AUDRA Fenofibrate 300mg Capsule 100's
RXDRUG-DR-XY32826
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
It is used in the treatment of type IIa, type IIb, type III, type IV, and type V hyperlipoproteinaemias. It reduces elevated plasma concentrations of triglycerides by reducing the concentration of very-low-density lipoproteins (VLDL). It reduces elevated plasma concentrations of cholesterol to a lesser extent, but the effect is variable.
Dosage/Direction for Use
300 mg - 1 capsule a day with food. Doses may be adjusted according to response to between 200 ang 400 mg daily or as prescribed by the physician.
Administration
Should be taken with food.
Special Precautions
Fenofibrate should not be given to patients with severe hepatic impairment, primarily biliary cirrhosis, gallstones or gallbladder disorders, or hypoalbuminaemic states as the nephritic syndrome. It should be used with caution in renal impairment.
Adverse Reactions
The common side effects of fenofibrate therapy are gastrointestinal upsets including anorexia, nausea, and gastric discomfort. Other adverse effects reported to occur less frequently include headache, dizziness, vertigo, fatigue, skin rashes, pruritus, alopecia, impotence, and anemia, leucopenia, and thrombocytopenia. Raised serum-aminotransferase concentrations have occasionally been reported. Elevated creatine phosphokinase concentrations during fenofibrate therapy may be associated with a syndrome of myositis, myopathy, and rarely rhabdomyolysis; patients with hypoalbuminaemia resulting from the nephrotic syndrome or other renal impairment may be at increased risk. Fenofibrate may increase the lithogenic index, but although there have been isolated reports of gallstones there is no evidence that the administration of fenofibrate is associated with an increased frequency of this adverse effects.
Drug Interactions
Fenofibrate and other fibrates may enhance the effects of oral anticoagulants; the dose of anticoagulants should be reduced when treatment with a fibrate is started, and then adjusted gradually if necessary. Recommendations concerning the amount that the anticoagulant dose should be reduced by vary between the manufacturers of the differing fibrates and are sometimes not even specified; the manufacturers of fenofibrate suggest a reduction of up to 50% in the dosage of anticoagulant.
The mechanism of the interaction has not yet been determined. Fibrates have been reported to displace warfarin from protein binding sites but other mechanism are probably also involved. A number of other drugs may be displaced from plasma proteins by fibrates including tolbutamide and other sulfonylurea antidiabetics, phenytoin, and, in patients with hypoalbuminaemia, frusemide (furosemide). The interaction with antidiabetics is complex since fenofibrate has been shown to alter glucose tolerance in both diabetic and non-diabetic patients. The dosage of antidiabetic may need adjusting during concomitant fenofibrate therapy.
The mechanism of the interaction has not yet been determined. Fibrates have been reported to displace warfarin from protein binding sites but other mechanism are probably also involved. A number of other drugs may be displaced from plasma proteins by fibrates including tolbutamide and other sulfonylurea antidiabetics, phenytoin, and, in patients with hypoalbuminaemia, frusemide (furosemide). The interaction with antidiabetics is complex since fenofibrate has been shown to alter glucose tolerance in both diabetic and non-diabetic patients. The dosage of antidiabetic may need adjusting during concomitant fenofibrate therapy.
Storage
Store at temperatures not exceeding 30°C.
Action
Fibrate.
Pharmacology: Fenofibrate, a fibric acid derivative, is a lipid regulating drug with actions on plasma lipids.
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 hydrolyzed to its active metabolite fenofibric acid which is extensively bound to plasma albumin. The plasma elimination half-life is about 20 hour. 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.
Pharmacology: Fenofibrate, a fibric acid derivative, is a lipid regulating drug with actions on plasma lipids.
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 hydrolyzed to its active metabolite fenofibric acid which is extensively bound to plasma albumin. The plasma elimination half-life is about 20 hour. 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
Audra
Full Details
Dosage Strength
300 mg
Drug Ingredients
- Fenofibrate
Drug Packaging
Capsule 100's
Generic Name
Fenofibrate
Dosage Form
Capsule
Registration Number
DR-XY32826
Drug Classification
Prescription Drug (RX)
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