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

aurobindo pharma limited - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg - ezetimibe tablets are indicated: - in combination with a statin, or alone when additional low-density lipoprotein cholesterol (ldl-c) lowering therapy is not possible, as an adjunct to diet to reduce elevated ldl-c in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh). - in combination with a statin as an adjunct to diet to reduce elevated ldl-c in pediatric patients 10 years of age and older with hefh. - in combination with fenofibrate as an adjunct to diet to reduce elevated ldl-c in adults with mixed hyperlipidemia. - in combination with a statin, and other ldl-c lowering therapies, to reduce elevated ldl-c levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (hofh). - as an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. when ezetimibe tablets are used in combination with a statin, fenofibrate, or other ldl-c lowering therapies, refer to the prescribing information of these products for information on the safe and effective use. ezetimibe tablets are contraindicated in patients with a known hypersensitivity to ezetimibe or any of the excipients in ezetimibe tablets. hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported [see adverse reactions (6.2)] . when used in combination with a statin, fenofibrate, or other ldl-c lowering therapy, ezetimibe tablets are contraindicated in patients for whom a statin, fenofibrate, or other ldl-c lowering therapy are contraindicated. refer to the prescribing information of these products for a list of their contraindications [see warnings and precautions (5.1)] . risk summary there are insufficient data on ezetimibe use in pregnant women to evaluate for 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 in pregnant rats and rabbits orally administered ezetimibe during the period of organogenesis at doses that resulted in up to 10 and 150 times, respectively, the human exposure at the mrhd, based on auc (see data) . ezetimibe should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when ezetimibe is administered with a statin, refer to the prescribing information for the statin. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in oral (gavage) embryo-fetal development studies of ezetimibe conducted in rats (gestation days 6-15) and rabbits (gestation days 7-19), there was no evidence of maternal toxicity or embryolethal effects at the doses tested (250, 500, 1,000 mg/kg/day). in rats, increased incidences of common fetal skeletal findings (extra pair of thoracic ribs, unossified cervical vertebral centra, shortened ribs) were observed at 1,000 mg/kg/day (~10 times the human exposure at 10 mg daily based on auc0-24hr   for total ezetimibe). in rabbits treated with ezetimibe, an increased incidence of extra thoracic ribs was observed at 1,000 mg/kg/day (150 times the human exposure at 10 mg daily based on auc0-24hr   for total ezetimibe). the animal-to-human exposure multiple for total ezetimibe at the no-observed effect level was 6 times for rat and 134 times for rabbit. fetal exposure to ezetimibe (conjugated and unconjugated) was confirmed in subsequent placental transfer studies conducted using a maternal dose of 1,000 mg/kg/day. the fetal maternal plasma exposure ratio (total ezetimibe) was 1.5 for rats on gestation day 20 and 0.03 for rabbits on gestation day 22. the effect of ezetimibe on prenatal and postnatal development and maternal function was evaluated in pregnant rats at doses of 100, 300 or 1,000 mg/kg/day from gestation day 6 through lactation day 21. no maternal toxicity or adverse developmental outcomes were observed up to and including the highest dose tested (17 times the human exposure at 10 mg daily based on auc0-24hr   for total ezetimibe). multiple-dose studies of ezetimibe given in combination with statins in rats and rabbits during organogenesis resulted in higher ezetimibe and statin exposures. reproductive findings occurred at lower doses in combination therapy compared to monotherapy. risk summary there is no information about the presence of ezetimibe in human milk. ezetimibe is present in rat milk (see data) . when a drug is present in animal milk, it is likely that the drug will be present in human milk. there is no information about the effects of ezetimibe on the breastfed infant or the effects of ezetimibe on milk production. ezetimibe should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant. data ezetimibe was present in the milk of lactating rats. the pup to maternal plasma ratio for total ezetimibe was 0.5 on lactation day 12. the safety and effectiveness of ezetimibe in combination with a statin as an adjunct to diet to reduce ldl-c have been established in pediatric patients 10 years of age and older with hefh. use of ezetimibe for this indication is based on a double-blind, placebo-controlled clinical trial in 248 pediatric patients (142 males and 106 postmenarchal females) 10 years of age and older with hefh [see clinical studies (14)] . in this limited controlled trial, there was no significant effect on growth or sexual maturation in the adolescent males or females, or on menstrual cycle length in females. the safety and effectiveness of ezetimibe in combination with a statin, and other ldl-c lowering therapies, to reduce ldl-c have been established in pediatric patients 10 years of age and older with hofh. use of ezetimibe for this indication is based on a 12-week double-blind, placebo-controlled clinical trial followed by an uncontrolled extension period in 7 pediatric patients 11 years of age and older with hofh [see clinical studies (14)] . the safety and effectiveness of ezetimibe as an adjunct to diet for the reduction of elevated sitosterol and campesterol levels have been established in adults and pediatric patients 9 years of age and older with homozygous familial sitosterolemia. use of ezetimibe for this indication is based on an 8-week double-blind, placebo-controlled clinical trial in 4 patients 9 years of age and older with homozygous sitosterolemia with elevated plasma sitosterol levels (>5 mg/dl) [see clinical studies (14)] . the safety and effectiveness of ezetimibe have not been established in pediatric patients younger than 10 years of age with hefh or hofh, in pediatric patients younger than 9 years of age with homozygous familial sitosterolemia, or in pediatric patients with other types of hyperlipidemia. of the 2,396 patients who received ezetimibe in clinical trials, 669 (28%) were 65 years of age and older, and 111 (5%) were 75 years of age and older. of the 11,308 patients who received ezetimibe in combination with a statin in clinical trials, 3587 (32%) were 65 years of age and older, and 924 (8%) were 75 years of age and older [see clinical studies (14)] . no overall differences in safety or effectiveness of ezetimibe have been observed between patients 65 years of age and older and younger patients. no clinically meaningful differences in the pharmacokinetics of ezetimibe were observed in geriatric patients compared to younger adult patients [see clinical pharmacology (12.3)]. no dosage adjustment of ezetimibe is necessary in patients with renal impairment. ezetimibe is not recommended for use in patients with moderate to severe hepatic impairment (child-pugh b or c) due to the unknown effects of the increased exposure to ezetimibe [see clinical pharmacology (12.3)] .

