AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Amlodipine besylate (UNII: 864V2Q084H) (Amlodipine - UNII:1J444QC288)

Verfügbar ab:

Apotex Corp.

INN (Internationale Bezeichnung):

Amlodipine besylate

Zusammensetzung:

Amlodipine 2.5 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE - AMLODIPINE AND BENAZEPRIL
HYDROCHLORIDE CAPSULE
APOTEX CORP.
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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 2.5/10 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): 2.5/10, 5/10, 5/20, 5/40, 10/20,
10/40 (3)
CONTRAINDICATIONS
Do not co-administer 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)
Amlodipine and benazepril hydr