Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Par Pharmaceutical, Inc.
OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL 20 mg
ORAL
PRESCRIPTION DRUG
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine 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 one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, su
Olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide tablets contain olmesartan medoxomil, amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine and hydrochlorothiazide in the strengths described below. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are supplied for oral administration in the following strength and package configurations: Tablet Strength (OM/AML equivalent HCTZ) Package Configuration NDC# Tablet Color 20/5/12.5 mg Bottle of 30 Bottle of 90 49884-786-11 49884-786-09 White, film coated, round shaped biconvex tablet, debossed with “p” on one side and “786” on the other 40/5/12.5 mg Bottle of 30 Bottle of 90 49884-787-11 49884-787-09 Pink, film coated, round shaped biconvex tablet, debossed with “p” on one side and “787” on the other 40/5/25 mg Bottle of 30 Bottle of 90 49884-788-11 49884-788-09 White, film coated, oval shaped biconvex tablet, debossed with “p” on one side and “788” on the other 40/10/12.5 mg Bottle of 30 Bottle of 90 49884-789-11 49884-789-09 Orange, film coated, round shaped biconvex tablet, debossed with “p” on one side and “789” on the other 40/10/25 mg Bottle of 30 Bottle of 90 49884-790-11 49884-790-09 Pink, film coated, oval shaped biconvex tablet, debossed with “p” on one side and “790” on the other Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE- OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE TABLET, FILM COATED PAR PHARMACEUTICAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2010 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS AS SOON AS POSSIBLE (5.1), 8.1). DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS (5.1, 8.1). INDICATIONS AND USAGE Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is a combination of an angiotensin II receptor blocker, a dihydropyridine calcium channel blocker, and a thiazide diuretic 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). Limitations of Use Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are not indicated for initial therapy. (1) DOSAGE AND ADMINISTRATION Dose one daily. Dosage may be increased after 2 weeks to a maximum dose of 40/10/25 mg once daily (2). Dose selection should be individualized based on previous therapy (2). DOSAGE FORMS AND STRENGTHS Tablets: (olmesartan medoxomil, amlodipine and hydrochlorothiazide) 20/5/12.5 mg, 40/5/12.5 mg, 40/5/25 mg, 40/10/12.5 mg and 40/10/25 mg (3) CONTRAINDICATIONS Anuria: Hypersensitivity to sulfonamide-derived drugs (4). Do not coadminister aliskiren with olmesartan medoxomil, amlodipine and hydrochlorothiazide in patients with diabete Przeczytaj cały dokument