AMLODIPINE BESYLATE tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Ascend Laboratories, LLC

INN (Isem Internazzjonali):

AMLODIPINE BESYLATE

Kompożizzjoni:

AMLODIPINE 2.5 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Amlodipine besylate tablets is 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

Sommarju tal-prodott:

2.5 mg Tablets Amlodipine besylate tablets, USP 2.5 mg (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as white to off white, round, flat-faced, beveled edge tablets '211' debossed on one side and plain on the other side and supplied as follows: NDC 67877-197-90    Bottle of 90 NDC 67877-197-05    Bottle of 500 NDC 67877-197-10    Bottle of 1000 NDC 67877-197-38    Carton of 100 tablets (10x10 unit-dose)    5 mg Tablets Amlodipine besylate tablets, USP 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white to off white, round, flat-faced, beveled edge tablets '210' debossed on one side and plain on the other side and supplied as follows: NDC 67877-198-90    Bottle of 90 NDC 67877-198-05    Bottle of 500 NDC 67877-198-10    Bottle of 1000 NDC 67877-198-38    Carton of 100 tablets (10x10 unit-dose) 10 mg Tablets Amlodipine besylate tablets, USP 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white to off white, round, flat-faced, beveled edge tablets '209' debossed on one side and plain on the other side and supplied as follows: NDC 67877-199-90    Bottle of 90 NDC 67877-199-05    Bottle of 500 NDC 67877-199-10    Bottle of 1000 NDC 67877-199-38    Carton of 100 tablets (10x10 unit-dose)  Storage Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature), and dispense in tight, light resistant container (USP). Manufactured by: Alkem Laboratories Ltd., INDIA.   Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised Date: October, 2021

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

AMLODIPINE BESYLATE - AMLODIPINE BESYLATE TABLET
ASCEND LABORATORIES, LLC
----------
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 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)
Amlodipine besylate tablets is 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)
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
Tablets: 2.5 mg, 5 mg, and 10 mg (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 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 in patients with severe hepatic impairment. (5.3)
ADVERSE REACTIONS
Most common adverse re