AMLODIPINE BESYLATE- amlodipine besylate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceutical

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE BESYLATE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. -  Chronic Stable Angina Amlodipine is indicated for the treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents.   -  Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents.   -  Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. Amlodipine is contraindicated in patients with known sensitivity to amlodipine. There are no adequate and well-controlled studies in pregnant women. Amlodipine should be used during pre

Product summary:

Amlodipine – 2.5 mg Tablets, USP (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, diamond shaped tablets engraved with "W59" on one side and supplied as follows:         Bottle of 30         Bottle of 90         Bottle of 100 Amlodipine – 5 mg Tablets, USP (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white, octagon shaped tablets engraved with "W60" on one side and supplied as follows:     Bottle of 30     Bottle of 90     Bottle of 100 Amlodipine – 10 mg Tablets, USP (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white, round tablets engraved with "W61" and supplied as follows:         Bottle of 30         Bottle of 90         Bottle of 100 Store bottles at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
HIKMA PHARMACEUTICAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE BESYLATE SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE BESYLATE.
AMLODIPINE BESYLATE TABLETS, USP
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Amlodipine is 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)
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, because of the
gradual onset of action, acute hypotension is unlikely. (5.1)
Worsening angina and acute myocardial infarction can develop after
starting or increasing the dose of amlodipine,
particularly in patients with severe obstructive coronary artery
disease. (5.2)
Titrate slowly when administering calcium channel blockers to patients
with severe hepatic impairment. (5.4)
ADVERSE REACTIONS
Most common adverse reactions are headache and edema which occurred in
a dose related manner. Other adverse
experiences not dose related but reported with an incidence >1% are
headache, fatigue, nausea, abdominal pain, and
somnolence. (6) (6)
TO REPO