Gemfibrozil: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

Oral
Hyperlipidaemias

Adult: 1.2 g daily in 2 divided doses. Alternatively, 900 mg as a single dose in the evening.

Renal Impairment

Mild to moderate (GFR 30-80 mL/min/1.73m²): Initially, 900 mg daily. Severe: Contraindicated.

Hepatic Impairment

Contraindicated.

Administration

Should be taken on an empty stomach. Take 30 min before meals.

Contraindications

History of photosensitivity or phototoxic reaction w/ fibrates. History of or pre-existing gall bladder or biliary tract disease (e.g. gallstones). Severe Hepatic (including primary biliary cirrhosis) and severe renal impairment. Lactation. Concomitant use w/ repaglinide, dasabuvir, or statins.

Special Precautions

Pregnancy. Mild to moderate renal impairment.

Adverse Reactions

Significant: Myopathy, myositis, rhabdomyolysis, elevated hepatic transaminases and CPK, decreased Hb, haematocrit, WBC; increased risk of cholelithiasis, malignancy. Rarely, bone marrow hypoplasia, anaemia, eosinophilia, leucopenia, thrombocytopenia.
Nervous: Dizziness, drowsiness, headache, fatigue, paraesthesia, depression, peripheral neuritis/neuropathy, vertigo, headache.
CV: AF.
GI: Dry mouth, taste disturbance, appendicitis, diarrhoea, constipation, nausea, vomiting, abdominal pain, flatulence.
Resp: Laryngeal oedema.
Hepatic: Cholecystitis, cholestatic jaundice.
Genitourinary: Impotence, reduced libido.
Musculoskeletal: Myasthenia, muscle pain, myalgia, synovitis.
Ophthalmologic: Blurred vision.
Dermatologic: Exfoliative dermatitis, circumscribed exanthema, pruritus, urticaria, angioedema, dermatomyositis, eczema, rash. Rarely, photosensitivity.
Others: Hypokalaemia.

Pregnancy Category (US FDA)

PO: C

Patient Counseling Information

Avoid exposure to sunlight.

Monitoring Parameters

Monitor lipid, blood sugar, blood count, and LFT.

Overdosage

Symptoms: Abdominal pain, cramps, abnormal LFT, diarrhoea, increased creatine phosphokinase (CPK), joint and muscle pain, nausea and vomiting. Management: Symptomatic and supportive treatment. In acute overdosage, perform gastric lavage immediately.

Drug Interactions

Increases the plasma concentration of rosiglitazone, pioglitazone, bexarotene. May potentiate the effect of coumarin type vit K antagonist anticoagulants (e.g. warfarin). Reduced bioavailability when given w/ resin-granule drugs (e.g. colestipol).
Potentially Fatal: Risk of severe hypoglycaemia w/ repaglinide. Increases dasabuvir exposure which may result in increased risk of QT prolongation. Increased risk of muscle related adverse effects (e.g. myopathy, rhabdomyolysis) w/ statins (e.g. simvastatin).

Action

Description: Gemfibrozil is a fibric acid derivative which decreases serum triglycerides and VLDL, and increases HDL cholesterol. The exact mechanism of its action has not been fully established but it has been shown to inhibit lipolysis of fat in adipose tissue and decrease hepatic fatty acid reuptake. It also inhibits the synthesis and increases the clearance of apolipoprotein B, a carrier molecule of VLDL.
Pharmacokinetics:
Absorption: Rapidly and completely absorbed from the GI tract. Bioavailability: Approx 100%. Time to peak plasma concentration: W/in 1-2 hr.
Distribution: Plasma protein binding: Approx 98%.
Metabolism: Metabolised in the liver via oxidation into hydroxymethyl and carboxyl metabolites; undergoes enterohepatic recirculation.
Excretion: Mainly via urine (approx 70%, mainly as glucuronide conjugates and metabolites); faeces (6%). Elimination half-life: Approx 1.5 hr.

Chemical Structure

Storage

Store between 20-25°C. Protect from light and moisture.

MIMS Class

Dyslipidaemic Agents

ATC Classification

C10AB04 - gemfibrozil ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.

References

Anon. Gemfibrozil. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/05/2017.

Buckingham R (ed). Gemfibrozil. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/05/2017.

Gemfibrozil Tablet, Film Coated (Apotex Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 23/05/2017.

Joint Formulary Committee. Gemfibrozil. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/05/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Gemfibrozil. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 23/05/2017.

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