RVP

Drug Catalog - Product Detail

AMLODIPINE BES 5/40MG WAT 100

NDC Mfr Size Str Form
00591-3761-01 ACTAVIS PHARMA 100 5-40MG CAPSULE
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Description
1 1 DESCRIPTION Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H -1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is: Its molecular formula is C 24 H 28 N 2 O 5 • HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is: Its molecular formula is C 20 H 25 ClN 2 O 5 • C 6 H 6 O 3 S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in 2 different strengths for oral administration with a combination of amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine, with 40 mg of benazepril hydrochloride providing for the following available combinations: 5 mg/40 mg, and 10 mg/40 mg. The inactive ingredients of the capsules are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica, crospovidone, lactose anhydrous, magnesium stearate, pregelatinized maize starch, purified talc, hypromellose, polyethylene glycol 400, gelatin and titanium dioxide. structural formula structural formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Amlodipine and benazepril hydrochloride capsules, USP are available as capsules containing amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine, with 40 mg of benazepril hydrochloride providing for the following available combinations: 5 mg/40 mg and 10 mg/40 mg. Amlodipine and benazepril hydrochloride capsules, USP 5 mg/40 mg are supplied as “a hard gelatin, white opaque capsule with “ ” over “ AB ” on the cap and “ 5 ” printed in black on the body.” Bottles of 100 0591-3761-01 Bottles of 500 0591-3761-05 Amlodipine and benazepril hydrochloride capsules, USP 10 mg/40 mg are supplied as “a hard gelatin, white opaque capsule with “ ” over “ AB ” on the cap and “ 6 ” printed in black on the body.” Bottles of 100 0591-3762-01 Bottles of 500 0591-3762-05 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). symbol symbol
Indications & Usage
1 INDICATIONS AND USAGE Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. ( 1 ) 1.1 Hypertension Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Usual starting dose is 2.5 mg/10 mg. ( 2.1 ) May be used as add-on therapy for patients not adequately controlled with either a dihydropyridine calcium channel blocker or an ACE inhibitor. ( 2.2 ) Patients who experience edema with amlodipine may be switched to amlodipine and benazepril hydrochloride capsules containing a lower dose of amlodipine. ( 2.1 ) 2.1 General C onsiderations The recommended initial dose of amlodipine and benazepril hydrochloride capsule is 1 capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily. It is usually appropriate to begin therapy with amlodipine and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema. The antihypertensive effect of amlodipine and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response. Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg to 10 mg while benazepril is effective in doses of 10 mg to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 mg to 10 mg and benazepril doses of 10 mg to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups. 2.2 Dosage A djustment in R enal I mpairment Renal Impairment: Amlodipine and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance (CrCl) less than or equal to 30 mL/min. No dose adjustment of amlodipine and benazepril hydrochloride capsules is required in patients with CrCl greater than 30 mL/min/1.73m 2 (serum creatinine roughly less than or equal to 3 mg/dL or 265 micromol/L) [see Warnings and Precautions (5.7) , Use in Specific Populations (8.7) , and Clinical Pharmacology (12.3) ] . 2.3 Replacement Therapy Amlodipine and benazepril hydrochloride capsules may be substituted for the titrated components.