AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Macleods Pharmaceuticals Limited

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 (CV) 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 Pre

Product summary:

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. Amlodipine and olmesartan medoxomil tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Amlodipine and olmesartan medoxomil tablets are supplied for oral administration in the following strength and package configurations: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE AND OLMESARTAN MEDOXOMIL - AMLODIPINE AND OLMESARTAN
MEDOXOMIL TABLET, FILM COATED
MACLEODS PHARMACEUTICALS LIMITED
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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
TABLETS AS SOON AS POSSIBLE (5.1, 8.1).
• DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO
THE DEVELOPING FETUS (5.1, 8.1).
INDICATIONS AND USAGE
• Amlodipine and olmesartan medoxomil tablets are a combination of
amlodipine besylate, a
dihydropyridine calcium channel blocker and olmesartan medoxomil, an
angiotensin II receptor blocker,
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 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; 10
mg/20 mg; 5 mg/40 mg; and 10
mg/40 mg (3).
CONTRAINDICATIONS
• Do not co-administer aliskiren with amlodipine and olmesartan
medoxomil tablets in patients with
diabetes (4).
WARNINGS AND PRECAUTIONS
• Anticipate hypotension in volume-or salt-depleted patients with
treatment initiation. Start treatment
under clos