Many people using this medication do not have serious side effects. This medication may rarely cause gallstones and liver problems.
This drug may rarely cause muscle problems which can rarely lead to a very serious condition called rhabdomyolysis. Tell your doctor right away if you develop any of these symptoms: A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction , including: This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US - Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at List Gemfibrozil side effects by likelihood and severity.
Precautions Before taking gemfibrozil , tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" such as fenofibrate ; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems.
Talk to your pharmacist for more details. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.
Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient.
Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. During the five year primary prevention component of the Helsinki Heart Study, mortality from any cause was 44 2. Noncoronary heart disease related mortality showed an excess in the group originally randomized to LOPID at the 8. The incidence of cancer excluding basal cell carcinoma discovered during the trial and in the 3.
There were 30 1. A comparative carcinogenicity study was also done in rats comparing three drugs in this class: Pancreatic acinar adenomas were increased in males and females on fenofibrate; hepatocellular carcinoma and pancreatic acinar adenomas were increased in males and hepatic neoplastic nodules in females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with gemfibrozil while testicular interstitial cell Leydig cell tumors were increased in males on all three drugs.
A gallstone prevalence substudy of Helsinki Heart Study participants showed a trend toward a greater prevalence of gallstones during the study within the LOPID treatment group 7. This result did not differ statistically from the increased incidence of cholecystectomy observed in the WHO study in the group treated with clofibrate.
Both clofibrate and gemfibrozil may increase cholesterol excretion into the bile , leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. LOPID therapy should be discontinued if gallstones are found. Cases of cholelithiasis have been reported with gemfibrozil therapy. Because of the more limited size of the Helsinki Heart Study, the observed difference in mortality from any cause between the Gemfibrozil and placebo groups at Year-5 or at year Noncoronary heart disease related mortality showed an excess in the group originally randomized to Gemfibrozil at the 8.
The incidence of cancer excluding basal cell carcinoma discovered during the trial and in the 3. There were 30 1. A comparative carcinogenicity study was also done in rats comparing three drugs in this class: Pancreatic acinar adenomas were increased in males and females on fenofibrate; hepatocellular carcinoma and pancreatic acinar adenomas were increased in males and hepatic neoplastic nodules in females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with Gemfibrozil while testicular interstitial cell Leydig cell tumors were increased in males on all three drugs.
A gallstone prevalence substudy of Helsinki Heart Study participants showed a trend toward a greater prevalence of gallstones during the study within the Gemfibrozil treatment group 7.
This result did not differ statistically from the increased incidence of cholecystectomy observed in the WHO study in the group treated with clofibrate.
Both clofibrate and Gemfibrozil may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Gemfibrozil therapy should be discontinued if gallstones are found. Cases of cholelithiasis have been reported with Gemfibrozil therapy. If a significant serum lipid response is not obtained, Gemfibrozil should be discontinued. Concomitant Anticoagulants-Caution should be exercised when warfarin is given in conjunction with Gemfibrozil.
The dosage of the warfarin should be reduced to maintain the prothrombin time at the desired level to prevent bleeding complications. Frequent prothrombin determinations are advisable until it has been definitely determined that the prothrombin level has stabilized. Concomitant therapy with Gemfibrozil and an HMG-CoA reductase inhibitor is associated with an increased risk of skeletal muscle toxicity manifested as rhabdomyolysis, markedly elevated creatine kinase CPK levels, and myoglobinuria, leading in a high proportion of cases to acute renal failure and death.
The use of fibrates alone, including Gemfibrozil, may occasionally be associated with myositis. Patients receiving Gemfibrozil and complaining of muscle pain, tenderness, or weakness should have prompt medical evaluation for myositis, including serum creatine-kinase level determination.
If myositis is suspected or diagnosed, Gemfibrozil therapy should be withdrawn. Initial Therapy-Laboratory studies should be done 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.
Continued Therapy-Periodic determination of serum lipids should be obtained, and the drug withdrawn if lipid response is inadequate after three months of therapy. The risk of myopathy and rhabdomyolysis is increased with combined Gemfibrozil and HMG-CoA reductase inhibitor therapy. Myopathy or rhabdomyolysis with or without acute renal failure have been reported as early as three weeks after initiation of combined therapy or after several months see WARNINGS.
There is no assurance that periodic monitoring of creatine kinase will prevent the occurrence of severe myopathy and kidney damage. In healthy volunteers, co-administration with Gemfibrozil mg twice daily for 3 days resulted in an 8.
In healthy volunteers given a single mg dose of enzalutamide after Gemfibrozil mg twice daily, the AUC of enzalutamide plus active metabolite N-desmethyl enzalutamide was increased by 2.
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