Gemfibrozil

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to gemfibrozil.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

You should tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you’re taking, especially:

• Anticoagulants (blood thinners), such as warfarin (Coumadin)
• Cholesterol-lowering medications (statins), such as atorvastatin (Lipitor), simvastatin (Zocor), fluvastatin (Lescol), lovastatin (Mevacor), rosuvastatin (Crestor), and pravastatin (Pravachol)
• Colchicine (Colcrys)
• Colestipol (Colestid)
• Cholestyramine (Questran)
• Repaglinide (Prandin, Prandimet)

Gemfibrozil and Alcohol

Alcohol may interfere with treatment. You should avoid drinking alcohol while taking gemfibrozil.

Gemfibrozil and Other Interactions

Gemfibrozil can cause drowsiness or dizziness. You should use caution when driving, operating machinery, or performing any other task that requires you to be alert until you know how this medication will affect you.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Before taking gemfibrozil, tell your doctor about all of your medical conditions. Escpecially tell your doctor if you:

• are allergic to gemfibrozil or to any of its ingredients
• have kidney disease
• have liver disease
• have gallbladder disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

If you take too much gemfibrozil, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If gemfibrozil is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

Storage

Oral

20–25°C.1 Protect from light and humidity.1

Gemfibrozil is used together with a proper diet to treat high cholesterol and triglyceride (fat) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides in the blood. Gemfibrozil may also be used to prevent certain types of heart problems in patients with risk factors for heart problems.

gemfibrozil is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Do not use gemfibrozil together with dasabuvir, repaglinide, or simvastatin. Using these medicines together may cause serious unwanted effects.

gemfibrozil may increase your risk of having gallstones. Check with your doctor right away if you have severe stomach pain with nausea and vomiting.

Check with your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of a serious muscle problem called myopathy.

Check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Do not stop taking gemfibrozil without first checking with your doctor. When you stop taking gemfibrozil, your blood cholesterol levels may increase again. Your doctor may want you to follow a special diet to help prevent this from happening.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Gemfibrozil, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg Gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline cellulose, NF; methylcellulose, USP and opadry white. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula:

The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.

• Cl-719

• Lopid

Refer to adult dosing.

Acipimox: May enhance the myopathic (rhabdomyolysis) effect of Fibric Acid Derivatives. Monitor therapy

Alitretinoin (Systemic): CYP2C8 Inhibitors (Strong) may increase the serum concentration of Alitretinoin (Systemic). Management: Consider reducing the alitretinoin dose to 10 mg when used together with strong CYP2C8 inhibitors. Monitor for increased alitretinoin effects/toxicities if combined with a strong CYP2C8 inhibitor. Consider therapy modification

Alitretinoin (Systemic): CYP2C9 Inhibitors (Strong) may increase the serum concentration of Alitretinoin (Systemic). Management: Consider reducing the alitretinoin dose to 10 mg when used together with strong CYP2C9 inhibitors. Monitor for increased alitretinoin effects/toxicities if combined with a strong CYP2C9 inhibitor. Consider therapy modification

Amodiaquine: CYP2C8 Inhibitors may increase the serum concentration of Amodiaquine. Avoid combination

Antidiabetic Agents (Thiazolidinedione): Gemfibrozil may decrease the metabolism of Antidiabetic Agents (Thiazolidinedione). Management: Limit pioglitazone maximum adult dose to 15 mg/day, and consider dose reduction of rosiglitazone, when used in combination with gemfibrozil. Consider therapy modification

Asunaprevir: OATP1B1/SLCO1B1 Inhibitors may increase the serum concentration of Asunaprevir. Avoid combination

AtorvaSTATin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of AtorvaSTATin. Gemfibrozil may increase the serum concentration of AtorvaSTATin. Avoid combination

Bexarotene (Systemic): Gemfibrozil may increase the serum concentration of Bexarotene (Systemic). Avoid combination

Bile Acid Sequestrants: May decrease the absorption of Fibric Acid Derivatives. Management: Separate doses by at least 2 hours to minimize this interaction; fenofibric acid labeling recommends administration one hour prior to or 4-6 hours after a bile acid sequestrant. Exceptions: Colesevelam. Consider therapy modification

Bosentan: CYP2C9 Inhibitors (Strong) may increase the serum concentration of Bosentan. Management: Concomitant use of both a CYP2C9 inhibitor and a CYP3A inhibitor or a single agent that inhibits both enzymes with bosentan is likely to cause a large increase in serum concentrations of bosentan and is not recommended. See monograph for details. Monitor therapy

Cannabis: CYP2C9 Inhibitors (Strong) may increase the serum concentration of Cannabis. More specifically, tetrahydrocannabinol serum concentrations may be increased. Monitor therapy

Carvedilol: CYP2C9 Inhibitors (Strong) may increase the serum concentration of Carvedilol. Specifically, concentrations of the S-carvedilol enantiomer may be increased. Monitor therapy

