Gemfibrozil

Trade Names:
Lopid
- Tablets 600 mg

Pharmacology

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Decreases blood levels of triglycerides and VLDL by decreasing their production. Also decreases cholesterol and increases HDL.

Pharmacokinetics

Absorption

Bioavailability is 100%. T _max is 1 to 2 h.

Max rate of absorption and a 50% to 60% increase in C _max when administered 30 min before meals vs with meals or fasting.

Distribution

Protein binding is high.

Metabolism

Mainly undergoes oxidation to form a hydroxymethyl and a carboxyl metabolite.

Elimination

Plasma t _½ is 1.5 h, biological t _½ is longer because of enterohepatic circulation and reabsorption in the GI tract. Approximately 70% excreted in urine (about 2% as unchanged); 6% excreted in feces.

Indications and Usage

Treatment of hypertriglyceridemia in adult patients with type IV or V hyperlipidemia that presents risk of pancreatitis and does not respond to diet; reduction of coronary heart disease risk in type IIb patients who have low HDL levels (in addition to elevated LDL and triglycerides) and have not responded to other measures.

Contraindications

Hepatic or severe renal function impairment, including primary biliary cirrhosis; preexisting gallbladder disease.

Dosage and Administration

PO 600 mg twice daily 30 min before morning and evening meals.

Storage/Stability

Store at room temperature in a tightly closed container.

Drug Interactions

Increases risk of rhabdomyolysis.

Anticoagulant effect may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Atrial fibrillation.

CNS

Fatigue; vertigo; headache.

Dermatologic

Eczema; rash.

EENT

Blurred vision.

GI

Dyspepsia; abdominal pain; diarrhea; nausea; vomiting; constipation; acute appendicitis.

Genitourinary

Impotence.

Hematologic

Anemia; leukopenia; bone marrow hypoplasia; eosinophilia.

Hepatic

Elevated LFT results; cholestatic jaundice.

Metabolic

Mild hyperglycemia.

Miscellaneous

Muscle pain or weakness; myositis; rhabdomyolysis; taste perversions.

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Cholelithiasis

Drug may increase cholesterol excretion into the bile, leading to cholelithiasis.

Patient Information

• Inform patient of need to restrict dietary intake of fats; teach patient dietary restrictions to follow.
• Emphasize importance of the following increased cardiac risk factors: smoking, alcohol consumption, lack of exercise.
• Instruct patient to report the following symptoms to health care provider: abdominal pain, persistent nausea and vomiting, bleeding, and irregular heartbeat.
• Advise patient that drug may cause dizziness or blurred vision and to use caution while driving or performing other tasks requiring mental alertness.

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