AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- amlodipine besylate 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.

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine besylate and benazepril hydrochloride capsules, USP 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, ACE inhibitors, including amlodipine besylate and benazepril hydrochloride capsules in patients with diabetes. - 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, to amlodipine, or to any of the excipients of amlodipine besylate and benazepril hydrochloride capsules. Pregnancy Category D Use of drugs that act on the renin-angiotensin system 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 deformati

Product summary:

Amlodipine besylate and benazepril hydrochloride capsules, USP 5 mg/10 mg are supplied as a hard gelatin, white opaque capsule with over AB on the cap and 2 printed in black on the body. NDC 68071-4066-3 Bottles of 30 NDC 68071-4066-9 Bottles of 90 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 BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE BESYLATE
AND
BENAZEPRIL HYDROCHLORIDE CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE BESYLATE AND BENAZEPRIL
HYDROCHLORIDE 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
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING _
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE BESYLATE AND
BENAZEPRIL HYDROCHLORIDE CAPSULES AS
SOON AS POSSIBLE ( 5.4). DRUGS THAT ACT DIRECTLY ON THE
RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH
TO THE DEVELOPING FETUS ( 5.4).
RECENT MAJOR CHANGES
Boxed Warning: Fetal Toxicity 01/2012
Dosage and Administration ( 2) 10/2012
Contraindications ( 4) 10/2012
Warnings and Precautions: Fetal Toxicity ( 5.5) 01/2012
INDICATIONS AND USAGE
Amlodipine besylate and benazepril hydrochloride capsules, USP 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, USP are
indicated for the treatment of hypertension 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
amlodipine besylate and benazepril hydrochloride
capsules containing a lower dose of amlodipine ( 2.2)
Start amlodipine besylate and benazepril hydrochloride capsules at 2.5
mg/10 mg in patients ≥ 75 years old or in
patients with hepatic impairment ( 2)
DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine mg/benazepril mg): 2.5 mg/10 mg, 5 mg/10 mg, 5
mg/20 mg, 10 mg/