Pays: États-Unis
Langue: anglais
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)
REMEDYREPACK INC.
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, USP 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 combinations: 5 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/12.5 mg, 10 mg/160 mg/25 mg, and 10 mg/320 mg/25 mg. All strengths are packaged in bottles of 30, 100, 500 tablets and 100 (10X10) unit dose blister package. 5 mg amlodipine/160 mg valsartan/12.5 mg hydrochlorothiazide Tablets – White to off-white colored, oval shaped, biconvex, film coated tablets debossed with "1326" on one side and plain on other side. Bottles of 30 NDC 13668-326-30 Bottles of 100 NDC 13668-326-01 Bottles of 500 NDC 13668-326-05 Carton of 100 tablets (10 x 10 unit-dose) NDC 13668-326-74 5 mg amlodipine/160 mg valsartan/25 mg hydrochlorothiazide Tablets – Yellow colored, capsule shaped, biconvex, film coated tablets debossed with "1329" on one side and plain on other side. Bottles of 30 NDC 13668-329-30 Bottles of 100 NDC 13668-329-01 Bottles of 500 NDC 13668-329-05 Carton of 100 tablets (10 x 10 unit-dose) NDC 13668-329-74 10 mg amlodipine/160 mg valsartan/12.5 mg hydrochlorothiazide Tablets – Pale yellow colored, oval shaped, biconvex, film coated tablets debossed with "1327" on one side and plain on other side. Bottles of 30 NDC 13668-327-30 Bottles of 100 NDC 13668-327-01 Bottles of 500 NDC 13668-327-05 Carton of 100 tablets (10 x 10 unit-dose) NDC 13668-327-74 10 mg amlodipine/160 mg valsartan/25 mg hydrochlorothiazide Tablets – Brown-yellow colored, capsule shaped, biconvex, film coated tablets debossed with "1328" on one side and plain on other side. Bottles of 30 NDC 13668-328-30 Bottles of 100 NDC 13668-328-01 Bottles of 500 NDC 13668-328-05 Carton of 100 tablets (10 x 10 unit-dose) NDC 13668-328-74 10 mg amlodipine/320 mg valsartan/25 mg hydrochlorothiazide Tablets – Brown-yellow colored, capsule shaped, biconvex, film coated tablets debossed with "1325" on one side and plain on other side. Bottles of 30 NDC 13668-325-30 Bottles of 100 NDC 13668-325-01 Bottles of 500 NDC 13668-325-05 Carton of 100 tablets (10 x 10 unit-dose) NDC 13668-325-74 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP.
Abbreviated New Drug Application
AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE- AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET REMEDYREPACK INC. ---------- 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 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, valsartan and hydrochlorothiazide tablets are a combination tablet 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 mg/320 mg/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 mg) 5/160/12.5, 5/160/25, 10/160/12.5, 10/160/25, 10/320/25 (3) (3) CONTRAINDICATIONS Anuria (4) Hypersensitivity t Lire le document complet