Adult: As an adjunct to diet in the treatment of type IIA, type IIb, type III, type IV and type V hyperlipoproteinaemia: 600 mg bid, given 30 minutes before breakfast and dinner. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Oral Primary prevention of coronary heart disease
Adult: In patients who have not responded to dietary and other measures: 600 mg bid, given 30 minutes before breakfast and dinner. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Renal Impairment
Mild to moderate (GFR 30-80 mL/min/1.73 m2): Initially, 900 mg daily. Severe: Contraindicated. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Hepatic Impairment
Contraindicated.
Administration
Should be taken on an empty stomach. Take 30 min before meals.
Contraindications
History of photoallergy or phototoxic reaction during treatment with fibrates; primary biliary cirrhosis, pre-existing or history of gall bladder or biliary tract disease (including gallstones). Hepatic and severe renal impairment. Lactation. Concomitant use with simvastatin, repaglinide, dasabuvir or selexipag.
Special Precautions
Mild to moderate renal impairment. Pregnancy.
Adverse Reactions
Significant: Myopathy, rhabdomyolysis, myositis, markedly elevated creatine phosphokinase; cholelithiasis, elevated serum transaminases; mild decrease in Hb, haematocrit and WBC. Rarely, anaemia, leucopenia, thrombocytopenia, eosinophilia, bone marrow hypoplasia. Ear and labyrinth disorders: Vertigo. Gastrointestinal disorders: Dyspepsia, diarrhoea, vomiting, nausea, abdominal pain, constipation, flatulence. General disorders and administration site conditions: Fatigue. Nervous system disorders: Headache. Skin and subcutaneous tissue disorders: Eczema, rash.
Increased risk of myopathy and rhabdomyolysis with HMG-CoA reductase inhibitors (e.g. simvastatin, rosuvastatin) and colchicine. Increased risk of hypoglycaemia with hypoglycaemic agents (e.g. repaglinide, insulin). Increased risk of QT prolongation with dasabuvir. Increases the serum concentration of selexipag, bexarotene, rosiglitazone and OATP1B1 substrates (e.g. bosentan, ezetimibe, olmesartan, valsartan, rifampicin). Increased risk of seizures with enzalutamide. May potentiate the effects of anticoagulants (e.g. warfarin, acenocoumarol). Reduced bioavailability with colestipol.
Action
Description: Mechanism of Action: Gemfibrozil is a fibric aid derivative. It is believed to inhibit lipolysis, therefore reducing the uptake of hepatic fatty acid and inhibits the secretion of very low-density lipoprotein (VLDL). This results in decreased serum VLDL and increased high-density lipoprotein-cholesterol (HDL-C) concentrations. Pharmacokinetics: Absorption: Readily absorbed from the gastrointestinal tract. Bioavailability: Approx 100%. Time to peak plasma concentration: Within 1-2 hours. Distribution: Crosses the placenta. Plasma protein binding: 99%. Metabolism: Metabolised in the liver via oxidation into hydroxymethyl and carboxyl metabolite. Undergoes enterohepatic recycling. Excretion: Via urine (approx 70%, mainly as conjugated drug); faeces (6%). Elimination half-life: Approx 1.5 hours.
Chemical Structure
Gemfibrozil Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3463, Gemfibrozil. https://pubchem.ncbi.nlm.nih.gov/compound/Gemfibrozil. Accessed Apr. 29, 2024.
Storage
Store between 20-25°C. Protect from light and moisture.
C10AB04 - gemfibrozil ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
References
Anon. Gemfibrozil. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 22/03/2024.Buckingham R (ed). Gemfibrozil. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/03/2024.Gemfibrozil 600 mg Film-coated Tablets (Tillomed Laboratories Limited). MHRA. https://products.mhra.gov.uk. Accessed 22/03/2024.Gemfibrozil Tablet (American Health Packaging). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 22/03/2024.Gemfibrozil. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 19/04/2024.Joint Formulary Committee. Gemfibrozil. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/03/2024.Saffid Capsule 300 mg (Idaman Pharma Manufacturing Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/03/2024.
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