Sign Out
Muscle effects: Muscle toxicity, including very rare cases of rhabdomyolysis (with and without acute renal failure), has been reported with other lipid-lowering agents.
Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis, muscle cramps and weakness and/or marked increases in CK (>5 times the upper limit of normal range [ULN]). In such cases, treatment with PARMODIA should be stopped.
An increased risk of rhabdomyolysis has been reported with other fibrates when co-administered with an HMG-CoA reductase inhibitor (statin), especially in cases of pre-existing muscular disease. PARMODIA should be used with caution in patients receiving statins.
Liver effects: In common with other lipid-lowering agents, PARMODIA should be used with caution in patients with hepatic disorder or those with a history of hepatic disorder. Abnormal liver function tests may occur. The plasma concentration of PARMODIA may increase in patients with hepatic disorder (Child-Pugh grade A cirrhosis, etc.) (see PHARMACOLOGY: Pharmacokinetics under Actions). Liver function should be monitored periodically during treatment.
Renal effects: In patients with renal impairment, renal function should be monitored periodically during treatment with PARMODIA. If eGFR is ≤30 mL/min/1.73 m2, dose reduction or prolonged dosing intervals should be considered. The maximum daily dose is 0.2 mg daily.
Cholelithiasis: Since cholelithiasis has been reported, PARMODIA should be used with caution in patients with a history of cholelithiasis.
LDL-cholesterol: Since increases in LDL-cholesterol levels may occur, LDL-cholesterol levels should be monitored periodically during treatment.
Effects on ability to drive and use machines: No studies of the effects of PARMODIA on a patient's ability to drive, or to measure a reduced capacity to safely use machines have been performed.
Use in Children: The safety of PARMODIA in low birth weight infants, newborns, infants, and children has not been established. No data are available.
