OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablet

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:

Alembic 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 supplied as: 20 mg/12.5 mg: Yellow film coated, round, biconvex tablets debossed with ‘346’ on one side and ‘L’ on other side. NDC 62332-149-30, Bottle of 30 tablets NDC 62332-149-90, Bottle of 90 tablets NDC 62332-149-91, Bottle of 1000 tablets NDC 62332-149-08, 10 Blister cards of 8 tablets NDC 62332-149-10, 10 Blister cards of 10 tablets 40 mg/12.5 mg: Yellow, film coated, oval shape, biconvex tablets debossed with ‘L347’ on one side and plain on other side. NDC 62332-150-30, Bottle of 30 tablets NDC 62332-150-90, Bottle of 90 tablets NDC 62332-150-91, Bottle of 1000 tablets NDC 62332-150-08, 10 Blister cards of 8 tablets NDC 62332-150-10, 10 Blister cards of 10 tablets 40 mg/25 mg: Yellow, film coated, oval shape, biconvex tablets debossed with ‘L348’ on one side and plain on other side. NDC 62332-151-30, Bottle of 30 tablets NDC 62332-151-90, Bottle of 90 tablets NDC 62332-151-91, Bottle of 1000 tablets NDC 62332-151-08, 10 Blister cards of 8 tablets NDC 62332-151-10, 10 Blister cards of 10 tablets    Storage   Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE - OLMESARTAN
MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET
ALEMBIC 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._
WHEN PREGNANCY IS DETECTED, DISCONTINUE OLMESARTAN MEDOXOMIL AND
HYDROCHLOROTHIAZIDEAS 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).
RECENT MAJOR CHANGES
Indications and Usage (1) 02/2016
INDICATIONS AND USAGE
Olmesartan medoxomil and hydrochlorothiazide tablet is 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).
DOSAGE AND ADMINISTRATION
• 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 mg /
25 mg olmesartan /
hydrochlorothiazide (2) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: (olmesartan medoxomil and hydrochlorothiazide) 20/12.5 mg; 40
/12.5 mg; 40/25 mg (3) (3)
CONTRAINDICATIONS
• Hypersensitivity to any component of olmesartan medoxomil and
hydrochlorothiazide tablets (4)
• Anuria (4)
• Do not co-administer aliskiren with olmesartan medoxomil and
hydrochlorothiazide tablets in patients
with diabetes. (4) (4)
WARNINGS AND PRECAUTI