AMLODIPINE AND VALSARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Torrent Pharmaceuticals Limited

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine and valsartan tablets, USP 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, USP. 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

Product summary:

Amlodipine and valsartan tablets, USP are available as non-scored tablets containing amlodipine besylate, USP equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan, USP 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, 100 and 500 count, and unit dose blister packages. 5/160 mg Tablets - Yellow to dark yellow colored, oval shaped, beveled edge, biconvex film coated tablets debossed with "1207" on one side and plain on other side. Bottles of 30                                  NDC 13668-207-30 Bottles of 100                                NDC 13668-207-01 Bottles of 500                                NDC 13668-207-05 100 Unit dose tablets                     NDC 13668-207-74 10/160 mg Tablets - Cream to light yellow colored, oval shaped, beveled edge, biconvex film coated tablets debossed with "1206" on one side and plain on other side. Bottles of 30                                  NDC 13668-206-30 Bottles of 100                                NDC 13668-206-01 Bottles of 500                                NDC 13668-206-05 100 Unit dose tablets                     NDC 13668-206-74 5/320 mg Tablets - Reddish brown colored, oval shaped, beveled edge, biconvex film coated tablets debossed with "1205" on one side and plain on other side. Bottles of 30                                  NDC 13668-205-30 Bottles of 100                                NDC 13668-205-01 Bottles of 500                                NDC 13668-205-05 100 Unit dose tablets                     NDC 13668-205-74 10/320 mg Tablets - Yellow to dark yellow colored, oval shaped, beveled edge, biconvex film coated tablets debossed with "1204" on one side and plain on other side. Bottles of 30                                  NDC 13668-204-30 Bottles of 100                                NDC 13668-204-01 Bottles of 500                                NDC 13668-204-05 100 Unit dose tablets                     NDC 13668-204-74 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE AND VALSARTAN- AMLODIPINE AND VALSARTAN TABLET
TORRENT PHARMACEUTICALS LIMITED
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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 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 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: (1)
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. (1)
DOSAGE AND ADMINISTRATION
GENERAL CONSIDERATIONS: (2)
Majority of effect attained within 2 weeks (2.1)
May be administered with other antihypertensive agents (2.1)
HYPERTENSION: (2)
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)
(3)
CONTRAINDICATIONS
Known