Gemfibrozil is an active pharmaceutical ingredient in the Fibrates group (C10AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
USOfficial regulatory label· revised June 18, 2021[1]
INDICATIONS AND USAGE
Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: 1. 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.
Patients who present such risk typically have serum triglycerides over 2,000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dL are unlikely to present a risk of pancreatitis.
Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1,000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied.
GBUnited Kingdom· MHRA
3 products
Uses
GBOfficial regulatory label· revised January 16, 2026[2]
g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol. - Mixed hyperlipidaemia when a statin is contraindicated or not tolerated. - Primary hypercholesterolaemia when a statin is contraindicated or not tolerated.
1).
How to take
CACanada· Health Canada
1 product
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
e. pancreatitis) from their hyperlipidemia. • Treatment of patients with hypercholesterolemia, Type IIa and IIb mixed dyslipidemias, to regulate lipid levels (reduce serum triglycerides and LDL cholesterol levels and increase HDL cholesterol).
TEVA-GEMFIBROZIL alone may not be adequate therapy in some patients with familial combined hyperlipidemia with Type IIb and IV hyperlipoproteinemia. Initial therapy for hyperlipidemia should include a specific diet, weight reduction, and an exercise program and for patients with diabetes mellitus, a good diabetic control.
Gemfibrozil is not indicated for the treatment of Type I hyperlipoproteinemia. 1 Pediatrics Pediatrics (0 to >18 years): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics No data is available.
Drug interactions
Known interactions involving Gemfibrozil. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 273. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]FDA DailyMed · 05bfbcdc-03ab-4f… · revised June 18, 2021 [PDF]
[2]MHRA (UK) · PL000570534 · revised January 16, 2026
[3]Health Canada (DPD) · 02142074 · revised March 22, 2025
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Drug therapy 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). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia.
2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS , PRECAUTIONS , and CLINICAL PHARMACOLOGY ).
The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil.
In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS.
GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. 4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I).
The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy.
Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated.
Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia.
The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
How to take
USOfficial regulatory label· revised June 18, 2021[1]
DOSAGE AND ADMINISTRATION
The recommended dose for adults is 1,200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ).
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 240 reports total. [4]
Drug Ineffective 23
Fatigue 17
Off Label Use 17
Diarrhoea 16
Nausea 16
Headache 12
Product Dose Omission Issue 10
Dizziness 9
Dyspnoea 8
Vomiting 8
Blood Pressure Increased 7
Sinusitis 7
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised June 18, 2021[1]
ADVERSE REACTIONS
In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2,046 patients received gemfibrozil for up to five years. 5% of placebo subjects in the primary prevention component, a 64% excess, which is not statistically different from the excess of gallbladder surgery observed in the clofibrate group compared to the placebo group of the WHO study.
07) in the secondary prevention component. 014). Nervous system and special senses adverse reactions were more common in the gemfibrozil group. These included hypesthesia, paresthesias, and taste perversion. Other adverse reactions that were more common among gemfibrozil treatment group subjects but where a causal relationship was not established include cataracts, peripheral vascular disease, and intracerebral hemorrhage.
From other studies it seems probable that gemfibrozil is causally related to the occurrence of MUSCULOSKELETAL SYMPTOMS (see WARNINGS ), and to ABNORMAL LIVER FUNCTION TESTS and HEMATOLOGIC CHANGES (see PRECAUTIONS ). Reports of viral and bacterial infections (common cold, cough, urinary tract infections) were more common in gemfibrozil treated patients in other controlled clinical trials of 805 patients.
