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

lupin pharmaceuticals, 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 angiotensin ii receptor blocker (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 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 valsartan tablets are indicated for the treatment of hypertension. 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 compared to monotherapy. individual blood pressure goals may vary based upon the patient's risk. data from the high-dose multifactorial study [see clinical studies (14)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and valsartan tablets compared to amlodipine or valsartan monotherapy. the figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with amlodipine and valsartan tablets 10/320 mg, based upon baseline systolic or diastolic blood pressure. the curve of each treatment group was estimated by logistic regression modeling. the estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. figure 1: probability of achieving systolic blood pressure <140 mmhg at week 8 figure 2: probability of achieving diastolic blood pressure <90 mmhg at week 8 figure 3: probability of achieving systolic blood pressure <130 mmhg at week 8 figure 4: probability of achieving diastolic blood pressure <80 mmhg at week 8 for example, a patient with a baseline blood pressure of 160/100 mmhg has about a 67% likelihood of achieving a goal of <140 mmhg (systolic) and 80% likelihood of achieving <90 mmhg (diastolic) on amlodipine alone, and the likelihood of achieving these goals on valsartan alone is about 47% (systolic) or 62% (diastolic). the likelihood of achieving these goals on amlodipine and valsartan tablets rises to about 80% (systolic) or 85% (diastolic). the likelihood of achieving these goals on placebo is about 28% (systolic) or 37% (diastolic). do not use in patients with known hypersensitivity to any component. do not coadminister aliskiren with amlodipine and valsartan in patients with diabetes [see drug interactions (7)] . risk summary amlodipine and 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, discontinue amlodipine and 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. 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 valsartan for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to amlodipine and 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: 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). risk summary there is limited information regarding the presence of amlodipine and valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. 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 and valsartan tablets. data valsartan was detected in the milk of lactating rats 15 minutes after oral administration of a 3 mg/kg dose. safety and effectiveness of amlodipine and valsartan tablets in pediatric patients have not been established. in controlled clinical trials, 323 (22.5%) hypertensive patients treated with amlodipine and valsartan tablets were ≥65 years and 79 (5.5%) were ≥75 years. no overall differences in the efficacy or safety of amlodipine and valsartan tablets were observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. amlodipine the recommended starting dose of amlodipine 2.5 mg is not an available strength with amlodipine and valsartan tablets. 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 area under the curve (auc) of approximately 40% to 60%. valsartan in the controlled clinical trials of valsartan, 1214 (36.2%) of 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. safety and effectiveness of amlodipine and valsartan tablets 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 [see clinical pharmacology (12.3)]. the recommended initial dose of amlodipine in patients with hepatic impairment is 2.5 mg, which is not an available strength with amlodipine and valsartan tablets. 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.

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

teva pharmaceuticals usa, 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 besylate and benazepril hydrochloride in patients with diabetes. - amlodipine 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 and benazepril hydrochloride capsules. - amlodipine and benazepril hydrochloride capsules are 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) ]. pregnancy

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

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)] .

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

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 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 besylate and benazepril hydrochloride in patients with diabetes. - amlodipine 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 and benazepril hydrochloride capsules. - amlodipine and benazepril hydrochloride capsules are 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) ]. pregnan

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - hydrochlorothiazide, quantity: 25 mg; valsartan, quantity: 320 mg; amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg) - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; crospovidone; hypromellose; purified talc; iron oxide yellow; macrogol 4000 - exforge hct is indicated only as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. treatment should not be initiated with these fixed-dose combinations (see dosage and administration).

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - hydrochlorothiazide, quantity: 25 mg; amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); valsartan, quantity: 160 mg - tablet, film coated - excipient ingredients: crospovidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 4000 - exforge hct is indicated only as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. treatment should not be initiated with these fixed-dose combinations (see dosage and administration).

Malta - English - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - amlodipine besylate, valsartan - film-coated tablet - amlodipine besylate 5 mg valsartan 160 mg - agents acting on the renin-angiotensin system

Malta - English - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - amlodipine besylate, valsartan - film-coated tablet - amlodipine besylate 10 mg valsartan 160 mg - agents acting on the renin-angiotensin system

Malta - English - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - amlodipine besylate, valsartan - film-coated tablet - amlodipine besylate 5 mg valsartan 80 mg - agents acting on the renin-angiotensin system

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

torrent pharmaceuticals limited - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - amlodipine 5 mg - amlodipine and valsartan 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 and the arb class to which valsartan principally belongs. there are no controlled trials demonstrating risk reduction with amlodipine and valsartan tablets, usp. 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 com