AMLODIPINE AND OLMESARTAN MEDOXOMIL- 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:

Apotex Corp.

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 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 Pressure

Product summary:

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg contain 6.9 mg amlodipine besylate USP equivalent to 5 mg amlodipine and 20 mg olmesartan medoxomil USP. They are white to off-white, circular film-coated tablets, debossed with ‘71’ on one side and ‘G’ on the other side, and supplied as follows: NDC 60505-4582-3 Bottle of 30 NDC 60505-4582-9 Bottle of 90 Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg contain 13.9 mg amlodipine besylate USP equivalent to 10 mg amlodipine and 20 mg olmesartan medoxomil USP. They are orange, circular film-coated tablets, debossed with ‘567’ on one side and ‘G’ on the other side and are supplied as follows: NDC 60505-4584-3 Bottle of 30 NDC 60505-4584-9 Bottle of 90 Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg contain 6.9 mg amlodipine besylate USP equivalent to 5 mg amlodipine and 40 mg olmesartan medoxomil USP. They are cream, circular film-coated tablets, debossed with ‘568’ on one side and ‘G’ on the other side and are supplied as follows: NDC 60505-4583-3 Bottle of 30 NDC 60505-4583-9 Bottle of 90 Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/40 mg contain 13.9 mg amlodipine besylate USP equivalent to 10 mg amlodipine and 40 mg olmesartan medoxomil USP. They are reddish-brown, circular film-coated tablets, debossed with ‘569’ on one side and ‘G’ on the other side and are supplied as follows: NDC 60505-4585-3 Bottle of 30 NDC 60505-4585-9 Bottle of 90 Store at 20o to 25o C (68o to 77o 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
APOTEX CORP.
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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._
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RECENT MAJOR CHANGES
Warnings and Precautions (5.9) 11/2016
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/olmesartan medoxomil content) 5/20 mg; 10/20 mg;
5/40 mg; and 10/40 mg (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reaction (incidence ≥3%) is edema (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT APOTEX CORP. AT
1-800-706-5575 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Amlodipine (7.1):
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE AND OLMESARTAN
MEDOXOMIL TABLETS 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).
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).
Recommended starting dose: 5/20 mg once daily (2).
Titrate as needed in two week intervals up to a maximum of 10/