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sandoz inc - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - amlodipine 5 mg - amlodipine and valsartan tablets may be used in patients whose blood pressure is not adequately controlled on either monotherapy. amlodipine and valsartan tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. the choice of amlodipine and valsartan tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks including whether the patient is likely to tolerate the lowest dose of amlodipine and valsartan tablets. patients with stage 2 hypertension (moderate or severe) are at a relatively higher 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 co

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lupin pharmaceuticals, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - amlodipine 2.5 mg - amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. - do not coadminister aliskiren with angiotensin receptor blockers (arbs), ace inhibitors, including amlodipine and benazepril hydrochloride in patients with diabetes. - amlodipine and benazepril hydrochloride is 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, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules. - amlodipine and benazepril hydrochloride is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan [see warnings and precautions (5.1)] . risk summary amlodipine and benazepril hydrochloride capsules can cause fetal harm when administered to a pregnant woman. use of drugs that act on the ras 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 ras from other antihypertensive agents. when pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsules 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. 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 amlodipine and benazepril hydrochloride for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to amlodipine and benazepril hydrochloride, 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 benazepril and amlodipine: when rats received benazepril:amlodipine at doses ranging from 5:2.5 to 50:25 mg/kg/day, dystocia was observed at an increasing dose-related incidence at all doses tested. on a body surface area basis, the 2.5 mg/kg/day dose of amlodipine is twice the amlodipine dose delivered when the maximum recommended dose of amlodipine and benazepril hydrochloride capsules is given to a 60 kg patient. similarly, the 5 mg/kg/day dose of benazepril is approximately equivalent with the benazepril dose delivered when the maximum recommended dose of amlodipine and benazepril hydrochloride capsules is given to a 60 kg patient. no teratogenic effects were seen when benazepril and amlodipine were administered in combination to pregnant rats or rabbits. rats received doses of up to 50:25 mg (benazepril:amlodipine)/kg/day (12 times the mrhd on a body surface area basis, assuming a 60 kg patient). rabbits received doses of up to 1.5:0.75 mg/kg/day (equivalent to the maximum recommended dose of amlodipine and benazepril hydrochloride capsules given to a 60 kg patient). risk summary minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril, so that a newborn child ingesting nothing but breast milk would receive less than 0.1% of the maternal doses of benazepril and benazeprilat. limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. no adverse effects of amlodipine on the breastfed infant have been observed. there is no available information on the effects of amlodipine or benazepril on milk production. safety and effectiveness in pediatric patients have not been established. in geriatric patients, exposure to amlodipine is increased, thus consider lower initial doses of amlodipine and benazepril hydrochloride [see clinical pharmacology (12.3)]. of the total number of patients who received amlodipine and benazepril hydrochloride in u.s. clinical studies of amlodipine and benazepril hydrochloride, over 19% were 65 years or older while about 2% were 75 years or older. overall differences in effectiveness or safety were not observed between these patients and younger patients. 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. exposure to amlodipine is increased in patients with hepatic insufficiency, thus consider using lower doses of amlodipine and benazepril hydrochloride capsules [see clinical pharmacology (12.3)] . in patients with severe renal impairment systemic exposure to benazepril is increased. the recommended dose of benazepril in this subgroup is 5 mg which is not an available strength with amlodipine and benazepril hydrochloride capsules. amlodipine and benazepril hydrochloride capsules are not recommended in patients with severe renal impairment. no dose adjustment of amlodipine and benazepril hydrochloride capsules is needed in patients with mild or moderate impairment of renal function [see dosage and administration (2.2), warnings and precautions (5.7) and clinical pharmacology (12.3)] .

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pd-rx pharmaceuticals, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - amlodipine 5 mg - amlodipine and benazepril hydrochloride capsules, usp are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. - do not coadminister aliskiren with angiotensin receptor blockers (arbs), ace inhibitors, including amlodipine and benazepril hydrochloride in patients with diabetes. - amlodipine and benazepril hydrochloride is 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, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules. - amlodipine and benazepril hydrochloride is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan

