Bandaríkin - enska - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 20 mg

Bandaríkin - enska - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 5 mg

Bandaríkin - enska - NLM (National Library of Medicine)

major pharmaceuticals - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 5 mg

Bandaríkin - enska - NLM (National Library of Medicine)

unit dose services - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 10 mg

Bandaríkin - enska - NLM (National Library of Medicine)

st marys medical park pharmacy - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 40 mg

Bandaríkin - enska - NLM (National Library of Medicine)

cardinal health 107, llc - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hcl 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 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 mm hg 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. it may be used alone or in combination with thiazide diuretics. benazepril hcl tablets are contraindicated in patients: benazepril hcl is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer benazepril hcl within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see warnings and precautions (5.2)]. do not co-administer aliskiren with angiotensin receptor blockers, ace inhibitors; including benazepril hcl tablets in patients with diabetes [see drug interactions (7.4)]. risk summary benazepril hcl 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. when pregnancy is detected, discontinue benazepril hcl as soon as possible. the estimated background risk of major birth defects and miscarriage for the indicated population are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the general u.s. 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 and 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. perform serial ultrasound examinations to assess the intra-amniotic environment. 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 benazepril hcl for hypotension, oliguria, and hyperkalemia. if oliguria or hypotension occur in neonates with a history of in utero exposure to benazepril hcl, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function . minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril. a newborn child ingesting entirely breast milk would receive less than 0.1% of the mg/kg maternal dose of benazepril and benazeprilat. the antihypertensive effects of benazepril hcl have been evaluated in a double-blind study in pediatric patients 7 to 16 years of age [see clinical pharmacology (12.3)]. the pharmacokinetics of benazepril hcl have been evaluated in pediatric patients 6 to 16 years of age [see clinical pharmacology (12.3)]. infants below the age of 1 year should not be given benazepril hcl because of the risk of effects on kidney development. safety and effectiveness of benazepril hcl have not been established in pediatric patients less than 6 years of age or in children with glomerular filtration rate < 30 ml/min/1.73 m² [see  dosage and administration (2.1) and clinical pharmacology (12.3)]. of the total number of patients who received benazepril in u.s. clinical studies of benazepril hcl, 18% were 65 or older while 2% were 75 or older. no overall differences in effectiveness or safety were observed between these patients and younger patients, and 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. benazepril and benazeprilat are substantially excreted by the kidney. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.2)] . ace inhibitors, including benazepril hcl, as monotherapy, have an effect on blood pressure that is less in black patients than in non-blacks.  dose adjustment of benazepril hcl is required in patients undergoing hemodialysis or whose creatinine clearance is ≤ 30 ml/min. no dose adjustment of benazepril hcl is required in patients with creatinine clearance > 30 ml/min [see  dosage and administration (2.2) and clinical pharmacology (12.3)].

Bandaríkin - enska - NLM (National Library of Medicine)

remedyrepack inc. - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hcl 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 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 mm hg 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. it may be used alone or in combination with thiazide diuretics. benazepril hcl tablets are contraindicated in patients: - who are hypersensitive to benazepril or to any other ace inhibitor - with a history of angioedema with or without previous ace inhibitor treatment benazepril hcl is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer benazepril hcl within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see warnings and precautions (5.2)]. do not co-administer aliskiren with angiotensin receptor blockers, ace inhibitors; including benazepril hcl tablets in patients with diabetes [see drug interactions (7.4)]. risk summary benazepril hcl 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. when pregnancy is detected, discontinue benazepril hcl as soon as possible. the estimated background risk of major birth defects and miscarriage for the indicated population are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the general u.s. 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 and 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. perform serial ultrasound examinations to assess the intra-amniotic environment. 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 benazepril hcl for hypotension, oliguria, and hyperkalemia. if oliguria or hypotension occur in neonates with a history of in utero exposure to benazepril hcl, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function . minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril. a newborn child ingesting entirely breast milk would receive less than 0.1% of the mg/kg maternal dose of benazepril and benazeprilat. the antihypertensive effects of benazepril hcl have been evaluated in a double-blind study in pediatric patients 7 to 16 years of age [see clinical pharmacology (12.3)]. the pharmacokinetics of benazepril hcl have been evaluated in pediatric patients 6 to 16 years of age [see clinical pharmacology (12.3)]. infants below the age of 1 year should not be given benazepril hcl because of the risk of effects on kidney development. safety and effectiveness of benazepril hcl have not been established in pediatric patients less than 6 years of age or in children with glomerular filtration rate < 30 ml/min/1.73 m² [see  dosage and administration (2.1) and clinical pharmacology (12.3)]. of the total number of patients who received benazepril in u.s. clinical studies of benazepril hcl, 18% were 65 or older while 2% were 75 or older. no overall differences in effectiveness or safety were observed between these patients and younger patients, and 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. benazepril and benazeprilat are substantially excreted by the kidney. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.2)] . ace inhibitors, including benazepril hcl, as monotherapy, have an effect on blood pressure that is less in black patients than in non-blacks.  dose adjustment of benazepril hcl is required in patients undergoing hemodialysis or whose creatinine clearance is ≤ 30 ml/min. no dose adjustment of benazepril hcl is required in patients with creatinine clearance > 30 ml/min [see  dosage and administration (2.2) and clinical pharmacology (12.3)].

Bandaríkin - enska - 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)] .

Bandaríkin - enska - 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

Bandaríkin - enska - 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, 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