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Pharmacologic class: Fibric acid derivative
Therapeutic class: Antihyperlipidemic
Pregnancy risk category C
Inhibits peripheral lipolysis, resulting in decreased triglyceride levels. Also inhibits synthesis and increases clearance of very-low-density lipoproteins.
Tablets: 600 mg
Indications and dosages
➣ Type IIb hyperlipidemia in patients without coronary artery disease who don't respond to other treatments; adjunctive therapy for types IV and V hyperlipidemia
Adults: 1,200 mg P.O. daily in two divided doses
• Hypersensitivity to drug
• Gallbladder disease
• Severe renal dysfunction
• Hepatic dysfunction
Use cautiously in:
• renal impairment, cholelithiasis, diabetes, hypothyroidism
• pregnant or breastfeeding patients
• children (safety not established).
• Give 30 minutes before a meal.
• Know that before starting drug and throughout therapy, patient should use dietary measures and exercise, as appropriate, to control hyperlipidemia.
CNS: fatigue, hypoesthesia, paresthesia, drowsiness, syncope, vertigo, dizziness, headache, seizures
EENT: cataracts, blurred vision, retinal edema, hoarseness
GI: nausea, vomiting, diarrhea, abdominal or epigastric pain, heartburn, flatulence, gallstones, dry mouth
GU: dysuria, erectile dysfunction, decreased male fertility
Hematologic: eosinophilia, anemia, bone marrow hypoplasia, leukopenia, thrombocytopenia
Musculoskeletal: joint, back, or muscle pain; myasthenia; myopathy; synovitis; myositis; rhabdomyolysis
Skin: alopecia, rash, urticaria, eczema, pruritus, angioedema
Other: abnormal taste, chills, weight loss, increased risk of bacterial and viral infection, lupuslike syndrome, anaphylaxis
Drug-drug. Chenodiol, ursodiol: decreased gemfibrozil efficacy
Cyclosporine: decreased cyclosporine effects
HMG-CoA reductase inhibitors: increased risk of rhabdomyolysis
Sulfonylureas: increased hypoglycemic effects
Warfarin: increased bleeding risk
Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, creatine kinase (CK), glucose, lactate dehydrogenase: increased values
Hematocrit, hemoglobin, potassium, white blood cells: decreased values
• Monitor kidney and liver function test results and serum lipid levels.
☞ Watch for signs and symptoms of adverse reactions, especially bleeding tendency and hypersensitivity reaction.
• Monitor periodic blood counts during first year of therapy.
• Check CK level if myopathy occurs.
• Tell patient to take drug 30 minutes before breakfast and dinner.
☞ Advise patient to immediately report signs or symptoms of anaphylaxis (such as difficulty breathing or rash) or other allergic reactions.
☞ Instruct patient to immediately report unusual bleeding or bruising or muscle pain.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Stress importance of diet and exercise in lowering lipid levels.
• Inform patient that he'll undergo regular blood testing during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.