AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE capsule

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Denton Pharma, Inc. dba Northwind Pharmaceuticals

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 in patients with diabetes. - Amlodipine and benazepril hydrochloride 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 and benazepril hydrochloride capsules. - Amlodipine and benazepril hydrochloride is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan [see

পণ্য সারাংশ:

Amlodipine and benazepril hydrochloride capsules USP are available as capsules containing amlodipine besylate equivalent to 5 mg of amlodipine, with 10 mg of benazepril hydrochloride providing for the following available combinations: 5 mg/10 mg. Amlodipine and benazepril hydrochloride capsules USP, 5 mg/10 mg are size '2' capsules with yellow opaque cap and yellow opaque body, imprinted with 'LU' (in black ink) on cap and 'E12' (in black ink) on body, containing white to off-white powder and white to off-white, circular tablet, debossed with '1' on one side and plain on the other side. NDC 70934-560-30 Bottles of 30 capsules Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature.] Protect from moisture. Dispense in tight container (USP).

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE BESYLATE
AND
BENAZEPRIL HYDROCHLORIDE CAPSULE
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
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 capsule, is a combination
capsule of amlodipine, a dihydropyridine calcium
channel blocker (DHP CCB) and benazepril, an angiotensin
converting-enzyme (ACE) inhibitor. Amlodipine and benazepril
hydrochloride capsule, is indicated for the treatment of hypertension
in patients not adequately controlled on monotherapy
with either agent ( 1).
DOSAGE AND ADMINISTRATION
Usual starting dose is 2.5/10 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/benazepril mg): 2.5/10, 5/10, 5/20, 5/40, 10/20,
10/40 ( 3)
CONTRAINDICATIONS
Do not coadminister aliskiren with ACE inhibitors, including
amlodipine and benazepril hydrochloride, in patients with
diabetes. ( 4)
Amlodipine and benazepril hydrochloride is contraindicated in patients
with a history of angioedema or patients who are
hypersensitive to benazepril or to amlo