension? •    store mixed (reconstituted) sildenafil for oral suspension below 30°c (86°f) or in a refrigerator between 2°c to 8°c (36°f to 46°f). •    do not freeze mixed sildenafil for oral suspension. •    throw away (discard) sildenafil for oral suspension 60 days after mixed by the pharmacist. see the "discard after" date written on the bottle label. keep sildenafil for oral suspension and all drugs 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. this instruction for use has been approved by the u.s. food and drug administration. manufactured by: zydus lifesciences ltd., baddi, india. distributed by: zydus pharmaceuticals (usa) inc. pennington, nj 08534 rev.: 12/2023

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

zydus lifesciences limited - 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, embryo toxicity, 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) product. 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)]. sildenafil (sil den' a fil) for oral suspension read this instructions for use before you start taking sildenafil for 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 prescribed dose of sildenafil for oral suspension. •   your pharmacist will mix (reconstitute) sildenafil for oral suspension before it is given to you. do not take or give sildenafil for 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 for oral suspension. if your carton does not come with an oral dosing syringe, contact your pharmacist. •   if the bottle adaptor is not in the bottle, contact your pharmacist. •   sildenafil for oral suspension should not be mixed with any other medicine or flavoring. supplies you will need to take or give a dose of sildenafil for oral suspension (see figure a): •   1 bottle of sildenafil for oral suspension with pre-inserted bottle adaptor •   1 oral dosing syringe (provided in the carton) step 1. shake the bottle of sildenafil for oral suspension for 10 seconds before each use. (see figure b)             step 2. remove the cap. open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise). (see figure c) step 3. fully push down (depress) the plunger of the oral dosing syringe. then insert the tip of the oral dosing syringe into the bottle adaptor while holding the bottle upright, on a flat surface. (see figure d) step 4. turn the bottle upside down while holding the oral dosing syringe in place. slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the ml marking on the syringe for your prescribed dose. (see figure e) if your dose of sildenafil for oral suspension is 1 ml (10 mg), measure 0.5 ml two times for a total of 1 ml of sildenafil for oral suspension. if your dose of sildenafil for oral suspension is more than 2 ml (20 mg), you will need to divide the dose. follow the instructions given to you by your healthcare provider or pharmacist about how to prepare the divided dose. if you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that sildenafil for oral suspension flows back into the bottle and repeat step 4. step 5. turn the bottle back upright with the oral dosing syringe still in place. place the bottle on a flat surface. remove the oral dosing syringe from the bottle adaptor by pulling straight up on the barrel of the oral dosing syringe. (see figure f) do not press on the plunger of the oral dosing syringe at this time. step 6. put the tip of the oral dosing syringe into your mouth and point it towards the inside of the cheek. slowly push the plunger of the oral dosing syringe all the way down to give the entire dose. do not squirt the medicine out quickly. (see figure g) if you are giving sildenafil for oral suspension to a child, make sure they are in an upright position before giving the medicine. step 7. replace the cap on the bottle, leaving the bottle adaptor in place. turn the cap in the direction of the arrow (clockwise) to close the bottle. (see figure h) step 8. wash the oral dosing syringe after each use. pull the plunger out of the barrel and rinse both parts with water. (see figure i) step 9. dry all parts with a clean paper towel. push the plunger back into the barrel. store the oral dosing syringe with the sildenafil for oral suspension bottle. how should i store sildenafil for oral suspension? •    store mixed (reconstituted) sildenafil for oral suspension below 30°c (86°f) or in a refrigerator between 2°c to 8°c (36°f to 46°f). •    do not freeze mixed sildenafil for oral suspension •    throw away (discard) sildenafil for oral suspension 60 days after mixed by the pharmacist. see the "discard after" date written on the bottle label. keep sildenafil for oral suspension and all drugs 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. this instruction for use has been approved by the u.s. food and drug administration. manufactured by: zydus lifesciences ltd., baddi, india. rev.: 12/2023

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

aurobindo pharma limited - 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) for oral suspension. 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/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) for oral suspension. 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)] .

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

a-s medication solutions - 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 citrate 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 citrate, 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 (2.3), drug interactions (7.1), and clinical pharmacology (12.2) ]. sildenafil tablets is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets, 25 mg, 50 mg and 100 mg and sildenafil tablets, 20 mg, or any component of the tablet. hypersensitivity reactions have been reported, including rash and urticaria [ see adverse reactions (6.1) ]. do not use sildenafil tablets in patients who are using a gc stimulator, such as riociguat. pde5 inhibitors, including sildenafil citrate, may potentiate the hypotensive effects of gc stimulators. sildenafil citrate is not indicated for use in females. there are no data with the use of sildenafil citrate in pregnant women to inform any drug-associated risks for adverse developmental outcomes. animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human dose (mrhd) of 100 mg/day on a mg/m 2 basis (see data ). no evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received oral doses up to 200 mg/kg/day during organogenesis. these doses represent, respectively, about 16 and 32 times the mrhd on a mg/m 2 basis in a 50 kg subject. in the rat pre- and postnatal development study, the no observed adverse effect dose was 30 mg/kg/day given for 36 days, about 2 times the mrhd on a mg/m 2 basis in a 50 kg subject. sildenafil citrate is not indicated for use in females. limited data indicate that sildenafil and its active metabolite are present in human milk. there is no information on the effects on the breastfed child, or the effects on milk production. sildenafil citrate is not indicated for use in pediatric patients. safety and effectiveness have not been established in pediatric patients. healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil resulting in approximately 84% and 107% higher plasma auc values of sildenafil and its active n-desmethyl metabolite, respectively, compared to those seen in healthy young volunteers (18 to 45 years) [ see clinical pharmacology (12.3) ]. due to age-differences in plasma protein binding, the corresponding increase in the auc of free (unbound) sildenafil and its active n-desmethyl metabolite were 45% and 57%, respectively [ see clinical pharmacology (12.3) ]. of the total number of subjects in clinical studies of sildenafil citrate, 18% were 65 years and older, while 2% were 75 years and older. no overall differences in safety or efficacy were observed between older (≥ 65 years of age) and younger (< 65 years of age) subjects. however, since higher plasma levels may increase the incidence of adverse reactions, a starting dose of 25 mg should be considered in older subjects due to the higher systemic exposure [ see dosage and administration (2.5) ]. no dose adjustment is required for mild (clcr=50 to 80 ml/min) and moderate (clcr=30 to 49 ml/min) renal impairment. in volunteers with severe renal impairment (clcr<30 ml/min), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (~2 fold), approximately doubling of c max and auc. a starting dose of 25 mg should be considered in patients with severe renal impairment [ see dosage and administration (2.5) and clinical pharmacology (12.3) ]. in volunteers with hepatic impairment (child-pugh class a and b), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (47% for c max and 85% for auc). the pharmacokinetics of sildenafil in patients with severely impaired hepatic function (child-pugh class c) have not been studied. a starting dose of 25 mg should be considered in patients with any degree of hepatic impairment [ see dosage and administration (2.5) and clinical pharmacology (12.3) ].

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

ascend laboratories, llc - 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)].   additional 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 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 anaphylacti