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FENOFAST Fenofibrate 200mg Capsule 50's

RXDRUG-DRP-4070
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Features

Brand
Fenofast
Full Details
Dosage Strength
200 mg
Drug Ingredients
  • Fenofibrate
Drug Packaging
Capsule 50's
Generic Name
Fenofibrate
Dosage Form
Capsule
Registration Number
DRP-4070
Drug Classification
Prescription Drug (RX)
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Description

Indications/Uses

It is used to reduce low-density lipoprotein (LDL)-cholesterol, total cholesterol, triglycerides and apolipoprotein B and increase high-density lipoprotein (HDL)-cholesterol. In the management of hyperlipidemias including type IIa, IIb, III, IV and V hyperlipoproteinemias.
 

Dosage/Direction for Use

Usual Dose: 200 mg once daily.
Or as prescribed by the physician.
 

Administration

Should be taken with food.
 

Contraindications

Hypersensitivity to active ingredient or any component of the formulation.
 

Special Precautions

Fenofibrate should not be given to patients with severe hepatic impairment or significant liver disease, gallstones or gallbladder disorders or hypoalbuminemic states such as, nephrotic syndrome. It should be used with caution in renal impairment and is contraindicated if creatinine clearance is below 15 mL/min unless the patient is on dialysis.
 

Use In Pregnancy & Lactation

Pregnancy: Fenofibrate should not be administered to women who are pregnant.
Lactation: There are no data on the excretion of fenofibrate and/or its metabolites into breast milk. It is therefore recommended that fenofibrate should not be administered to women who are breastfeeding.
 

Adverse Reactions

The common adverse effect of fenofibrate therapy is gastrointestinal disturbances including anorexia, nausea and gastric discomfort. Other adverse effects reported to occur less frequently include headache, dizziness, vertigo, fatigue, skin rashes, pruritus, photosensitivity, alopecia, impotence, anemia, leucopenia and thrombocytopenia. Raised serum-aminotransferase concentration have occasionally been reported.
 

Drug Interactions

Fenofibrate is highly protein-bound and may displace other drugs from protein-binding sites. Interactions may also occur through changes in the activity of cytochrome P450 isoenzymes particularly CYP3A4. Fenofibrate may enhance the effects of anticoagulants; the dose of anticoagulant should be reduced when treatment with a fibrate is started, and then adjusted gradually if necessary. Recommendations vary; licensed product information for fenofibrate suggest a reduction of up 50% in the dosage of anticoagulant. The mechanism of the interaction is unclear; fibrates have been reported to displace warfarin from protein binding sites but other mechanisms are probably also involved.
Other drugs that may displaced from plasma proteins by fenofibrate include tolbutamide and other sulfonylurea antidiabetics, phenytoin and in patients with hypoalbuminemia, furosemide. The interaction with antidiabetics is complex since fibrates may alter glucose tolerance in diabetic patients. The dosage of antidiabetics may need adjusting during bezafibrate therapy.
There is an increase risk of myopathy of fenofibrate are used with strains.
Fenofibrate may interact with ciclosporin, although reports have been conflicting. However, nephrotoxicity associated with increased ciclosporin concentrations has been reported with bezafibrate and renal function should be monitored.
Cholestasis has been reported in patient given fenofibrate with raloxifene.
 

Storage

Store at a temperature not exceeding 30°C.
 

Action

Pharmacology: Pharmacokinetics: Fenofibrate is readily absorbed from the gastrointestinal tract when taken with food; absorption may be reduced if fenofibrate is given on an empty stomach, although this depends on the formulation. It is rapidly hydrolyzed to its metabolite fenofibric acid which is about 99% bound to plasma albumin. The plasma elimination half-life is about 20 hours. Fenofibric acid is excreted mainly in the urine, mainly as the glucuronide conjugate, but also a reduced form of fenofibric acid and its glucuronide, it is not removed by hemodialysis.
 

MedsGo Class

Dyslipidaemic Agents
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