AMLODIPINE AND VALSARTAN tablet, film coated

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:

Aurobindo Pharma Limited

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 angiotensin II receptor blocker (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

Product summary:

Amlodipine and valsartan tablets USP are available as non-scored tablets containing amlodipine besylate USP (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively) with valsartan USP 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 counts, 3 x 10’s Unit-dose blister cartons. 5 mg/160 mg Tablets – yellow colored, ovaloid shaped, beveled edge, biconvex film-coated tablets, debossed with ‘L’ on one side and ‘35’ on other side.                     Bottles of 30                                           NDC 65862-737-30                     Bottles of 90                                           NDC 65862-737-90                     3 x 10 Unit-dose Tablets                        NDC 65862-737-03 10 mg/160 mg Tablets – light yellow colored, ovaloid shaped, beveled edge, biconvex, film-coated tablets, debossed with ‘L’ on one side and ‘36’ on other side.                     Bottles of 30                                           NDC 65862-739-30                     Bottles of 90                                           NDC 65862-739-90                     3 x 10 Unit-dose Tablets                        NDC 65862-739-03 5 mg/320 mg Tablets – very dark yellow colored, ovaloid shaped, beveled edge, biconvex film-coated tablets, debossed with ‘L’ on one side and ‘37’ on other side.                     Bottles of 30                                           NDC 65862-738-30                     Bottles of 90                                           NDC 65862-738-90                     3 x 10 Unit-dose Tablets                        NDC 65862-738-03 10 mg/320 mg Tablets – yellow colored, ovaloid shaped, beveled edge, biconvex film-coated tablets, debossed with ‘L’ on one side and ‘38’ on other side.                     Bottles of 30                                           NDC 65862-740-30                     Bottles of 90                                           NDC 65862-740-90                     3 x 10 Unit-dose Tablets                        NDC 65862-740-03 Store at 20º to 25ºC (68º to 77ºF) [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, FILM
COATED
AUROBINDO PHARMA 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 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 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)
_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
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 and valsartan): 5 mg/160 mg, 10 mg/160 mg, 5
mg/320 mg, and 10 mg/320 mg (3)
CON