Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
NuCare Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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 coadminister aliskiren with angiotensin receptor blockers (ARBs), ACE inhibitors, including amlodipine besylate and benazepril hydrochloride in patients with diabetes. - Amlodipine besylate 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 besylate and benazepril hydrochloride. Pregnancy Category D Use of drugs that act on the RAS 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 deformations. Potential neonatal adverse effects include sku
\ Amlodipine and benazepril hydrochloride capsules USP, 2.5 mg/10 mg contain white to off-white powder and size “4” hard gelatin capsules of ivory color cap and ivory color body, filled in size “1” hard gelatin capsule with bluish green color cap and ivory color body, imprinted “RDY”on cap and “338”on body with black ink and are supplied in Bottles of 30 NDC 68071-1956-3 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 NUCARE PHARMACEUTICALS, INC. ---------- 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 AND BENAZEPRIL HYDROCHLORIDE CAPSULES USP, 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 besylate and benazepril hydrochloride 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 Warnings and Precautions: Fetal Toxicity ( 5.1) 04/2015 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 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 besylate 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 besylate and benazepril hydrochloride in patients with diabetes. (4) Amlodipine besylate and benazepril hydrochloride is co Đọc toàn bộ tài liệu