| DESCRIPTION |
Noficon® capsule contains Fenolibrate (micronised). It is a fibric acid derivative. Fenolibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, Fenofibric Acid. Fenofibric Acid produces reductions in tolal cholesterol,LDL cholesterol, apo-lipoprotein 5, total triglycerides end triglyceride rich lipoprotein (VLDL) in treated patients. In addition, treatment with Fenofibrate results in increases in HOl and apoproteIns apo AI end apo All. Fenofibrate also reduces serum uric acid levels in hyperuricsmic and nonnaI individuals by increasing the urinary excretion or uric acid. The micronised form of Fenofibrate has enhancsd absorption over the non-micronised formulation. |
| INDICATIONS |
| Noficon® is indicated for the treatment of hyperlipidaemias of types lIa, lib, III, IV and V in patients who have not responded adequately to diet and other appropriate measures . |
| DOSAGE AND ADMINISTRATION |
The initial adult dose of the micronized formulation is one 200 mg capsule once daily. Patients should be placed on an appropriate lipid-lowering diet before receiving Noficon® end should continue during treatment. Noficon® should be given IMth meals, thereby optimizing the bioavailability of the medication. |
| PHARMACOKINETICS |
Absorption and Distribution: Fenofibrate is well absorbed from the gastro-intestinal tract. Peak plasma levels of Fenofibric Acid occur within 6 to 8 hours after administration. The absorption of Fenofibrate is Increased when administered with food by approximately 35% In healthy volunteers, steady- state plasma levels of fanoflbric acid were shown to be achieved within 5 days of dosing. Serum protein binding was approximately 99% In normal end hyperlipidemic subjects. Metabolism and Excretion: Following oral administration, Fenoflbrate is rapidly hydrolyzed by esterases to the active metabolite, Fenoflbric Acid; no unchanged Fenofibrate is detected in plasma. In vivo metabolism data indicate that neither Fenofibrale nor Fenoflbric Acid undergo oxidative metabolism (e.g., cytochrome P450) to a significant extent. After absorption, Fenoflbrate is mainly excreted in the urine In the fonn of metabolites, primarily Fenofibric Acid and Fenofibric Acid Glucuronide, after administration of radiolabelled Fenofibrate, approximately 60% of the dose appeared In the urine end 25% was excreted in the feces. The mean plasma half•life is 22.1 h (Range: 19.6-26.6 h)in healthy young adults, allowing once daily administration in a clinical setting. |
| CONTRAINDICATlONS |
| Fenofibrate is contraindicated in patiants with hypersensitivity to Fanofibrate, hepatic or severe renal dysfunction, including primary biliary cirrlloais and patients with unexplained persistent liver function abnonnality. Fenoflbrate is also contraindicated in patients with preexisting gallbladder disease. |
| SIDE-EFFECTS |
Gastro-intestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dlzzjness, vertigo, fatigue, halr loss and myotoxicily (with myaathenla or myalgia), anaemia, leucopenia, thrombocytopenia. |
| PRECAUTIONS |
Precautions of Fenoftbrate Include risks of pancreatlUs end myopathy. Transient hematologic changes have been reported in some cases. Tlvombocytopania end agranulocytosis have been reported rarely. Fenoflbrale dose should be reduced In presence of renal Insufficiency . |
| USE IN PREGNANCY & LACTATION |
Fenoflbrale is not recommended for pregnant women. Fenofibrete is not recommended In nursing mothers and the safely and efficacy of the drug has not been estabIished In pediatric patients. |
| DRUG INTERACTIONS |
Fenoflbrale potentiate the action of oral anticoagulants. In patients recalling oral anticoagulant therapy, the dose should be reduced by one third on starting Fenofibrate and then adjusted according to the international nonnaiized ratio (Prothrombin time). Fenoflbrate should not be used in combination with parllaxlline maleate or with monoamine oxidase inhibitors (MAC Is). Fenofibrate has been given in combination with statins In resistant hyparlipidemias but Ihe incidence of muScle problems end rIlabdomyolysis is increased end care must be exeroised. |
| PHARMACEUTICAL PRECAUTIDN |
Store in a dry place, away from light. Keep out of reach of children. |
| PACKAGING |
| Noficon® Capsule: Box containing 4 strips of 10 capsules each. Each capsule contains Fenofibrate BP 200 mg. Capsule: Box containing 4 strips of 10 capsules each. Each capsule contains Fenofibrate BP 200 mg. |
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