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zydus lifesciences limited - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate 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 amlodipine besylate. 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 cl

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mylan institutional inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate 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 amlodipine besylate 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 pharmaco

미국 - 영어 - NLM (National Library of Medicine)

kali laboratories, inc., a wholly owned subsidiary of par pharmaceutical companies - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - tablet - 2.5 mg - 1. hypertension amlodipine besylate is indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive agents. 2. chronic stable angina amlodipine besylate is indicated for the treatment of chronic stable angina. amlodipine besylate may be used alone or in combination with other antianginal agents. 3. vasospastic angina (prinzmetal's or variant angina) amlodipine besylate is indicated for the treatment of confirmed or suspected vasospastic angina. amlodipine besylate may be used as monotherapy or in combination with other antianginal drugs. amlodipine besylate is contraindicated in patients with known sensitivity to amlodipine.

미국 - 영어 - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate tablets, usp are indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive agents. chronic stable angina amlodipine besylate tablets, usp are indicated for the symptomatic treatment of chronic stable angina. amlodipine besylate tablets, usp may be used alone or in combination with other antianginal agents. vasospastic angina (prinzmetal’s or variant angina) amlodipine besylate tablets, usp are indicated for the treatment of confirmed or suspected vasospastic angina. amlodipine besylate tablets, usp may be used as monotherapy or in combination with other antianginal agents. angiographically documented cad in patients with recently documented cad by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets, usp are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. amlodipine besylate tablets are contraindicated in patients w

미국 - 영어 - NLM (National Library of Medicine)

cardinal health - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate 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 amlodipine besylate 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 pharmaco

미국 - 영어 - NLM (National Library of Medicine)

avpak - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate 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 amlodipine besylate. 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 cla

미국 - 영어 - NLM (National Library of Medicine)

ncs healthcare of ky, inc dba vangard labs - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 5 mg - amlodipine besylate tablets are indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive agents. amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. amlodipine besylate tablets may be used alone or in combination with other antianginal agents. amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents. in patients with recently documented cad by angiography and without heart failure or an ejection fraction < 40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine. there are no adequate and well controlled studies in pregnant women. amlodipine should be used dur

미국 - 영어 - NLM (National Library of Medicine)

ncs healthcare of ky, inc dba vangard labs - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - amlodipine 5 mg - amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.   amlodipine besylate and benazepril hydrochloride capsules are contraindicated in patients with a history of angioedema, with or without previous ace inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ace inhibitor, or to amlodipine. pregnancy category d [see warnings and precautions (5 .4 ) ] the use of ace inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. prematurity, intrauterine growth re

미국 - 영어 - NLM (National Library of Medicine)