Additional adverse reactions that have been reported for gemfibrozil are listed below by system. These are categorized according to whether a causal relationship to treatment with gemfibrozil is probable or not established: CAUSAL RELATIONSHIP PROBABLE CAUSAL RELATIONSHIP NOT ESTABLISHED General: weight loss Cardiac: extrasystoles Gastrointestinal: cholestatic jaundice pancreatitis hepatoma colitis Central Nervous System: dizziness somnolence paresthesiaperipheral neuritisdecreased libidodepression headache confusion convulsions syncope Eye: blurred vision retinal edema Genitourinary: impotence decreased male fertility renal dysfunction Musculoskeletal: myopathy myasthenia myalgia painful extremities arthralgia synovitis rhabdomyolysis (see WARNINGS and Drug Interactions under PRECAUTIONS ) Clinical Laboratory: increased creatine phosphokinase increased bilirubin increased liver transaminases (AST, ALT) increased alkaline phosphatase positive antinuclear antibody Hematopoietic: anemia leukopenia bone marrow hypoplasia eosinophilia thrombocytopenia Immunologic: angicedema laryngeal edema urticaria anaphylaxis Lupus-like syndrome vasculitis Integumentary: exfoliative dermatitis rash dermatitis pruritus alopecia photosensitivity Additional adverse reactions that have been reported include cholecystitis and cholelithiasis ( see WARNINGS ).
USOfficial regulatory label· Warnings and precautions· revised June 18, 2021[1]
WARNINGS 1. Because of chemical, pharmacological, and clinical similarities between gemfibrozil and clofibrate, the adverse findings with clofibrate in two large clinical studies may also apply to gemfibrozil. In the first of those studies, the Coronary Drug Project, 1,000 subjects with previous myocardial infarction were treated for five years with clofibrate.
There was no difference in mortality between the clofibrate-treated subjects and 3,000 placebo-treated subjects, but twice as many clofibrate-treated subjects developed cholelithiasis and cholecystitis requiring surgery. In the other study, conducted by the World Health Organization (WHO), 5,000 subjects without known coronary heart disease were treated with clofibrate for five years and followed one year beyond.
There was a statistically significant (44%) higher age-adjusted total mortality in the clofibrate-treated group than in a comparable placebo-treated control group during the trial period. The excess mortality was due to a 33% increase in non-cardiovascular causes, including malignancy, post-cholecystectomy complications, and pancreatitis.
The higher risk of clofibrate-treated subjects for gallbladder disease was confirmed. 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 is not statistically significantly different from the 29% excess mortality reported in the clofibrate group in the separate WHO study at the nine year follow-up (see CLINICAL PHARMACOLOGY ).
Noncoronary heart disease related mortality showed an excess in the group originally randomized to gemfibrozil primarily due to cancer deaths observed during the open-label extension. 1%) in the group originally randomized to placebo (hazard ratio 1:20 in favor of placebo).
5 is not statistically significantly different from the 29% excess mortality reported in the clofibrate group in the separate WHO study at the nine year follow-up. 5 year follow-up (65 gemfibrozil versus 45 placebo noncoronary deaths).
5%) in both originally randomized groups. 22). 11). Adverse outcomes, including coronary events, were higher in gemfibrozil patients in a corresponding study in men with a history of known or suspected coronary heart disease in the secondary prevention component of the Helsinki Heart Study (see CLINICAL PHARMACOLOGY ).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised June 18, 2021[1]
CONTRAINDICATIONS
Hepatic or severe renal dysfunction, including primary biliary cirrhosis. Preexisting gallbladder disease (see WARNINGS ). Hypersensitivity to gemfibrozil. Combination therapy of gemfibrozil with simvastatin (see WARNINGS and PRECAUTIONS ).
Combination therapy of gemfibrozil with repaglinide (see PRECAUTIONS ). Combination therapy of gemfibrozil with dasabuvir (see PRECAUTIONS ). Combination therapy of gemfibrozil with selexipag (see PRECAUTIONS ).
This is not medical advice. Consult a qualified healthcare professional.
Prior to initiating gemfibrozil, other medical problems such as hypothyroidism and diabetes mellitus must be controlled as best as possible and patients should be placed on a standard lipid-lowering diet, which should be continued during treatment.
Lopid should be taken orally. Posology Adult The dose range is 900 mg to 1200 mg daily. The only dose with documented effect on morbidity is 1200 mg daily. See Method of administration. Elderly (over 65 years old) As for adults Children and adolescents Gemfibrozil therapy has not been investigated in children.
Due to the lack of data the use of Lopid in children is not recommended. 73 m2, respectively), start treatment at 900 mg daily and assess renal function before increasing dose. 3). 3). Method of administration The 1200 mg dose is taken as 600 mg twice daily, half an hour before breakfast and half an hour before the evening meal.
