AMLODIPINE BESYLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Redpharm Drug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

16.1 How Supplied Amlodipine Besylate Tablets, USP 2.5mg Light yellow round flat faced beveled edge tablets debossed with 'U' on one side and '2' on the other side Bottle of 90              (29300-396-19) Bottle of 500           (29300-396-05) Bottle of 1,000         (29300-396-10) Amlodipine Besylate Tablets, USP 5mg White to off-white round flat faced beveled edge tablets debossed with 'U' on one side and '5' on the other side Bottle of 90             (29300-397-19) Bottle of 500           (29300-397-05) Bottle of 1,000         (29300-397-10) Amlodipine Besylate Tablets, USP 10mg White to off-white round flat faced beveled edge tablets debossed with 'U' on one side and '10' on the other side Bottle of 90             (29300-398-19) Bottle of 500           (29300-398-05) Bottle of 1,000         (29300-398-10) 16.2 Storage Store at 20° to 25°C (68° to 77° F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and dispense in tight, light-resistant containers. Additional Summary of Information About leaflets can be obtained by calling Unichem at 1-866-562-4616. Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India. and UNICHEM LABORATORIES LTD. Ind Area, Meerut Road, Ghaziabad – 201 003, India Manufactured for: East Brunswick, NJ 08816 10-R-08/2022 13014142

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
REDPHARM DRUG
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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 CALCIUM CHANNEL BLOCKERS AND MAY BE
USED ALONE OR IN
COMBINATION WITH OTHER ANTIHYPERTENSIVE AND ANTIANGINAL AGENTS FOR THE
TREATMENT OF:
Hypertension ( 1.1)
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)
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 reaction to amlodipine 
                                
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