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:

Proficient Rx LP

INN (Tên quốc tế):

AMLODIPINE BESYLATE

Thành phần:

AMLODIPINE 10 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Amlodipine besylate and benazepril hydrochloride capsules, USP are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.  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 as soon as possible.  These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy.  Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system fro

Tóm tắt sản phẩm:

Amlodipine besylate and benazepril hydrochloride capsules, USP are available as capsules containing amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine, with 40 mg of benazepril hydrochloride providing for the following available combinations: 5 mg/40 mg and 10 mg/40 mg. Amlodipine besylate and benazepril hydrochloride capsules, USP 10 mg/40 mg are supplied as “a hard gelatin, white opaque capsule with ‘ ’ over ‘AB’ on the cap and ‘6’ printed in black on the body.” Bottles of 30 63187-370-30 Bottles of 60 63187-370-60 Bottles of 90 63187-370-90 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
PROFICIENT RX LP
----------
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 , USP
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 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
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, USP 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, USP are
indicated for the treatment of hypertension in
patients not adequately controlled on monotherapy with either agent
(1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine mg/benazepril mg): 5 mg/40 mg, 10 mg/40 mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
Discontinuation because of adverse reactions occurred in 4% of
amlodipine besylate and benazepril hydrochloride-treated
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