संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

advagen pharma ltd - 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

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

proficient rx lp - 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: 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 error! hyperlink reference not valid. ). 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 error! hyperlink reference not valid. ). 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 2-4% and 15-20%, 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 tablets to an infant during lactation. 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 tablets, 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 tablets on exercise capacity as measured by cardiopulmonary exercise testing in pediatric patients developmentally able to perform the test (n = 115). administration of sildenafil tablets 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 tablets remained on his/her dose of sildenafil tablets or, if originally randomized to placebo, was randomized to low-, medium-, or high-dose sildenafil tablets. 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 tablets 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 tablets 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 tablets, particularly chronic use, is not recommended in children. clinical studies of sildenafil tablets 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)].

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

novadoz pharmaceuticals llc - 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 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

संयुक्त राज्य - अंग्रेज़ी - 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

संयुक्त राज्य - अंग्रेज़ी - 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

यूनाइटेड किंगडम - अंग्रेज़ी - VMD (Veterinary Medicines Directorate)

ayrton saunders limited - piperazine citrate - tablet - anthelmintic - cats, dogs

यूनाइटेड किंगडम - अंग्रेज़ी - VMD (Veterinary Medicines Directorate)

ayrton saunders limited - piperazine citrate -

संयुक्त राज्य - अंग्रेज़ी - 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)] .

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

redpharm drug 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 nitrate

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

northwind pharmaceuticals - 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 nitrate