AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)

Disponible depuis:

REMEDYREPACK INC.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 in patients with diabetes. - Amlodipine 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 and benazepril hydrochloride capsules. - Amlodipine and benazepril hydrochloride is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan [see Warnings and Precautions ( 5.1)] . Risk Summary Amlo

Descriptif du produit:

Amlodipine and benazepril hydrochloride capsules USP, 5 mg/10 mg are size '2' capsules with yellow opaque cap and yellow opaque body, imprinted with 'LU' (in black ink) on cap and 'E12' (in black ink) on body, containing white to off-white powder and white to off-white, circular tablet, debossed with '1' on one side and plain on the other side. NDC: 70518-3303-00 PACKAGING: 28 in 1 BLISTER PACK Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature.] Protect from moisture. Dispense in tight container (USP). Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE
BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE
REMEDYREPACK 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 capsule, is a combination
capsule of amlodipine, a
dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an
angiotensin converting-enzyme
(ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is
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 coadminister aliskiren with ACE inhibitors, including
amlodipine and benazepril hydrochloride, in
patients with diabetes. ( 4)
Amlodipine and benazepril hydrochloride is contraindicated in patients
with a history of angioedema or
patients who are hypersensitive to benazepril or to amlodipine. ( 4)
Amlodipine and bena