AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

amlodipine besylate (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), benazepril hydrochloride (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)

Tersedia dari:

Rebel Distributors Corp

INN (Nama Internasional):

amlodipine besylate

Komposisi:

AMLODIPINE 5 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

{template} Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. {template} Pregnancy Category D [see Warnings and Precautions (5.4)]  The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to the ACE inhibitor exposure.  In addition, use of ACE inhibitors during the first trimester of pregnancy has been associat

Ringkasan produk:

Amlodipine besylate and benazepril hydrochloride capsules, 5 mg/40 mg contain white to off-white powder and size “4” hard gelatin capsules of white opaque color cap and white opaque color body, filled in size “1” hard gelatin capsule with dark brown opaque color cap and ivory opaque color body, imprinted “RDY” on cap and “587” on body with black ink and are supplied in bottles of 30.  Bottles of 30                                                               NDC 42254-073-30 Amlodipine besylate and benazepril hydrochloride capsules, 10 mg/40 mg contain white to off-white powder and size “4” hard gelatin capsules of white opaque color cap and white opaque color body, filled in size “1” hard gelatin capsule with purple opaque color cap and ivory opaque color body, imprinted “RDY” on cap and “586” on body with black ink and are supplied in bottles of 30.  Bottles of 30                                                               NDC 42254-074-30 Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Protect from moisture. Dispense in tight container (USP). 

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE BESYLATE
AND
BENAZEPRIL HYDROCHLORIDE CAPSULE
REBEL DISTRIBUTORS CORP
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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 BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES
INITIAL U.S. APPROVAL: 1995
WARNING: AVOID USE IN PREGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE BESYLATE AND
BENAZEPRIL HYDROCHLORIDE AS SOON AS
POSSIBLE. DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN
CAUSE INJURY AND DEATH TO THE
DEVELOPING FETUS (5.4)
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 (1) in patients not
adequately controlled on monotherapy with either agent (2)
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
2.5/10 mg in patients ≥75 years old or in patients
with hepatic impairment (2.1)
DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine/benazepril mg): 5/40, 10/40 (3)
CONTRAINDICATIONS
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
hy