Applies to the following strength(s): 600 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Hyperlipidemia
600 mg orally twice a day, 30 minutes before the morning and evening meal.
Renal Dose Adjustments
The manufacturer considers gemfibrozil to be contraindicated in patients with severe renal dysfunction.
Liver Dose Adjustments
The manufacturer considers gemfibrozil to be contraindicated in patients with hepatic dysfunction, including primary biliary cirrhosis.
Concurrent administration of gemfibrozil with cerivastatin is contraindicated due to the increased risk of myopathy and rhabdomyolysis. Gemfibrozil is considered contraindicated in patients with a history of gallbladder disease. Gemfibrozil decreases bile acid and increases cholesterol secretion thus increasing the lithogenicity of the bile and promoting gallstone formation. Gemfibrozil is contraindicated for use in patients with clinically significant renal or hepatic dysfunction, including patients with primary biliary cirrhosis or persistent hepatic abnormalities.
Gemfibrozil should be used cautiously, if at all, in patients who are at risk of developing renal failure from rhabdomyolysis (for example, patients with severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine, or electrolyte disorders, and uncontrolled seizures). Additionally, concomitant administration of gemfibrozil and cerivastatin, a hydroxymethylglutaryl Co-enzyme A (HMG-CoA) reductase inhibitor, has resulted in increased reports of rhabdomyolysis prompting the manufacturer of cerivastatin to voluntarily withdraw the drug from the market in August, 2001. Gemfibrozil therapy should be promptly discontinued in patients with elevated creatinine phosphokinase levels or myositis.
Determination of serum transaminase levels should be performed at baseline and periodically during therapy to assess hepatic function. Gemfibrozil should be discontinued if transaminase levels persist. Transaminase elevations are usually reversible after the drug is stopped.
Gemfibrozil is chemically, pharmacologically, and clinically similar to clofibrate and fenofibrate. Adverse effects observed with clofibrate and fenofibrate may also apply to gemfibrozil. In one study, clofibrate-treated patients developed cholelithiasis and cholecystitis requiring surgery. In another study, there was a higher age-adjusted total mortality in the clofibrate-treated cohort during the trial period. The excess mortality was due to a 33% increase in non-cardiovascular causes, including malignancy, pancreatitis, and post-cholecystectomy complications. The higher risk of clofibrate-treated patients for gallbladder disease was confirmed.
In another study where patients were randomized to receive gemfibrozil or placebo, a non-statistically significant increase in the incidence of cancer (excluding basal cell carcinoma) was discovered in the 3.5 years after the trial was completed. In addition, there were 16 cases of basal cell carcinomas in the group originally randomized to gemfibrozil. Since a reduction of mortality from coronary heart disease has not been observed and because liver and interstitial cell testicular tumors were increased in rats for fenofibrate, gemfibrozil should be given only to those patients described in the section. If a significant serum lipid response is not obtained, gemfibrozil therapy should be discontinued.
If cholelithiasis is suspected, gallbladder studies are indicated. Gemfibrozil treatment should be discontinued if gallstones are found. Cases of cholelithiasis have been reported with gemfibrozil therapy.
Laboratory studies should be conducted to ascertain that the lipid levels are consistently abnormal. Before instituting gemfibrozil therapy, every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities.
Periodic determination of serum lipids should be obtained, and the drug withdrawn if lipid response is inadequate after three months of treatment.
Mild hemoglobin, hematocrit and white blood cell decreases have been observed in occasional patients following initiation of gemfibrozil treatment. However, these levels stabilize during long-term use. Rarely, severe anemia, leukopenia, thrombocytopenia, and bone marrow hypoplasia have been observed. Therefore, periodic blood counts are advised during the first 12 months of gemfibrozil administration.
Abnormal liver function tests have been noted occasionally during gemfibrozil administration, including elevations of AST (SGOT), ALT (SGPT), LDH, bilirubin, and alkaline phosphatase. These are usually reversible when gemfibrozil is withdrawn. Therefore, periodic liver function studies are advised and gemfibrozil therapy should be terminated if abnormalities persist.
There have been reports of worsening renal insufficiency upon the addition of gemfibrozil treatment in individuals with baseline plasma creatinine greater than 2 mg/dL. In such patients, the use of alternative treatment should be considered against the risks and benefits of a lower dose of gemfibrozil.
The safety and efficacy in pediatric patients have not been determined.
Gemfibrozil is not removed by hemodialysis.
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