AMLODIPINE BESYLATE- amlodipine besylate tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Mylan Pharmaceuticals Inc.

INN (الاسم الدولي):

AMLODIPINE BESYLATE

تركيب:

AMLODIPINE 2.5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 pharmacologic

ملخص المنتج:

Amlodipine Besylate Tablets, USP are available containing amlodipine besylate, USP equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine. The 2.5 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and A8 on the other side. They are available as follows: NDC 0378-5208-77 bottles of 90 tablets NDC 0378-5208-05 bottles of 500 tablets The 5 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and A9 on the other side. They are available as follows: NDC 0378-5209-77 bottles of 90 tablets NDC 0378-5209-05 bottles of 500 tablets The 10 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and A10 on the other side. They are available as follows: NDC 0378-5210-77 bottles of 90 tablets NDC 0378-5210-05 bottles of 500 tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
MYLAN PHARMACEUTICALS INC.
----------
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:
•
•
DOSAGE AND ADMINISTRATION
•
•
IMPORTANT LIMITATION: Doses in excess of 5 mg daily have not been
studied in pediatric patients. (2.2)
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reaction to amlodipine is edema which occurred in
a dose related manner. Other adverse
experiences not dose related but reported with an incidence > 1.0% are
fatigue, nausea, abdominal pain, and somnolence.
(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
Hypertension (1.1)
o
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)
o
o
o
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%
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)
Tablets: 2.5 mg, 5 mg, and 10 mg (3)
Known sen