Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
amlodipine besylate (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), benazepril hydrochloride (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Rebel Distributors Corp
amlodipine besylate
AMLODIPINE 5 mg
ORAL
PRESCRIPTION DRUG
{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
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).
Abbreviated New Drug Application
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE REBEL DISTRIBUTORS CORP ---------- 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 Perskaitykite visą dokumentą