AMLODIPINE BESYLATE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

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13-01-2020

Virkt innihaldsefni:

amlodipine besylate (UNII: 864V2Q084H) (amlodipine - UNII:1J444QC288)

Fáanlegur frá:

Upsher-Smith Laboratories, LLC

INN (Alþjóðlegt nafn):

amlodipine besylate

Samsetning:

amlodipine 2.5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, 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 amlodipine besylate 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 Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmaco

Vörulýsing:

Amlodipine besylate tablets, USP 2.5 mg (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged, one side debossed "ALP" over "2 1/2", one side debossed "832" and supplied as follows: Amlodipine besylate tablets, USP 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white, round, flat-faced, beveled edged, one side debossed "ALP" over "5", one side debossed "832" and supplied as follows: Amlodipine besylate tablets, USP 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white, round, flat-faced, beveled edged, one side debossed "ALP" over "10", one side debossed "832" and supplied as follows: Storage 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]. Dispense in a tight, light-resistant container as defined in the USP. Protect from light

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

                                AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
UPSHER-SMITH LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE BESYLATE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE
BESYLATE TABLETS
AMLODIPINE BESYLATE TABLETS, FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Amlodipine besylate tablets are a calcium channel blocker and may be
used alone or in combination with other
antihypertensive and antianginal agents for the treatment of:
Hypertension (1.1)
Amlodipine besylate tablets are indicated for the treatment of
hypertension, to lower blood pressure. Lowering
blood pressure reduces the risk of fatal and nonfatal cardiovascular
events, primarily strokes and myocardial
infarctions .
Coronary Artery Disease (1.2)
Chronic Stable Angina
Vasospastic Angina (Prinzmetal's or Variant Angina)
Angiographically Documented Coronary Artery Disease in patients
without heart failure or an ejection fraction <
40%
DOSAGE AND ADMINISTRATION
Adult recommended starting dose: 5 mg once daily with maximum dose 10
mg once daily. (2.1)
Small, fragile, or elderly patients, or patients with hepatic
insufficiency may be started on 2.5 mg once daily. (2.1)
Pediatric starting dose: 2.5 mg to 5 mg once daily. (2.2)
IMPORTANT LIMITATION: Doses in excess of 5 mg daily have not been
studied in pediatric patients. (2.2)
DOSAGE FORMS AND STRENGTHS
2.5 mg, 5 mg, and 10 mg Tablets (3)
CONTRAINDICATIONS
Known sensitivity to amlodipine (4)
WARNINGS AND PRECAUTIONS
Symptomatic hypotension is possible, particularly in patients with
severe aortic stenosis. However, acute hypotension is
unlikely. (5.1)
Worsening angina and acute myocardial infarction can develop after
starting or increasing the dose of amlodipine
besylate tablets, particularly in patients with severe obstructive
coronary artery disease. (5.2)
Titrate slowly in patients with severe hepatic impairment. (5.3)
ADVERSE REACTIONS
Most common adverse
                                
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