AMLODIPINE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMLODIPINE BENZOATE (UNII: XD75TQ8A2P) (AMLODIPINE - UNII:1J444QC288)

Available from:

Amneal Pharmaceuticals NY LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine oral suspension is indicated for the treatment of hypertension in adults and children 6 years and older, 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.  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

Product summary:

Amlodipine oral suspension is a white to off-white homogeneous, oral suspension that contains 1 mg of amlodipine per milliliter (equivalent to 1.30 mg of amlodipine benzoate). It is supplied as 150 mL in a 185 mL white HDPE penicillin round bottle with a child-resistant cap and tamper-evident seal. SHAKE BEFORE USING .  NDC 69238-2026-7 Storage  Amlodipine oral suspension, 1 mg/mL, should be stored refrigerated (2°C to 8°C/36°F to 46°F). Avoid freezing and excessive heat. Protect from light.  Trademarks are the property of their respective owner. Distributed by:  Amneal Pharmaceuticals LLC  Bridgewater, NJ 08807  Rev. 01-2022-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE- AMLODIPINE SUSPENSION
AMNEAL PHARMACEUTICALS NY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR AMLODIPINE ORAL
SUSPENSION.
AMLODIPINE ORAL SUSPENSION, FOR ORAL USE
INITIAL U.S. APPROVAL:1992
INDICATIONS AND USAGE
Amlodipine oral suspension 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 oral suspension is indicated for the treatment of
hypertension in adults and children 6 years
and older, 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 orally 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)
SHAKE BEFORE USING
DOSAGE FORMS AND STRENGTHS
Oral suspension: 1 mg/mL. (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