The 900 mg dose is taken as a single dose half an hour before the evening meal.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised January 16, 2026[2]
Most commonly reported adverse reactions are of gastrointestinal character and are seen in approximately 7% of the patients. These adverse reactions do not usually lead to discontinuation of the treatment. Adverse reactions are ranked according to frequency using the following convention: Very common (>1/10), Common (>1/100 to <1/10), Uncommon (>1/1,000 to <1/100), Rare (>1/10,000 to <1/1,000), Very rare (<1/10,000), including isolated reports: System Organ Class Undesirable effect Blood and lymphatic system disorders Rare Bone marrow failure, severe anaemia, thrombocytopenia, leukopenia, eosinophilia Psychiatric disorders Rare Depression, decreased libido Nervous system disorders Common Vertigo, headache Rare Neuropathy peripheral, paraesthesia, dizziness, somnolence Eye disorders Rare Vision blurred Cardiac disorders Uncommon Atrial fibrillation Respiratory, thoracic and mediastinal disorders Rare Laryngeal oedema Gastrointestinal disorders Very common Dyspepsia Common Diarrhoea, vomiting, nausea, abdominal pain constipation, flatulence Rare Pancreatitis, appendicitis Hepatobiliary disorders Rare Jaundice cholestatic, hepatitis, cholelithiasis, cholecystitis, hepatic function abnormal Skin and subcutaneous tissue disorders Common Eczema, rash Rare Angioedema, dermatitis exfoliative, urticaria, dermatitis, alopecia, photosensitivity reaction, pruritus Musculoskeletal and connective tissue disorders Rare Rhabdomyolysis, myopathy, myositis, muscular weakness, synovitis, myalgia, arthralgia, pain in extremity Reproductive system and breast disorder Rare Erectile dysfunction General disorders and administration site conditions Common Fatigue Investigations Rare Haemoglobin decreased, haematocrit decreased, white blood cell count decreased, blood creatine phosphokinase increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
GBOfficial regulatory label· Warnings and precautions· revised January 16, 2026[2]
4. Special warnings and special precautions for use Muscle disorders (myopathy/rhabdomyolysis) There have been reports of myositis, myopathy and markedly elevated creatine phosphokinase associated with gemfibrozil. Rhabdomyolysis has also been reported rarely.
Muscle damage must be considered in any patient presenting with diffuse myalgia, muscle tenderness and/or marked increase in muscle CPK levels (>5x ULN); under these conditions treatment must be discontinued. Concomitant HMG CoA reductase inhibitors The concomitant administration of gemfibrozil with simvastatin, as well as with rosuvastatin at 40 mg is contraindicated.
Concomitant therapy of gemfibrozil with lower doses of rosuvastatin should be used only when the benefit outweighs the risks. 5). 5) and dosage adjustments may be necessary. The benefit of further alterations in lipid levels by the combined use of gemfibrozil and HMG-CoA reductase inhibitors should be carefully weighed against the potential risks of such combinations and clinical monitoring is recommended.
A creatine phosphokinase (CPK) level should be measured before starting such a combination in patients with pre-disposing factors for rhabdomyolysis as follows: • renal impairment • hypothyroidism • alcohol abuse • age > 70 years • personal or family history of hereditary muscular disorders • previous history of muscular toxicity with another fibrate or HMG-CoA reductase inhibitor In most subjects who have had an unsatisfactory lipid response to either drug alone, the possible benefits of combined therapy with HMG-CoA reductase inhibitors and gemfibrozil does not outweigh the risks of severe myopathy, rhabdomyolysis and acute renal failure.
Use in patients with gallstone formation Gemfibrozil may increase cholesterol excretion into the bile raising the potential for gallstone formation. Cases of cholelithiasis have been reported with gemfibrozil therapy. If cholelithiasis is suspected, gallbladder studies are indicated.
Gemfibrozil therapy should be discontinued if gallstones are found. Monitoring serum lipids Periodic determinations of serum lipids are necessary during treatment with gemfibrozil. Sometimes a paradoxical increase of (total and LDL) cholesterol can occur in patients with hypertriglyceridaemia.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised January 16, 2026[2]
1. 5) • Patients with previous history of photoallergy or phototoxic reaction during treatment with fibrates
This is not medical advice. Consult a qualified healthcare professional.
