Country: United States
Language: English
Source: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
NCS HealthCare of KY, Inc dba Vangard Labs
AMLODIPINE BESYLATE
AMLODIPINE 5 mg
ORAL
PRESCRIPTION DRUG
Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. Amlodipine Besylate and Benazepril Hydrochloride Capsules are contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibitor, or to amlodipine. Pregnancy Category D [see Warnings and Precautions (5 .4 ) ] The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth re
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: Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from moisture. Dispense in tight container (USP).
New Drug Application
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES INITIAL U.S. APPROVAL: 1995 WARNING: AVOID USE IN PREGNANCY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES AS SOON AS POSSIBLE. DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS (5.4) INDICATIONS AND USAGE Amlodipine Besylate 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 Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension (1) in patients not adequately controlled on monotherapy with either agent. (1) DOSAGE AND 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 capsules containing a lower dose of amlodipine (2.2) Start Amlodipine Besylate and Benazepril Hydrochloride Capsules at 2.5/10 mg in patients ≥ 75 years old or in patients with hepatic impairment (2) DOSAGE FORMS AND STRENGTHS Capsules (amlodipine/benazepril mg): 2.5/10, 5/10, 5/20, 5/40, 10/20, 10/40 (3) (3) CONTRAINDICATIONS Amlodipine Besylate and Benazepril Hydrochloride Capsules are contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients Read the complete document