Gemfibrozil

What is Gemfibrozil?

• Gemfibrozil (Lopid) is a lipid regulating agent which decreases serum triglycerides and very low density lipoprotein (VLDL) cholesterol, and increases high density lipoprotein (HDL) cholesterol.

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Gemfibrozil

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Gemfibrozil Structural Formula V.2

What are the uses of this medicine?

Gemfibrozil (Lopid) is used as adjunctive therapy to diet for:

• Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
• people with a combination of low high-density lipoprotein (HDL; 'good cholesterol') levels and high low-density lipoprotein (LDL; 'bad cholesterol') and triglyceride levels to reduce the risk of heart disease.

How does this medicine work?

• The mechanism of action of gemfibrozil has not been definitely established.
• Gemfibrozil has been shown to inhibit peripheral lipolysis and to decrease the hepatic extraction of free fatty acids, thus reducing hepatic triglyceride production.
• Gemfibrozil inhibits synthesis and increases clearance of VLDL carrier apolipoprotein B, leading to a decrease in VLDL production.
• Animal studies suggest that gemfibrozil may, in addition to elevating HDL-cholesterol, reduce incorporation of long-chain fatty acids into newly formed triglycerides, accelerate turnover and removal of cholesterol from the liver, and increase excretion of cholesterol in the feces.
• Gemfibrozil is well absorbed from the gastrointestinal tract after oral administration.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• cerivastatin due to the increased risk of myopathy and rhabdomyolysis
• Hepatic or severe renal dysfunction, including primary biliary cirrhosis.
• Preexisting gallbladder disease
• Hypersensitivity to gemfibrozil

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• atorvastatin (Lipitor, in Caduet), bosentan (Tracleer), colchicine (Colcrys, Mitigare, in Col-Probenecid), dabrafenib (Tafinlar), enzalutamide (Xtandi), ezetimibe (Zetia, in Vytorin), fluvastatin (Lescol), glyburide (Diabeta, Glynase, in Glucovance), irinotecan (Camptosar, Onivyde), loperamide (Imodium), lovastatin (Altoprev), montelukast (Singulair), olmesartan (Benicar, in Azor, Tribenzor), paclitaxel (Abraxane, Taxol), pioglitazone (Actos, in Actoplus Met, Duetact, Oseni), pitavastatin (Livalo), pravastatin (Pravachol), rifampin (Rifadin, Rimactane, in Rifamate, Rifater), rosiglitazone (Avandia), rosuvastatin (Crestor), valsartan (Diovan, in Entresto, Exforge), warfarin (Coumadin, Jantoven), dasabuvir (in Viekira Pak), simvastatin (Zocor, in Vytorin), or repaglinide (Prandin, in Prandimet)

• If you are taking colestipol (Colestid), take this medication 2 hours before or 2 hours after gemfibrozil.

Is this medicine FDA approved?

• Gemfibrozil was patented in 1968 and came into medical use in 1982.
• It is available as a generic medication.
• In 2020, it was the 189th most commonly prescribed medication in the United States, with more than 2 million prescriptions.

How should this medicine be used?

Recommended dosage:

• The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal.

Administration:

• Gemfibrozil comes as a tablet to take by mouth.
• It is usually taken twice a day, 30 minutes before the morning and evening meals.
• Take gemfibrozil at around the same times every day.
• Gemfibrozil controls high triglycerides and low HDL, but does not cure them.
• Continue to take gemfibrozil even if you feel well.
• Do not stop taking gemfibrozil without talking to your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As tablet for oral administration contains 600 mg of gemfibrozil.

This medicine is available in fallowing brand namesː

• Lopid

What side effects can this medication cause?

The most common side effects of this medicine include:

• Dyspepsia
• Abdominal pain
• Acute appendicitis
• Atrial fibrillation
• Diarrhea
• Fatigue
• Nausea/Vomiting
• Eczema
• Rash
• Vertigo
• Constipation
• Headache
• hypesthesia
• paresthesias
• taste perversion
• cataracts
• peripheral vascular disease
• intracerebral hemorrhage
• viral and bacterial infections (common cold, cough, urinary tract infections)

Less common side effects may include:

• cholestatic jaundice
• dizziness
• somnolence
• paresthesia
• peripheral neuritis
• decreased libido
• depression
• headache
• blurred vision
• impotence
• myopathy
• myasthenia
• myalgia
• painful extremities
• arthralgia
• synovitis
• rhabdomyolysis

What special precautions should I follow?

• Caution should be exercised when anticoagulants are given in conjunction with gemfibrozil. The dosage of the anticoagulant 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.
• 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.
• Periodic determination of serum lipids should be obtained, and the drug withdrawn if lipid response is inadequate after three months of therapy.
• It is not known whether this drug is excreted in human milk.
• Mild hemoglobin, hematocrit and white blood cell decreases have been observed in occasional patients following initiation of gemfibrozil therapy. Rarely, severe anemia, leukopenia, thrombocytopenia, and bone marrow hypoplasia have been reported. Therefore, periodic blood counts are recommended during the first 12 months of gemfibrozil administration.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• abdominal cramps, abnormal liver function tests, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Symptomatic supportive measures should be taken, if an overdose occur.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies in pregnant women.
• Gemfibrozil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and efficacy in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• Gemfibrozil

Inactive Ingredients:

• calcium stearate
• colloidal silicon dioxide
• croscarmellose sodium
• FD & C red #40 aluminum lake
• FD & C red #6 aluminum lake
• hydroxypropyl cellulose
• microcrystalline cellulose
• polyethylene glycol
• polysorbate 80
• pregelatinized starch
• titanium dioxide

Who manufactures and distributes this medicine?

Manufactured for:

• Watson Laboratories, Inc.
• Corona, CA USA

Manufactured by:

• Patheon Pharmaceuticals Inc.
• Cincinnati, OH USA

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 20°-25°C (68°-77°F).
• Dispense in a tight container as defined in USP/NF.

Lipid lowering medications

• Bile Acid Resins/Sequestrants

• • Cholestyramine
  • Colesevelam
  • Colestipol

• Fibrates
  • Clofibrate
  • Fenofibrate
  • Gemfibrozil

• Monoclonal Antibodies - Anti-PCSK9
  • Alirocumab
  • Evolocumab

• Niacin (Nicotinic Acid)

• • Omega-3 Fatty Acids,
  • Icosapent Ethyl
  • Omega-3 Acid Ethyl Esters
  • Omega-3 Carboxylic Acids

• Statins
  • Atorvastatin
  • Fluvastatin
  • Lovastatin
  • Pitavastatin
  • Pravastatin
  • Rosuvastatin
  • Simvastatin

• Miscellaneous
  • Ezetimibe
  • Lomitapide
  • Mipomersen

• Dailymed label info on Gemfibrozil
• FDA Gemfibrozil

Gemfibrozil Resources
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