How to take
CAOfficial regulatory label· revised March 22, 2025[3]
1 Dosing Considerations • Initial Therapy: Before instituting gemfibrozil therapy, attempts should be made to control serum lipids and lipoproteins with appropriate diet, exercise, weight loss in obese patients, and control of diabetes mellitus.
• Long-term Therapy: Because long-term administration of gemfibrozil is recommended, pre- treatment clinical chemistry studies should be performed to ensure that the patient has elevated serum lipid or low HDL cholesterol levels. Periodic determinations of serum lipids should be done during gemfibrozil administration, including measurement of LDL- cholesterol/HDL-cholesterol ratio, particularly in Type IV hyperlipoproteinemic patients.
• Since a reduction of total mortality has not been demonstrated, gemfibrozil should be administered only in those patients described in the Indications section. 2 Recommended Dose and Dosage Adjustment The recommended dose for adults is 1200 mg administered in two divided doses (one 600 mg tablet twice a day).
The maximum recommended daily dose is 1500 mg. 4 Administration TEVA-GEMFIBROZIL should be administered as a 600 mg tablet twice a day, morning and evening, 30 minutes before the meals. 5 Missed Dose If patient misses a dose, it should be taken immediately unless the time is close to the next dose.
In such an event, patient should wait for next scheduled dose and continue on the regular schedule. A double dose should not be taken to make up for a missed dose.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[3]
1 Adverse Reaction Overview Gemfibrozil has been carefully evaluated in over 3000 patients having received the drug in monitored clinical studies prior to marketing. The principal symptoms for which incidence was greater with gemfibrozil than with placebo involved the gastrointestinal system.
Nausea and vomiting, and abdominal and epigastric pain occurred more often in the gemfibrozil group than in the placebo group. 7%. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Symptoms reporting during the controlled phase in studies of 805 subjects were considered for safety.
The symptoms listed in Table 2 are those which occurred in at least 5 patients and all skin reactions whatever their incidence. 3% Additional adverse reactions that have been reported, where a causal relationship to treatment with gemfibrozil is probable are: Gastrointestinal: Cholestatic jaundice, pancreatitis Central nervous system: Dizziness, somnolence, peripheral neuritis, depression, decreased libido, Genitourinary: Impotence TEVA-GEMFIBROZIL (Gemfibrozil) Page 11 of 32 Musculoskeletal: Arthralgia, synovitis, myalgia, myopathy, myasthenia, rhabdomyolysis, (See 7 WARNINGS AND PRECAUTIONS;
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[3]
). • Pregnant or breast-feeding patients. TEVA-GEMFIBROZIL (Gemfibrozil) Page 5 of 32 • Concomitant use with the repaglinide (see 9 DRUG INTERACTIONS, Drug-Drug Interactions). • Concomitant use with simvastatin because of a possible risk of rhabdomyolysis (see 7 WARNINGS AND PRECAUTIONS; 9 DRUG INTERACTIONS, Drug-Drug Interactions).
1 Dosing Considerations • Initial Therapy: Before instituting gemfibrozil therapy, attempts should be made to control serum lipids and lipoproteins with appropriate diet, exercise, weight loss in obese patients, and control of diabetes mellitus.
• Long-term Therapy: Because long-term administration of gemfibrozil is recommended, pre- treatment clinical chemistry studies should be performed to ensure that the patient has elevated serum lipid or low HDL cholesterol levels. Periodic determinations of serum lipids should be done during gemfibrozil administration, including measurement of LDL- cholesterol/HDL-cholesterol ratio, particularly in Type IV hyperlipoproteinemic patients.
• Since a reduction of total mortality has not been demonstrated, gemfibrozil should be administered only in those patients described in the Indications section. 2 Recommended Dose and Dosage Adjustment The recommended dose for adults is 1200 mg administered in two divided doses (one 600 mg tablet twice a day).
The maximum recommended daily dose is 1500 mg. 4 Administration TEVA-GEMFIBROZIL should be administered as a 600 mg tablet twice a day, morning and evening, 30 minutes before the meals. 5 Missed Dose If patient misses a dose, it should be taken immediately unless the time is close to the next dose.
