Nofiate 200 mg Tab

Nofiate 200 mg is indicated for hyperlipidemias of type lla, llb, III, IV & V in patients who have not responded adequately to diet & other appropriate measures.

Fibrates

Nofiate 200 mg is a fibric acid derivative, a prodrug comprising fenofibric acid linked to an isopropyl ester. Nofiate 200 mg is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. The effects of fenofibric acid seen in clinical practice have been explained in vivo in transgenic mice and in vitro in human hepatocyte cultures by the activation of peroxisome proliferator activated receptor α (PPARα)It lowers lipid levels by activating peroxisome proliferator-activated receptor alpha (PPARα). PPARα activates lipoprotein lipase and reduces apoprotein CIII (an inhibitor of lipoprotein lipase activity), which increases lipolysis and elimination of triglyceride-rich particles from plasma. The resulting fall in triglycerides produces an alteration in the size and composition of LDL from small, dense particles (which are thought to be atherogenic due to their susceptibility to oxidation), to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidlyPPARα also increases apoproteins AI and AII, reduces VLDL- and LDL-containing apoprotein B, and increases HDL-containing apoprotein AI and AII. Nofiate 200 mg also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid.

The dose is one 200 mg capsule per day. Dosage should be individualized according to patient response, and should be increased sequentially if necessary following repeat serum triglyceride estimations at 4 to 8 week intervals. Patients should be placed on an appropriate triglyceride-lowering diet before receiving Nofiate 200 mg, and should continue this diet during treatment with Nofiate 200 mg. Nofiate 200 mg should be given with meals, thereby optimizing the bioavailability of the medication.

For the treatment of adult patients with hypercholesterolemia or mixed hyperlipidemia, the initial dose of Nofiate 200 mg is 200 mg per day. For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day. Dose should be individualized according to patient response. Nofiate 200 mg should be given with meal there by, optimizing the bioavailability of the medication. Or, as directed by the registered physician.

Nofiate 200 mg has been reported to potentiate the anticoagulant effects of warfarin. When administered with antidiabetic drug it may improve glucose tolerance and have additive effect. Nofiate 200 mg may also increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, cautions should be taken against the use of Nofiate 200 mg with HMG-CoA reductase inhibitors. However, the use of low-dose statins with Nofiate 200 mg appears to be well tolerated.

Nofiate 200 mg is contraindicated in patients with hypersensitivity to Nofiate 200 mg, severe renal or hepatic impairment, existing gall bladder disease, breast feeding mothers, photosensitivity to ketoprofen.

Gastro-intestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dizziness, vertigo, fatigue, hair loss; myotoxicity.

Pregnancy Category C. Nofiate 200 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Nursing mothers: Nofiate 200 mg should not be used in nursing mothers. Because of the potential for tumorigenicity seen in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug.

Special care needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity; discontinue if myotoxicity suspected or creatinine kinase concentration increases significantly. Liver function tests recommended every 3 months for first year.

There is no specific treatment for overdose with Nofiate 200 mg. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because Nofiate 200 mg is highly bound to plasma proteins, hemodialysis should not be considered.

Do not store above 30°C. Keep away from light and out of the reach of children.

Geriatrics: This indicates that a similar dosage regimen can be used in the elderly, without increasing accumulation of the drug or metabolites.Pediatrics: No data are available. Nofiate 200 mg is not indicated for use in the pediatric population.Gender: No pharmacokinetic difference between male and female has been observed for Nofiate 200 mg.Renal insufficiency: The dosage of Nofiate 200 mg should be minimized in patients who have severe renal impairment, while no modification of dosage is required in patients having moderate renal impairment.Hepatic insufficiency: No pharmacokinetic study has been conducted in patients having hepatic insufficiency.

Fibrates

Nofiate 200 mg is a fibric acid derivative. Nofiate 200 mg is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Nofiate 200 mg results in increases in HDL and apo-proteins apoAI apoAII. Nofiate 200 mg also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid. The micronised form of Nofiate (Nofiate 200 mg) has enhanced absorption over the non-micronised formulation.

Nofiate 200 mg is not recommended for pregnant women.