Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Clinical Solutions Wholesale
AMLODIPINE BESYLATE
AMLODIPINE 2.5 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. 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, or to amlodipine. 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 deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Amlodipine Besylate and Benazepril Hydrochloride Capsules as soon as possible. These adverse outcomes are usually associat
Amlodipine Besylate and Benazepril Hydrochloride Capsules are available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from moisture. Dispense in tight container (USP).
New Drug Application Authorized Generic
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE CLINICAL SOLUTIONS WHOLESALE ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USEAMLODIPINEBESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY.SEE FULL PRESCRIBING INFORMATION FORAMLODIPINEBESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINEBESYLATE AND BENAZEPRILHYDROCHLORIDE CAPSULES INITIAL U.S. APPROVAL:1995 WARNING:FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINEBESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES AS SOON AS POSSIBLE (5.4). DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS (5.4). RECENT MAJOR CHANGES Boxed Warning: Fetal Toxicity 01/2012 Warnings and Precautions: Fetal Toxicity (5.4) 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 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) DOSAGE FORMS AND STRENGTHS Capsules (amlodipine/benazepril mg): 2.5/10, 5/10, 5/20, 5/40, 10/20, 10/40 (3) CONTRAINDICATIONS Amlodipine Besylate and Benazepril Hydrochloride Capsules are contraindicated in patients with a hist Lees het volledige document