Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Par Pharmaceutical, Inc.
AMLODIPINE BESYLATE
AMLODIPINE 5 mg
ORAL
PRESCRIPTION DRUG
Amlodipine/valsartan/hydrochlorothiazide 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, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine/valsartan/hydrochlorothiazide. 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 P
Amlodipine/valsartan/hydrochlorothiazide is 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: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg or 10/320/25 mg. All strengths are packaged in bottles of 30, 90 and 500 tablets. 5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets - White to off-white, film coated, oval shaped biconvex tablets, debossed with "P" on one side of the tablet and "172" on the other Bottles of 30 NDC 49884-172-11 Bottles of 90 NDC 49884-172-09 Bottles of 500 NDC 49884-172-05 10 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets – Peach to light brown, film coated, oval shaped biconvex tablets, debossed with "P" on one side of the tablet and "174" on the other. Bottles of 30 NDC 49884-174-11 Bottles of 90 NDC 49884-174-09 Bottles of 500 NDC 49884-174-05 5 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets – Yellow, film-coated, oval shaped biconvex tablets debossed with “P” on one side of the tablet and “173” on the other. Bottles of 30 NDC 49884-173-11 Bottles of 90 NDC 49884-173-09 Bottles of 500 NDC 49884-173-05 10 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets – Bright yellow, film-coated oval shaped, biconvex tablets debossed with “P” on one side of the tablet and “185” on the other. Bottles of 30 NDC 49884-185-11 Bottles of 90 NDC 49884-185-09 Bottles of 500 NDC 49884-185-05 10 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets – White to off white, film coated, oval shaped biconvex tablets, debossed with "P" on one side of the tablet and "175" on the other Bottles of 30 NDC 49884-175-11 Bottles of 90 NDC 49884-175-09 Bottles of 500 NDC 49884-175-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15º to 30°C (59º to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
Abbreviated New Drug Application
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE- AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE TABLET, FILM COATED AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE- AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE TABLET, FILM COATED PAR PHARMACEUTICAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE TABLETS. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2009 RX ONLY WARNING: FETAL TOXICITY SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE/VALSARTAN/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/hydrochlorothiazide is 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/Hydrochlorothiazide 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 (1) Limitation of Use Amlodipine/valsartan/hydrochlorothiazide is not indicated for initial treatment of hypertension. DOSAGE AND ADMINISTRATION Dose once-daily. Titrate up to a maximum dose of 10/320/25 mg Amlodipine/valsartan/hydrochlorothiazide 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/hydrochlorothiazide may be substituted for its individually titrated components (2). DOSAGE FORMS AND STRENGTHS Tablets: (amlodipine/valsartan/hy Baca dokumen lengkap