Supralip NT 145

Supralip NT 145 Special Precautions





Zuellig Pharma
Full Prescribing Info
Special Precautions
Secondary cause of hypercholesterolemia eg, uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment, alcoholism, should be adequately treated before fenofibrate therapy is initiated.
For hyperlipidemic patients taking estrogens or contraceptives containing estrogens, it should be ascertained whether the hyperlipidemia is of primary or secondary nature (possible elevation of lipid values caused by oral estrogen).
Liver Function: As with other lipid lowering agents, increases have been reported in transaminase levels in some patients. In the majority of cases, these elevations were transient, minor and asymptomatic. It is recommended that transaminase levels be monitored every 3 months during the first 12 months of treatment. Attention should be paid to patients who show increases in transaminase levels and therapy should be discontinued if ASAT and ALAT levels increase to >3 times the upper limit of the normal range or 100 IU.
Pancreatitis have been reported in patients taking fenofibrate. This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct.
Muscle: Muscle toxicity, including very rare cases of rhabdomyolysis, has been reported with administration of fibrates and other lipid-lowering agents. Patients with hypoalbuminemia and renal insufficiency in their personal history have a higher incidence of myotoxicity. Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis, muscular cramps and weakness and/or marked increases in CPK (levels exceeding 5 times the upper normal range). In such cases, treatment with fenofibrate should be stopped.
Patients with predisposing factors for myopathy and/or rhabdomyolysis, including patients >70 years, personal or familial history of hereditary muscular disorders, renal impairment, hypoalbuminemia, hypothyroidism and high alcohol intake, may be at an increased risk of developing rhabdomyolysis. For these patients, the putative benefits and risks of fenofibrate therapy should be carefully weighed.
The risk of muscle toxicity may be increased if the drug is administered with another fibrate or an HMG-CoA reductase inhibitor (statins), especially in cases of preexisting muscular disease. Consequently, the co-prescription of fenofibrate with a statin should be reserved to patients with severe combined dyslipidemia and high cardiovascular risk without any history of muscular disease. This combination therapy should be used with caution and patients should be monitored closely for signs of muscle toxicity.
Renal Function: Treatment should be interrupted in case of an increase in creatinine levels >50% of ULN (upper limit of normal). It is recommended that creatinine measurement be considered during the first 3 months after initiation of treatment.
Supralip NT 145 contains lactose, therefore, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. It also contains sucrose, therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
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