AMLODIPINE AND VALSARTAN tablet AMLODIPINE AND VALSARTAN tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)

제공처:

Novel Laboratories, Inc.

INN (International Name):

AMLODIPINE BESYLATE

구성:

AMLODIPINE 5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Amlodipine and Valsartan Tablets  are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Amlodipine and Valsartan Tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on

제품 요약:

Amlodipine and Valsartan Tablets are available as  biconvex, modified oval shaped tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg and 10 mg/320 mg. All strengths are packaged in bottles of 30 and 90 count. 5 mg/160 mg Tablets – White to off white biconvex, modified oval shaped tablet, debossed “N 83” on one side and plain on the other side. Bottles of 30 NDC # 40032-083-03 Bottles of 90 NDC # 40032-083-09 10 mg/160 mg Tablets - White to off white, biconvex, modified oval shaped tablet, debossed “N 82” on one side and plain on the other side. Bottles of 30 NDC # 40032-082-03 Bottles of 90 NDC # 40032-082-09 5 mg/320 mg Tablets – White to off white, biconvex, modified oval shaped tablet, debossed “N 81” on one side and plain on the other side. Bottles of 30 NDC # 40032-081-03 Bottles of 90 NDC # 40032-081-09 10 mg/320 mg Tablets – White to off white, biconvex, modified oval shaped tablet, debossed “N 08” on one side and plain on the other side. Bottles of 30 NDC # 40032-080-03 Bottles of 90 NDC # 40032-080-09 Store at 20o to 25o C (68o to 77o F); excursions permitted to 15o to 30o C (59o to 86o F). [See USP Controlled Room Temperature.] Protect from moisture.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

AMLODIPINE AND VALSARTAN- AMLODIPINE AND VALSARTAN TABLET
AMLODIPINE AND VALSARTAN- AMLODIPINE AND VALSARTAN TABLET
NOVEL LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE AND VALSARTAN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE AND
VALSARTAN.
AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN) TABLET FOR ORAL
USE.
INITIAL U.S. APPROVAL: 2007
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE AND VALSARTAN
TABLETS AS SOON AS POSSIBLE. (5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS. (5.1)
INDICATIONS AND USAGE
Amlodipine and Valsartan Tablets are the combination tablets of
amlodipine, a dihydropyridine calcium channel blocker
(DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB).
Amlodipine and Valsartan Tablets are indicated for
the treatment of hypertension, to lower blood pressure:
In patients not adequately controlled on monotherapy (1)
As initial therapy in patients likely to need multiple drugs to
achieve their blood pressure goals (1).
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarctions .
DOSAGE AND ADMINISTRATION
GENERAL CONSIDERATIONS:
Majority of effect attained within 2 weeks (2.1)
May be administered with other antihypertensive agents (2.1)
HYPE RTE NSIO N:
May be used as add-on therapy for patients not controlled on
monotherapy (2.2)
Patients who experience dose-limiting adverse reactions on monotherapy
may be switched to Amlodipine and
Valsartan Tablets containing a lower dose of that component (2.2)
May be substituted for titrated components (2.3)
When used as initial therapy: Initiate with 5 mg/160 mg, then titrate
upwards as necessary to a maximum of 10 mg/320
mg once daily (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets (amlodipine/valsartan