Drug Class: Lipid Modifying Agent.
Pharmacology: Mechanism of Action: Fenofibrate (Fib-Col) is a fibric acid derivative. The primary mode of action of Fenofibrate is to lower plasma triglycerides concentrations by inhibiting triglyceride synthesis and by stimulating the catabolism of triglyceride-rich lipoproteins.
Fenofibrate (Fib-Col) is indicated in the treatment of type IIa, type IIb, type III, type IV and the type V hyperlipoproteinaemias.
Initial dose: 300 mg daily in divided doses. May be adjusted according to response to between 200 and 400 mg daily, or as prescribed by physician.
Children: 5 mg/kg body weight or as prescribed by the physician.
There is no specific treatment for overdosage with fenofibrate. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur.
Fib-Col is contraindicated in patients with: Known hypersensitivity to fenofibrate or to any of the excipients of Fib-Col.
Severe renal dysfunction.
Hepatic dysfunction including primary biliary cirrhosis and unexplained persistent liver function abnormality.
Pre-existing gallbladder disease.
Children.
Known photo allergy or phototoxic reaction during treatment with fenofibrate or ketoprofen.
Chronic or acute pancreatitis with the exemption of acute pancreatitis due to severe hypertriglyceridemia.
Fenofibrate (Fib-Col) should not be given to patients with: Severe hepatic impairment; primary biliary cirrhosis; gallstones or gallbladder disorders; hypoalbuminaemic states as the nephritic syndrome; it should be used with caution in renal impairment.
Pregnancy category C. The safety in pregnant women has not been established.
Fenofibrate (Fib-Col) should not be used during breastfeeding.
The frequently reported adverse effect in Fib-col were: Abdominal pain, back pain, headache, chest pain, nausea, diarrhea, constipation, anemia, leg cramps, dizziness, respiratory disorder, weight loss, GI disturbances, urinary frequency, conjunctivitis, skin disorder.
See table.
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Store at temperatures not exceeding 30°C.
Shelf-Life: 24 months.
C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
Fib-Col cap 200 mg
30's (P1,018/box)
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