EXFORGE- amlodipine besylate and valsartan tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Novartis Pharmaceuticals Corporation

INN (Alþjóðlegt nafn):

AMLODIPINE BESYLATE

Samsetning:

AMLODIPINE 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Exforge (amlodipine and valsartan) is 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 angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge. 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 Com

Vörulýsing:

Exforge is available as non-scored tablets containing amlodipine besylate (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively) 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 tablets. 5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side.       Bottles of 30                                     NDC 0078-0488-15 10/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side.       Bottles of 30                                     NDC 0078-0489-15 5/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side.       Bottles of 30                                     NDC 0078-0490-15 10/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side.       Bottles of 30                                     NDC 0078-0491-15 Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Protect from moisture.

Leyfisstaða:

New Drug Application

Vara einkenni

EXFORGE- AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EXFORGE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EXFORGE.
EXFORGE (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 EXFORGE 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
Exforge is the combination tablet of amlodipine, a dihydropyridine
calcium channel blocker (DHP CCB), and
valsartan, an angiotensin II receptor blocker (ARB). Exforge is
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)
_Hypertension:_
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 Exforge
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 component;
Do not coadminister aliskiren with Exforge in patients with diabetes
(4)
WARNINGS AND PRECAUTIONS
Hypot