Соединенные Штаты - английский - NLM (National Library of Medicine)

dr. reddy's laboratories limited - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of venlaf

Соединенные Штаты - английский - 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)] .

Соединенные Штаты - английский - NLM (National Library of Medicine)

aurobindo pharma limited - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. risk summary there are no available data on darifenacin extended-release tablets use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in animal studies, darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 and 28 times the maximum recommended human dose (mrhd) of 15 mg, respectively. effects on embryofetal development were observed following administration of darifenacin during pregnancy (dilated ureter and/or kidney pelvis in rabbits at about 9 times the mrhd, post-implantation loss in rabbits at about 28 times, and delayed ossification in rats at about 59 times) and during pregnancy and lactation (developmental delays in rats at about 17 times the mrhd), which was associated with maternal toxicity (see data). dystocia was observed in rat dams at about 17 times the mrhd. 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. data animal data embryofetal development studies were conducted with oral darifenacin in female rats (0, 3, 10, and 50 mg/kg/day) and rabbits (0, 3, 10, and 30 mg/kg/day) during the period of organogenesis (gestation days 6 to 17 in the rat and gestation days 6 to 18 in the rabbit). darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in pregnant rats, there was a delay in the ossification of the sacral and caudal vertebrae (associated with a decrease in maternal and pup body weight gains) which was not observed at an exposure approximately 13 times the auc at the mrhd. at five times the auc (3 mg/kg/day), there were no effects on dams or pups.   in pregnant rabbits, an exposure of darifenacin approximately 28 times the auc at the mrhd of 15 mg (30 mg/kg/day) was shown to increase post-implantation loss (associated with decreased maternal body weight gain), with a no effect level at 10 mg/kg/day (9 times the auc at the mrhd). dilated ureter and/or kidney pelvis was also observed in offspring at this highest dose along with urinary bladder dilation consistent with the pharmacological action of darifenacin, with one case observed at the mid dose of 10 mg/kg/day (9 times the mrhd ). no effect was observed at the lowest dose of 3 mg/kg/day ((approximately 2.8 times the auc at the mrhd). a pre- and post-natal development study was conducted with oral darifenacin in female rats (0, 3, 10, and 50 mg/kg/day) throughout gestation and lactation. decreased body weight gain and dystocia were observed in dams at 10 mg/kg/day (approximately 17 times the mrhd) and above. slight developmental delays (surface righting reflex, incisor eruption, eyelid opening, vaginal opening, preputial separation) were observed in pups at these doses. at 5 times the auc at the mrhd (3 mg/kg/day), there were no effects on dams or pups. risk summary there are no data on the presence of darifenacin in human milk, the effects on the breastfed infant, or the effects of darifenacin extended-release tablets on milk production. darifenacin 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. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for darifenacin and any potential adverse effects on the breastfed child from darifenacin or from the underlying maternal conditions. data after a single oral dose of 14 c radiolabeled darifenacin to lactating rats, darifenacin was detected in maternal milk. the safety and effectiveness of darifenacin extended-release tablets in pediatric patients have not been established. in the fixed-dose, placebo-controlled, clinical studies, 30% of patients treated with darifenacin extended-release tablets were over 65 years of age. no overall differences in safety or efficacy were observed between patients over 65 years (n = 207) and younger patients less than 65 years (n = 464). no dose adjustment is recommended for elderly patients [see clinical pharmacology (12.3) and clinical studies (14)] . subjects with severe hepatic impairment (child-pugh c) have not been studied, therefore darifenacin extended-release tablets are not recommended for use in these patients [see dosage and administration (2) and warnings and precautions (5.6)] . the daily dose of darifenacin extended-release tablets should not exceed 7.5 mg once daily for patients with moderate hepatic impairment (child-pugh b) [see dosage and administration (2) and warnings and precautions (5.6)] . after adjusting for plasma protein binding, unbound darifenacin exposure was estimated to be 4.7-fold higher in subjects with moderate hepatic impairment than subjects with normal hepatic function. no dose adjustment is recommended for patients with mild hepatic impairment (child-pugh a). a study of subjects with varying degrees of renal impairment (creatinine clearance between 10 and 136 ml/min) demonstrated no clear relationship between renal function and darifenacin clearance. no dose adjustment is recommended for patients with renal impairment [see clinical pharmacology (12.3)] . no dose adjustment is recommended based on gender [see clinical pharmacology (12.3) and clinical studies (14)] .

Соединенные Штаты - английский - 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

Соединенные Штаты - английский - 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

Соединенные Штаты - английский - 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

