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

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 )  

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

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.

Date of Approval        1999

Indication-

Hyperlipidaemia resitent to diet

Dosage-

200mg once daily with food

Children - 67mg per 20kg body weight once daily

Use contraindicated. Observe caution