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, 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 (ARBs), ACE inhibitors, including amlodipine besylate and benazepril hydrochloride 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 adverse ef

Product summary:

Amlodipine and benazepril hydrochloride capsules, USP are available as capsules containing amlodipine besylate, USP equivalent to of amlodipine, with of benazepril hydrochloride, USP providing for the following available combinations: 5 mg/40 mg, All 6 strengths are packaged with a desiccant in bottles. They are available as follows: 5 mg/40 mg capsules: a hard gelatin capsule with a light turquoise blue opaque cap and light turquoise blue opaque body, filled with white to off-white powder, imprinted “TEVA” on the cap and “7670” on the body in bottles of 30 NDC 68071-1878-3 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, with a child-resistant closure (as required).

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, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR AMLODIPINE AND BENAZEPRIL
HYDROCHLORIDE CAPSULES, USP.
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, USP 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).
RECENT MAJOR CHANGES
Warning and Precautions ( 5.1) 04/2015
INDICATIONS AND USAGE
Amlodipine 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 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
Usual starting dose is 2.5/10 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/benazepril mg): 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20
mg, 5 mg/40 mg, 10 mg/20 mg, 10 mg/40 mg (
3)
CONTRAINDICATIONS
Do not coadminister aliskiren with ACE inhibitors, including
amlodipine and benazepril hydrochloride, in patients with
diabetes. ( 4)
Amlodipine and benazepril hydrochloride capsules are contraindicated
in patien