Lipidof 200 mg Capsule, 1 strip

Lipidof 200 mg Capsule, 1 strip

DESCRIPTION

LIPIDOF 200 (Fenofibrate) is a lipid-regulating agent. Fenofibric acid, the active metabolite of Fenofibrate, lowers plasma triglycerides apparently by inhibiting triglyceride synthesis, resulting in a reduction of

VLDL released into the circulation, and also by stimulating the catabolism of triglyceride rich lipoprotein (i.e. VLDL). Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid.

COMPOSITION

LIPIDOF 200: Each capsule contains micronized Fenofibrate BP 200 mg.

INDICATIONS

LIPIDOF 200 (Fenofibrate) is indicated as adjunctive therapy to diet for the treatment of hypertriglyceridemia (Fredrickson Types IV and V) and also for primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa, IIb) who are at risk of pancreatitis and who do not respond adequately to dietary effort.

DOSAGE AND ADMINISTRATION

Patients should be placed on an appropriate lipid lowering diet before receiving Fenofibrate, and should continue this diet during treatment with it. It should be taken with meal for better absorption.

The recommended dose of LIPIDOF 200 mg capsule is once daily for the treatment of primary hypercholesterolemia, hypertriglyceridemia, or mixed hyperlipidemia.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

The most common side effects of Fenofibrate therapy are gastrointestinal upsets including nausea, anorexia, and gastric disorder. Other adverse effects reported to occur less frequently include pruritus, urticaria, headache, dizziness, vertigo, fatigue, hair loss, myotoxicity (with myasthenia or myalgia), skin rash, anemia, leucopenia, and thrombo-cytopenia.

CONTRAINDICATIONS

Fenofibrate is contraindicated in patients who exhibit hypersensitivity to it. Fenofibrate is also contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality. It is also contraindicated in patients with preexisting gall bladder disease.

PRECAUTIONS

During Fenofibrate therapy monitoring of liver function tests in every 3 months for first year should be performed and therapy should be discontinued if enzyme levels persist above three times the normal limit.

Use in pregnancy & lactation

Pregnancy : Fenofibrate is not recommended for pregnant women.

Lactation : Fenofibrate should not be used in lactating mothers.

USE IN CHILDREN

Safety and effectiveness in children have not been established.

DRUG INTERACTIONS

Anticoagulant: Fenofibrate may enhance the effects of oral anticoagulants; thus the dose of anticoagulants should be reduced to maintain the Prothrombin Time at the desired level to prevent bleeding complications when treatment with Fenofibrate is started, and then adjusted gradually if necessary.

Cyclosporine: Because cyclosporine can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including Fenofibrate, there is a risk that an interaction will lead to deterioration.

OVERDOSAGE

There is no specific treatment for overdose with Fenofibrate. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur.

Because Fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

SUPPLY

LIPIDOF 200 : Each box contains 2 X 10 capsules in blisters.

strips.