Lopid

Lopid is used for treating high blood cholesterol and triglycerides.

Product dosage: 300mg
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Synonyms Apo-gemfibrozil Pms-gemfibrozil

Lopid (gemfibrozil) is a lipid-regulating agent indicated as an adjunct to diet and exercise for the management of dyslipidemia in specific patient populations. As a fibric acid derivative, it exerts its therapeutic effects through multiple mechanisms to address atherogenic dyslipidemia, characterized by elevated triglycerides and low high-density lipoprotein (HDL) cholesterol. This medication represents a well-established option in the pharmacological armamentarium for cardiovascular risk reduction when lifestyle modifications prove insufficient. Its clinical utility is particularly noted in patients with hypertriglyceridemia who require targeted intervention to mitigate pancreatitis risk and improve overall lipid profiles.

Features

• Active ingredient: Gemfibrozil 600 mg
• Pharmaceutical form: Film-coated tablets
• Mechanism: Activates peroxisome proliferator-activated receptor-alpha (PPAR-α)
• Primary actions: Reduces hepatic VLDL production, enhances lipoprotein lipase activity
• Bioavailability: Well-absorbed orally with peak plasma concentrations within 1-2 hours
• Protein binding: Extensive (>95%) to albumin
• Metabolism: Hepatic oxidation via CYP3A4 with subsequent glucuronidation
• Elimination: Primarily renal (70%) with fecal excretion of unchanged drug
• Half-life: Approximately 1.5 hours following single dose
• Special packaging: Blister packs with moisture barrier protection

Benefits

• Significantly reduces serum triglyceride levels by 35-50% in responsive patients
• Increases HDL cholesterol concentrations by 10-20% through apolipoprotein A-I and A-II synthesis
• Modestly decreases LDL cholesterol in certain dyslipidemic patterns
• Reduces risk of pancreatitis in patients with severe hypertriglyceridemia
• Demonstrates cardiovascular event reduction in selected patient subgroups
• Provides complementary lipid effects when combined with statin therapy in appropriate cases

Common use

Lopid is primarily prescribed for adult patients with type IV or V hyperlipoproteinemia who present with elevated triglyceride levels (typically >500 mg/dL) despite adequate dietary control. It is particularly indicated when the risk of pancreatitis outweighs the potential for other complications. The medication finds additional application in patients with mixed dyslipidemia who have failed to achieve target lipid levels with statin monotherapy, though combination therapy requires careful monitoring. Clinical guidelines support its use in patients with diabetes mellitus and concomitant dyslipidemia where triglyceride reduction is a priority. Off-label applications include management of dyslipidemia in patients with metabolic syndrome and those with HIV-associated lipid abnormalities under specialist supervision.

Dosage and direction

The recommended adult dosage is 600 mg administered orally twice daily, approximately 30 minutes before the morning and evening meals. This timing maximizes absorption and aligns with postprandial lipid metabolism. Dosage adjustment is generally not required for elderly patients with normal renal and hepatic function. For patients with renal impairment (creatinine clearance <30 mL/min), alternative agents should be considered due to increased risk of adverse effects. Treatment should be initiated only after secondary causes of hyperlipidemia have been addressed and a trial of diet and exercise has proven inadequate. Therapeutic response should be assessed after 3 months of therapy, with periodic reevaluation thereafter. Dosage adjustments beyond the standard regimen are not typically recommended, as higher doses have not demonstrated additional efficacy.

Precautions

Baseline laboratory evaluation should include complete lipid profile, liver transaminases, creatinine kinase, serum creatinine, and complete blood count. Regular monitoring of these parameters is recommended during therapy. Patients should be advised to report any unexplained muscle pain, tenderness, or weakness promptly, as these may signal myopathy. Special caution is warranted in patients with preexisting gallbladder disease, as fibrates may increase cholesterol secretion into bile. Hepatic function should be monitored periodically, with discontinuation considered if transaminase levels persist at >3 times the upper limit of normal. The drug may increase serum homocysteine levels, potentially requiring additional nutritional supplementation. Patients with impaired renal function require careful assessment before initiation and close monitoring during treatment.

Contraindications

Lopid is contraindicated in patients with hypersensitivity to gemfibrozil or any component of the formulation. It must not be used in patients with preexisting hepatic dysfunction including primary biliary cirrhosis, active liver disease, or persistent transaminase elevations. Contraindications include severe renal impairment (creatinine clearance <30 mL/min) and end-stage renal disease requiring dialysis. The medication is prohibited in patients with gallbladder disease or a history of cholelithiasis. Concomitant use with repaglinide is absolutely contraindicated due to risk of severe hypoglycemia. It should not be administered to patients taking simvastatin due to increased risk of rhabdomyolysis. Pregnancy category C advises against use during pregnancy unless potential benefits justify potential risks to the fetus.

