Amlodipine + benazepril


Full Generic Medicine Info
Dosage/Direction for Use

Oral
Hypertension
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.
Renal impairment: CrCl ≤30 mL/min: Contraindicated.
Hepatic impairment: Start w/ 2.5 mg amlodipine component once daily.
Administration
May be taken with or without food.
Contraindications
History of angioedema. Concomitant use w/ aliskiren esp in patients w/ DM. Severe renal impairment (CrCl ≤30 mL/min). Pregnancy and lactation.
Special Precautions
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. Monitoring Parameters Monitor BUN, serum creatinine, electrolytes, and BP.
Adverse Reactions
Cough, peripheral oedema, angioedema, headache, dizziness; asthenia, fatigue; insomnia, nervousness, anxiety, tremor, decreased libido; flushing, hot flashes, rash, skin nodule, dermatitis; dry mouth, nausea, abdominal pain, constipation, diarrhoea, dyspepsia, oesophagitis, neutropenia; hypokalaemia, back and musculoskeletal pain, muscle cramps; pharyngitis, impotence, polyuria.
Drug Interactions
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.
Action
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.
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.
Storage
Oral: Store at 25°C. Protect from moisture.
ATC Classification
C09AA07 - benazepril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.
C08CA01 - amlodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Disclaimer: This information is independently developed by CIMS based on amlodipine + benazepril from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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