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:

Cipla USA 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 capsules 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. - Amlodipine and benazepril hydrochloride capsules are 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

Descriptif du produit:

Amlodipine and benazepril hydrochloride capsules, USP is available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. All four strengths are packaged with a desiccant in bottles of 30, 100 and 500 capsules. Capsules are imprinted with "Cipla" and a portion of the NDC code. Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature.] Protect from moisture. Dispense in tight, light-resistant container (USP).

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE BESYLATE
AND
BENAZEPRIL HYDROCHLORIDE CAPSULE
CIPLA USA 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).
RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions, Anaphylactoid and Possibly Related Reactions
(5.1) 08/2017
INDICATIONS AND USAGE
Amlodipine and benazepril hydrochloride 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 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 mg/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 mg/benazepril mg): 2.5 mg/10 mg, 5 mg/10 mg, 5
mg/20 mg, 10 mg/20 mg (3)
CONTRAINDICATIONS
Do not coadminister aliskiren with ACE inhibitors, including
amlodipine and benazepril hydrochloride capsules, in
patients with diabetes. (4)
Amlodipine and benazepril hydrochloride capsules are con