AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Zydus Lifesciences Limited

INN (Internationale Bezeichnung):

AMLODIPINE BESYLATE

Zusammensetzung:

AMLODIPINE 5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Amlodipine and olmesartan medoxomil  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 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 amlodipine and olmesartan medoxomil 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 as those of the National High Blood Pressur

Produktbesonderheiten:

Amlodipine and olmesartan medoxomil  tablets contain amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine and olmesartan  medoxomil in the strengths described below. 5 mg/20 mg tablets: White to off-white, round shaped, film-coated tablets, debossed with "927" on one side and plain on the other side. NDC 70771-1186-6 in bottle of 30 tablets NDC 70771-1186-9 in bottle of 90 tablets NDC 70771-1186-1 in bottle of 100 tablets NDC 70771-1186-5 in bottle of 500 tablets   NDC 70771-1186-0 in bottle of 1000 tablets 10 mg/20 mg tablets: Light orange colored, round shaped, film-coated tablets, debossed with "928" on one side and plain on the other side. NDC 70771-1187-6 in bottle of 30 tablets NDC 70771-1187-9 in bottle of 90 tablets NDC 70771-1187-1 in bottle of 100 tablets NDC 70771-1187-5 in bottle of 500 tablets   NDC 70771-1187-0 in bottle of 1000 tablets NDC 70771-1187-4 in cartons of 100 tablets (10 x 10 unit-dose blisters) 5 mg/40 mg tablets: Pale yellow colored, round shaped, film-coated tablets, debossed with "929" on one side and plain on the other side. NDC 70771-1188-6 in bottle of 30 tablets NDC 70771-1188-9 in bottle of 90 tablets NDC 70771-1188-1 in bottle of 100 tablets NDC 70771-1188-5 in bottle of 500 tablets   NDC 70771-1188-0 in bottle of 1000 tablets NDC 70771-1188-4 in cartons of 100 tablets (10 x 10 unit-dose blisters) 10 mg/40 mg tablets: Light orange colored, round shaped, film-coated tablets, debossed with "930" on one side and plain on the other side. NDC 70771-1189-6 in bottle of 30 tablets NDC 70771-1189-9 in bottle of 90 tablets NDC 70771-1189-1 in bottle of 100 tablets NDC 70771-1189-5 in bottle of 500 tablets   NDC 70771-1189-0 in bottle of 1000 tablets NDC 70771-1189-4 in cartons of 100 tablets (10 x 10 unit-dose blisters) Storage Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

AMLODIPINE AND OLMESARTAN MEDOXOMIL - AMLODIPINE AND OLMESARTAN
MEDOXOMIL TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1186-3
Amlodipine and olmesartan medoxomil tablets, 5/20 mg
Rx only
30 tablets
NDC 70771-1187-3
Amlodipine and olmesartan medoxomil tablets, 10/20 mg
Rx only
30 tablets
NDC 70771-1188-3
Amlodipine and olmesartan medoxomil tablets, 5/40 mg
Rx only
30 tablets
NDC 70771-1189-3
Amlodipine and olmesartan medoxomil tablets, 10/40 mg
Rx only
30 tablets
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine and olmesartan medoxomil tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1186
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)
AMLODIPINE
5 mg
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN -
UNII:8W1IQP3U10)
OLMESARTAN
MEDOXOMIL
20 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
7mm
FLAVOR
IMPRINT CODE
927
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1186-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
01/04/2018
2
NDC:70771-
1186-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
01/04/2018
3
NDC:70771-
1186-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
01/04/2018
4
NDC:70771-
1186-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
01/04/