Trade Names:Simcor- Tablets, extended-release niacin 500 mg/simvastatin 20 mg- Tablets, extended-release niacin 750 mg/simvastatin 20 mg- Tablets, extended-release niacin 1,000 mg/simvastatin 20 mg
Reduce total cholesterol, LDL cholesterol, apolipoprotein B, non-HDL cholesterol, or triglycerides, or increase HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson type IIa and IIb); reduce triglycerides in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia).
Active liver disease; active peptic ulcer disease; arterial bleeding; women who are pregnant or may become pregnant; breast-feeding mothers; hypersensitivity to any component of the product.
PO Patients not currently receiving niacin extended-release and patients currently on niacin products other than extended-release should start with a single niacin 500 mg/simvastatin 20 mg tablet daily at bedtime. The dosage of niacin extended-release should not be increased by more than 500 mg daily every 4 weeks. The recommended maintenance dosage is 1,000/20 mg to 2,000/40 mg once daily depending on tolerability and lipid levels. Doses of more than 2,000/40 mg daily are not recommended.
Store at 68° to 77°F.
May increase the risk of myopathy and rhabdomyolysis. Avoid concurrent use.Antihypertensive therapy (eg, ganglionic blocking agents, vasoactive agents)
Niacin may potentiate the effects of these agents, resulting in postural hypotension.Aspirin
Metabolic Cl of niacin may be decreased.Bile acid sequestrants (eg, cholestyramine, colestipol)
Because niacin may bind to these agents, separate the administration times by as much as possible (at least 4 to 6 h).Bosentan, carbamazepine, efavirenz, rifamycins (eg, rifampin)
Simvastatin metabolism may be increased, resulting in a decrease in simvastatin plasma levels and efficacy.Coumarin anticoagulants (eg, warfarin)
Bleeding and increased PT and INR may occur. Monitor anticoagulant function when starting, stopping, or changing the Simcor dose.Digoxin
Digoxin plasma concentrations may be elevated.Propranolol
Simvastatin plasma levels may be decreased.St. John's wort
May decrease simvastatin levels; avoid coadministration.
Niacin may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines; niacin may give false-positive reactions with cupric sulfate solution (Benedict reagent) in urine glucose tests.
The following adverse reactions were reported with Simcor administration. Adverse reactions occurring with administration of either niacin or simvastatin are listed in their respective monographs.
Flushing; (59%); pruritus (3%).
Diarrhea, nausea (3%).
Abnormal thyroid function tests; elevated alkaline phosphatase, amylase, bilirubin, fasting blood glucose, glutamyl transpeptidase, LDH, serum transaminases, and uric acid; decreased phosphorus and platelet counts; prolonged PT.
Back pain (3%).
Closely monitor patients with renal function impairment. Monitor lipid panel at regular intervals. Monitor LFTs before treatment begins, every 12 wk for the first 6 mo, then periodically thereafter (every 6 mo).
Category X .
Excreted in breast milk.Simvastatin
Safety and efficacy not established.
Use with caution. Do not start treatment in patients with severe renal function impairment unless patient already tolerates treatment with simvastatin 10 mg or higher.
Contraindicated in active liver disease or unexplained transaminase elevations. Use with caution in patients with a history of liver disease.
Use with caution in patients who consume substantial quantities of alcohol.
May increase fasting blood glucose.
Frequency or severity of niacin-induced flushing may be reduced by taking aspirin or other NSAIDs approximately 30 minutes prior to Simcor . Flushing, pruritus, and GI distress may be reduced by gradually increasing the niacin dose and avoiding administration on an empty stomach.
Severe hepatic toxicity, including fulminant hepatic necrosis, has occurred in patients substituting sustained-release niacin for immediate-release niacin in equivalent doses.
Have been reported when simvastatin is used in combination with lipid-lowering doses of niacin.
Insufficient data. Patients have recovered from a simvastatin overdose of 3.6 g without sequelae.
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