NIASPAN- niacin tablet, film coated, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

AbbVie Inc.

INN (Международно Name):

NIACIN

Композиция:

NIACIN 500 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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. - NIASPAN is 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. - NIASPAN in combination with a bile acid binding resin is indicated to reduce elevated TC an

Каталог на резюме:

NIASPAN tablets are supplied as unscored, medium-orange, film-coated, capsule-shaped (containing 500 or 750 mg of niacin) or oval shaped (containing 1000 mg of niacin) tablets, in an extended-release formulation. Tablets are supplied in bottles of 90 as shown below. Storage: Store at room temperature 20° to 25°C (68° to 77°F).

Статус Оторизация:

New Drug Application

Данни за продукта

NIASPAN- NIACIN TABLET, FILM COATED, EXTENDED RELEASE
ABBVIE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NIASPAN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NIASPAN.
NIASPAN (NIACIN EXTENDED-RELEASE TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
NIASPAN contains extended-release niacin (nicotinic acid), and is
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 NIASPAN did not reduce cardiovascular morbidity or
mortality among patients treated with
simvastatin in a large, randomized controlled trial. (5.1)
DOSAGE AND ADMINISTRATION
NIASPAN should be taken at bedtime with a low-fat snack. (2.1)
Dose range: 500 mg to 2000 mg once daily. (2.1)
Therapy with NIASPAN 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: 1000 to 2000 mg once daily. (2.2)
Doses greater than 2000 mg daily are not recommended. (2.2)
DOSAGE FORMS AND STRENGTHS
Unscored film-coated tablets for oral administration: 500, 750 and
1000 mg niacin extended-release. (3)
CONTRAINDICATIONS
Active liver disease, which may include unexplained persistent
elevations in hepatic transaminase
levels. (4, 5.3)
Active peptic ulcer dise