In such an event, patient should wait for next scheduled dose and continue on the regular schedule. A double dose should not be taken to make up for a missed dose. 5 OVERDOSAGE Overdosage has been reported with gemfibrozil. Symptoms reported with overdosage were abdominal cramps, abnormal LFTs, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting.
In one case of accidental overdosage, where a child ingested 9 g of gemfibrozil, non- specific symptoms of nausea and vomiting were reported. The patient fully recovered. TEVA-GEMFIBROZIL (Gemfibrozil) Page 6 of 32 Symptomatic supportive measures should be taken should overdosage occur.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Description TEVA-GEMFIBROZIL is available as white, oval shaped, film coated tablets, engraved novo on one side and 600 on the reverse.
Available in bottles of 100 tablets. 7 WARNINGS AND PRECAUTIONS General If a significant serum lipid response is not obtained in 3 months, TEVA-GEMFIBROZIL should be discontinued. Gemfibrozil clinically, pharmacologically and chemically shows similarities with clofibrate.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[3]
10/2023 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ...............................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 9 8 ADVERSE REACTIONS ..................................................................................................
11 9 DRUG INTERACTIONS ................................................................................................ 13 10 CLINICAL PHARMACOLOGY .......................................................................................
14 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 16 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 16 PART II: SCIENTIFIC INFORMATION .......................................................................................
17 13 PHARMACEUTICAL INFORMATION ............................................................................ 17 14 CLINICAL TRIALS ........................................................................................................
23 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 26 PATIENT MEDICATION INFORMATION .................................................................................. e. pancreatitis) from their hyperlipidemia.
• Treatment of patients with hypercholesterolemia, Type IIa and IIb mixed dyslipidemias, to regulate lipid levels (reduce serum triglycerides and LDL cholesterol levels and increase HDL cholesterol). TEVA-GEMFIBROZIL alone may […]
This is not medical advice. Consult a qualified healthcare professional.
7 times the human dose). 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.
2. 9% for the placebo group, a 55% excess for the gemfibrozil group). A trend toward a greater incidence of gallbladder surgery was observed for the gemfibrozil group (17 versus 11 subjects, a 54% excess). 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. 3. Since a reduction of mortality from coronary heart disease has not been demonstrated and because liver and interstitial cell testicular tumors were increased in rats, gemfibrozil should be administered only to those patients described in the INDICATIONS AND USAGE section.
If a significant serum lipid response is not obtained, gemfibrozil should be discontinued. 4. Concomitant Anticoagulants-Caution should be exercised when warfarin is given in conjunction with gemfibrozil. The dosage of 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. 5. The concomitant administration of gemfibrozil with simvastatin is contraindicated (see CONTRAINDICATIONS and PRECAUTIONS ).
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.
IN PATIENTS WHO HAVE HAD AN UNSATISFACTORY LIPID RESPONSE TO EITHER DRUG ALONE, THE BENEFIT OF COMBINED THERAPY WITH GEMFIBROZIL and an HMG-CoA REDUCTASE INHIBITOR DOES NOT OUTWEIGH THE RISKS OF SEVERE MYOPATHY, RHABDOMYOLYSIS, AND ACUTE RENAL FAILURE (see PRECAUTIONS , Drug Interactions ).
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. 6. 3%, of male rats treated with gemfibrozil at 10 times the human dose. 7. CYP2C8 substrates -Gemfibrozil, a strong inhibitor of CYP2C8, may increase exposure of CYP2C8 substrates when administered concomitantly (see PRECAUTIONS , Drug Interactions ).
8. , atrasentan, atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, SN-38 [active metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan). Therefore, dosing reductions of drugs that are substrates of OATP1B1 may be required when gemfibrozil is used concomitantly (see PRECAUTIONS , Drug Interactions ).
Combination therapy of gemfibrozil with simvastatin or with repaglinide, which are OATP1B1 substrates, is contraindicated (see CONTRAINDICATIONS ).
If the response is insufficient after 3 months of therapy at recommended doses treatment should be discontinued and alternative treatment methods considered. Monitoring liver function Elevated levels of ALAT, ASAT, alkaline phosphatase, LDH, CK and bilirubin have been reported.
