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zydus lifesciences limited - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil  tablets,usp are indicated for the treatment of erectile dysfunction (ed). tadalafil tablets, usp are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph). tadalafil tablets, usp are indicated for the treatment of ed and the signs and symptoms of bph (ed/bph). if tadalafil tablets, usp are used with finasteride to initiate bph treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see clinical studies (14.3) ]. administration of tadalafil to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. in clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates [see clinical pharmacology (12.2)] . tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil. hypersensitivity reacti

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torrent pharmaceuticals limited - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve exercise ability. studies establishing effectiveness included predominately patients with nyha functional class ii – iii symptoms and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (23%). tadalafil is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. do not use nitrates within 48 hours of the lst dose of tadalafil. tadalafil potentiates the hypotensive effect of nitrates. this potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cgmp pathway [see clinical pharmacology ( 12.2)] . coadministration of gc stimulators, such as riociguat with tadalafil is contraindicated. tadalafil may potentiate the hypotensive effects of gc stimulators. tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets). hypersensitivity reactions have been reported, including stevens-johnson syndrome and exfoliative dermatitis [see adverse reactions ( 6.2)] . risk summary limited data from case series with tadalafil use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures 7 times the exposure at the maximum recommended human dose (mrhd) of 40 mg/day based on auc (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 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 tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats. animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at unbound tadalafil exposures up to 7 times the exposure at the maximum recommended human dose (mrhd) of 40 mg/day during organogenesis based on auc. in one of two perinatal/postnatal developmental studies in rats, a reduction of postnatal pup survival was observed at dose levels of 60, 200 and 1,000 mg/kg. the no-observed effect-level (noel) for developmental toxicity was 30 mg/kg, which provided maternal exposure to unbound tadalafil concentrations approximately 5 times the exposure at the mrhd based on auc. signs of maternal toxicity occurred at doses greater than 200 mg/kg/day, which produced aucs greater than 8 times the exposure at the mrhd. surviving offspring had normal development and reproductive performance. risk summary there are no data on the presence of tadalafil and/or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-times that found in the plasma. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tadalafil tablets and any potential adverse effects on the breastfed child from tadalafil tablets or from the underlying maternal condition. infertility males based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months. this effect was not seen in the study of 20 mg tadalafil taken for 6 months. there was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone. the clinical significance of the decreased sperm concentrations in the two studies is unknown. there have been no studies evaluating the effect of tadalafil on fertility in men or women [see clinical pharmacology ( 12.2)] . safety and effectiveness of tadalafil tablets in pediatric patients have not been established. of the total number of subjects in the clinical study of tadalafil for pulmonary arterial hypertension, 28 percent were 65 and over, while 8 percent were 75 and over. no overall differences in safety were observed between subjects over 65 years of age compared to younger subjects or those over 75 years of age. no dose adjustment is warranted based on age alone; however, a greater sensitivity to medications in some older individuals should be considered. [see clinical pharmacology ( 12.3)] . for patients with mild or moderate renal impairment, start tadalafil tablets at 20 mg once daily. increase the dose to 40 mg once daily based upon individual tolerability [see dosage and administration ( 2.2), and clinical pharmacology ( 12.3)] . in patients with severe renal impairment, avoid use of tadalafil tablets because of increased tadalafil exposure (auc), limited clinical experience, and the lack of ability to influence clearance by dialysis  [see clinical pharmacology ( 12.3)] . because of limited clinical experience in patients with mild to moderate hepatic cirrhosis (child-pugh class a or b), consider a starting dose of tadalafil tablets 20 mg once daily. patients with severe hepatic cirrhosis (child-pugh class c) have not been studied, thus avoid use of tadalafil tablets in such patients [see dosage and administration ( 2.3), and clinical pharmacology ( 12.3)] .

