AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- amlodipine besylate and benazepril hydrochloride capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)

Sẵn có từ:

Bryant Ranch Prepack

INN (Tên quốc tế):

AMLODIPINE BESYLATE

Thành phần:

AMLODIPINE 5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Amlodipine besylate and benazepril hydrochloride capsules is 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 in patients with diabetes. ● Amlodipine besylate and benazepril hydrochloride capsules 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 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 deformations. Potential neonatal adverse effects include skull hypop

Tóm tắt sản phẩm:

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: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg or 10 mg/40 mg. All six strengths are packaged with desiccant in bottles of 100 or 500 capsules. Capsules are imprinted with “Par” and appropriate code. Storage: Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature.] Protect from moisture. Dispense in tight container (USP).

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE - AMLODIPINE BESYLATE
AND
BENAZEPRIL HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
----------
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
RECENT MAJOR CHANGES
Boxed Warning: Fetal Toxicity 01/2012
Dosage and Administration (2) 10/2012
Contraidications (4) 10/2012
Warnings and Precautions: Fetal Toxicity ( 5.4) 01/2012
INDICATIONS AND USAGE
Amlodipine besylate and benazepril hydrochloride capsules is a
combination tablet of amlodipine, a dihydropyridine
calcium channel blocker (DHP CCB) and benazepril, an angiotensin
converting enzyme (ACE) inhibitor. Amlodipine
besylate and benazepril hydrochloride capsules is 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
2.5/10 mg in patients ≥ 75 years old or in patients
with hepatic impairment (2)
DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine besylate and benazepril hydrochloride): 2.5 mg/10
mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg,
10 mg/20 mg, 10 mg/40 mg (3)
CONTRAINDICATIONS
Do not co-administer aliskiren with ARBs or ACEI’s, including
Amlodipine besylate and benazepril hydrochloride capsules
in patients with diabetes. (4)
Amlodipine besylate and benazepril hydrochloride capsules is
contraindicated in patients with a