Chenodiol: Fibric Acid Derivatives may diminish the therapeutic effect of Chenodiol. Management: Monitor clinical response to chenodiol closely when used together with any fibric acid derivative. Monitor therapy

Ciprofibrate: May enhance the adverse/toxic effect of Fibric Acid Derivatives. Avoid combination

Colchicine: Fibric Acid Derivatives may enhance the myopathic (rhabdomyolysis) effect of Colchicine. Monitor therapy

CycloSPORINE (Systemic): May enhance the nephrotoxic effect of Fibric Acid Derivatives. Fibric Acid Derivatives may decrease the serum concentration of CycloSPORINE (Systemic). Management: Careful consideration of the risks and benefits should be undertaken prior to use of this combination; extra monitoring of renal function and cyclosporine concentrations will likely be required. Adjustment of cyclosporine dose may be necessary. Consider therapy modification

CYP2C8 Substrates: CYP2C8 Inhibitors (Strong) may decrease the metabolism of CYP2C8 Substrates. Consider therapy modification

CYP2C9 Substrates: CYP2C9 Inhibitors (Strong) may decrease the metabolism of CYP2C9 Substrates. Consider therapy modification

Dabrafenib: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Dabrafenib. Avoid combination

Dasabuvir: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Dasabuvir. Avoid combination

Diclofenac (Systemic): CYP2C9 Inhibitors (Strong) may increase the serum concentration of Diclofenac (Systemic). Management: Consider using a lower dose of diclofenac when used together with a strong CYP2C9 inhibitor. Arthrotec (diclofenac and misoprostol) labeling specifically recommends limiting the total daily dose to a maximum of 50 mg twice/day. Consider therapy modification

Dronabinol: CYP2C9 Inhibitors (Strong) may increase the serum concentration of Dronabinol. Monitor therapy

Eluxadoline: Gemfibrozil may increase the serum concentration of Eluxadoline. Management: Decrease the eluxadoline dose to 75 mg twice daily if combined with gemfibrozil and monitor patients for increased eluxadoline effects/toxicities. Consider therapy modification

Enzalutamide: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Enzalutamide. Management: Avoid concurrent use of strong CYP2C8 inhibitors and enzalutamide if possible. If the combination must be used, reduce enzalutamide to 80 mg once daily. Avoid combination

Ezetimibe: Gemfibrozil may enhance the adverse/toxic effect of Ezetimibe. Specifically, the risk of myopathy and cholelithiasis may be increased. Gemfibrozil may increase the serum concentration of Ezetimibe. Avoid combination

Fluvastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Fluvastatin. Avoid combination

Grazoprevir: OATP1B1/SLCO1B1 Inhibitors may increase the serum concentration of Grazoprevir. Avoid combination

Imatinib: Gemfibrozil may decrease serum concentrations of the active metabolite(s) of Imatinib. Specifically N-desmethylimatinib concentrations may be decreased. Gemfibrozil may decrease the serum concentration of Imatinib. Monitor therapy

Irinotecan Products: UGT1A1 Inhibitors may increase serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, concentrations of SN-38 may be increased. UGT1A1 Inhibitors may increase the serum concentration of Irinotecan Products. Avoid combination

Lacosamide: CYP2C9 Inhibitors (Strong) may increase the serum concentration of Lacosamide. Monitor therapy

Lovastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Lovastatin. Gemfibrozil may increase the serum concentration of Lovastatin. More specifically, gemfibrozil may increase the serum concentrations of lovastatin acid (active form of parent drug). Avoid combination

Montelukast: Gemfibrozil may increase the serum concentration of Montelukast. Monitor therapy

OATP1B1/SLCO1B1 Substrates: Gemfibrozil may increase the serum concentration of OATP1B1/SLCO1B1 Substrates. See separate drug interaction monographs for agents listed as exceptions. Exceptions: AtorvaSTATin; Eluxadoline; Ezetimibe; Fluvastatin; Pitavastatin; Pravastatin; Repaglinide; Rosuvastatin; Simvastatin. Monitor therapy

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir. Specifically, the serum concentrations of dasabuvir may increase significantly. Avoid combination

Ospemifene: CYP2C9 Inhibitors (Strong) may increase the serum concentration of Ospemifene. Monitor therapy

Parecoxib: CYP2C9 Inhibitors (Strong) may increase the serum concentration of Parecoxib. Monitor therapy

Pioglitazone: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Pioglitazone. Management: Limit pioglitazone adult maximum dose to 15 mg/day when used in combination with any strong CYP2C8 inhibitor. Consider therapy modification

Pitavastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Pitavastatin. Gemfibrozil may increase the serum concentration of Pitavastatin. Avoid combination

Pravastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Pravastatin. Gemfibrozil may increase the serum concentration of Pravastatin. Avoid combination

Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of Fibric Acid Derivatives. Monitor therapy

Ramelteon: CYP2C9 Inhibitors (Strong) may increase the serum concentration of Ramelteon. Monitor therapy

