OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

זמין מ:

Par Pharmaceutical, Inc.

INN (שם בינלאומי):

OLMESARTAN MEDOXOMIL

הרכב:

OLMESARTAN MEDOXOMIL 20 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

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].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE /
HYDROCHLOROTHIAZIDE- OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE /
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
PAR PHARMACEUTICAL, INC.
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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