NIACIN tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

NIACIN

Composition:

NIACIN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. - Niacin extended-release tablets are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. - In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. - In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease. - Niacin extended-release tablets in combination with a bile acid bi

Product summary:

Niacin extended-release tablets, 500 mg are supplied as light orange to orange colored, round shaped, film-coated tablets debossed with “AN 321” on one side and plain on the other side. They are available as follows: Bottles of 30:              NDC 65162-321-03 Bottles of 90:              NDC 65162-321-09 Bottles of 500:            NDC 65162-321-50 Niacin extended-release tablets, 1000 mg are supplied as light orange to orange colored, capsule shaped, film-coated tablets debossed with “AN 323” on one side and plain on the other side. They are available as follows: Bottles of 30:              NDC 65162-323-03 Bottles of 90:              NDC 65162-323-09 Bottles of 500:            NDC 65162-323-50 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIACIN- NIACIN TABLET, EXTENDED RELEASE
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NIACIN EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR NIACIN
EXTENDED-RELEASE TABLETS.
NIACIN EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Niacin extended-release tablets contain extended-release niacin
(nicotinic acid) and are indicated:
To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in
patients with primary
hyperlipidemia and mixed dyslipidemia. (1)
To reduce the risk of recurrent nonfatal myocardial infarction in
patients with a history of myocardial
infarction and hyperlipidemia. (1)
In combination with a bile acid binding resin:
Slows progression or promotes regression of atherosclerotic disease in
patients with a history of
coronary artery disease (CAD) and hyperlipidemia. (1)
As an adjunct to diet to reduce elevated TC and LDL-C in adult
patients with primary hyperlipidemia. (1)
To reduce TG in adult patients with severe hypertriglyceridemia. (1)
LIMITATIONS OF USE:
Addition of niacin extended-release tablets did not reduce
cardiovascular morbidity or mortality among
patients treated with simvastatin in a large, randomized controlled
trial. (5.1)
DOSAGE AND ADMINISTRATION
Niacin extended-release tablets should be taken at bedtime with a
low-fat snack. (2.1)
Dose range: 500 mg to 2,000 mg once daily. (2.1)
Therapy with niacin extended-release tablets must be initiated at 500
mg at bedtime in order to reduce
the incidence and severity of side effects which may occur during
early therapy and should not be
increased by more than 500 mg in any 4-week period. (2.1)
Maintenance dose: 1,000 to 2,000 mg once daily. (2.2)
Doses greater than 2,000 mg daily are not recommended. (2.2)
DOSAGE FORMS AND STRENGTHS
Unscored film-coated tablets for oral administration: 500 mg and 1,000
mg niacin extended-release. (3)
CONTRAINDICATIONS
Active li