OLMESARTAN MEDOXMIL AND HYDROCHLOROTHIAZIDE- olmesartan medoxmil 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), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

OLMESARTAN MEDOXOMIL

Composition:

OLMESARTAN MEDOXOMIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)] . 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil 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

Product summary:

Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP. The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with M on one side of the tablet and 413 on the other side. They are available as follows: NDC 0378-1413-93 bottles of 30 tablets NDC 0378-1413-77 bottles of 90 tablets The 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with M on one side of the tablet and 422 on the other side. They are available as follows: NDC 0378-1422-93 bottles of 30 tablets NDC 0378-1422-77 bottles of 90 tablets The 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with M on one side of the tablet and 425 on the other side. They are available as follows: NDC 0378-1425-93 bottles of 30 tablets NDC 0378-1425-77 bottles of 90 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OLMESARTAN MEDOXMIL AND HYDROCHLOROTHIAZIDE- OLMESARTAN MEDOXMIL AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLMESARTAN MEDOXOMIL AND
HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS.
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Indications and Usage (1) 02/2016
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: (olmesartan medoxomil and hydrochlorothiazide) 20/12.5 mg;
40/12.5 mg; 40/25 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 2%) are nausea,
hyperuricemia, dizziness, and upper respiratory infection
(6.1)
WHEN PREGNANCY IS DETECTED, DISCONTINUE OLMESARTAN MEDOXOMIL AND
HYDROCHLOROTHIAZIDE TABLETS 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).
Olmesartan medoxomil and hydrochlorothiazide tablets are a combination
of olmesartan, an angiotensin II receptor
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)
Recommended starting dose in patients not adequately controlled with
olmesartan monotherapy, 40/12.5 mg (2)
Recommended starting dose in patients not adequately controlled with
hydrochlorothiazide monotherapy, 20/12.5
mg (2)
Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40/25 mg
olmesartan and hydrochlorothiazide (2)
Hypersensitivity to any component of olmesar