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TEVA-GEMFIBROZIL is a brand name for Gemfibrozil, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TEVA-GEMFIBROZIL (gemfibrozil tablet) is indicated in adults as an adjunct to diet and other therapeutic measures for: • Treatment of patients with very high serum triglyceride levels, Fredrickson classification Type IV and V hyperlipidemias, who are at high risk of sequelae and complications (i.e. pancreatitis) from…
Verbatim from this product's HC label. Tap a section to expand.
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.
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;
). • 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.
10/2023 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ...............................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSAGE..............................................................................................................
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 ........................................................................................................
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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.
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 […]
22 15 MICROBIOLOGY ........................................................................................................ 23 16 NON-CLINICAL TOXICOLOGY .....................................................................................
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 […]