Соединенные Штаты - английский - 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 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 classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs. olmesartan medoxomil and hydrochlorothiazide tablets are contraindicated: - in patients with hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide tablets [see adverse reactions (6.1, 6.2)] - in patients with anuria [see warnings and precautions (5.3) and adverse reactions (6.1)] - for coadministration with aliskiren in patients with diabetes [see drug interactions (7.4)]. pregnancy category d use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity, and death. resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. when pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide as soon as possible. these adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. in the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. perform serial ultrasound examinations to assess the intraamniotic environment. if oligohydramnios is observed, discontinue olmesartan medoxomil and hydrochlorothiazide, unless it is considered lifesaving for the mother. fetal testing may be appropriate, based on the week of pregnancy. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. closely observe infants with histories of in utero exposure to olmesartan medoxomil and hydrochlorothiazide for hypotension, oliguria, and hyperkalemia [see use in specific populations (8.4)]. it is not known whether olmesartan is excreted in human milk, but olmesartan is secreted at low concentration in the milk of lactating rats. thiazides appear in human milk. because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue olmesartan medoxomil and hydrochlorothiazide, taking into account the importance of the drug to the mother. neonates with a history of in utero exposure to olmesartan medoxomil and hydrochlorothiazide: if oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function. safety and effectiveness of olmesartan medoxomil and hydrochlorothiazide in pediatric patients have not been established. clinical studies of olmesartan medoxomil and hydrochlorothiazide 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, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy. olmesartan and hydrochlorothiazide are substantially excreted by the kidney, and the risk of toxic reactions to olmesartan medoxomil and hydrochlorothiazide may be greater in patients with impaired renal function. safety and effectiveness of olmesartan medoxomil and hydrochlorothiazide in patients with severe renal impairment (crcl ≤ 30 ml/min) have not been established. no dose adjustment is required in patients with mild (crcl 60 to 90 ml/min) or moderate (crcl 30 to 60) renal impairment. olmesartan medoxomil no dose adjustment is necessary for patients with mild-to-severe liver disease. hydrochlorothiazide minor alterations of fluid and electrolyte balance may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.

Соединенные Штаты - английский - 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 one year 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 program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. valsartan tablets may be used alone or in combination with other antihypertensive agents. valsartan tablets are indicated to reduce the risk of hospitalization for heart failure in adult patients with heart failure (nyha class ii to iv). there is no evidence that valsartan tablets provides added benefits when they are used with an adequate dose of an angiotensin converting enzyme (ace) inhibitor [see clinical studies (14.2)]. in clinically stable adult patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, valsartan tablets are indicated to reduce the risk of cardiovascular mortality [see clinical studies (14.3)]. do not use in patients with known hypersensitivity to any component. do not coadminister aliskiren with valsartan tablets in patients with diabetes [see drug interactions (7.3)]. risk summary valsartan can cause fetal harm when administered to a pregnant woman. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see clinical considerations ). when pregnancy is detected, consider alternative drug treatment and discontinue valsartan as soon as possible. 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 hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. fetal/neonatal adverse reactions oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. in the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. in patients taking valsartan during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. fetal testing may be appropriate, based on the week of gestation. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. if oligohydramnios is observed, consider alternative drug treatment. closely observe neonates with histories of in utero exposure to valsartan for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to valsartan, if oliguria or hypotension occurs, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. data animal data no teratogenic effects were observed when valsartan was administered to pregnant mice and rats at oral doses of up to 600 mg/kg/day (9 and 18 times the maximum recommended human dose (mrhd) on a mg/m2 basis) and to pregnant rabbits at oral doses of up to 10 mg/kg/day.  in rats, oral valsartan administered at maternally toxic doses (600 mg/kg/day) during organogenesis or late gestation and lactation, resulted in decreased fetal and pup weight, pup survival and delayed developmental milestones. in rabbits administered maternally toxic doses of 5 and 10 mg/kg/day, fetotoxicity was observed. risk summary there is no information regarding the presence of valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. valsartan is present in rat milk. because of the potential for serious adverse reactions in breastfed infants from exposure to valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with valsartan. data valsartan was detected in the milk of lactating rats 15 minutes after oral administration of a 3 mg/kg dose. the antihypertensive effects of valsartan have been evaluated in 5 clinical studies in pediatric patients from 1 to 16 years of age [see clinical studies (14.1)]. the pharmacokinetics of valsartan have been evaluated in pediatric patients 1 to 16 years of age [see clinical pharmacology (12.3)]. the adverse experience profile of valsartan was similar to that described for adults [see adverse reactions (6.1)].   in children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated. use of valsartan is not recommended in children less than 1 year of age. [see nonclinical toxicology (13.2)] . it is not known whether post-natal use of valsartan, before maturation of renal function is complete, has a long- term deleterious effect on the kidney.    no data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate less than 30 ml/min/1.73 m2 . in the controlled clinical trials of valsartan, 1,214 (36.2%) hypertensive patients treated with valsartan were ≥ 65 years and 265 (7.9%) were ≥ 75 years. no overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. exposure [measured by area under the curve (auc)] to valsartan is higher by 70% in the elderly than in the young, however no dosage adjustment is necessary [see clinical pharmacology (12.3)] . of the 2,511 patients with heart failure randomized to valsartan in the valsartan heart failure trial, 45% (1,141) were 65 years of age or older. in the valsartan in acute myocardial infarction trial (valiant), 53% (2,596) of the 4,909 patients treated with valsartan and 51% (2,515) of the 4,885 patients treated with valsartan + captopril were 65 years of age or older. there were no notable differences in efficacy or safety between older and younger patients in either trial. safety and effectiveness of valsartan in patients with severe renal impairment (glomerular filtration rate less than 30 ml/min/1.73 m2 ) have not been established. no dose adjustment is required in patients with mild (glomerular filtration rate 60 to 90 ml/min/1.73 m2 ) or moderate (glomerular filtration rate 30 to 60 ml/min/1.73 m2 ) renal impairment. no dose adjustment is necessary for patients with mild-to-moderate liver disease. no dosing recommendations can be provided for patients with severe liver disease.

Соединенные Штаты - английский - 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

Соединенные Штаты - английский - 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