Niacin / simvastatin Disease Interactions
There are 9 disease interactions with niacin / simvastatin:
- Liver Disease
- Coronary Artery Disease
- Peptic Ulcer Disease
- Renal Dysfunction
The use of HMG-CoA reductase inhibitors is contraindicated in patients with active liver disease or unexplained, persistent elevations of serum transaminases. HMG-CoA reductase inhibitors are extensively metabolized by the liver. Decreased drug metabolism may lead to accumulation and increased risk of toxicity, including biochemical abnormalities of liver function and, rarely, jaundice, hepatitis, cirrhosis, fatty change in the liver, and fulminant hepatic necrosis. Therapy with HMG-CoA reductase inhibitors should be administered cautiously in patients with a history of liver disease and/or heavy alcohol use. A lower initial dosage may be appropriate, and clinical monitoring of liver transaminase levels according to the individual product package labeling is recommended. Patients who develop elevated ALT or AST levels during therapy should be monitored until abnormalities resolve. If an increase above 3 times the upper limit of normal persists, consideration should be given to a reduction in dosage or withdrawal of therapy.
Severe myopathy, including rhabdomyolysis with acute renal failure secondary to myoglobinuria, has been reported rarely with the use of HMG-CoA reductase inhibitors. The myopathy may be dose-related and is characterized by muscle aches and/or weakness in conjunction with increases in creatine phosphokinase (CPK) values exceeding 10 times the upper limit of normal. Therapy with HMG-CoA reductase inhibitors should be administered cautiously in patients with preexisting myopathy or a myoneural disorder, since it may delay the recognition or confound the diagnosis of a drug-induced musculoskeletal effect. Patients should be advised to report promptly any unusual muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Periodic CPK determinations may be considered in some patients, although the value of such monitoring is uncertain. HMG-CoA reductase inhibitor therapy should be withdrawn if markedly elevated CPK levels occur or if drug-related myopathy is diagnosed or suspected.
The Coronary Drug Project (1975) reported a significant increase in cardiac arrhythmias associated with the use of niacin at lipid-lowering dosages. Treatment using pharmacologic dosages of niacin and niacinamide (nicotinamide) should be administered cautiously in patients with coronary heart disease or arrhythmias. Particular caution is advised in the presence of unstable angina or in the acute phase of myocardial infarction, especially if the patient is also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents.
The use of nicotinic acid and its derivatives at dosages substantially exceeding those for physiologic requirements is contraindicated in patients with active liver disease or unexplained, persistent elevations of serum transaminases. Hepatotoxicity, including biochemical abnormalities of liver function, cholestatic jaundice, increased prothrombin time, and fulminant hepatic necrosis and failure, has been reported during therapy with niacin and niacinamide (nicotinamide), particularly in patients who have substituted sustained-release nicotinic acid products for immediate-release preparations at equivalent dosages. Treatment using pharmacologic dosages (e.g., lipid-lowering dosages) of these agents should be administered cautiously in patients with gallbladder disease or a history of jaundice, liver disease and/or heavy alcohol use. Liver transaminase levels should be evaluated prior to initiation of therapy, every 6 to 12 weeks for the first year, and periodically thereafter (e.g., semiannually). Patients who develop elevated ALT or AST levels during therapy should be monitored until abnormalities resolve. If an increase above 3 times the upper limit of normal persists, therapy should be withdrawn. Liver biopsy should be considered in patients with elevations that persist beyond cessation of therapy.
The use of niacin and niacinamide (nicotinamide) is contraindicated in patients with severe hypotension. These agents have peripheral vasodilating effects and may commonly cause flushing at dosages substantially exceeding those for physiologic requirements (e.g., lipid-lowering dosages).
The use of niacin and niacinamide (nicotinamide) at dosages substantially exceeding those for physiologic requirements is contraindicated in patients with active peptic ulcer disease. These agents have been reported to activate peptic ulcer. Treatment using pharmacologic dosages (e.g., lipid-lowering dosages) should be administered cautiously in patients with a history of peptic ulcer disease.
Although simvastatin itself is not eliminated by the kidney, the plasma concentrations of total HMG-CoA reductase inhibitors after a single dose of simvastatin may be increased in patients with significant renal impairment, presumably due to the accumulation of active metabolites. Increased HMG-CoA reductase inhibitory activity may be associated with a greater risk of adverse effects, including hepatic and musculoskeletal toxicities. Therapy with simvastatin should be administered cautiously at a reduced dosage in patients with severe renal impairment. Close clinical monitoring is recommended.
Elevated fasting blood sugars and decreased glucose tolerance have been reported during niacin and niacinamide (nicotinamide) therapy at dosages substantially exceeding those for physiologic requirements. Patients with diabetes mellitus should be monitored more closely during therapy with these agents, and adjustments made accordingly in their antidiabetic regimen.
Large doses of niacin and niacinamide (nicotinamide) can compete with uric acid for excretion by the kidney. Hyperuricemia and precipitation of gout have been reported during long-term therapy. Treatment using pharmacologic dosages (e.g., lipid-lowering dosages) of these agents should be administered cautiously in patients with or predisposed to gout.
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Drug Interaction Classification
The classifications below are a general guideline only. It is difficult to determine the relevance of a particular drug interaction to any individual given the large number of variables.
|Major||Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.|
|Moderate||Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.|
|Minor||Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.|
Do not stop taking any medications without consulting your healthcare provider.
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