AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL- amlodipine besylate and olmesartran 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:

Alembic 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 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 are supplied as follows: 5 mg/20 mg: White round shape, film-coated debossed with ‘454’ on one side and plain on other side. Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90 Bottles of 1000                                                  NDC# 46708-212-91 5 mg/40 mg: Cream round shape, film-coated tablets debossed with ‘456’ on one side and plain on other side. Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90 Bottles of 1000                                                  NDC# 46708-213-91 10 mg/20 mg: Grayish orange round shape, film-coated tablets debossed with ‘455’ on one side and plain on other side. Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90 Bottles of 1000                                                   NDC# 46708-214-91 10 mg/40 mg: Brownish red round shape, film-coated tablets debossed with ‘457’ on one side and plain on the other side. Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90 Bottles of 1000                                                    NDC# 46708-215-91 Store at 25°C (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 BESYLATE AND OLMESARTRAN MEDOXOMIL - AMLODIPINE
BESYLATE AND OLMESARTRAN MEDOXOMIL TABLET, FILM COATED
ALEMBIC 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).
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
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
initial therapy in patients likely to
need multiple antihypertensive agents to achieve their blood pressure
goals (1) (1)
DOSAGE AND ADMINISTRATION
• Recommended starting dose: 5/20 mg once daily (2).
• Titrate as needed in two weeks intervals up to a maximum of 10/40
mg once daily (2).
(2)
DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/olmesartan medoxomil content) 5/20 mg; 10/20 mg;
5/40 mg; and 10/40 mg (3). (3)
CONTRAINDICATIONS
Do not co-administer 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 anticipate