OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

OLMESARTAN MEDOXOMIL

Composition:

OLMESARTAN MEDOXOMIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Olmesartan medoxomil, amlodipine, 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, such

Product summary:

Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are available as: 20 mg/5 mg/12.5 mg - light pink to pink, film-coated, round biconvex tablet, debossed with "TEVA" on one side and "5005" on the other side of the tablet and contains 20 mg of olmesartan medoxomil, 6.93 mg amlodipine besylate equivalent to 5 mg of amlodipine base, and 12.5 mg hydrochlorothiazide. They are available in bottles of 30 (NDC 0093-5005-56). 40 mg/5 mg/12.5 mg - yellow to dark yellow, film-coated, round biconvex tablet, debossed with "TEVA" on one side and "5006" on the other side of the tablet and contains 40 mg of olmesartan medoxomil, 6.93 mg amlodipine besylate equivalent to 5 mg of amlodipine base, and 12.5 mg hydrochlorothiazide. They are available in bottles of 30 (NDC 0093-5006-56). 40 mg/5 mg/25 mg - yellow to dark yellow, film-coated, modified capsule shaped tablet, debossed with "TEVA" on one side and "5004" on the other side of the tablet and contains 40 mg of olmesartan medoxomil, 6.93 mg amlodipine besylate equivalent to 5 mg of amlodipine base, and 25 mg hydrochlorothiazide. They are available in bottles of 30 (NDC 0093-5004-56). 40 mg/10 mg/12.5 mg - pink, film-coated, round biconvex tablet, debossed with "TEVA" on one side and "5003" on the other side of the tablet and contains 40 mg of olmesartan medoxomil, 13.86 mg amlodipine besylate equivalent to 10 mg of amlodipine base, and 12.5 mg hydrochlorothiazide. They are available in bottles of 30 (NDC 0093-5003-56). 40 mg/10 mg/25 mg - pink, film-coated, modified capsule shaped tablet, debossed with "TEVA" on one side and "5002" on the other side of the tablet and contains 40 mg of olmesartan medoxomil, 13.86 mg amlodipine besylate equivalent to 10 mg of amlodipine base, and 25 mg hydrochlorothiazide. They are available in bottles of 30 (NDC 0093-5002-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE-
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET, FILM
COATED
TEVA PHARMACEUTICALS USA, 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, 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 are
a combination of olmesartan
medoxomil, an angiotensin II receptor blocker, amlodipine, a
dihydropyridine calcium channel blocker, and
hydrochlorothiazide, 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 once daily. Dosage may be increased after 2 weeks to a maximum
dose of 40 mg/10 mg/25 mg
once daily (2).
Dose selection should be individualized based on previous therapy (2).
DOSAGE FORMS AND STRENGTHS
Tablets: (olmesartan medoxomil/amlodipine/hydrochlorothiazide) (3)
20 mg/5 mg/12.5 mg
40 mg/5 mg/12.5 mg
40 mg/5 mg/25 mg
40 mg/10 mg/12.5 mg
40 mg/10 mg/25 mg
CONTRAINDICATIONS
Anuria: Hypersensitivity to sulfonamide-derived drugs (4).
Do not coadminister aliskiren with olmesartan me