Adult Dosing

Hypertriglyceridemia and other hyperlipoproteinemias

• 600 mg PO bid; take 30 minutes before the morning and evening meal

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• As an adjunct in the treatment of hypertriglyceridemia in adult patients with type IV or V hyperlipidemia who present a risk of pancreatitis and who do not respond adequately to dietary control
• Adjunctive therapy for reducing the coronary heart disease (CHD) risk in patients with type IIb hyperlipoproteinemia without clinical evidence of CHD who have low HDL levels in addition to elevated LDL and triglycerides, and who have not responded adequately to other measures

• Hypersensitivity to any of the ingredients of the product
• Hepatic or severe renal dysfunction, including primary biliary cirrhosis
• Preexisting gallbladder disease
• Combination therapy of gemfibrozil with repaglinide

• N/A

Renal Dose Adjustment

• Severe renal impairment: Contraindicated

Hepatic Dose Adjustment

• Hepatic impairment: Contraindicated

• Gemfibrozil may increase cholesterol excretion into the bile leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated; discontinue the therapy if gallstones are found
• Higher mortality rates have been reported, which could be due to increase in non-cardiovascular events such as malignancy, post-cholecystectomy complications, and pancreatitis
• Caution should be exercised while using anticoagulants in conjunction with gemfibrozil. To maintain prothrombin time adequate to prevent bleeding complications, reduce the dose of anticoagulant and monitor prothrombin levels frequently
• Increased risk of skeletal muscle toxicity manifested as rhabdomyolysis, markedly elevated creatine kinase (CPK) levels, myoglobinuria, acute renal failure and death are associated with the use of gemfibrozil in combination with HMG-CoA reductase inhibitor. In patients with unsatisfactory response to either drug alone, the benefit of combined therapy does not outweigh the risks of severe myopathy rhabdomyolysis, and acute renal failure
• Withdraw the drug if myositis is suspected or diagnosed
• Concomitant use of repaglinide with gemfibrozil is contraindicated because it increases the risk of severe hypoglycemia
• Perform lab studies to confirm that the lipid levels are consistently abnormal. Every attempt should be made to control serum lipids using other measures; control any medical problems such as diabetes mellitus and hypothyroidism that predisposes lipid abnormalities
• Obtain serum lipids regularly during therapy; discontinue if lipid response is inadequate after 3 months of therapy
• Monitor periodic blood counts during the first 12 months of the therapy

Lopid interacts with :

	Acenocoumarol
	Actos
	Altropev
	Atorvastatin
	Avandia
	Coumadin
	Crestor
	Jantoven
	Lipitor
	Livalo
	Lovastatin
	Mevacor
	Pioglitazone
	Pitavastatin
	Prandin
	Repaglinide
	Rosiglitazone
	Rosuvastatin
	Simvastatin
	Warfarin
	Zocor

Pregnancy Category:C

Breastfeeding: As per manufacturer's data, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.

• GI: Dyspepsia, abdominal pain, acute appendicitis, diarrhea, nausea, vomiting, constipation, taste perversion, cholestatic jaundice, cholelithiasis
• CNS: Fatigue, vertigo, headache, intracerebral hemorrhage, dizziness, depression
• NEURO: Paresthesia, somnolence, peripheral neuritis, decreased libido
• MUSC: Myositis, rhabdomyolysis, myopathy, myasthenia, myalgia, painful extremities, arthralgia, synovitis, rhabdomyolysis
• EENT: Blurred vision
• HEMA: Thrombocytopenia, anemia, leukopenia, bone marrow hypoplasia, eosinophilia
• CV: Atrial fibrillation, peripheral vascular disease, angioedema
• GU: Impotence
• LABTEST: Increased CPK, bilirubin, AST, ALT, alkaline phosphatase
• DERM: Eczema, rash, exfoliative dermatitis, urticaria, pruritus
• MISC: Hypersensitivity reactions

• Lipid-regulating agent; reduces triglyceride synthesis by inhibiting peripheral lipolysis and decreasing the hepatic extraction of free fatty acids; inhibits synthesis and increases clearance of VLDL carrier apolipoprotein B resulting in reduced VLDL production; also increases HDL levels
• Metabolized in liver; CYP450: 2C8, 2C9 inhibitor
• Excretion: Urine 70% (<2% unchanged), feces 6%
• Half-life: 1.5 hrs

US Trade Name(s)

• Lopid

US Availability

gemfibrozil (generic)

• TABS: 600 mg

Lopid

• TABS: 600 mg

Canadian Trade Name(s)

• Lopid

Canadian Availability

gemfibrozil (generic)

• CAPS: 300 mg
• TABS: 600 mg

Lopid

• CAPS: 300 mg
• TABS: 600 mg

UK Trade Name(s)

• Lopid

UK Availability

Lopid

• CAPS: 300 mg
• TABS: 600 mg

Australian Trade Name(s)

• Ausgem
• Gemhexal
• Jezil
• Lipazil
• Lopid
• Lipigem

Australian Availability

Ausgem, Gemhexal, Jezil, Lipazil, Lopid, Lipigem

• TABS: 600 mg

[Outline]

Endocrine/Metabolic

Antihyperlipidemic Agents

Fibric Acid Derivatives

Cardiovascular

Antihyperlipidemic Agents

Fibric Acid Derivatives

Pricing data from www.DrugStore.com in U.S.A.

• Gemfibrozil 600 MG TABS [Bottle] (CAMBER PHARMACEUTICALS)
  60 mg = $22.99
  90 mg = $29.98
• Lopid 600 MG TABS [Bottle] (PFIZER U.S.)
  60 mg = $176.29
  180 mg = $506.33

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Gemfibrozil 600 MG Oral Tablet (Caraco Pharmaceutical Laboratories, Ltd.)
• Gemfibrozil 600 MG Oral Tablet (Contract Pharmacy Services-PA)
• Gemfibrozil 600 MG Oral Tablet (Global Pharmaceuticals, Division of Impax Laboratories Inc.)
• Gemfibrozil 600 MG Oral Tablet (KAISER FOUNDATION HOSPITALS)
• Gemfibrozil 600 MG Oral Tablet (State of Florida DOH Central Pharmacy)
• Gemfibrozil 600 MG Oral Tablet (TEVA Pharmaceuticals USA Inc)
• Gemfibrozil 600 MG Oral Tablet (Watson Laboratories, Inc.)
• Lopid 600 MG Oral Tablet (Parke-Davis Div of Pfizer Inc)