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solco healthcare us, llc - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve exercise ability. studies establishing effectiveness included predominately patients with nyha functional class ii – iii symptoms and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (23%). tadalafil tablets are contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. do not use nitrates within 48 hours of the last dose of tadalafil tablets. tadalafil tablets potentiate the hypotensive effect of nitrates. this potentiation is thought to result from the combined effects of nitrates and tadalafil tablets on the nitric oxide/cgmp pathway [see clinical pharmacology (12.2)] . coadministration of gc stimulators such as riociguat with tadalafil tablets are contraindicated. tadalafil tablets may potentiate the hypotensive effects of gc stimulators. tadalafil tablets are contraindicated in patients with a k

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camber pharmaceuticals, inc. - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablet is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve exercise ability. studies establishing effectiveness included predominately patients with nyha functional class ii to iii symptoms and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (23%). tadalafil is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. do not use nitrates within 48 hours of the last dose of tadalafil. tadalafil potentiates the hypotensive effect of nitrates. this potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cgmp pathway [see clinical pharmacology ( 12.2)]. coadministration of gc stimulators such as riociguat with tadalafil is contraindicated. tadalafil may potentiate the hypotensive effects of gc stimulators.   tadalafil tablet is contraindicated in patients with a known serious hypersensitivity to tadalaf

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lupin pharmaceuticals, inc. - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve exercise ability. studies establishing effectiveness included predominately patients with nyha functional class ii – iii symptoms and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (23%).   tadalafil is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. do not use nitrates within 48 hours of the last dose of tadalafil. tadalafil potentiates the hypotensive effect of nitrates. this potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cgmp pathway [see clinical  pharmacology (12.2)] . coadministration of gc stimulators such as riociguat with tadalafil is contraindicated. tadalafil may potentiate the hypotensive effects of gc stimulators. tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil or cialis. hypersensitivity reactions have been reported, including stevens-johnson syndrome and exfoliative dermatitis [see adverse reactions (6.2)] . risk summary limited data from case series with tadalafil use in pregnant women have not identified a drugassociated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures 7 times the exposure at the maximum recommended human dose (mrhd) of 40 mg/day based on auc (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 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 tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats. animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at unbound tadalafil exposures up to 7 times the exposure at the maximum recommended human dose (mrhd) of 40 mg/day during organogenesis based on auc. in one of two perinatal/postnatal developmental studies in rats, a reduction of postnatal pup survival was observed at dose levels of 60, 200 and 1000 mg/kg. the no-observed- effect-level (noel) for developmental toxicity was 30 mg/kg, which provided maternal exposure to unbound tadalafil concentrations approximately 5 times the exposure at the mrhd based on auc. signs of maternal toxicity occurred at doses greater than 200 mg/kg/day, which produced aucs greater than 8 times the exposure at the mrhd. surviving offspring had normal development and reproductive performance risk summary there are no data on the presence of tadalafil and/or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-times that found in the plasma. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tadalafil and any potential adverse effects on the breastfed child from tadalafil or from the underlying maternal condition. infertility males based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months. this effect was not seen in the study of 20 mg tadalafil taken for 6 months. there was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone. the clinical significance of the decreased sperm concentrations in the two studies is unknown. there have been no studies evaluating the effect of tadalafil on fertility in men or women [see clinical pharmacology (12.2)] . safety and effectiveness of tadalafil in pediatric patients have not been established. of the total number of subjects in the clinical study of tadalafil for pulmonary arterial hypertension, 28 percent were 65 and over, while 8 percent were 75 and over. no overall differences in safety were observed between subjects over 65 years of age compared to younger subjects or those over 75 years of age. no dose adjustment is warranted based on age alone; however, a greater sensitivity to medications in some older individuals should be considered. [see dosage and administration (2.2) and clinical pharmacology (12.3)] . for patients with mild or moderate renal impairment, start tadalafil at 20 mg once daily. increase the dose to 40 mg once daily based upon individual tolerability [see dosage and administration (2.2) and clinical pharmacology (12.3)] . in patients with severe renal impairment, avoid use of tadalafil because of increased tadalafil exposure (auc), limited clinical experience, and the lack of ability to influence clearance by dialysis [see clinical pharmacology (12.3)] . because of limited clinical experience in patients with mild to moderate hepatic cirrhosis (child-pugh class a or b), consider a starting dose of tadalafil 20 mg once daily. patients with severe hepatic cirrhosis (child-pugh class c) have not been studied, thus avoid use of tadalafil in such patients [see dosage and administration (2.3) and clinical pharmacology (12.3)] .

