AMLODIPINE AND OLMESARTAN MEDOXOMIL- 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:

Jubilant Cadista Pharmaceuticals Inc.

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 Hi

Produktbesonderheiten:

Amlodipine and olmesartan medoxomil tablets are available for oral administration as: The 5 mg/20 mg tablets are white, round, film coated tablets, debossed with 'E9' on one side and 'C' on the other side. Bottle of 30’s                                                   NDC 59746-526-30 Bottle of 90’s                                                   NDC 59746-526-90 Bottle of 100’s                                                 NDC 59746-526-01 Bottle of 1000’s                                               NDC 59746-526-10 The 5 mg/40 mg tablets are cream colored, round, film coated tablets, debossed with ‘F1’ on one side and ‘C’ on the other side. Bottle of 30’s                                                   NDC 59746-527-30 Bottle of 90’s                                                   NDC 59746-527-90 Bottle of 100’s                                                 NDC 59746-527-01 Bottle of 1000’s                                               NDC 59746-527-10 The 10 mg/20 mg tablets are greyish orange colored, round, film coated tablets, debossed with ‘F2’ on one side and ‘C’ on the other side. Bottle of 30’s                                               NDC 59746-528-30 Bottle of 90’s                                               NDC 59746-528-90 Bottle of 100’s                                             NDC 59746-528-01 Bottle of 1000’s                                           NDC 59746-528-10 The 10 mg/40 mg tablets are brownish red colored, round, film coated tablets, debossed with ‘F3’ on one side and ‘C’ on the other side. Bottle of 30’s                                                NDC 59746-529-30 Bottle of 90’s                                                NDC 59746-529-90 Bottle of 100’s                                              NDC 59746-529-01 Bottle of 1000’s                                            NDC 59746-529-10 Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

AMLODIPINE AND OLMESARTAN MEDOXOMIL - AMLODIPINE AND OLMESARTAN
MEDOXOMIL TABLET, FILM COATED
JUBILANT CADISTA PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE AND OLMESARTAN
MEDOXOMIL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AMLODIPINE AND
OLMESARTAN MEDOXOMIL TABLETS.
AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2007
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE AND OLMESARTAN
MEDOXOMIL 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).
RECENT MAJOR CHANGES
Warnings and Precautions (5.7) 11/2016
INDICATIONS AND USAGE
Amlodipine and olmesartan medoxomil tablet is a combination of a
dihydropyridine calcium channel blocker and
angiotensin II receptor blocker combination product 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.
(1).
Amlodipine and olmesartan medoxomil tablets may also be used as as
initial therapy in patients likely to need multiple
antihypertensive agents to achieve their blood pressure goals (1).
DOSAGE AND ADMINISTRATION
Recommended starting dose: 5 mg/20 mg once daily (2).
Titrate as needed in two week intervals up to a maximum of 10 mg/40 mg
once daily (2).
DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/olmesartan medoxomil content) 5 mg/20 mg; 5 mg/40
mg; 10 mg/20 mg; and 10 mg/40 mg (3).
CONTRAINDICATIONS
Do not co-administer aliskiren with amlodipine and olmesartan
medoxomil in patients with diabetes (4).
WARNINGS AND PRECAUTIONS
Hypotension in volume- or salt-depleted patients with treatment
initiation may be anticipated. Start treatment under
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