AMLODIPINE - amlodipine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)

Available from:

Macleods Pharmaceuticals Limited

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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

Product summary:

5 mg Tablets USP Amlodipine besylate – 5 mg Tablets USP (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white to off white, capsule shaped, biconvex, uncoated tablets with 'ML' and '22' debossed, on one side and plain on other side and supplied as follows: NDC 33342-015-10  Bottle of 90 NDC 33342-015-12  Unit dose package of 100 10 mg Tablets USP Amlodipine besylate – 10 mg Tablets USP (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white to off white, round, biconvex, uncoated, tablets with  'ML' & '23' debossed, on one side and plain on the other side  and supplied as follows: NDC 33342-016-10 Bottle of 90 NDC 33342-016-12 Unit dose package of 100 Storage Store at 20º - 25º C (68º - 77º F); See USP Controlled Room Temperature and dispense in tight, light-resistant containers (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE - AMLODIPINE TABLET
MACLEODS PHARMACEUTICALS LIMITED
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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: 1992
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)
o Amlodipine besylate tablets are indicated for the tretament of
hypertension, to lower blood pressure. Lowering blood
pressure reduces the risk of
fatal and nonfatal cerdiovascular events, primarily strokes and
myocardial infarctions.
•Coronary Artery Disease (1.2)
o Chronic Stable Angina
o Vasospastic Angina (Prinzmetal's or Variant Angina)
o 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)
o 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
• 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
unlike ly.(5.1)
Worsening angina and acute myocardial infarction can develop after
starting or increasing the dose of amlodipine
besylate, 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