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Niaspan (Niacin Extended-Release) - Indications and Dosage

 
 



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. 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.


  1. NIASPAN is indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).

  2. NIASPAN in combination with simvastatin or lovastatin is indicated for the treatment of primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb) when treatment with NIASPAN, simvastatin, or lovastatin monotherapy is considered inadequate.

  3. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.

  4. 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.

  5. NIASPAN in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia (Type IIa).

  6. Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.

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, or lovastatin monotherapy has been established. NIASPAN has not been studied in Fredrickson Type I and III dyslipidemias.

DOSAGE AND ADMINISTRATION

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 in order to reduce the incidence and severity of side effects which may occur during early therapy. The recommended dose escalation is shown in Table 1 below.

Table 1. Recommended Dosing
Week(s) Daily dose NIASPAN Dosage

* After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate, increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Daily dose should not be increased more than 500 mg in a 4-week period, and doses above 2000 mg daily are not recommended. Women may respond at lower doses than men.

INITIAL
TITRATION
1 to 4 500 mg
1 NIASPAN 500 mg tablet at bedtime
SCHEDULE 5 to 8 1000 mg
1 NIASPAN 1000 mg tablet or
2 NIASPAN 500 mg tablets at bedtime
* 1500 mg
2 NIASPAN 750 mg tablets or
3 NIASPAN 500 mg tablets at bedtime
* 2000 mg
2 NIASPAN 1000 mg tablets or
4 NIASPAN 500 mg tablets at bedtime

Maintenance Dose

The daily dosage of NIASPAN should not be increased by more than 500 mg in any 4–week period. The recommended maintenance dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) to 2000 mg (two 1000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2000 mg daily are not recommended. Women may respond at lower NIASPAN doses than men [see Clinical Studies ].

Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable.

If lipid response to NIASPAN alone is insufficient or if higher doses of NIASPAN are not well tolerated, some patients may benefit from combination therapy with a bile acid binding resin or statin [see Drug Interactions , Concomitant Therapy below and Clinical Studies (14.3, 14.4) ].

Flushing of the skin [see Adverse Reactions ] may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to NIASPAN dose). Tolerance to this flushing develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of niacin and avoiding administration on an empty stomach. Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of NIASPAN ingestion.

Equivalent doses of NIASPAN should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin [see Warnings and Precautions (5) ]. Patients previously receiving other niacin products should be started with the recommended NIASPAN titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response.

If NIASPAN therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1).

NIASPAN tablets should be taken whole and should not be broken, crushed or chewed before swallowing.

Concomitant Therapy

Concomitant Therapy with Lovastatin or Simvastatin

Patients already receiving a stable dose of lovastatin or simvastatin who require further TG-lowering or HDL-raising (e.g., to achieve NCEP non-HDL-C goals), may receive concomitant dosage titration with NIASPAN per NIASPAN recommended initial titration schedule [see Dosage and Administration (2) ]. For patients already receiving a stable dose of NIASPAN who require further LDL-lowering (e.g., to achieve NCEP LDL-C goals), the usual recommended starting dose of lovastatin and simvastatin is 20 mg once a day. Dose adjustments should be made at intervals of 4 weeks or more. Combination therapy with NIASPAN and lovastatin or NIASPAN and simvastatin should not exceed doses of 2000 mg NIASPAN and 40 mg lovastatin or simvastatin daily.

Dosage in Patients with Renal or Hepatic Impairment

Use of NIASPAN in patients with renal or hepatic impairment has not been studied. NIASPAN is contraindicated in patients with significant or unexplained hepatic dysfunction. NIASPAN should be used with caution in patients with renal impairment [see Warnings and Precautions (5) ].

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

HOW SUPPLIED/STORAGE AND HANDLING

NIASPAN tablets are supplied as unscored, medium-orange, film-coated, capsule-shaped tablets containing 500, 750 or 1000 mg of niacin in an extended-release formulation. Tablets are debossed KOS on one side and the tablet strength (500, 750 or 1000) on the other side. Tablets are supplied in bottles of 90 and 100 as shown below.

500 mg tablets: bottles of 90 - NDC# 0074—3074—90

500 mg tablets: bottles of 100 - NDC# 0074—3074—11

750 mg tablets: bottles of 90 - NDC# 0074—3079—90

750 mg tablets: bottles of 100 - NDC# 0074—3079—11

1000 mg tablets: bottles of 90 - NDC# 0074—3080—90

1000 mg tablets: bottles of 100 - NDC# 0074—3080—11


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

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