Fenofibrate - Anti-hyperlipaemic (Dec 1999)
Drug Name:
Fenofibrate - Anti-hyperlipaemic (Dec 1999)
List Of Brands:
Indication Type Description:
Drug Interaction:
Anticoagulants, cyclosporin Statins, Fibrates, Phenylbutazone
Anti-diabetics Other nephro-toxic drugs
Allow at least 1 hour before or 4-6 hours after bile acid sequestrants
Indication:
Hyperlipidaemia resistent to diet
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Fenofibrate Anti-Hyperlipidaemia 22-12-1999
INFORMATION - UPDATE
FENOFIBRATE AND HEART ATTACK
As per United States Food and Drugs Administration ( USFDA ) the addition of fenofibrate to satins dose nor result in any incremental benefit on cardiovascular mortality. It is known that fenofibrate when used in combination with a statin increases the risk of an adverse reaction called rhabdomylosis. The breakdown of muscles in rhabdomylosis can lead to kidney damage and death. Symptoms of muscle injury include muscle pain, tenderness, and weakness.
The USFDA decison is based on analysis of two large clincal trials: the ACCORD Lipid trial
involving subjects over 4.7 years years and Fenofibrate intervention and Event Lowering in
Diabetes ( FIELD ) study involiving 9795 patients. ( MIMS )
Adverse Reaction:
GI upset, Rash photosensitivity
Alopecia Hepatitis, elevated liver enzymes Headache, fatigue, Vertigo, Interstital pneumopathies Pancreatitis, Pulmonary embolism
Deep vein thrombosis , Thrombophlebitis, Gall bladder stone , Muscle toxicity ( discontinue )
Transcient hematological changes Blood dyscrasias
Contra-Indications:
Renal or hepatic impairment Gall bladder disease Photoallergy or phototoxic reactions with fibrates ketoprofen
Pregnancy Lactation
Special precautions-
Pancreatitis
Monitor CBC for 1st year Monitor liver enzymes every 3 months during first year of treatment
Discontinue if ALT (SGPT ) levels > 3 x ULN persist Risk factors for myopathy or rhabdomyolysis
Discontinue if markedly elevated CPK levels,myopathy, or gall stones occur.
Dosages/ Overdosage Etc:
Date of Approval 1999
Indication-
Hyperlipidaemia resitent to diet
Dosage-
200mg once daily with food
Children - 67mg per 20kg body weight once daily
Pregnancy and lactation:
Use contraindicated. Observe caution
