Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Aurobindo Pharma 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
Amlodipine, valsartan and hydrochlorothiazide is available as film-coated 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, and hydrochlorothiazide USP 12.5 mg or 25 mg, providing for the following available combinations: 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. All strengths are packaged in bottles of 30, 90 and 500 tablets. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 5 mg/160 mg/12.5 mg – White colored, ovaloid, beveled edge, biconvex film-coated tablet, debossed with ‘J’ on one side and ‘88’ on the other side. Bottles of 30 NDC 65862-834-30 Bottles of 90 NDC 65862-834-90 Bottles of 500 NDC 65862-834-05 Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 10 mg/160 mg/12.5 mg – Pale yellow colored, ovaloid, beveled edge, biconvex film-coated tablet, debossed with ‘J’ on one side and ‘90’ on the other side. Bottles of 30 NDC 65862-836-30 Bottles of 90 NDC 65862-836-90 Bottles of 500 NDC 65862-836-05 Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 5 mg/160 mg/25 mg – Yellow colored, ovaloid, beveled edge, biconvex film-coated tablet, debossed with ‘J’ on one side and ‘89’ on the other side. Bottles of 30 NDC 65862-835-30 Bottles of 90 NDC 65862-835-90 Bottles of 500 NDC 65862-835-05 Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 10 mg/160 mg/25 mg – Brown colored, ovaloid, beveled edge, biconvex film-coated tablet, debossed with ‘J’ on one side and ‘91’ on the other side. Bottles of 30 NDC 65862-837-30 Bottles of 90 NDC 65862-837-90 Bottles of 500 NDC 65862-837-05 Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 10 mg/320 mg/25 mg – Brown colored, ovaloid, beveled edge, film-coated tablet, debossed with ‘J’ on one side and ‘92’ on the other side. Bottles of 30 NDC 65862-838-30 Bottles of 90 NDC 65862-838-90 Bottles of 500 NDC 65862-838-05 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. Dispense in tight container (USP).
Abbreviated New Drug Application
AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE - AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED AUROBINDO PHARMA 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 a combination 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) Limitation of Use Amlodipine, valsartan and hydrochlorothiazide tablets are not indicated for initial treatment of hypertension. DOSAGE AND ADMINISTRATION Dose once-daily. Titrate up to a maximum dose of 10 mg/320 mg/25 mg. (2.1) 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. (2.2) Amlodipine, valsartan and hydrochlorothiazide tablets may be substituted for its individually titrated components. (2.3) DOSAGE FORMS AND STRENGTHS Tablets: (amlodipine/valsartan/hydrochlorothiazid Lue koko asiakirja