Repaglinide: Gemfibrozil may increase the serum concentration of Repaglinide. The addition of itraconazole may augment the effect of gemfibrozil on repaglinide. Avoid combination

Rosuvastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Gemfibrozil may increase the serum concentration of Rosuvastatin. Management: If possible, avoid concomitant use of rosuvastatin with gemfibrozil. If concomitant can not be avoided, limit rosuvastatin to 10 mg/day (US recommendation) or 20 mg/day (Canadian recommendation). Monitor for signs/symptoms of rhabdomyolysis. Avoid combination

Selexipag: CYP2C8 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of Selexipag. CYP2C8 Inhibitors (Strong) may increase the serum concentration of Selexipag. Avoid combination

Simvastatin: Gemfibrozil may enhance the myopathic (rhabdomyolysis) effect of Simvastatin. Gemfibrozil may increase the serum concentration of Simvastatin. Concentrations of the active simvastatin acid metabolite may also be increased by gemfibrozil. Avoid combination

Sulfonylureas: Fibric Acid Derivatives may enhance the hypoglycemic effect of Sulfonylureas. Monitor therapy

Tetrahydrocannabinol: CYP2C9 Inhibitors (Strong) may increase the serum concentration of Tetrahydrocannabinol. Monitor therapy

Treprostinil: CYP2C8 Inhibitors (Strong) may increase the serum concentration of Treprostinil. Management: Reduce the initial treprostinil extended release tablet dose to 0.125 mg twice daily, titrating by 0.125 mg twice daily every 3 to 4 days. No preemptive dose adjustment is recommended for other treprostinil products. Consider therapy modification

Ursodiol: Fibric Acid Derivatives may diminish the therapeutic effect of Ursodiol. Monitor therapy

Vitamin K Antagonists (eg, warfarin): Fibric Acid Derivatives may enhance the anticoagulant effect of Vitamin K Antagonists. Consider therapy modification

Voxilaprevir: OATP1B1/SLCO1B1 Inhibitors may increase the serum concentration of Voxilaprevir. Avoid combination

Concerns related to adverse effects:

• Cholelithiasis: May increase risk of cholelithiasis; discontinue if gallstones are found upon gallbladder studies.

• Elevated transaminases: Elevations in serum transaminases may be seen with use; periodic monitoring recommended.

• Hematologic effects: May cause mild decreases in hemoglobin, hematocrit, and WBC upon initiation which usually stabilizes with long-term therapy. Anemia, leukopenia, thrombocytopenia, and bone marrow hypoplasia have rarely been reported. Periodic monitoring recommended during the first year of therapy.

• Malignancy: Possible increased risk of malignancy.

• Myopathy/rhabdomyolysis: Has been associated with rare myositis or rhabdomyolysis; patients should be monitored closely. Patients should be instructed to report unexplained muscle pain, tenderness, weakness, or brown urine.

Disease-related concerns:

• Renal impairment: Use with caution in patients with mild-to-moderate renal impairment; contraindicated in patients with severe impairment. Deterioration has been seen when used in patients with a serum creatinine >2 mg/dL.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Appropriate use: Secondary causes of hyperlipidemia should be ruled out prior to therapy. Be careful in patient selection, this is not a first- or second-line choice; other agents may be more suitable. Discontinue if lipid response not seen.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Gemfibrozil is usually taken twice daily, 30 minutes before breakfast and dinner.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Gemfibrozil is only part of a treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

While using gemfibrozil, you may need frequent blood tests to check your liver function. Your kidney function may also need to be tested.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Hyperlipidemia:

600 mg orally twice a day, 30 minutes before the morning and evening meal.

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Administration advice:
-Take orally twice a day, 30 minutes before the morning and evening meals
-Administer 2 hours or more apart from bile acid-binding resins.

Storage requirements:
-Store at controlled room temperature; protect from light and humidity.

General:
-Treatment is not indicated for patients with Type I hyperlipoproteinemia who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL), nor is it indicated in patients with low HDL as their only lipid abnormality.
-Due to the potential for toxicity, this drug is not indicated for treatment in patients with Type IIa elevations of LDL when this is the only abnormality.
-Diseases that may contribute to hyperlipidemia (e.g., hypothyroidism, diabetes mellitus) should be adequately treated prior to beginning therapy.

Monitoring:
-Hepatic: Periodically measure liver function tests.
-Hematologic: Measure blood counts periodically during first 12 months of therapy.
-Metabolic: Periodically measure serum lipid levels; treatment should be withdrawn if lipid response is inadequate after 3 months of therapy.

Patient advice:
-Advise patients to report muscle pain, weakness, or tenderness, immediately.
-Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding.

You should not take gemfibrozil if you have severe liver or kidney disease, gallbladder disease, or if you are also taking repaglinide (Prandin), dasabuvir (Viekira Pak), or simvastatin (Zocor, Vytorin, Juvisync, Simcor).

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.