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

lupin pharmaceuticals, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - amlodipine 5 mg - amlodipine, valsartan and hydrochlorothiazide 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, hydrochlorothiazide, and the arb class to which valsartan principally belongs. there are no controlled trials demonstrating risk reduction with amlodipine, valsartan 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 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 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. limitation of use amlodipine, valsartan and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see dosage and administration  (2) ]. do not use in patients with anuria, hypersensitivity to other sulfonamide-derived drugs, or hypersensitivity to any component of this product. do not coadminister aliskiren with amlodipine, valsartan and hydrochlorothiazide in patients with diabetes [see drug interactions  (7) ]. risk summary amlodipine, valsartan and hydrochlorothiazide 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, discontinue amlodipine, valsartan and hydrochlorothiazide 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 valsartan 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. if oligohydramnios is observed, consider alternative drug treatment. closely observe neonates with histories of in utero exposure to amlodipine, valsartan and hydrochlorothiazide for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to amlodipine, valsartan and hydrochlorothiazide, 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. hydrochlorothiazide thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. it accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in umbilical vein plasma. use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. since they do not prevent or alter the course of eph (edema, proteinuria, hypertension) gestosis (preeclampsia), these drugs should not be used to treat hypertension in pregnant women. the use of hctz for other indications (e.g., heart disease) in pregnancy should be avoided. data animal data: valsartan and amlodipine in rats, administered 20 mg/kg/day amlodipine plus 320 mg/kg/day valsartan, treatment-related maternal and fetal effects (developmental delays and alterations noted in the presence of significant maternal toxicity) were noted with the high dose combination. this corresponds to dose multiples of 9 and 19.5 times, respectively, the maximum recommended human dose (mrhd) of 10 mg/day for amlodipine and 320 mg/day for valsartan (based on body surface area and considering a -60 kg patient). hydrochlorothiazide no teratogenic effects were observed when hydrochlorothiazide was administered to mice and rats via gavage at doses of up to 3000 and 1000 mg/kg/day (608 and 405 times the mrhd), on gestation days 6 through 15. risk summary there is limited information regarding the presence of amlodipine, valsartan and hydrochlorothiazide in human milk, the effects on the breastfed infant, or the effects on milk production. hydrochlorothiazide is present in human milk and valsartan is present in rat milk. limited published studies report that amlodipine is present in human milk. because of the potential for serious adverse reactions in breastfed infants, advise a nursing woman that breastfeeding is not recommended during treatment with amlodipine, valsartan and hydrochlorothiazide. data valsartan was detected in the milk of lactating rats 15 minutes after oral administration of a 3 mg/kg dose. the safety and effectiveness of amlodipine, valsartan and hydrochlorothiazide in pediatric patients have not been established. amlodipine clinical studies of amlodipine besylate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, 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% [see clinical pharmacology (12.3) ]. the recommended starting dose of amlodipine 2.5 mg is not an available strength with amlodipine, valsartan and hydrochlorothiazide [see clinical studies (14) ]. safety and effectiveness of amlodipine, valsartan 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 ml/min) renal impairment. amlodipine exposure to amlodipine is increased in patients with hepatic insufficiency. the recommended initial dose of amlodipine in patients with hepatic impairment is 2.5 mg, which is not an available strength with amlodipine, valsartan and hydrochlorothiazide [see clinical pharmacology  (12.3) ]. valsartan no dose adjustment is necessary for patients with mild-to-moderate disease. no dosing recommendations can be provided for patients with 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.

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

bluepoint laboratories - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - amlodipine 2.5 mg - amlodipine and benazepril hydrochloride capsules, are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. - do not co-administer aliskiren with angiotensin receptor blockers (arbs), ace inhibitors, including amlodipine and benazepril hydrochloride in patients with diabetes. - amlodipine and benazepril hydrochloride is 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, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules. - amlodipine and benazepril hydrochloride is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan (see warnings and precautions 5.1). risk summary aml

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par pharmaceutical, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - amlodipine 5 mg - amlodipine/valsartan/hydrochlorothiazide is 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, hydrochlorothiazide, and the arb class to which valsartan principally belongs. there are no controlled trials demonstrating risk reduction with amlodipine/valsartan/hydrochlorothiazide. 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 p

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

novel laboratories, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - amlodipine 5 mg - amlodipine and valsartan 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 and the arb class to which valsartan principally belongs. there are no controlled trials demonstrating risk reduction with amlodipine and 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 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

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

proficient rx lp - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - amlodipine 10 mg - amlodipine besylate and benazepril hydrochloride capsules, usp are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.  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 amlodipine besylate and benazepril hydrochloride 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 fro

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nucare pharmaceuticals, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - amlodipine 5 mg - amlodipine besylate and benazepril hydrochloride capsules, usp are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.  - do not coadminister aliskiren with angiotensin receptor blockers, ace inhibitors, including amlodipine besylate and benazepril hydrochloride capsules in patients with diabetes. - 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, to amlodipine, or to any of the excipients of amlodipine besylate and benazepril hydrochloride capsules. 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 deformati

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

nucare pharmaceuticals, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - amlodipine 5 mg - amlodipine besylate and benazepril hydrochloride capsules, usp are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.  - do not coadminister aliskiren with angiotensin receptor blockers, ace inhibitors, including amlodipine besylate and benazepril hydrochloride capsules in patients with diabetes. - 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, to amlodipine, or to any of the excipients of amlodipine besylate and benazepril hydrochloride capsules. 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 deformati