OLMESARTAN MEDOXOMIL tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)

Beschikbaar vanaf:

Zydus Lifesciences Limited

INN (Algemene Internationale Benaming):

OLMESARTAN MEDOXOMIL

Samenstelling:

OLMESARTAN MEDOXOMIL 5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Olmesartan medoxomil tablets are 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. 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. 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 as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation,

Product samenvatting:

Olmesartan Medoxomil Tablets, 5 mg are supplied as white to off-white, round, film-coated biconvex tablets, debossed with '643' on one side and plain on other side and are supplied as follows: NDC 70771-1059-3 in bottle of 30 tablets NDC 70771-1059-9 in bottle of 90 tablets NDC 70771-1059-1 in bottle of 100 tablets NDC 70771-1059-5 in bottle of 500 tablets NDC 70771-1059-0 in bottle of 1000 tablets NDC 70771-1059-7 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Olmesartan Medoxomil Tablets, 20 mg are supplied as white to off-white, round, film-coated biconvex tablets, debossed with '644' on one side and plain on other side and are supplied as follows: NDC 70771-1060-3 in bottle of 30 tablets NDC 70771-1060-9 in bottle of 90 tablets NDC 70771-1060-1 in bottle of 100 tablets NDC 70771-1060-5 in bottle of 500 tablets NDC 70771-1060-0 in bottle of 1000 tablets NDC 70771-1060-7 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Olmesartan Medoxomil Tablets, 40 mg are supplied as white to off-white, oval, film-coated tablets, debossed with '645' on one side and plain on other side and are supplied as follows: NDC 70771-1061-3 in bottle of 30 tablets NDC 70771-1061-9 in bottle of 90 tablets NDC 70771-1061-1 in bottle of 100 tablets NDC 70771-1061-5 in bottle of 500 tablets NDC 70771-1061-0 in bottle of 1000 tablets NDC 70771-1061-7 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Storage   Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Dispense in a tightly closed container with a child-resistant closure (as required). Keep out of the reach of children.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

OLMESARTAN MEDOXOMIL - OLMESARTAN MEDOXOMIL TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
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OLMESARTAN MEDOXOMIL TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1059-1
Olmesartan Medoxomil Tablets, 5 mg
Rx only
100 TABLETS
NDC 70771-1060-1
Olmesartan Medoxomil Tablets, 20 mg
Rx only
100 TABLETS
NDC 70771-1061-1
Olmesartan Medoxomil Tablets, 40 mg
Rx only
100 TABLETS
OLMESARTAN MEDOXOMIL
olmesartan medoxomil tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1059
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN -
UNII:8W1IQP3U10)
OLMESARTAN
MEDOXOMIL
5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
9mm
FLAVOR
IMPRINT CODE
643
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1059-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
04/24/2017
2
NDC:70771-
1059-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
04/24/2017
3
NDC:70771-
1059-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
04/24/2017
4
NDC:70771-
1059-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
04/24/2017
5
NDC:70771-
1059-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
04/24/2017
6
NDC:70771-
1059-7
10 in 1 CARTON
04/24/2017
6
NDC:70771-
1059-2
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA20