Gemfibstad 300

Rx

Indications

Gemfibstad 300 is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

• Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
• Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
• Primary hypercholesterolaemia when a statin is contraindicated or not tolerated.
• Primary prevention.
• Reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event when a statin is contraindicated or not tolerated.

Dosage

• Adults: The dose range is 900 mg to 1200 mg daily.
  The 900 mg dose is taken as a single dose half an hour before the evening meal.
  The 1200 mg dose is taken as 600 mg twice daily, half an hour before breakfast and half an hour before the evening meal.
• Elderly (over 65 years old): As for adults.
• Due to the lack of data the use of gemfibrozil in children is not recommended.
• Renal impairment: In patients with mild to moderate renal impairment, start treatment at 900 mg daily and assess renal function before increasing dose.
• Gemfibrozil should not be used in patients with hepatic impairment, severely impaired renal function.

Usage

• Gemfibstad 300 should be taken orally.
• Prior to initiating gemfibrozil, other medical problems such as hypothyroidism and diabetes mellitus must be controlled as best as possible and patients should be placed on a standard lipid-lowering diet, which should be continued during treatment.
  

• Hypersensitivity to any of the ingredients.
• Hepatic impairment.
• Severe renal impairment.
• History of/or pre-existing gall bladder or biliary tract disease, including gallstones.
• Concomitant use of repaglinide, dasabuvir, selexipag, simvastatin, or rosuvastatin at 40 mg.
• Patients with previous history of photoallergy or phototoxic reaction during treatment with fibrates.

Very common

• Dyspepsia.

Common

• Vertigo, headache
• Diarrhoea, vomiting, nausea, abdominal pain constipation, flatulence.
• Eczema, rash.
• Fatigue.

• There have been reports of myositis, myopathy and markedly elevated creatine phosphokinase associated with gemfibrozil. Rhabdomyolysis has also been reported rarely.
• Combined therapy with HMG-CoA reductase inhibitors and gemfibrozil is contraindicated.
• Gemfibrozil may increase cholesterol excretion into the bile raising the potential for gallstone formation. If cholelithiasis is suspected, gallbladder studies are indicated. Gemfibrozil therapy should be discontinued if gallstones are found.
• Periodic determinations of serum lipids are necessary during treatment with gemfibrozil. If the response is insufficient after 3 months of therapy at recommended doses treatment should be discontinued.
• Liver function tests should be performed periodically. Gemfibrozil therapy should be terminated if abnormalities persist.
• Periodic blood count determinations are recommended during the first 12 months of gemfibrozil administration.

Interactions with other medicinal products

• Gemfibrozil potently inhibits CYP2C8, CYP2C9, CYP2C19, CYP1A2, and UDP glucuronyltransferase (UGTA1 and UGTA3) enzymes and also inhibits organic anion-transporting polypeptide 1B1 (OATP1B1). In addition, gemfibrozil is metabolised to gemfibrozil 1-O-β-glucuronide which also inhibits CYP2C8 and OATP1B1.
• There have been reports of hypoglycaemic reactions after concomitant use with gemfibrozil and hypoglycaemic agents (oral agents and insulin). Monitoring of glucose levels is recommended.
  Gemfibrozil may potentiate the effects of coumarin type vitamin K antagonist anticoagulants such as warfarin, acenocoumarol, or phenprocoumon. The concomitant administration of gemfibrozil with these anticoagulants necessitates careful monitoring of prothrombin time. Caution should be exercised when such a coumarin type vitamin K antagonist anticoagulant is given concomitantly with gemfibrozil. The dosage of the anticoagulant may need to be reduced to maintain desired prothrombin time levels.
• This medicinal product contains less than 1 mmol sodium (23 mg) per tablet.
• Gemfibrozil should not be used during pregnancy and lactation.
• No studies on the effects on the ability to drive and use machines have been performed. In isolated cases dizziness and visual disturbances can occur which may negatively influence driving.