FENOLIT Fenofibrate 200mg Capsule 1's

Name: FENOLIT Fenofibrate 200mg Capsule 1's
Brand: Fenolit
SKU: RXDRUG-DR-XY33626-1pc
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Description

Indications/Uses

Treatment of type IIa, IIb, III, IV and V hyperlipoproteinemias. It reduces elevated plasma concentrations of triglycerides by reducing the concentration of very low-density lipoprotein. It reduces elevated plasma concentrations of cholesterol to a lesser extent but the effect is variable

Dosage/Direction for Use

One cap daily during meal. Doses may be adjusted according to response to between 200 and 400 mg daily.

Administration

Should be taken with food.

Contraindications

Severe hepatic impairment, primary biliary cirrhosis, gallstones or gallbladder disorders, hypoalbuminemic states eg, nephrotic syndrome.

Special Precautions

Fenofibrate should not be given to patients with severe hepatic impairment, primarily biliary cirrhosis, gallstones or gallbladder disorders, or hypoalbuminemic states as the nephrotic syndrome. It should be used with caution in renal impairment.

Adverse Reactions

The common adverse 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, anemia, leukopenia and thrombocytopenia. Raised serum-aminotranferase concentrations have occasionally been reported. Elevated creatinine phosphokinase concentrations during fenofibrate therapy may be associated with a syndrome of myositis, myopathy, and rarely, rhabdomyolysis. Patients with hypoalbuminemia resulting from the nephrotic syndrome or other renal impairment may be at increased risk. Fenofibrate may increase the lithogenic index. 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 effect.

Drug Interactions

Fenofibrate and other fibrates may enhance the effects of oral anticoagulants. The dose of the anticoagulant 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 the anticoagulant. The mechanism of the interaction has not yet been determined. Fibrates have been reported to displace warfarin from protein-binding sites but other mechanisms 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 hypoalbuminemia, furosemide. The interaction with antidiabetics is complex since fenofibrate has been shown to alter glucose tolerance in both diabetic and nondiabetic patients. The dosage of antidiabetics may need adjusting during concomitant fenofibrate therapy.

Storage

Store at temperatures not exceeding 30°C.

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 t_½ is about 20 hrs. Fenofibric acid is excreted predominantly in the urine, mainly as the glucuronide conjugate but also as a reduced form of fenofibric and its glucuronide.

MedsGo Class

Dyslipidaemic Agents