|Dosage and administration||
Adult: 1 tablet, twice daily.
Hypersensitivity to gemfibrozil and any of the excipients of this medicine.
|Warnings and precautions for use||
Initial Therapy: 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.
|Recommendation for pregnancy and breastfeeding||
Pregnancy: Gemfibrozil crosses the placenta. There are no adequate and well-controlled studies in pregnant women; Gemfibrozil should not be used during pregnancy.
|Effects on ability to drive and use machines||
No studies on the effect of gemfibrozil on the ability to drive and use machines have been performed. However, Lopigim 600 may cause drowsiness, dizziness, headache, blurred vision. If affected, caution should be considered when driving and operating machines.
|Interactions, incompatibilities of medicine||
Anticoagulants, coumarin derivatives or indandione: Coadministration with gemfibrozil may significantly increase the anticoagulant effect of these medicines; Anticoagulant dose should be adjusted based on routine investigation of prothrombin time.
|Undesirable effects (ADRs)||
Generally, ADRs of Gemfibrozil are uncommon and mild, however, because of chemical, pharmacological and clinical similarity with clofibrate, gemfibrozil may cause the same ADR as clofibrate. The ADRs of gemfibrozil commonly seen in the gastrointestinal tract are sometimes severe and discontinuation of gemfibrozile is required.
|Overdose and management||
Symptoms of overdose: Symptoms reported with overdosage were abdominal cramps, abnormal liver function tests, diarrhea, increased creatine phosphokinase (CPK), joint and muscle pain, nausea and vomiting. These patients have recovered completely.
Gemfibrozil is a non-halogenated fibric acid derivative with hypolipidemic effects.
Absorption: Gemfibrozil is rapidly and well absorbed (98 ± 1% bioavailability). Maximum bioavailability is achieved when the drug is taken 30 minutes before meals. Peak plasma levels occur in one to two hours.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.
Composition: Each tablet contains:
Gemfibrozil. . . . . . . . . . . . . . . . . . . . . . . 600 mg
Box of 3 blisters x 10 tablets.
Gemfibrozil is a lipid regulating agent, which is indicated for the following cases:
Primary prevention of coronary heart disease (CHD) and myocardial infarction (MI) in patients with hypercholesterolaemia, mixed dyslipidemia and hypertriglyceridemia, types IIa, IIb and IV according to the Fredrickson classification.
Treatment of other dyslipidemia:
– Dyslipidemia type III and type V according to the Fredrickson classification.
– Dyslipidemia in patients with diabetes mellitus.
– Dyslipidemia in patients with xanthoma.
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.