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mylan pharmaceuticals inc. - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablets are indicated for the treatment of erectile dysfunction (ed). tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph). tadalafil tablets are indicated for the treatment of ed and the signs and symptoms of bph (ed/bph). if tadalafil tablets are used with finasteride to initiate bph treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown [see clinical studies (14.3)] . administration of tadalafil tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. in clinical pharmacology studies, tadalafil tablets were shown to potentiate the hypotensive effect of nitrates [see clinical pharmacology (12.2)] . tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil

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

sunshine lake pharma co., ltd. - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve exercise ability. studies establishing effectiveness included predominately patients with nyha functional class ii – iii symptoms and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (23%). tadalafil is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. do not use nitrates within 48 hours of the last dose of tadalafil. tadalafil potentiates the hypotensive effect of nitrates. this potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cgmp pathway [see clinical pharmacology ( 12.2)] . coadministration of gc stimulators such as riociguat with tadalafil is contraindicated. tadalafil may potentiate the hypotensive effects of gc stimulators. tadalafil is contraindicated in patients with a known serious hypers

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

teva pharmaceuticals usa, inc. - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablets are indicated for the treatment of erectile dysfunction (ed). tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph). tadalafil tablets are indicated for the treatment of ed and the signs and symptoms of bph (ed/bph). if tadalafil tablets are used with finasteride to initiate bph treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown [see clinical studies (14.3)]. administration of tadalafil tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. in clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates [see clinical pharmacology (12.2) ]. tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (or adcirca® ). hypersensitivity reactions have been reported, including stevens-johnson syndrome and exfoliative dermatitis [see adverse reactions (6.2) ]. do not use tadalafil in patients who are using a gc stimulator, such as riociguat. pde5 inhibitors, including tadalafil, may potentiate the hypotensive effects of gc stimulators. risk summary tadalafil tablets are not indicated for use in females. there are no data with the use of tadalafil tablets in pregnant women to inform any drug-associated risks for adverse developmental outcomes. in animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures up to 11 times the maximum recommended human dose (mrhd) of 20 mg/day (see data). data animal data animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given orally to pregnant rats or mice at exposures up to 11 times the maximum recommended human dose (mrhd) of 20 mg/day during organogenesis. in a prenatal/postnatal developmental study in rats, postnatal pup survival decreased following maternal exposure to tadalafil doses greater than 10 times the mrhd based on auc. signs of maternal toxicity occurred at doses greater than 16 times the mrhd based on auc. surviving offspring had normal development and reproductive performance. in another rat prenatal and postnatal development study at doses of 60, 200, and 1000 mg/kg, a reduction in postnatal survival of pups was observed. the no observed effect level (noel) for maternal toxicity was 200 mg/kg/day and for developmental toxicity was 30 mg/kg/day. this gives approximately 16 and 10 fold exposure multiples, respectively, of the human auc for the mrhd of 20 mg. tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats. risk summary tadalafil tablets are not indicated for use in females. there is no information on the presence of tadalafil and/or metabolites in human milk, the effects on the breastfed child, or the effects on milk production. tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-fold greater than found in the plasma. infertility based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months. this effect was not seen in the study of 20 mg tadalafil taken for 6 months. there was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone. the clinical significance of the decreased sperm concentrations in the two studies is unknown. there have been no studies evaluating the effect of tadalafil on fertility in men [see clinical pharmacology (12.2)] . based on studies in animals, a decrease in spermatogenesis was observed in dogs, but not in rats [see nonclinical toxicology (13.1)] . tadalafil tablets are not