Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Aidarex Pharmaceuticals LLC
AMLODIPINE BESYLATE
AMLODIPINE 5 mg
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 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
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).
Abbreviated New Drug Application
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 Soma hati kamili