*The initial dose for patients already receiving niacin extended-release should not exceed 2000/40 mg daily.
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Indications and Important Safety Information
Indications
- SIMCOR (niacin extended-release/simvastatin) is indicated as an adjunct to diet to reduce total-C, LDL-C, Apo B, non-HDL-C, or TG or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson type IIa and IIb) when treatment with simvastatin monotherapy or niacin extended-release monotherapy
is considered inadequate.
- SIMCOR is indicated to reduce TG in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia)
when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.
- Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response
to diet and other nonpharmacological measures alone has been inadequate.
- No incremental benefit of SIMCOR on cardiovascular
morbidity and mortality over and above that demonstrated
for simvastatin monotherapy and niacin monotherapy
has been established.
Important Safety Information
- SIMCOR is contraindicated in patients with active liver
disease or unexplained persistent elevations of serum
transaminases, active peptic ulcer disease, arterial bleeding;
in women who are pregnant or may become pregnant,
nursing mothers, and in patients with hypersensitivity
to any product ingredient.
- SIMCOR contains simvastatin, which occasionally causes myopathy manifested as muscle pain, tenderness,
or weakness with CK levels above 10x ULN. Myopathy sometimes takes the form of rhabdomyolysis with
or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy/rhabdomyolysis is dose-related and is increased by high plasma concentrations of a statin.
- The use of SIMCOR concomitantly with potent CYP3A4 inhibitors: itraconazole, ketoconazole and other antifungal azoles, erythromycin, clarithromycin and telithromycin,
HIV protease inhibitors, nefazodone, and grapefruit juice
in large quantities (>1 quart daily) should be avoided because
of the increased risk of myopathy/rhabdomyolysis.
Concomitant use of SIMCOR with cyclosporine, danazol, gemfibrozil, other fibrates, amiodarone, and verapamil
should also be avoided because of increased risk
of myopathy/rhabdomyolysis.
- Myopathy and/or rhabdomyolysis have been reported when simvastatin is used in combination with lipid-altering doses
(≥ 1 g/day) of niacin. Patients on SIMCOR should be monitored
for muscle pain, tenderness or weakness, particularly during
the initial month of treatment or during upward dose titration. Periodic CK determinations may be considered in such situations. SIMCOR therapy should be discontinued if CK levels above 10x ULN occur or if myopathy is diagnosed or suspected.
- SIMCOR should not be substituted for equivalent doses
of immediate-release niacin. Severe hepatic toxicity
has occurred in patients substituting sustained-release
niacin for immediate-release niacin at equivalent doses.
If switching from immediate-release niacin to SIMCOR,
initiate with the lowest SIMCOR dose (500/20 mg) and titrate
to the desired therapeutic response. Doses greater
than 2000/40 mg are not recommended.
- SIMCOR should be used with caution in patients
who consume substantial quantities of alcohol and/or
who have a past history of liver disease.
- Liver function tests should be performed on all patients before treatment begins and every 12 weeks for the first 6 months, and periodically thereafter (eg, at approximately 6-month
intervals). Should an increase in transaminase levels of more
than 3x ULN persist, or if transaminase elevations are
associated with symptoms of nausea, fever, and/or malaise, withdrawal of SIMCOR therapy is recommended.
- Niacin treatment can increase fasting blood glucose.
Glucose levels should be closely monitored in diabetic
or potentially diabetic patients particularly during the first
few months of use. Adjustment of diet and/or hypoglycemic therapy or discontinuation of SIMCOR may be necessary.
- In patients taking coumarin anticoagulants, monitor prothrombin time and INR before initiating SIMCOR and frequently after initiation or alteration of SIMCOR therapy until stable.
- Caution should be exercised when SIMCOR is administered
to patients with renal disease.
- The most common adverse event with SIMCOR is flushing (warmth, redness, itching and/or tingling) which occurred
in 59% of patients and resulted in study discontinuation
for 6% of patients. Flushing may vary in severity and is more
likely to occur with initiation of therapy or during dose
increases. Spontaneous reports with niacin extended-release
and clinical studies of SIMCOR suggest that flushing may
be accompanied by symptoms of dizziness, syncope,
tachycardia, palpitations, shortness of breath, sweating,
chills and/or edema.
- Other common adverse events occurring in ≥3% of patients treated with SIMCOR included headache, pruritus, nausea, back pain, and diarrhea.
Reference: 1. SIMCOR [package insert]. North Chicago, IL: Abbott Laboratories.
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