Niacindosage

Niacin extended-release tablets should be taken at bedtime with a low-fat snack.

Dose range: 500 mg to 2,000 mg once daily. Therapy with niacin extended-release tablets 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.

Maintenance dose: 1,000 mg to 2,000 mg once daily. Doses greater than 2,000 mg daily are not recommended.

2.1 Initial

Dosing Niacin extended-release tablets should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with niacin extended-release tablets 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 Niacin Extended-Release Tablets Dosage INITIAL TITRATION SCHEDULE 1 to 4 500 mg 1 Niacin extended-release 500 mg tablet at bedtime 5 to 8 1,000 mg 1 Niacin extended-release 1,000 mg tablet or 2 Niacin extended-release 500 mg tablets at bedtime * 1,500 mg 2 Niacin extended-release 750 mg tablets or 3 Niacin extended-release 500 mg tablets at bedtime * 2,000 mg 2 Niacin extended-release 1,000 mg tablets or 4 Niacin extended-release 500 mg tablets at bedtime * After Week 8, titrate to patient response and tolerance. If response to 1,000 mg daily is inadequate, increase dose to 1,500 mg daily; may subsequently increase dose to 2,000 mg daily. Daily dose should not be increased more than 500 mg in a 4-week period, and doses above 2,000 mg daily are not recommended. Women may respond at lower doses than men.

2.2 Maintenance

Dose The daily dosage of niacin extended-release tablets should not be increased by more than 500 mg in any 4-week period. The recommended maintenance dose is 1,000 mg (two 500 mg tablets or one 1,000 mg tablet) to 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2,000 mg daily are not recommended. Women may respond at lower niacin extended-release tablet doses than men. Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1,000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable. 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 niacin extended-release tablets 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 niacin extended-release tablets ingestion. Equivalent doses of niacin extended-release tablets 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 niacin extended-release tablets titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response. If niacin extended-release tablets therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1). Niacin extended-release tablets should be taken whole and should not be broken, crushed or chewed before swallowing.

2.3 Dosage in

Patients with Renal or Hepatic Impairment Use of niacin extended-release tablets in patients with renal or hepatic impairment has not been studied. Niacin extended-release tablets are contraindicated in patients with significant or unexplained hepatic dysfunction. Niacin extended-release tablets should be used with caution in patients with renal impairment.