NIASPAN Film coated tablet / Extended-release tablet (2020)

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AbbVie Inc.

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1. Indications and Usage

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. ...

2. Dosage and Administration

2.1 Initial Dosing NIASPAN should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with NIASPAN must be initiated at 500 mg at bedtime ...

3. Dosage Forms and Strengths

500 mg unscored, medium-orange, film-coated, capsule-shaped tablets 750 mg unscored, medium-orange, film-coated, capsule-shaped tablets 1000 mg unscored, medium-orange, film-coated, capsule-shaped tablets ...

4. Contraindications

NIASPAN is contraindicated in the following conditions: Active liver disease or unexplained persistent elevations in hepatic transaminases [see Warnings and Precautions (5.3)] Patients with active ...

5. Warnings and Precautions

NIASPAN preparations should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to NIASPAN, therapy with NIASPAN should ...

6. Adverse Reactions

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...

6.1. Clinical Trials Experience

In the placebo-controlled clinical trials database of 402 patients (age range 21-75 years, 33% women, 89% Caucasians, 7% Blacks, 3% Hispanics, 1% Asians) with a median treatment duration of 16 weeks, 16% ...

6.2. Postmarketing Experience

Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ...

7. Drug Interactions

7.1 Statins Caution should be used when prescribing niacin (≥1 gm/day) with statins as these drugs can increase risk of myopathy/rhabdomyolysis [see Warnings and Precautions (5) and Clinical Pharmacology ...

8. Use in Specific Populations

8.8 Gender Data from the clinical trials suggest that women have a greater hypolipidemic response than men at equivalent doses of NIASPAN.

8.1. Pregnancy

Risk Summary Discontinue NIASPAN when pregnancy is recognized in patients receiving the drug for the treatment of hyperlipidemia. Assess the individual risks and benefits of continuing NIASPAN during pregnancy ...

8.2. Lactation

Risk Summary Niacin is present in human milk and the amount of niacin increases with maternal supplementation. There is no information on the effects of the doses of niacin in NIASPAN on the breastfed ...

8.4. Pediatric Use

Safety and effectiveness of niacin therapy in pediatric patients (≤16 years) have not been established.

8.5. Geriatric Use

Of 979 patients in clinical studies of NIASPAN, 21% of the patients were age 65 and over. No overall differences in safety and effectiveness were observed between these patients and younger patients, and ...

8.6. Renal Impairment

No studies have been performed in this population. NIASPAN should be used with caution in patients with renal impairment [see Warnings and Precautions (5)].

8.7. Hepatic Impairment

No studies have been performed in this population. NIASPAN should be used with caution in patients with a past history of liver disease and/or who consume substantial quantities of alcohol. Active liver ...

10. Overdosage

Supportive measures should be undertaken in the event of an overdose.

11. Description

NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline ...

12.1. Mechanism of Action

The mechanism by which niacin alters lipid profiles has not been well defined. It may involve several actions including partial inhibition of release of free fatty acids from adipose tissue, and increased ...

12.3. Pharmacokinetics

Absorption Due to extensive and saturable first-pass metabolism, niacin concentrations in the general circulation are dose dependent and highly variable. Time to reach the maximum niacin plasma concentrations ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Niacin administered to mice for a lifetime as a 1% solution in drinking water was not carcinogenic. The mice in this study received approximately 6 to 8 times a human dose of 3000 mg/day as determined ...

14. Clinical Studies

14.1 Niacin Clinical Studies Niacins ability to reduce mortality and the risk of definite, nonfatal myocardial infarction (MI) has been assessed in long-term studies. The Coronary Drug Project, completed ...

16.1. How Supplied

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. ...

16.2. Storage and Handling

Store at room temperature 20° to 25°C (68° to 77°F).

17. Patient Counseling Information

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP) recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel. Patients should ...