AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Zydus Pharmaceuticals USA Inc.

INN (इंटरनेशनल नाम):

AMLODIPINE BESYLATE

रचना:

AMLODIPINE 5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

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 68382-927-06 in bottle of 30 tablets NDC 68382-927-16 in bottle of 90 tablets NDC 68382-927-01 in bottle of 100 tablets NDC 68382-927-05 in bottle of 500 tablets   NDC 68382-927-10 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 68382-928-06 in bottle of 30 tablets NDC 68382-928-16 in bottle of 90 tablets NDC 68382-928-01 in bottle of 100 tablets NDC 68382-928-05 in bottle of 500 tablets   NDC 68382-928-10 in bottle of 1000 tablets NDC 68382-928-77 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 68382-929-06 in bottle of 30 tablets NDC 68382-929-16 in bottle of 90 tablets NDC 68382-929-01 in bottle of 100 tablets NDC 68382-929-05 in bottle of 500 tablets   NDC 68382-929-10 in bottle of 1000 tablets NDC 68382-929-77 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 68382-930-06 in bottle of 30 tablets NDC 68382-930-16 in bottle of 90 tablets NDC 68382-930-01 in bottle of 100 tablets NDC 68382-930-05 in bottle of 500 tablets   NDC 68382-930-10 in bottle of 1000 tablets NDC 68382-930-77 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].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

AMLODIPINE AND OLMESARTAN MEDOXOMIL - AMLODIPINE AND OLMESARTAN
MEDOXOMIL TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
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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 (5.9) 11/2016
INDICATIONS AND USAGE
Amlodipine and olmesartan medoxomil tablets are a combination of a
dihydropyridine calcium
channel blocker and an 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
initial therapy in patients likely to
need multiple antihypertensive agents to achieve their blood pressure
goals (1).
DOSAGE AND ADMINISTRATION
Recommended starting dose: 5/20 mg once daily (2).
Titrate as needed in two week intervals up to a maximum of 10/40 mg
once daily (2).
DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/olmesartan medoxomil content) 5/20 mg; 10/20 mg;
5/40 mg; and 10/40 mg (3).
CONTRAINDICATIONS
Do not coadminister aliskiren with amlodipine and olmesartan medoxomil
tablets in patients with
diabetes (4).
WARNINGS AND PRECAUTIONS
Hypotension in volume- or salt-depleted patients with treatment
initiation may be anticipated. Start
treatment under close supervision (5.2).
Incre