Gemfibrozil

Gemfibrozil is used along with a proper diet to help lower fats (triglycerides) and raise "good" cholesterol (HDL) in the blood. It may also help to lower "bad" cholesterol (LDL). Gemfibrozil belongs to a group of drugs known as "fibrates." It works by decreasing the amount of fat produced by the liver. Lowering triglycerides in people with very high triglyceride blood levels may also decrease the risk of pancreas disease (pancreatitis). However, gemfibrozil might not lower your risk of a heart attack or stroke. Talk to your doctor about the risk and benefits of gemfibrozil.

In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help gemfibrozil work better include exercising, drinking less alcohol, losing weight if overweight, and stopping smoking.

Gemfibrozil is available under the following different brand names: Lopid.

Dosage Forms and Strengths

Tablets

• 600mg

Dosing Consideraations – Should be Given as Follows:

Hypertriglyceridemia, Hypercholesterolemia

• 600 mg orally every 12 hours
• Administration: 30 min before morning and evening meals

Dosing Considerations

Monitor: Serum lipoproteins

May be beneficial for prophylaxis of cardiovascular events in at-risk patients, even if patients have normal levels of cholesterol.

Overdose management

• Adverse drug reactions from overdose may include peripheral neuropathy, diarrhea, increased potassium, myopathy, rhabdomyolysis, acute renal failure, elevated liver function tests (LFT's), eye lens opacities
• Treatment is supportive

Dosing Modifications

Renal impairment

• Mild to moderate: Use caution, if baseline serum creatine in patient is greater than 2mg/dL; deterioration of renal function reported in such patients
• Severe: Contraindicated

Hepatic impairment

• Contraindicated

Pediatric

• Safety and efficacy not established

Common Side effects of Gemfibrozil include:

• Indigestion/heartburn
• Stomach/abdominal pain
• Atrial fibrillation
• Diarrhea
• Fatigue
• Nausea
• Vomiting
• Eczema
• Rash
• Spinning sensation (vertigo)
• Constipation
• Headache
• Stomach upset
• Dizziness
• Drowsiness
• Joint pain
• Loss of interest in sex
• Impotence
• Difficulty having an orgasm
• Numbness or tingly feeling
• Cold symptoms such as stuffy nose, sneezing, sore throat

Less common side effects of gemfibrozil include:

• Muscle pain
• Muscle wasting (rhabdomyolysis) (especially with administration with statin)
• Acute appendicitis
• Gallstones
• Skin swelling
• Low blood potassium (hypokalemia)
• Eosinophilia
• Muscle disease
• Synovitis
• Taste disturbance
• Dry mouth
• Gas (flatulence)
• Rash
• Liver problems

Serious side effects of gemfibrozil include:

• Severe stomach/abdominal pain
• Persistent nausea or vomiting
• Yellowing eyes or skin (jaundice)
• Dark urine

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of gemfibrozil include:

• atorvastatin
• fluvastatin
• ombitasvir/paritaprevir/ritonavir and dasabuvir
• pitavastatin
• pravastatin
• repaglinide
• rosuvastatin
• simvastatin

Serious interactions of gemfibrozil include:

• atorvastatin
• belinostat
• cilostazol
• colchicine
• dabrafenib
• eluxadoline
• fluvastatin
• irinotecan
• irinotecan liposomal
• lovastatin
• pirfenidone
• pitavastatin
• pravastatin
• repaglinide
• rosuvastatin
• selexipag
• warfarin

Gemfibrozil has moderate interactions with at least 31 different drugs.

Mild interactions of gemfibrozil include:

• colestipol
• ezetimibe
• octacosanol

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

• This medication contains gemfibrozil. Do not take Lopid if you are allergic to gemfibrozil or any ingredients contained in this drug.
• Keep out of reach of children
• In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Hypersensitivity
• Severe liver/renal disease
• Primary biliary cirrhosis
• Preexisting gallbladder disease
• Coadministration with repaglinide, simvastatin, or dasabuvir

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Gemfibrozil?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Gemfibrozil?"

Cautions

• If response inadequate after 3 months, discontinue gemfibrozil
• Risk for myopathy/rhabdomyolysis increases with renal impairment
• Risk for myopathy/rhabdomyolysis increases with concurrent HMG-CoA reductase inhibitors use (e
• g, atorvastatin, pravastatin)
• If coadministered with anticoagulants, reduce anticoagulant dose and monitor prothrombin time until stabilized
• Coadministration with bile acid resin binding agents decreases gemfibrozil AUC by 30%
• May increase risk of malignancy
• Rule out secondary causes of hyperlipidemia prior to initiating therapy; discontinue if lipid response not seen
• Use with caution in patients taking warfarin; adjustments in warfarin may be required
• Cases of cholelithiasis reported with gemfibrozil therapy; gemfibrozil may increase cholesterol excretion into bile; if cholelithiasis suspected, perform gallbladder studies; discontinue therapy if gallstones found
• Coadministration with repaglinide shown to increase repaglinide plasma concentrations (8-fold increase); prolongs hypoglycemic effect; may result in severe hypoglycemia
• Gemfibrozil inhibits CYP2C8 enzyme activity; may increase exposure of CYP2C8 substrates; consider dose reduction of CYP2C8 substrates when administered concomitantly
• Gemfibrozil may increase exposure of OATP1B1 drug substrates when administered concomitantly; consider dose reduction of OATP1B1 substrates when administered concomitantly
• Myopathy, including rhabdomyolysis, reported with chronic administration of colchicine at therapeutic doses; use caution, especially in the elderly and patients with renal dysfunction
• Rarely, severe anemia, leukopenia, thrombocytopenia, and bone marrow hypoplasia reported; periodic blood counts are recommended during first 12 months of therapy
• Elevations in serum transaminases seen with use; periodic liver function studies recommended; therapy should be terminated if abnormalities persist
• Worsening renal insufficiency upon addition of therapy in individuals with baseline plasma creatinine greater than 2
• 0 mg/dL reported; in such patients, consider the use of alternative therapy against risks and benefits of a lower dose of metformin

Pregnancy and Lactation

• Use gemfibrozil with caution during pregnancy if benefits outweigh risks
• Animal studies show risk and human studies are not available or neither animal nor human studies were done
• It is not known if gemfibrozil is excreted in breast milk; use caution if breastfeeding