AMLODIPINE AND VALSARTAN tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

LUPIN LIMITED

INN (International namn):

AMLODIPINE BESYLATE

Sammansättning:

AMLODIPINE 5 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

Amlodipine and Valsartan  is available as 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: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. All strengths are packaged in bottles of 30, 90 and 500 count, and unit dose blister packages. 5/160 mg Tablets – Mustard coloured, capsule shaped, film coated, biconvex tablets debossed 'LU' on one side and 'Q12' on the other side. Bottles of 30                           NDC # 68180-764-06 Bottles of 90                           NDC # 68180-764-09 Bottles of 500                         NDC # 68180-764-02 Unit Dose 100 tablets (10 x 10 tablets blister cards) NDC # 68180-764-13 10/160 mg Tablets - Yellow, capsule shaped, film coated, biconvex tablets debossed 'LU' on one side and 'Q14' on the other side. Bottles of 30                           NDC # 68180-765-06 Bottles of 90                           NDC # 68180-765-09 Bottles of 500                         NDC # 68180-765-02 Unit Dose 100 tablets (10 x 10 tablets blister cards) NDC # 68180-765-13 5/320 mg Tablets - Mustard coloured, capsule shaped, film coated, biconvex tablets debossed 'LU' on one side and 'Q13' on the other side. Bottles of 30                           NDC # 68180-766-06 Bottles of 90                           NDC # 68180-766-09 Bottles of 500                         NDC # 68180-766-02 Unit Dose 100 tablets (10 x 10 tablets blister cards) NDC # 68180-766-13 10/320 mg Tablets - Yellow, capsule shaped, film coated, biconvex tablets debossed 'LU' on one side and 'Q15' on the other side Bottles of 30                           NDC # 68180-767-06 Bottles of 90                           NDC # 68180-767-09 Bottles of 500                         NDC # 68180-767-02 Unit Dose 100 tablets (10 x 10 tablets blister cards) NDC # 68180-767-13 Store at 250 C (770 F); excursions permitted to 15 to 300 C (59 to 860 F). [See USP Controlled Room Temperature.] Protect from moisture.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

AMLODIPINE AND VALSARTAN- AMLODIPINE AND VALSARTAN TABLET
LUPIN LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE AND VALSARTAN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMLODIPINE AND VALSARTAN TABLETS.
AMLODIPINE AND VALSARTAN TABLETS, 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 tablet is the combination tablet 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 5/160 mg, then titrate
upwards as necessary to a maximum of 10/320 mg
once daily (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets (amlodipine/valsartan mg): 5/160, 10/160, 5/320, 10/320 (3)
CONTRAINDICATIONS
Known hypersensitivity to any