Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
LUPIN LIMITED
AMLODIPINE BESYLATE
AMLODIPINE 5 mg
ORAL
PRESCRIPTION DRUG
Amlodipine, valsartan and hydrochlorothiazide 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, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine, valsartan and hydrochlorothiazide 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
Amlodipine, valsartan and hydrochlorothiazide tablets are available as film-coated tablets containing amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg and hydrochlorothiazide 12.5 mg or 25 mg, providing for the following available combination: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg and 10/320/25 mg. All strengths are packaged in bottles of 30, 90 and 500 tablets. Amlodipine, valsartan and hydrochlorothiazide tablets, 5 mg/160 mg/12.5 mg – White to off-white, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W41' on the other side. Bottles of 30 NDC 68180-771-06 Bottles of 90 NDC 68180-771-09 Bottles of 500 NDC 68180-771-02 Amlodipine, valsartan and hydrochlorothiazide tablets, 10 mg/160 mg/12.5 mg – Mustard colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W43' on the other side. Bottles of 30 NDC 68180-772-06 Bottles of 90 NDC 68180-772-09 Bottles of 500 NDC 68180-772-02 Amlodipine, valsartan and hydrochlorothiazide tablets, 5 mg/160 mg/25 mg – Yellow colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W42' on the other side. Bottles of 30 NDC 68180-773-06 Bottles of 90 NDC 68180-773-09 Bottles of 500 NDC 68180-773-02 Amlodipine, valsartan and hydrochlorothiazide tablets, 10 mg/160 mg/25 mg – Beige colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W44' on the other side. Bottles of 30 NDC 68180-774-06 Bottles of 90 NDC 68180-774-09 Bottles of 500 NDC 68180-774-02 Amlodipine, valsartan and hydrochlorothiazide tablets, 10 mg/320 mg/25 mg – Light brick red colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W45' on the other side. Bottles of 30 NDC 68180-775-06 Bottles of 90 NDC 68180-775-09 Bottles of 500 NDC 68180-775-02 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
Abbreviated New Drug Application
AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE- AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED LUPIN LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2009 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE 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, valsartan and hydrochlorothiazide tablets are combination tablets of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), valsartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a thiazide diuretic. Amlodipine, valsartan and hydrochlorothiazide 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. (1) Not indicated for initial therapy DOSAGE AND ADMINISTRATION Dose once-daily. Titrate up to a maximum dose of 10/320/25 mg Amlodipine, valsartan and hydrochlorothiazide tablets may be used as add-on/switch therapy for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. Amlodipine, valsartan and hydrochlorothiazide tablets may be substituted for its individually titrated components (2). DOSAGE FORMS AND STRENGTHS Tablets: (amlodipine/valsartan/hydrochlorothiazide) 5 mg/160 mg/12.5 mg, 10 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/25 mg and 10 mg/320 mg/25 mg (3) CONTRAINDIC read_full_document