Fenolip-145mg

Class: Antihyperlipidemic Actions Mechanism not well established. Apparently decreases plasma levels of triglycerides by decreasing their synthesis. Also reduces plasma levels of very low density lipoproteins (VLDL) cholesterol by reducing their release into the circulation and increasing their catabolism. Reduces serum uric acid levels by increasing urinary excretion of uric acid. Indications Adjunctive therapy to diet for treatment of hypertriglyceridemia in adult patients with type IV or V hyperlipidemia who are at risk of pancreatitis; adjunctive therapy to diet for the reduction of HDL cholesterol, total cholesterol, triglycerides, and apolipoprotein B, and to increase HDL cholesterol in adults with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb). Contraindications Hepatic or severe renal dysfunction including primary biliary cirrhosis; patients with unexplained persistent liver function abnormality; pre-existing gallbladder disease. Route/Dosage Primary Hypercholesterolemia/Mixed Hyperlipidemia: ADULTS: PO Initial dose is 160 mg/day. Hypertriglyceridemia: ADULTS: PO Start with 54 to 160 mg/day (max, 160 mg/day). Interactions Bile acid sequestrants (eg, cholestryramine): Reduces absorption of fenofibrate. Cyclosporine (eg, Sandimmune): Increases risk of nephrotoxicity. HMG-CoA reductase inhibitors (eg, lovastatin): Increased risk of severe myopathy, rhabdomyolysis, and acute renal failure. Oral anticoagulants (eg, warfarin): Anticoagulant effect may be increased. Lab Test Interferences None well documented. Adverse Reactions CARDIOVASCULAR: Arrhythmia. CNS: Dizziness; insomnia; paresthesia; headache; fatigue. DERMATOLOGIC: Rash; pruritus. EENT: Eye irritation; blurred vision; conjunctivitis; eye floaters; earache. GI: Dyspepsia; nausea; vomiting; diarrhea; constipation; abdominal pain; flatulence; eructation; increased appetite. GU: Decreased libido; polyuria; vaginitis. HEMATOLOGIC: Anemia; leukopenia. HEPATIC: Elevated liver enzymes. RESPIRATORY: Rhinitis; sinusitis; cough. OTHER: Flu syndrome; arthralgia. Precautions Pregnancy: Category C. Lactation: Do not use in nursing women. Discontinue drug or discontinue nursing. Children: Safety and efficacy not established. Cholelithiasis: May increase cholesterol secretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Discontinue therapy if gallstones are found. Hepatic function impairment: Drug can cause significant increases in serum transaminases. Perform regular periodic monitoring of liver function for duration of therapy; discontinue therapy if enzyme levels persist more than 3 times the normal limit. Monitoring: Evaluate serum lipids periodically (eg, 4 to 8 wk) during initial therapy to determine lowest effective dose; withdraw therapy if an adequate response is not achieved after 2 mo of treatment with the maximum dose. Perform periodic blood counts during first 12 mo of therapy to detect rare episodes of thrombocytopenia and granulocytopenia. Myopathy/Myositis: Can be used by fibrates alone or in combination with HMG-CoA reductase inhibitors. Consider in any patient with diffuse myalgia, muscle tenderness or weakness, or marked CPK elevations. Discontinue therapy if myopathy/myositis is suspected or diagnosed. Renal impairment (Ccr below 50 mL/min): Initiate therapy at 67 mg/day and increase only after evaluation of the effects on renal function and triglyceride levels at this dose. PATIENT CARE CONSIDERATIONS Administration/Storage Administer with meals. Store at room temperature. Protect from moisture. Assessment/Interventions Obtain patient history including drug history and any known allergies. Document blood counts. In patients with impaired renal function, increase the dose only after assessing the effects of the current dose on renal function and triglyceride levels; monitor changes. Document baseline cholesterol and triglyceride levels; monitor changes. Monitor LFTs. If patient is receiving anticoagulants, monitor PT for assistance in determining appropriate dose. Monitor for signs of bleeding. Patient/Family Education Teach patient importance of compliance with drug therapy. If an adequate reduction in fasting chylomicronemia does not occur, discontinue drug. Explain necessity of strict adherence to special diets (eg, low triglycerides). Advise patient to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise and fever, to health care provider.