ajanta pharma usa inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10) - amlodipine 5 mg - amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) 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 amlodipine and olmesartan medoxomil 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. amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. the decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. individual blood pressure goals may vary based upon the patient’s risk. data from an 8-week, placebo-controlled, parallel-group factorial study [see clinical studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. the figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. the curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. the right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures.      the figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., week 8 sbp <140 mmhg or <130 mmhg or a dbp <90 mmhg or <80 mmhg) for the high-dose treatment groups evaluated in the study. amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. for example, a patient with a baseline blood pressure of 160/100 mmhg has about a 48% likelihood of achieving a goal of <140 mmhg (systolic) and a 51% likelihood of achieving a goal of <90 mmhg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmhg (systolic) and a 60% likelihood of achieving a goal of <90 mmhg (diastolic) on monotherapy with amlodipine 10 mg. the likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg. do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes [see drug interactions ( 7.2 )]. risk summary amlodipine and olmesartan medoxomil tablets 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 [see clinical considerations]. 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. when pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible. consider alternative antihypertensive therapy during pregnancy. 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 olmesartan medoxomil 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. 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. closely observe infants with histories of in utero exposure to olmesartan for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to olmesartan, if oliguria or hypotension occur, utilize measures to maintain adequate blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function [see use in specific populations (8.4)]. data animal data no reproductive studies have been conducted with the combination of olmesartan medoxomil, and amlodipine. however, these studies have been conducted for olmesartan medoxomil and amlodipine alone. olmesartan medoxomil no teratogenic effects were observed when olmesartan medoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximum recommended human dose [mrhd] on a mg/m2 basis) or pregnant rabbits at oral doses up to 1 mg/kg/day (half the mrhd on a mg/m2 basis; higher doses could not be evaluated for effects on fetal development as they were lethal to the does). in rats, significant decreases in pup birth weight and weight gain were observed at doses ≥1.6 mg/kg/day, and delays in developmental milestones (delayed separation of ear auricular, eruption of lower incisors, appearance of abdominal hair, descent of testes, and separation of eyelids) and dose-dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥ 8 mg/kg/day. the no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the mrhd of 40 mg/day. amlodipine  no evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses of up to 10mg amlodipine/kg/day (respectively about 10 and 20 times the maximum recommended human dose of 10 mg amlodipine on a mg/m2 basis) during their respective periods of major organogenesis (calculations based on a patient weight of 60 kg). however, litter size was significantly decreased (by about 50%), and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. amlodipine maleate has been shown to prolong both the gestational period and the duration of labor in rats at this dose. risk summary there is limited information regarding the presence of amlodipine and olmesartan medoxomil tablets in human milk, the effects on the breastfed infant, or the effects on milk production. amlodipine is present in human milk. olmesartan is present in rat milk [see data] . because of the potential for adverse effects on the nursing infant, advise a nursing woman that breastfeeding is not recommended during treatment with amlodipine and olmesartan medoxomil tablets. data presence of olmesartan in milk was observed after a single oral administration of 5 mg/kg [14 c] olmesartan medoxomil to lactating rats. the safety and effectiveness of amlodipine and olmesartan medoxomil tablets in pediatric patients have not been established. of the total number of subjects in the double-blind clinical study of amlodipine and olmesartan medoxomil tablets, 20% (384/1940) were 65 years of age or older and 3% (62/1940) were 75 years or older. no overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects. elderly patients have decreased clearance of amlodipine. starting amlodipine or adding amlodipine at 2.5 mg in patients ≥75 years old is recommended. the lowest dose of amlodipine and olmesartan medoxomil tablets is 5/20 mg; therefore, initial therapy with amlodipine and olmesartan medoxomil tablets is not recommended in patients ≥75 years old. amlodipine. 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 disease or other drug therapy. elderly patients have decreased clearance of amlodipine with a resulting increase of auc of approximately 40% to 60%, and a lower initial dose may be required. olmesartan medoxomil. of the total number of hypertensive patients receiving olmesartan medoxomil in clinical studies, more than 20% were 65 years of age and over, while more than 5% were 75 years of age and older. no overall differences in effectiveness or safety were observed between elderly patients and younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. there are no studies of amlodipine and olmesartan medoxomil tablets in patients with hepatic insufficiency, but both amlodipine and olmesartan medoxomil show moderate increases in exposure in patients with hepatic impairment. the recommended initial dose of amlodipine in patients with severe hepatic impairment is 2.5 mg, a dose not available with amlodipine and olmesartan medoxomil tablets. amlodipine. amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t½) is 56 hours in patients with severely impaired hepatic function [see warnings and precautions (5.5)] . olmesartan medoxomil. increases in auc0-∞ and peak plasma concentration (cmax) for olmesartan were observed with moderate hepatic impairment compared to those in matched controls with an increase in auc of about 60%. there are no studies of amlodipine and olmesartan medoxomil tablets in patients with renal impairment. amlodipine. the pharmacokinetics of amlodipine are not significantly influenced by renal impairment. patients with renal failure may therefore receive the usual initial dose. olmesartan medoxomil. patients with renal insufficiency have elevated serum concentrations of olmesartan compared with patients with normal renal function. after repeated dosing, auc was approximately tripled in patients with severe renal impairment (creatinine clearance <20 ml/min). no initial dosage adjustment is recommended for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min). of the total number of subjects in the double-blind clinical study of amlodipine and olmesartan medoxomil tablets, 25% (481/1940) were black patients. amlodipine and olmesartan medoxomil tablets were effective in treating black patients (usually a low-renin population), and the magnitude of blood pressure reduction in black patients approached that observed for non-black patients.

미국 - 영어 - NLM (National Library of Medicine)

celgene corporation - enasidenib mesylate (unii: uf6pc17xav) (enasidenib - unii:3t1ss4e7ag) - enasidenib mesylate 50 mg - idhifa is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (aml) with an isocitrate dehydrogenase-2 (idh2) mutation as detected by an fda-approved test. none. based on animal embryo-fetal toxicity studies, idhifa can cause fetal harm when administered to a pregnant woman. there are no available data on idhifa use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in animal embryo-fetal toxicity studies, oral administration of enasidenib to pregnant rats and rabbits during organogenesis was associated with embryo-fetal mortality and alterations to growth starting at 0.1 times the steady state clinical exposure based on the auc at the recommended human dose (see data). advise pregnant women of the potential risk to a fetus. 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. enasidenib administered to pregnant rats at a dose of 30 mg/kg twice daily during organogenesis (gestation days 6-17) was associated with maternal toxicity and adverse embryo-fetal effects including post-implantation loss, resorptions, decreased viable fetuses, lower fetal birth weights, and skeletal variations. these effects occurred in rats at approximately 1.6 times the clinical exposure at the recommended human daily dose of 100 mg/day. in pregnant rabbits treated during organogenesis (gestation days 7-19), enasidenib was maternally toxic at doses equal to 5 mg/kg/day or higher (exposure approximately 0.1 to 0.6 times the steady state clinical exposure at the recommended daily dose) and caused spontaneous abortions at 5 mg/kg/day (exposure approximately 0.1 times the steady state clinical exposure at the recommended daily dose). risk summary there are no data on the presence of enasidenib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with idhifa and for 2 months after the last dose. based on animal embryo-fetal toxicity studies, idhifa can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . verify pregnancy status in females of reproductive potential prior to starting idhifa. advise females of reproductive potential to use effective contraception during treatment with idhifa and for 2 months after the last dose. coadministration of idhifa may decrease the concentrations of combined hormonal contraceptives. advise patients using hormonal contraceptives to use an effective non-hormonal contraceptive method during treatment with idhifa and for 2 months after the last dose [see drug interactions (7.1)] . advise males with female partners of reproductive potential to use effective contraception during treatment with idhifa and for 2 months after the last dose of idhifa. based on findings in animals, idhifa may impair fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see nonclinical toxicology (13.1)] . safety and effectiveness of idhifa in pediatric patients have not been established. no dosage adjustment is required for idhifa based on age. in the clinical study, 61% of 214 patients were aged 65 years or older, while 24% were older than 75 years. no overall differences in effectiveness or safety were observed between patients aged 65 years or older and younger patients.