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:

Dispensing Solutions, Inc.

INN (Международно Name):

NIACIN

Композиция:

NIACIN 1000 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. - NIASPAN in combination with simvastatin or lovastatin is indicated for the treatment of primary hyperlipidemia and mixed dyslipidemia when treatment with NIASPAN, simvastatin, or lovastatin monotherapy is considered inadequate. - 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,

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 printed with the Abbott ‘A’ logo and the tablet strength (500, 750 or 1000). Tablets are supplied in bottles of 30 and 90 as shown below. 500 mg tablets: bottles of 30 - NDC# 0074–3074–30 500 mg tablets: bottles of 90 - NDC# 0074–3074–90 750 mg tablets: bottles of 30 - NDC# 0074–3079–30 750 mg tablets: bottles of 90 - NDC# 0074–3079–90 1000 mg tablets: bottles of 30 - NDC# 0074–3080–30 1000 mg tablets: bottles of 90 - NDC# 0074–3080–90 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
DISPENSING SOLUTIONS, 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) TABLET, FILM COATED, EXTENDED
RELEASE 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)
In combination with simvastatin or lovastatin: to treat primary
hyperlipidemia and mixed dyslipidemia when treatment
with NIASPAN, simvastatin, or lovastatin monotherapy is considered
inadequate.(1)
To reduce the risk of recurrent nonfatal myocardial infarction in
patients with a history of myocardial infarction and
hype rlipide mia.(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:
No incremental benefit of NIASPAN coadministered with simvastatin or
lovastatin on cardiovascular morbidity and
mortality over and above that demonstrated for niacin, simvastatin and
lovastatin monotherapy, has been established.
DOSAGE AND ADMINISTRATION
NIASPAN should be taken at bedtime with a low-fat snack. (2)
Dose range: 500 mg to 2000 mg once daily. (2)
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 four week
period. (2)
Maintenance dose: 1000 to 2000 mg once daily. (2)
Doses greater than 2000 mg daily are not recommen