These are usually reversible when gemfibrozil is discontinued. Therefore liver function tests should be performed periodically. Gemfibrozil therapy should be terminated if abnormalities persist. Monitoring blood counts Periodic blood count determinations are recommended during the first 12 months of gemfibrozil administration.
8). 5) Concomitant use with CYP2C8, CYP2C9, CYP2C19, CYP1A2, UGTA1, UGTA3 and OATP1B1 substrates The interaction profile of gemfibrozil is complex resulting in increased exposure of many medicinal products if administered concomitantly with gemfibrozil.
5). In addition, gemfibrozil is metabolised to gemfibrozil 1-O-β-glucuronide which also inhibits CYP2C8 and OATP1B1. Concomitant use with hypoglycaemic agents There have been reports of hypoglycaemic reactions after concomitant use with gemfibrozil and hypoglycaemic agents (oral agents and insulin).
Monitoring of glucose levels is recommended. Concomitant anticoagulants Gemfibrozil may potentiate the effects of coumarin type vitamin K antagonist anticoagulants such as warfarin, acenocoumarol, or phenprocoumon. The concomitant administration of gemfibrozil with these anticoagulants necessitates careful monitoring of prothrombin time (INR - International Normalised Ratio).
Caution should be exercised when such a coumarin type vitamin K antagonist anticoagulant is given concomitantly with gemfibrozil. 5). Dietary sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet. Patients on low sodium diets should be informed that this medicinal product is essentially ‘sodium-free’.
Physicians prescribing gemfibrozil should also be familiar with the risks and benefits of clofibrate. If TEVA-GEMFIBROZIL is chosen for treatment, the prescribing physicians should discuss the proposed therapy and inform the patient of the expected benefits and potential risks which may be associated with long-term administration.
Carcinogenesis and Mutagenesis No Carcinogenicity or mutagenicity data in humans are available. (See 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity and mutagenicity) Cardiovascular Cardiac Arrhythmias: Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet / 600 mg Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, silicon dioxide and sodium lauryl sulfate TEVA-GEMFIBROZIL (Gemfibrozil) Page 7 of 32 Although no clinically significant abnormalities occurred that could be attributed to gemfibrozil, the possibility exists that such abnormalities may occur.
Cholesterol Hematologic A mild hemoglobin or hematocrit decrease has been observed in occasional patients following initiation of gemfibrozil therapy. The levels then stabilize during long-term administration. Rarely, severe anaemia, leukopenia, thrombocytopenia, eosinophilia and bone marrow hypoplasia have been reported.
Therefore, periodic blood count determinations are recommended during the first 12 months of gemfibrozil administration. Hepatic/Biliary/Pancreatic Abnormal liver function tests have been observed occasionally during gemfibrozil administration, including elevations of AST, ALT, LDH, and alkaline phosphatase, creatine kinase, bilirubin.
These are usually reversible when gemfibrozil is discontinued. Therefore, periodic liver function studies are recommended and gemfibrozil therapy should be terminated if abnormalities persist. In patients with past history of jaundice or hepatic disorder, gemfibrozil should be used with caution.
Cholelithiasis:
Gemfibrozil may increase cholesterol excretion into the bile leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are suggested. TEVA-GEMFIBROZIL (gemfibrozil) should be discontinued if gallstones are found.
Musculoskeletal Muscle Effects:
There have been reports of severe myalgia, myositis and rhabdomyolysis accompanied by markedly elevated creatinine kinase when gemfibrozil and HMG CoA reductase inhibitors were used concomitantly (see 2 CONTRAINDICATIONS; 9 DRUG INTERACTIONS, Drug-Drug Interactions).
When rhabdomyolysis is severe the ensuing myoglobinuria can lead to acute renal failure. Therefore, HMG CoA reductase inhibitors should not be used concomitantly with TEVA-GEMFIBROZIL. Myopathy, defined as muscle aching or muscle weakness, associated with increases in plasma creatine phosphokinase (CPK) values to greater than 10 times the ULN, should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK.
Patients should be advised to report promptly unexplained muscle pain, tenderness, or […]