Monograph Details
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Cardiovascular System
> Hyperlipoproteinemias
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SIMCOR 500/20 |
| Manufacturer |
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Abbott Laboratories |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Nicotinic acid deriv. + HMG-CoA reductase inhibitor |
| Generic Name |
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Niacin ext-rel 500mg, simvastatin 20mg; tabs. |
| Also |
• SIMCOR 1000/20
• SIMCOR 750/20
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| Indications |
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Adjunct to diet in primary hypercholesterolemia, mixed dyslipidemia, and hypertriglyceridemia if monotherapy is inadequate. |
| Children |
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Not recommended. |
| Adults |
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Take once daily at bedtime with low-fat snack. Swallow whole. Naive to or switching from immediate-release niacin: initially one 500/20 tab. May increase at 4-wk intervals by up to 500mg/day (ext-rel niacin component); maintenance: 1000/20 to 2000/40 once daily. May substitute for previously-titrated ext-rel niacin at equivalent doses. Re-titrate if therapy interrupted ≥7 days. To reduce flushing, pretreat with aspirin or an NSAID. |
| Contraindications |
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Active liver or peptic ulcer disease. Unexplained persistent elevated transaminases. Arterial bleeding. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
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Do not substitute for equivalent doses of immediate-release niacin. Substantial alcohol consumption. History of liver disease. Monitor transaminases (at baseline, every 12wks for 1st 6 mos, then periodically); discontinue if levels ≥3xULN persist or if signs/symptoms of liver disease occur. Discontinue if myopathy is diagnosed or suspected. Suspend therapy before surgery and if major medical event occurs. Renal dysfunction. Gout. Monitor blood glucose, PT, platelets. |
| Interactions |
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Avoid other niacin, potent CYP3A4 inhibitors (eg, azole antifungals, macrolides, HIV PIs, nefazodone, grapefruit juice >1qt/day), gemfibrozil, fenofibrate, cyclosporine, danazol. Potentiated by amiodarone and verapamil (limit simvastatin to 20mg/day). Separate dosing of bile acid sequestrants by 4–6hrs. Postural hypotension with ganglionic blockers, vasoactive drugs. Monitor warfarin, digoxin, antidiabetics. |
| Adverse Reactions |
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Flushing, headache, pruritus, GI upset, back pain; elevated ALT/AST, myopathy, rhabdomyolysis with renal failure. |
| How Supplied |
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Tabs—90 |
| Additional Resources |
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• Related Prescribing Note |
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