ADVICOR Rx

Indications for ADVICOR:

Adjunct to diet in primary hypercholesterolemia and mixed dyslipidemia in patients treated with lovastatin who need further decreases in TG or increases in HDL-C, or those treated with niacin who need further decreases in LDL-C, and who may benefit from combination therapy.

Adult Dose for ADVICOR:

≥18yrs: not for initial therapy. Patients on stable doses of Niaspan: switch to niacin equivalent of Advicor. Patients not on Niaspan: see literature. Swallow whole at bedtime with low-fat snack. Avoid concomitant alcohol, hot drinks, grapefruit juice; may pre-treat with aspirin or other NSAID ½ hour before dosing (to reduce flushing). May increase by up to 500mg (niacin component) every 4 weeks. Max 2000mg/40mg daily. Concomitant danazol, diltiazem, verapamil: max lovastatin 20mg/day. Concomitant amiodarone: max lovastatin 40mg/day. Severe renal insufficiency (CrCl<30mL/min): caution with dose increases of lovastatin >20mg/day. If discontinued for >7 days, retitrate from lowest dose.

Children's Dose for ADVICOR:

<18yrs: not recommended.

Pharmacological Class:

Nicotinic acid deriv. + HMG-CoA reductase inhibitor.

Contraindications:

Active liver or peptic ulcer disease. Unexplained persistent elevated serum transaminases. Arterial bleeding. Concomitant strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone). Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:

Do not substitute for equivalent doses of immediate-release niacin (hepatotoxicity may occur). Substantial alcohol consumption. History of liver or hepatobiliary disease. Monitor serum transaminase levels (at baseline, every 6–12 weeks for first 6 months, then periodically); discontinue if levels ≥3xULN persist or if signs of liver disease occur. Discontinue if myopathy is diagnosed or suspected (may monitor creatine kinase). Renal dysfunction. Cardiovascular disease (eg, unstable angina, acute MI). Gout. Hypophosphatemia. Suspend before surgery; monitor PT, platelets. Diabetes. Follow-up if endocrine dysfunction occurs.

Interactions:

See Contraindications. Increased risk of myopathy with strong CYP3A4 inhibitors. May be potentiated by voriconazole, ranolazine; consider dose adjustment of lovastatin. Avoid gemfibrozil, alcohol, grapefruit juice (>1 quart daily), cyclosporine. Suspend before giving azole antifungals, macrolides. Caution with other fibrates, colchicine. May potentiate ganglionic blockers, vasoactive drugs. Separate dosing of bile acid sequestrants by 4–6 hours. Monitor warfarin, antidiabetics; and for myopathy with cyclosporine. Concomitant aspirin may decrease clearance of niacin. May produce false elevations in plasma or urinary catecholamines. May cause false (+) with Benedict's tests.

Adverse Reactions:

Flushing, headache, pain, pruritus, dyspepsia, flu syndrome, rash, asthenia, hyperglycemia, myalgia, orthostatic hypotension, elevated ALT/AST, myopathy, rhabdomyolysis with renal dysfunction; rare: immune-mediated necrotizing myopathy.

How Supplied:

Tabs—90