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:

Actavis Pharma, Inc.

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

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. 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 adverse effects include skull hypop

Product summary:

Amlodipine and benazepril hydrochloride capsules, USP are available as capsules containing amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine, with 40 mg of benazepril hydrochloride providing for the following available combinations: 5 mg/40 mg and 10 mg/40 mg. Amlodipine and benazepril hydrochloride capsules, USP 5 mg/40 mg are supplied as “a hard gelatin, white opaque capsule with “” over “AB ” on the cap and “5 ” printed in black on the body.” Bottles of 100 0591-3761-01 Bottles of 500 0591-3761-05 Amlodipine and benazepril hydrochloride capsules, USP 10 mg/40 mg are supplied as “a hard gelatin, white opaque capsule with “” over “AB ” on the cap and “6 ” printed in black on the body.” Bottles of 100 0591-3762-01 Bottles of 500 0591-3762-05 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
ACTAVIS PHARMA, 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 CAPSULES 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).
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 mg/benazepril mg): 5 mg/40 mg, 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 history of angioedema or
patients who are hypersensitive to benazepril or to amlodipine. (4)
WARNINGS AND PRECAUTIONS
Anaphyla