Adult: Each cap contains amlodipine (mg)/benazepril (mg): 2.5/10, 5/10, 5/20, 5/40, 10/20 or 10/40: Initially, 2.5 mg/10 mg once daily, may be titrated according to clinical response. Max: Amlodipine 10 mg and benazepril 40 mg once daily. Elderly: Start w/ 2.5 mg amlodipine component once daily.
CrCl ≤30 mL/min: Contraindicated.
Start w/ 2.5 mg amlodipine component once daily.
May be taken with or without food.
History of angioedema. Concomitant use w/ aliskiren esp in patient w/ DM. Severe renal impairment (CrCl ≤30 mL/min). Pregnancy and lactation.
Patient w/ severe obstructive coronary artery disease, aortic/mitral stenosis, obstructive hypertrophic cardiomyopathy, volume and salt depletion, CHF w/ or w/o renal insufficiency, DM, collagen vascular disease (e.g. SLE), severe heart failure, MI. Patient undergoing surgery or during anaesthesia. Hepatic and severe renal impairment. Elderly.
Monitor BUN, serum creatinine, electrolytes, and BP.
Increased risk of hyperkalaemia w/ K supplements and K-sparing diuretics. Increased amlodipine systemic exposure w/ CYP3A4 inhibitors. May cause worsening of renal function and loss of antihypertensive effect w/ NSAIDs. May increase systemic exposure of simvastatin. May increase serum levels and toxicity of lithium. May cause nitritoid reaction w/ Na aurothiomalate. May increase risk of angioedema w/ mammalian target of rapamycin (mTOR) inhibitors (e.g. sirolimus, everolimus, temsirolimus). Potentially Fatal: May increase risk of hypotension, hyperkalaemia, and changes in renal function w/ aliskiren.
Description: Amlodipine, a dihydropyridine Ca channel blocker, inhibits transmembrane influx of Ca ions into vascular smooth muscles to produce peripheral arterial vasodilation, thereby reducing vascular resistance and BP. Additionally, it also acts on cardiac muscles. Benazepril, a prodrug of benazeprilat, is an inhibitor of ACE, which results in decreased plasma angiotensin II, thereby reducing both vasopressor activity and aldosterone secretion. Onset: Amlodipine: 24-48 hr. Duration: Amlodipine: 24-72 hr. Pharmacokinetics: Absorption: Amlodipine: Well absorbed. Bioavailability: 64-90%. Time to peak plasma concentration: 6-12 hr. Benazepril: Rapidly (37%) absorbed. Time to peak plasma concentration: 0.5-1 hr. Distribution: Amlodipine: Volume of distribution: 21 L/kg. Plasma protein binding: Approx 93%. Benazepril: Volume of distribution: 0.7 L/kg. Plasma protein binding: Approx 97%. Metabolism: Amlodipine: Extensively metabolised in the liver into inactive metabolites. Benazepril: Rapidly and extensively metabolised in the liver via enzymatic hydrolysis into its active metabolite, benazeprilat; undergoes extensive first-pass effect. Excretion: Amlodipine: Via urine (10% as unchanged drug; 60% as metabolites). Terminal elimination half-life: 30-50 hr. Benazepril: Via urine (<1% as unchanged drug, 20% as benazeprilat, 12% as other metabolites). Terminal elimination half-life: Approx 22 hr.
C09BB13 - benazepril and amlodipine ; Belongs to the class of ACE inhibitors and calcium channel blockers. Used in the treatment of cardiovascular diseases.
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