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Dosing and titration

ADVICOR® 1000 mg/40 mg…combined lipid control, dosing ease and convenience

ADVICOR® (niacin extended-release/lovastatin tablets) 1000 mg/40 mg single tablet makes dosing easier and convenient for your patients. One tablet, one prescription, and one co-pay may enhance patient compliance. Moreover, data have shown that ADVICOR 1000 mg/40 mg provides greater improvements compared to the starting dose to help your patients achieve their NCEP ATP III targets.

To achieve optimal results, ADVICOR therapy should be initiated at 500 mg/20 mg, qd at bedtime, and then titrated at 4 weeks to ADVICOR 1000 mg/40 mg.1


Flexibility and convenience in a single tablet…once-a-day, one prescription, one co-pay

For patients requiring lipid improvements beyond 1000 mg/40 mg, titrate to
1500 mg/40 mg, and if necessary, to 2000 mg/40 mg


*ADVICOR should not be increased by more than 500 mg every 4 weeks up to a maximum of 2000 mg/day. The maximum dose of ADVICOR is 2000 mg/40 mg per day.1

ADVICOR is available in four strengths for flexible dosing:

  • 500 mg/20 mg
  • 750 mg/20 mg
  • 1000 mg/20 mg
  • 1000 mg/40 mg

Please see full prescribing information.

Next page: Safety and tolerability

 

ADVICOR® (niacin extended-release/lovastatin tablets) is a fixed-dose combination product and is not indicated for initial therapy. Initial single-agent therapy is indicated as an adjunct to diet for patients who respond inadequately to restrictions in saturated fat and cholesterol and to other nonpharmacologic measures alone.

ADVICOR is indicated for the treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb) in patients treated with (1) lovastatin who require further TG-lowering or HDL-C-raising who may benefit from having niacin added to their regimen, or (2) niacin who require further LDL-C-lowering who may benefit from having lovastatin added to their regimen.

The effect of combined therapy with niacin and lovastatin on cardiovascular morbidity and mortality has not been determined. Epidemiological investigations have established that cardiovascular morbidity and mortality vary directly with the level of TC and LDL-C, and inversely with the level of HDL-C.

IMPORTANT SAFETY INFORMATION

ADVICOR is contraindicated in patients with a hypersensitivity to product components; active liver disease or unexplained persistent elevations in serum transaminases; active peptic ulcer disease; arterial bleeding; nursing or pregnant.

ADVICOR should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to NIASPAN® (niacin extended-release tablets), therapy with NIASPAN should be initiated with low doses (i.e., 500 mg once daily at bedtime) and the NIASPAN dose should then be titrated to the desired therapeutic response. Cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release (modified-release, timed-release) niacin products for immediate-release (crystalline) niacin at equivalent doses.

ADVICOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. Liver function tests should be performed on all patients during therapy with ADVICOR. Serum transaminase levels should be monitored before treatment begins, every 6 to 12 weeks for the first 6 months, and periodically thereafter.

Myopathy and/or rhabdomyolysis have been reported when lovastatin is used in combination with lipid-altering doses (≥1g/day) of niacin. The incidence and severity of myopathy may be increased by concomitant administration of ADVICOR with drugs that can cause myopathy when given alone, such as gemfibrozil and other fibrates. Periodic CK determinations may be considered in such situations, but there is no assurance that such monitoring will prevent myopathy. ADVICOR therapy should be discontinued if myopathy is diagnosed or suspected.

Flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse events in controlled clinical studies occurring in 53% to 83% of patients; 8% of patients discontinued because of flushing. Spontaneous reports with NIASPAN and clinical studies with ADVICOR suggest that flushing may also be accompanied by symptoms of dizziness or syncope, tachycardia, palpitations, shortness of breath, sweating, chills, and/or edema. Other common adverse events (≥5% patients) with ADVICOR included asthenia, flu, headache, infection, pain, diarrhea, nausea, pruritus, and rash.

Diabetic patients may experience a dose-related rise in fasting blood sugar. Diabetic or potentially diabetic patients should be observed closely during treatment with ADVICOR, and adjustment of diet and/or hypoglycemic therapy may be necessary.

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