AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Aidarex Pharmaceuticals LLC

INN (Nome Internazionale):

AMLODIPINE BESYLATE

Composizione:

AMLODIPINE 5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 co-administer aliskiren with angiotensin receptor blockers, ACE inhibitors, including amlodipine besylate and benazepril hydrochloride capsules in patients with diabetes. - Amlodipine besylate 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 besylate and benazepril hydrochloride capsules. Pregnancy Category D  Use of drugs that act on the renin-angiotensin system 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 deformatio

Dettagli prodotto:

Amlodipine besylate and benazepril hydrochloride is available as capsules containing amlodipine besylate equivalent to 5 mg of amlodipine, with 20 mg of benazepril hydrochloride providing for the following available combinations: 5 mg/20 mg. They are available as follows: Amlodipine Besylate and Benazepril Hydrochloride Capsules, 5 mg/20 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of pink cap and pink body imprinted with ‘I’ on pink cap and ‘98’ on pink body with black edible ink.                Bottles of 30                            NDC 33261-0982-30             Bottles of 60                            NDC 33261-0982-60              Bottles of 90                            NDC 33261-0982-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE BESYLATE
AND
BENAZEPRIL HYDROCHLORIDE CAPSULE
AIDAREX PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE BESYLATE AND BENAZEPRIL
HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR AMLODIPINE BESYLATE AND BENAZEPRIL
HYDROCHLORIDE CAPSULES.
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES
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 CAN CAUSE INJURY AND DEATH TO THE
DEVELOPING FETUS. (5.5)
RECENT MAJOR CHANGES
Boxed Warning: Fetal Toxicity 01/2012
Dosage and Administration (2) 10/2012
Contraindications (4) 10/2012
Warnings and Precautions: Fetal Toxicity (5.5) 01/2012
INDICATIONS AND USAGE
Amlodipine besylate 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
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
Dose once-daily.
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. (2.2)
Start amlodipine besylate and benazepril hydrochloride capsules at 2.5
mg/10 mg in patients ≥ 75 years old or in
patients with hepatic impairment. (2)
DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine and benazepril): 2.5 mg/10 mg, 5 mg/10 mg, 5
mg/20 mg, 5 m