Drug Catalog - Product Detail
AMLODIPINE/BENAZEPRIL 5/10MG CP 500CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 55111-0339-05 | DR.REDDY'S LABORATORIES, INC. | 500 | 5-10MG | CAPSULE |
PACKAGE FILES
Generic Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Substance Name
AMLODIPINE BESYLATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA077183
Description
11 DESCRIPTION Amlodipine and benazepril hydrochloride capsules USP are combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride USP is a white to off-white crystalline powder. Freely soluble in methanol and ethanol, soluble in Water. 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 0 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 or almost white powder. Freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. 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 0 5 •C 6 H 6 0 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 6 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 colloidal silicon dioxide, crospovidone, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and talc. Each hard-gelatin capsule contains gelatin, sodium lauryl sulfate, titanium dioxide, D&C yellow # 10 and D&C red # 28, (5 mg/20 mg, 10 mg/40 mg), FD&C blue # 1 and FD&C red # 40 (5 mg/20 mg, 5 mg/40 mg), FD & C Yellow 6 (5 mg/40 mg), FD&C green # 3 (2.5 mg/10 mg), iron oxide black (10 mg/20 mg) and iron oxide red (5 mg/20 mg and 10 mg/20 mg ) as coloring agents.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Amlodipine and benazepril hydrochloride is 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. All six strengths are packaged with 1 desiccant in bottles of 30 capsules, 2 desiccants in bottles of 100 capsules and 3 desiccants in bottles of 500 capsules. Amlodipine and benazepril hydrochloride capsules USP, 2.5 mg/10 mg contain white to off-white powder and size “4” hard gelatin capsules of ivory color cap and ivory color body, filled in size “1” hard gelatin capsule with bluish green color cap and ivory color body, imprinted “RDY”on cap and “338”on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30 NDC 55111-338-30 Bottles of 100 NDC 55111-338-01 Bottles of 500 NDC 55111-338-05 Amlodipine and benazepril hydrochloride capsules USP, 5 mg/10 mg contain white to off-white powder and size “4” hard gelatin capsules of ivory color cap and ivory color body, filled in size “1” hard gelatin capsule with yellow color cap and ivory color body, imprinted “RDY”on cap and “339” on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30 NDC 55111-339-30 Bottles of 100 NDC 55111-339-01 Bottles of 500 NDC 55111-339-05 Amlodipine and benazepril hydrochloride capsules USP, 5 mg/20 mg contain white to off-white powder and size “4” hard gelatin capsules of flesh color cap and flesh color body, filled in size “1” hard gelatin capsule with medium orange color cap and ivory color body, imprinted “RDY” on cap and “340” on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30 NDC 55111-340-30 Bottles of 100 NDC 55111-340-01 Bottles of 500 NDC 55111-340-05 Amlodipine and benazepril hydrochloride capsules USP, 5 mg/40 mg contain white to off-white powder and size “4” hard gelatin capsules of white opaque color cap and white opaque color body, filled in size “1” hard gelatin capsule with dark brown opaque color cap and ivory opaque color body, imprinted “RDY” on cap and “587” on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30 NDC 55111-587-30 Bottles of 100 NDC 55111-587-01 Bottles of 500 NDC 55111-587-05 Amlodipine and benazepril hydrochloride capsules USP, 10 mg/20 mg contain white to off-white powder and size “4” hard gelatin capsules of flesh color cap and flesh color body, filled in size “1” hard gelatin capsule with light grey color cap and ivory color body, imprinted “RDY” on cap and “341” on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30 NDC 55111-341-30 Bottles of 100 NDC 55111-341-01 Bottles of 500 NDC 55111-341-05 Amlodipine and benazepril hydrochloride capsules USP, 10 mg/40 mg contain white to off-white powder and size “4” hard gelatin capsules of white opaque color cap and white opaque color body, filled in size “1” hard gelatin capsule with purple opaque color cap and ivory opaque color body, imprinted “RDY” on cap and “586” on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30 NDC 55111-586-30 Bottles of 100 NDC 55111-586-01 Bottles of 500 NDC 55111-586-05 Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.] Protect from moisture. Dispense in tight container (USP).
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 2.5/10 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 Considerations The recommended initial dose of amlodipine and benazepril hydrochloride capsules is 1 capsule of amlodipine 2.5 mg/benazepril 10 mg orally once-daily. 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. 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 Replacement Therapy Amlodipine and benazepril hydrochloride capsules may be substituted for the titrated components.