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.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine besylate 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 besylate and benazepril hydrochloride in patients with diabetes. - Amlodipine besylate and benazepril hydrochloride is 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. 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 sku

Product summary:

\ Amlodipine and benazepril hydrochloride capsules USP, 2.5 mg/10 mg contain white to off-white powder and size “4” hard gelatin capsules of ivory color cap and ivory color body, filled in size “1” hard gelatin capsule with bluish green color cap and ivory color body, imprinted “RDY”on cap and “338”on body with black ink and are supplied in Bottles of 30 NDC 68071-1956-3 Storage: Store at 20°-25°C (68°-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 CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AMLODIPINE BESYLATE AND
BENAZEPRIL HYDROCHLORIDE CAPSULES.
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 besylate 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: Fetal Toxicity ( 5.1) 04/2015
INDICATIONS AND USAGE
Amlodipine besylate and benazepril hydrochloride capsules is 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 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 besylate and benazepril hydrochloride
capsules containing a lower dose of amlodipine (2.1)
DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine/benazepril mg): 2.5/10, 5/10, 5/20, 5/40, 10/20,
10/40 ( 3)
CONTRAINDICATIONS
Do not coadminister aliskiren with ACE Inhibitors, including
amlodipine besylate and benazepril hydrochloride in
patients with diabetes. (4)
Amlodipine besylate and benazepril hydrochloride is co