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Indications/Uses
Fenofibrate (ZINOF 200) 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/Direction for Use
Patients should be placed on an appropriate lipid lowering diet before receiving Fenofibrate (ZINOF 200), and should continue this diet during treatment. It should be taken with meal for better absorption.
The usual initial dose is 200 - 400 mg daily in divided doses with food. Doses may be adjusted according to patient's response and should be increased sequentially if necessary following repeat serum triglyceride estimations at 4 to 8 weeks interval.
Children may be given 5 mg per kg body-weight daily.
OR AS DIRECTED BY THE PHYSICIAN.
The usual initial dose is 200 - 400 mg daily in divided doses with food. Doses may be adjusted according to patient's response and should be increased sequentially if necessary following repeat serum triglyceride estimations at 4 to 8 weeks interval.
Children may be given 5 mg per kg body-weight daily.
OR AS DIRECTED BY THE PHYSICIAN.
Administration
Should be taken with food: Take w/ meals for better absorption.
Contraindications
This medicinal product should never be prescribed in the following situations: hepatic insufficiency, renal insufficiency, in association with another fibrate, in children.
This medicine is usually not advised in association with inhibitors of HMG-CoA reductase.
This medicine is usually not advised in association with inhibitors of HMG-CoA reductase.
Special Precautions
Regular monitoring of liver function test should be performed during therapy with fenofibrate. Therapy should be discontinued if enzymes levels persist above three times the normal limit.
Use In Pregnancy & Lactation
Not recommended for pregnant or breastfeeding mother.
Adverse Reactions
See table.
Drug Interactions
Other fibrates: increased risk of adverse events such as rhabdomyolysis.
Oral anticoagulants: increase the effect of the oral anticoagulant with the risk of hemorrhage (due to their displacement from plasma proteins).
More frequent checks on the prothrombin index are necessary expressed as International Normalised Ratio (INR) and the adjustment of the dose of oral anticoagulant during the treatment with fenofibrate and for 8 days after stopping it.
Ciclosporin: With decrease in creatinine clearance and rises in serum creatinine can cause nephrotoxicity.
The primary route of elimination of fibrate drugs is thru renal excretion.
Oral anticoagulants: increase the effect of the oral anticoagulant with the risk of hemorrhage (due to their displacement from plasma proteins).
More frequent checks on the prothrombin index are necessary expressed as International Normalised Ratio (INR) and the adjustment of the dose of oral anticoagulant during the treatment with fenofibrate and for 8 days after stopping it.
Ciclosporin: With decrease in creatinine clearance and rises in serum creatinine can cause nephrotoxicity.
The primary route of elimination of fibrate drugs is thru renal excretion.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Action
Pharmacology: Pharmacokinetics: Fenofibrate is readily absorbed from the gastrointestinal tract when taken with food; absorption is substantially reduced if fenofibrate is administered after an overnight fast. It is rapidly hydrolysed to its active metabolite fenofibric acid which is extensively bound to plasma albumin. The plasma elimination half-life is about 20 hours. Fenofibric acid is excreted predominantly in the urine, mainly as the glucuronide conjugate, but also as a reduced form of fenofibric acid and its glucuronide.
MedsGo Class
Dyslipidaemic Agents
Features
Brand
Zinof 200
Full Details
Dosage Strength
200mg
Drug Ingredients
- Fenofibrate
Drug Packaging
Capsule 1's
Generic Name
Fenofibrate
Dosage Form
Capsule
Registration Number
DRP-6547
Drug Classification
Prescription Drug (RX)