AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE- amlodipine and benazepril hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)

Available from:

NuCare Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. - Do not coadminister aliskiren with angiotensin receptor blockers (ARBs), ACE inhibitors, including amlodipine and benazepril hydrochloride capsules in patients with diabetes. - Amlodipine 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, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules. Teratogenic Effects Pregnancy Category D Use of drugs that act on the RAS during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal

Product summary:

Amlodipine and benazepril hydrochloride is available as capsules containing amlodipine besylate equivalent to amlodipine, with 10 mg, 20 mg, of benazepril hydrochloride providing for the following available combinations: 10mg, 20 mg, They are available as follows: Amlodipine and Benazepril Hydrochloride Capsules USP, 10 mg/20 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size 0 of purple cap and purple body imprinted with J on purple cap and 02 on purple body with black edible ink. Bottles of 30 NDC 68071-1918-3 Bottles of 90 NDC 68071-1918-9 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE AND BENAZEPRIL
HYDROCHLORIDE CAPSULE
NUCARE PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE AND BENAZEPRIL
HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AMLODIPINE AND
BENAZEPRIL HYDROCHLORIDE CAPSULES.
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _
_ _
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE AND BENAZEPRIL
HYDROCHLORIDE AS SOON AS POSSIBLE
(5.5). DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM (RAS)
CAN CAUSE INJURY AND DEATH TO THE
DEVELOPING FETUS ( 5.5) .
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.1) 04/2015
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)
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)
DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine and benazepril): 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. (3)
CONTRAINDICATIONS
Do not coadminister aliskiren with ACE inhibitors, including
amlodipine and benazepril hydrochloride capsules, in
patients with diabetes. (4)
Amlodipine and benazepril hydrochloride capsules are contraindicated
in patients with a h