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 below.
Table 1. Recommended Dosing
|1 to 4
||1 NIASPAN 500 mg tablet at bedtime
||5 to 8
||1 NIASPAN 1000 mg tablet or 2 NIASPAN 500 mg tablets at bedtime
||2 NIASPAN 750 mg tablets or 3 NIASPAN 500 mg tablets at bedtime
||2 NIASPAN 1000 mg tablets or 4 NIASPAN 500 mg tablets at bedtime
|* 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.
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, below and.
[see Drug Interactions
Clinical Studies, ]
Flushing of the skin 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.
[see Adverse Reactions ]
Equivalent doses of NIASPAN should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin. Patients previously receiving other niacin products should be started with the recommended NIASPAN titration schedule (see), and the dose should subsequently be individualized based on patient response.
[see Warnings and Precautions ]
If NIASPAN therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see).
NIASPAN tablets should be taken whole and should not be broken, crushed or chewed before swallowing.
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. 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.
[see Dosage and Administration ]
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 ]
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