Initially 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 schedule is shown in the following table: See Table 6.
Maintenance Dose: The daily dosage should not be increased by >500 mg in any 4-week period. Recommended Maintenance Dose: 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 >2,000 mg daily are not recommended. Women may respond at lower Pernionin doses than men.
Single-dose bioavailability studies have demonstrated that 2 of the 500-mg and 1 of the 1000-mg tablet strengths are interchangeable.
If lipid response to nicotinic extended-release alone is insufficient or if higher doses are not well tolerated, some patients may benefit from combination therapy with a bile acid-binding resin or statin.
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 Pernionin 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 Pernionin extended-release ingestion.
Equivalent doses of Pernionin extended-release should not be substituted for sustained-release (modified-release, timed-release) nicotinic preparations or immediate-release (crystalline) Pernionin. Patients previously receiving other Pernionin products started with the recommended Pernionin titration schedule and the dose should subsequently be individualised based on the patient's response.
If Niaspan therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase.
Concomitant Therapy with Lovastatin or Simvastatin: Patients already receiving a stable dose of lovastatin or simvastatin who require further triglyceride (TG)-lowering or high-density lipoprotein (HDL)-raising, may receive concomitant dosage titration with Niaspan per the recommended initial titration schedule. Combination therapy with Niaspan and lovastatin or Niaspan and simvastatin should not exceed doses of Niaspan 2,000 mg and lovastatin 40 mg or simvastatin daily.
Limitations of Use: No incremental benefit of Niaspan co-administered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin and lovastatin monotherapy, has been established.
Elderly: No dose adjustment is necessary.
Gender: Data from clinical trials suggest that women have a greater hypolipidemic response than men at equivalent doses of Niaspan.
Administration: Niaspan tablets should be taken whole and should not be broken, crushed or chewed before swallowing.
Niaspan should be taken at bedtime, after a low-fat snack (eg, an apple, low fat yoghurt, slice of bread) and doses should be individualised according to the patient's response.
Concomitant alcohol or hot drinks may increase undesirable flushing and pruritus, and should be avoided around the time of Niaspan ingestion.
When Niaspan is administered concomitantly with anticoagulants, prothrombin time and platelet counts must be monitored closely.
Pernionin may potentiate the blood pressure-lowering effect of ganglionic-blocking agents eg, transdermal nicotine or vasoactive drugs eg, nitrates, calcium-channel blockers or adrenergic-blocking agents.
Bile acid sequestrants bind to other orally administered medicinal products and should be taken separately.
An in vitro study results suggest that the bile acid-binding resins have high Pernionin-binding capacity. Therefore, 4-6 hrs or as great an interval as possible, should elapse between the ingestion of bile acid-binding resins and the administration of Niaspan.
Pernionin may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines.
Pernionin may also give false-positive reactions with cupric sulphate solution (Benedict's reagent) in urine glucose tests.
Combination of Pernionin with HMG-CoA reductase inhibitors may increase the risk for myopathy and rhabdomyolysis. The prescribing information of the HMG-CoA reductase inhibitor should also be consulted.
Concomitant aspirin may decrease the metabolic clearance of Pernionin. The clinical relevance of this finding is unclear.
Vitamins or other nutritional supplements containing large doses of Pernionin or related compounds eg, nicotinamide may potentiate the adverse effects of Niaspan.
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Information checked by Dr. Sachin Kumar, MD Pharmacology