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

dr. reddy's laboratories limited - metoprolol succinate (unii: th25pd4ccb) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 25 mg - metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic

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

torrent pharmaceuticals limited - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine 200 mg - carbamazepine is indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by carbamazepine (see precautions, general). carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. beneficial results have also been reported in glossopharyngeal neuralgia. this drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. carbamazepine should not be used in patients with a history of previous bone marro

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

torrent pharmaceuticals limited - olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - olmesartan medoxomil 20 mg - olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see dosage and administration (2)] . lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals

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

aurobindo pharma limited - olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - olmesartan medoxomil 20 mg - olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see dosage and administration (2) ]. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goa

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

aurobindo pharma limited - valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - valsartan 40 mg - valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which valsartan principally belongs. there are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education

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

aurobindo pharma limited - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 0.5 mg - entecavir tablets are indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the apr are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. entecavir use during   pregnancy has been evaluated in a limited number of individuals reported to the apr and the number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population. the estimated background rate for

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

aurobindo pharma limited - telmisartan (unii: u5syw473rq) (telmisartan - unii:u5syw473rq) - telmisartan 20 mg - telmisartan tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of

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

zydus lifesciences limited - telmisartan (unii: u5syw473rq) (telmisartan - unii:u5syw473rq) - telmisartan 20 mg - telmisartan tablets, usp are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.   control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a vari

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

torrent pharmaceuticals limited - telmisartan (unii: u5syw473rq) (telmisartan - unii:u5syw473rq) - telmisartan 20 mg - telmisartan tablets, usp are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variet