Drug Catalog - Product Detail
AMLODIPINE/BENAZEPRIL CP 5/40MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68180-0759-01 | LUPIN PHARMACEUTICALS | 100 | 5-40MG | CAPSULE |
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Description
DESCRIPTION Amlodipine besylate and benazepril hydrochloride capsule is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>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- 1H -1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is Its empirical 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 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 empirical 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 besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide. MM1 MM2
How Supplied
HOW SUPPLIED Amlodipine besylate and benazepril hydrochloride capsules are available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. Amlodipine besylate and benazepril hydrochloride capsules, 2.5 mg/10 mg are size '2' capsules with white opaque cap and white opaque body, imprinted with 'LU' (in black ink) on cap and 'E11' (in black ink) on body, containing white to off-white powder and white to off-white, circular tablets, debossed with '1' on one side and plain on the other side. NDC 68180-755-01 Bottles of 100 capsules NDC 68180-755-02 Bottles of 500 capsules NDC 68180-755-03 Bottles of 1000 capsules Amlodipine besylate and benazepril hydrochloride capsules, 5 mg/10 mg are size '2' capsules with light brown opaque cap and light brown opaque body, imprinted with 'LU' (in black ink) on cap and 'E12' (in black ink) on body, containing white to off-white powder and white to off-white, circular tablets, debossed with '1' on one side and plain on the other side. NDC 68180-756-01 Bottles of 100 capsules NDC 68180-756-02 Bottles of 500 capsules NDC 68180-756-03 Bottles of 1000 capsules Amlodipine besylate and benazepril hydrochloride capsules, 5 mg/20 mg are size '2' capsules with flesh opaque cap and flesh opaque body, imprinted with 'LU' (in black ink) on cap and 'E13' (in black ink) on body, containing white to off-white powder and white to off-white, circular tablets, debossed with '2' on one side and plain on the other side. NDC 68180-757-01 Bottles of 100 capsules NDC 68180-757-02 Bottles of 500 capsules NDC 68180-757-03 Bottles of 1000 capsules Amlodipine besylate and benazepril hydrochloride capsules, 5 mg/40 mg are size '2' capsules with dark green cap and white body, imprinted with 'LU' (in black ink) on cap and 'E15' (in black ink) on body, containing white to off-white powder and two white to off-white, circular tablets, debossed with '2' on one side and plain on the other side. NDC 68180-759-01 Bottles of 100 capsules NDC 68180-759-02 Bottles of 500 capsules NDC 68180-759-03 Bottles of 1000 capsules Amlodipine besylate and benazepril hydrochloride capsules, 10 mg/20 mg are size '2' capsules with purple cap and purple body, imprinted with 'LU' (in black ink) on cap and 'E14' (in black ink) on body, containing white to off-white powder and white to off-white, circular tablets, debossed with '2' on one side and plain on the other side. NDC 68180-758-01 Bottles of 100 capsules NDC 68180-758-02 Bottles of 500 capsules NDC 68180-758-03 Bottles of 1000 capsules Amlodipine besylate and benazepril hydrochloride capsules, 10 mg/40 mg are size '2' capsules with dark blue cap and white body, imprinted with 'LU' (in black ink) on cap and 'E16' (in black ink) on body, containing white to off-white powder and two white to off-white, circular tablets, debossed with '2' on one side and plain on the other side. NDC 68180-760-01 Bottles of 100 capsules NDC 68180-760-02 Bottles of 500 capsules NDC 68180-760-03 Bottles of 1000 capsules Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in tight container (USP).
Indications & Usage
INDICATIONS & USAGE Amlodipine besylate and benazepril hydrochloride capsule is a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine besylate and benazepril hydrochloride is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1 ). Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
Dosage and Administration
DOSAGE & ADMINISTRATION Dose once-daily 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 besylate and benazepril hydrochloride containing a lower dose of amlodipine ( 2.2 ) Start amlodipine besylate and benazepril hydrochloride at 2.5 mg/10 mg in patients ≥ 75 years old or in patients with hepatic impairment ( 2 ) The recommended initial dose of amlodipine besylate and benazepril hydrochloride is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily. It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride 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 besylate and benazepril hydrochloride 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 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 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. Renal Impairment Amlodipine besylate and benazepril hydrochloride is not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride is required in patients with creatinine clearance > 30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). [see WARNINGS AND PRECAUTIONS ( 5.7 ), USE IN SPECIFIC POPULATIONS ( 8.7 ) and CLINICAL PHARMACOLOGY ( 12.3 )]. Amlodipine besylate and benazepril hydrochloride may be substituted for the titrated components.