Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)
Mylan Pharmaceuticals Inc.
AMLODIPINE BESYLATE
AMLODIPINE 2.5 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Lesen Sie das vollständige Dokument