Amlodipine 10 MG Benazepril hydrochloride 40 MG Oral Capsule
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.
Mylan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Amlodipine and Benazepril Hydrochloride capsules, USP are available containing amlodipine besylate, USP equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride, USP providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg or 10 mg/40 mg. The 2.5 mg/10 mg capsule is a hard-shell gelatin capsule with a Lavender opaque cap and a Lavender opaque body axially printed with MYLAN over 6895 in black ink on both the cap and the body. The capsule is filled with one blue, round tablet with no markings and one white, film-coated, round tablet with no markings. They are available as follows: NDC 0378-6895-01 bottles of 100 capsules The 5 mg/10 mg capsule is a hard-shell gelatin capsule with a blue opaque cap and a blue opaque body axially printed with MYLAN over 6896 in black ink on both the cap and the body. The capsule is filled with one blue, round tablet with no markings and one white, film-coated, round tablet with no markings. They are available as follows: NDC 0378-6896-01 bottles of 100 capsules The 5 mg/20 mg capsule is a hard-shell gelatin capsule with a Lavender opaque cap and a peach opaque body axially printed with MYLAN over 6897 in black ink on both the cap and the body. The capsule is filled with one blue, round tablet with no markings and one white, film-coated, round tablet with no markings. They are available as follows: NDC 0378-6897-01 bottles of 100 capsules The 10 mg/20 mg capsule is a hard-shell gelatin capsule with a blue opaque cap and a peach opaque body axially printed with MYLAN over 6898 in black ink on both the cap and the body. The capsule is filled with one blue, round tablet with no markings and one white, film-coated, round tablet with no markings. They are available as follows: NDC 0378-6898-01 bottles of 100 capsules The 5 mg/40 mg capsule is a hard-shell gelatin capsule with a blue opaque cap and a light pink opaque body axially printed with MYLAN over 6899 in black ink on both the cap and the body. The capsule is filled with one blue, round tablet with no markings and one beige, film-coated, round tablet with no markings. They are available as follows: NDC 0378-6899-01 bottles of 100 capsules The 10 mg/40 mg capsule is a hard-shell gelatin capsule with a Lavender opaque cap and a light pink opaque body axially printed with MYLAN over 6900 in black ink on both the cap and body. The capsule is filled with one blue, round tablet with no markings and one beige, film-coated, round tablet with no markings. They are available as follows: NDC 0378-6900-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
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