AMLODIPINE BESYLATE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

McKesson Contract Packaging

INN (שם בינלאומי):

AMLODIPINE BESYLATE

הרכב:

AMLODIPINE 2.5 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
MCKESSON CONTRACT PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AMLODIPINE BESYLATE TABLETS.
AMLODIPINE BESYLATE TABLETS, USP FOR ORAL ADMINISTRATION
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