Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Actavis Pharma, Inc.
AMLODIPINE BESYLATE
AMLODIPINE 5 mg
ORAL
PRESCRIPTION DRUG
Amlodipine 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 and benazepril hydrochloride capsules in patients with diabetes. - Amlodipine 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 and benazepril hydrochloride capsules. 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 skull hypop
Amlodipine and benazepril hydrochloride capsules, USP are available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg. Amlodipine and benazepril hydrochloride capsules, USP 2.5 mg/10 mg are supplied as “a hard gelatin, white opaque capsule with “” over “AB ” on the cap and “1 ” printed in black on the body.” Bottles of 100 0591-3757-01 Amlodipine and benazepril hydrochloride capsules, USP 5 mg/10 mg are supplied as “a hard gelatin, white opaque capsule with “” over “AB ” on the cap and “2 ” printed in black on the body.” Bottles of 100 0591-3758-01 Bottles of 500 0591-3758-05 Amlodipine and benazepril hydrochloride capsules, USP 5 mg/20 mg are supplied as “a hard gelatin, white opaque capsule with “” over “AB ” on the cap and “3 ” printed in black on the body.” Bottles of 100 0591-3759-01 Bottles of 500 0591-3759-05 Amlodipine and benazepril hydrochloride capsules, USP 10 mg/20 mg are supplied as “a hard gelatin, white opaque capsule with “” over “AB ” on the cap and “4 ” printed in black on the body.” Bottles of 100 0591-3760-01 Bottles of 500 0591-3760-05 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 AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, 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 AND BENAZEPRIL HYDROCHLORIDE CAPSULES 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). INDICATIONS AND USAGE Amlodipine 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 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 mg/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 and benazepril hydrochloride capsules containing a lower dose of amlodipine. (2.1) DOSAGE FORMS AND STRENGTHS Capsules (amlodipine mg/benazepril mg): 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 10 mg/20 mg (3) CONTRAINDICATIONS Do not coadminister aliskiren with ACE inhibitors, including amlodipine and benazepril hydrochloride capsules in patients with diabetes. (4) Amlodipine and benazepril hydrochloride capsules are contraindicated in patients with a history of angioedema or patients who are hypersensitive to benazepril or to amlodipine. (4) WARNING Прочитать полный документ