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

aurobindo pharma limited - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 10 mg - benazepril hydrochloride 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

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

physicians total care, inc. - moexipril hydrochloride (unii: q1umg3uh45) (moexiprilat - unii:h3753190js) - moexipril hydrochloride 7.5 mg - moexipril hydrochloride is indicated for treatment of patients with hypertension. it may be used alone or in combination with thiazide diuretics. in using moexipril hydrochloride, consideration should be given to the fact that another ace inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. available data are insufficient to show that moexipril hydrochloride does not have a similar risk (see warnings ). in considering use of moexipril hydrochloride, it should be noted that in controlled trials ace inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. in addition, ace inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see warnings , angioedema ). moexipril hydrochloride is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment wi

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

cadila healthcare limited - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. metformin hydrochloride tablets and metformin hydrochloride extended-release tablets are contraindicated in patients with: - renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance)which may also result from conditions such as cardiovascular collapse (shock),acute myocardial infarction, and septicemia (see warnings andprecautions). - known hypersensitivity to metformin hydrochloride. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with orwithout coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride tablets and metformin hydrochloride exten

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

heritage pharmaceuticals inc. - moexipril hydrochloride (unii: q1umg3uh45) (moexiprilat - unii:h3753190js), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - moexipril hydrochloride 7.5 mg - moexipril hydrochloride and hydrochlorothiazide tablets are indicated for treatment of patients with hypertension. this fixed combination is not indicated for the initial therapy of hypertension ( see dosage and administration). in using moexipril hydrochloride and hydrochlorothiazide tablets, consideration should be given to the fact that another ace inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. available data are insufficient to show that moexipril hydrochloride and hydrochlorothiazide tablets does not have a similar risk (see warnings, neutropenia/agranulocytosis ). in addition, ace inhibitors, for which adequate data are available, cause a higher rate of angioedema in black than in nonblack patients (see warnings, angioedema ). moexipril hydrochloride and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related

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

inventia healthcare private limited - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride extended release tablets usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. metformin hydrochloride are contraindicated in patients with: - renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions ). - known hypersensitivity to metformin hydrochloride. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (see also precautions.

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

solco healthcare u.s., llc - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 10 mg - benazepril hydrochloride 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

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

st. mary's medical park pharmacy - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 20 mg - benazepril hydrochloride 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

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - amiloride hydrochloride dihydrate 5.7mg equivalent to amiloride hydrochloride 5 mg - tablet - 5 mg - active: amiloride hydrochloride dihydrate 5.7mg equivalent to amiloride hydrochloride 5 mg excipient: croscarmellose sodium iron oxide yellow lactose monohydrate magnesium stearate microcrystalline cellulose - indicated as concomitant therapy with diuretics to conserve potassium during periods of vigorous diuresis and during long-term maintenance therapy with thiazides or other more potent diuretics. apo-amiloride when used alone has mild diuretic and antihypertensive activity.

Namibia - English - Namibia Medicines Regulatory Council

specpharm (pty) ltd - amiloride hcl; hydrochlorothiazide - tablet - each tablet contains amiloride hydrochloride 5 mg and hydrochlorothiazide 50 mg

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)] .