Possible side effect

Common adverse reactions (≥5%) include dyspepsia (8.5%), abdominal pain (6.6%), diarrhea (4.8%), and nausea (4.0%). Musculoskeletal effects such as arthralgia (3.5%) and myalgia (2.5%) may occur. Laboratory abnormalities include elevated liver enzymes (AST/ALT) in 3-5% of patients and increased creatine phosphokinase in 1-3%. Less frequent but clinically significant effects include cholelithiasis (1.5%), rash (1.8%), and dizziness (1.7%). Rare but serious adverse events include rhabdomyolysis (<0.1%), hepatic necrosis (<0.01%), and severe hematologic reactions including anemia, leukopenia, and thrombocytopenia. Patients may experience decreased hemoglobin and hematocrit values (2-4%) without clinical significance in most cases.

Drug interaction

Gemfibrozil demonstrates significant interaction potential due to its effects on various CYP450 enzymes and transport proteins. It potently inhibits CYP2C8, CYP2C9, and OATP1B1 transport, leading to increased concentrations of repaglinide (contraindicated), pioglitazone, rosiglitazone, and various statins. Combination with statins increases the risk of myopathy by 5-10 fold, particularly with simvastatin (absolute contraindication) and to a lesser extent with atorvastatin and pravastatin. It may enhance the effects of oral anticoagulants, requiring frequent INR monitoring and dosage adjustment. Concomitant use with bile acid sequestrants reduces gemfibrozil absorption by 30-35%, necessitating administration at least 2 hours apart. The medication may decrease cyclosporine levels through uncertain mechanisms, requiring therapeutic drug monitoring.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed administration. The effectiveness of the medication depends on consistent maintenance of therapeutic levels, so occasional missed doses may reduce lipid-lowering efficacy. If multiple doses are missed over several days, patients should contact their healthcare provider for guidance on resumption of therapy. Patterned non-adherence should be addressed through patient education regarding the importance of consistent dosing for optimal therapeutic outcomes.

Overdose

Acute overdose may manifest as abdominal cramps, diarrhea, nausea, and vomiting. No specific antidote exists, and management should focus on supportive care. Gastric lavage may be considered if presentation occurs within 1-2 hours of ingestion. Activated charcoal can be administered to reduce absorption, though gemfibrozil’s extensive protein binding may limit effectiveness. Hemodialysis is not effective due to high protein binding. Symptomatic treatment should include antiemetics for nausea and intravenous hydration for gastrointestinal losses. Liver function tests and creatine kinase should be monitored for several days following significant overdose. Patients should be observed for signs of muscle toxicity including myalgia and weakness. Medical toxicology consultation is recommended for intentional overdoses or ingestion of large quantities.

Storage

Store at controlled room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from moisture and light by keeping tablets in their original blister packaging until administration. The medication should not be stored in bathrooms or other areas with high humidity. Keep securely closed in the manufacturer’s container to maintain stability. Do not freeze the medication. Keep out of reach of children and pets. Properly discard any medication that has expired or is no longer needed through medication take-back programs or according to FDA-recommended disposal methods. Do not flush medications down the toilet unless specifically instructed to do so.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. The content is not intended to be a substitute for professional medical judgment, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication regimen. Never disregard professional medical advice or delay in seeking it because of information contained herein. The manufacturer and distributor disclaim any liability, loss, or risk incurred directly or indirectly from the use or application of this information. Full prescribing information should be consulted before initiating therapy.

Reviews

Clinical studies demonstrate that Lopid produces median triglyceride reductions of 40-50% in responsive patients, with HDL cholesterol increases of 10-15%. The Helsinki Heart Study showed a 34% reduction in coronary events in patients with type IIb dyslipidemia. More recent meta-analyses confirm its efficacy in triglyceride reduction but note variable effects on cardiovascular outcomes depending on patient characteristics. Patient-reported outcomes indicate generally good tolerability, though gastrointestinal side effects lead to discontinuation in approximately 5% of users. Long-term observational data support its safety profile when used appropriately in selected populations. Specialist consensus acknowledges its particular value in severe hypertriglyceridemia where pancreatitis prevention is the primary concern.