indicated for use in pediatric patients. safety and efficacy in patients below the age of 18 years have not been established. a randomized, double-blind, placebo-controlled trial in pediatric patients (7 to 14 years of age) with duchenne muscular dystrophy, who received tadalafil tablets 0.3 mg/kg, tadalafil tablets 0.6 mg/kg, or placebo daily for 48 weeks failed to demonstrate any benefit of treatment with tadalafil tablets on a range of assessments of muscle strength and performance. juvenile animal study no adverse effects were observed in a study in which tadalafil was administered orally at doses of 60, 200, and 1000 mg/kg/day to juvenile rats on postnatal days 14 to 90. the highest plasma tadalafil exposures (auc) achieved were approximately 10-fold that observed at the mrhd. of the total number of subjects in ed clinical studies of tadalafil, approximately 19 percent were 65 and over, while approximately 2 percent were 75 and over. of the total number of subjects in bph clinical studies of tadalafil (including the ed/bph study), approximately 40 percent were over 65, while approximately 10 percent were 75 and over. in these clinical trials, no overall differences in efficacy or safety were observed between older (>65 and ≥75 years of age) and younger subjects (≤65 years of age). however, in placebo-controlled studies with tadalafil for use as needed for ed, diarrhea was reported more frequently in patients 65 years of age and older who were treated with tadalafil (2.5% of patients) [see adverse reactions (6.1)] . no dose adjustment is warranted based on age alone. however, a greater sensitivity to medications in some older individuals should be considered [see clinical pharmacology (12.3)]. in clinical pharmacology studies, tadalafil exposure (auc) in subjects with mild or moderate hepatic impairment (child-pugh class a or b) was comparable to exposure in healthy subjects when a dose of 10 mg was administered. there are no available data for doses higher than 10 mg of tadalafil in patients with hepatic impairment. insufficient data are available for subjects with severe hepatic impairment (child-pugh class c) [see dosage and administration (2.6) and warnings and precautions (5.8)]. in clinical pharmacology studies using single-dose tadalafil (5 to 10 mg), tadalafil exposure (auc) doubled in subjects with creatinine clearance 30 to 80 ml/min. in subjects with end-stage renal disease on hemodialysis, there was a two-fold increase in cmax and 2.7- to 4.8-fold increase in auc following single-dose administration of 10 or 20 mg tadalafil. exposure to total methylcatechol (unconjugated plus glucuronide) was 2- to 4-fold higher in subjects with renal impairment, compared to those with normal renal function. hemodialysis (performed between 24 and 30 hours post-dose) contributed negligibly to tadalafil or metabolite elimination. in a clinical pharmacology study (n=28) at a dose of 10 mg, back pain was reported as a limiting adverse event in male patients with creatinine clearance 30 to 50 ml/min. at a dose of 5 mg, the incidence and severity of back pain was not significantly different than in the general population. in patients on hemodialysis taking 10- or 20 mg tadalafil, there were no reported cases of back pain [see dosage and administration (2.6) and warnings and precautions (5.7)].

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avkare - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablets are indicated for the treatment of erectile dysfunction (ed). tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph). tadalafil tablets are indicated for the treatment of ed and the signs and symptoms of bph (ed/bph). if tadalafil tablets are used with finasteride to initiate bph treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decrease from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown [see clinical studies ( 14.3)]. administration of tadalafil tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. in clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates [ see clinical pharmacology ( 12.2) ]. tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (or a

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

cipla usa inc. - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve exercise ability. studies establishing effectiveness included predominately patients with nyha functional class ii – iii symptoms and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (23%). tadalafil tablets are contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. do not use nitrates within 48 hours of the last dose of tadalafil tablets. tadalafil potentiates the hypotensive effect of nitrates.this potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cgmp pathway [see clinical pharmacology (12.2)] . coadministration of gc stimulators such as riociguat with tadalafil tablets is contraindicated. tadalafil may potentiate the hypotensive effects of gc stimulators. tadalafil tablet is contraindicated in patients with a known serious hypersensitivi