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Lipanthyl supra 160

 

NAME OF THE MEDICINAL PRODUCT

LIPANTHYL SUPRA 160 mg


PHARMACEUTICAL FORM

Film-coated tablet.


COMPOSITION FOR ONE TABLET
Active ingredient: Fenofibrate (INN) 160 mg.
Excipients: Sodium laurilsulfate, lactose monohydrate, povidone, cellulose microcrystalline, silica colloidal anhydrous, crospovidone, sodium stearyl fumarate.
Composition of the coating: polyvinyl alcohol, titanium dioxide (E171), talc, (soybean) lecithin, xanthan gum.


PHARMACOLOGICAL PROPERTIES
Serum Lipid Reducing Agents/Cholesterol and Triglycerides Reducers/Fibrates.
ATC code: C10 AB 05

Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPARα ).

 

Through activation of PPARα , fenofibrate increases the lipolysis and elimination of atherogenic triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein CIII. Activation of PPARα also induces an increase in the synthesis of apoproteins AI and AII.


The above stated effects of fenofibrate on lipoproteins lead to a reduction in very low- and low density fractions (VLDL and LDL) containing apoprotein B and an increase in the high density lipoprotein fraction (HDL) containing apoprotein AI and AII.

 

In addition, through modulation of the synthesis and the catabolism of VLDL fractions, fenofibrate increases the LDL clearance and reduces small and dense LDL, the levels of which are elevated in the atherogenic lipoprotein phenotype, a common disorder in patients at risk for coronary heart disease.


During clinical trials with fenofibrate, total cholesterol was reduced by 20 to 25%, triglycerides by 40 to 55% and HDL cholesterol was increased by 10 to 30%.


In hypercholesterolaemic patients, where LDL cholesterol levels are reduced by 20 to 35%, the overall effect on cholesterol results in a decrease in the ratios of total cholesterol to HDL cholesterol, LDL cholesterol to HDL cholesterol, or Apo B to Apo AI, all of which are markers of atherogenic risk.


Because of its significant effect on LDL cholesterol and triglycerides, treatment with fenofibrate should be beneficial in hypercholesterolaemic patients with or without hypertriglyceridaemia, including secondary hyperlipoproteinaemia such as type 2 diabetes mellitus.


At the present time, no results of long-term controlled clinical trials are available to demonstrate the efficacy of fenofibrate in the primary or secondary prevention of atherosclerotic complications. Extravascular deposits of cholesterol (tendinous and tuberous xanthoma) may be markedly reduced or even entirely eliminated during fenofibrate therapy.


Patients with raised levels of fibrinogen treated with fenofibrate have shown significant reductions in this parameter, as have those with raised levels of Lp(a). Other inflammatory markers such as C Reactive Protein are reduced with fenofibrate treatment.

 

The uricosuric effect of fenofibrate leading to reduction in uric acid levels of approximately 25% should be of additional benefit in those dyslipidaemic patients with hyperuricaemia.

 

Fenofibrate has been shown to possess an anti-aggregatory effect on platelets in animals and in a clinical study, which showed a reduction in platelet aggregation induced by ADP, arachidonic acid and epinephrine.


Pharmacokinetic properties
LIPANTHYL SUPRA 160 mg is a film-coated tablet containing 160 mg of micronised fenofibrate and is suprabioavailable (larger bioavailability) compared to the previous formulations.


Absorption: Maximum plasma concentrations occur within 4 to 5 hours after oral administration. Plasma concentrations are stable during continuous treatment in any given individual. The absorption of fenofibrate is increased when administered with food.


Distribution: Fenofibric acid is strongly bound to plasma albumin (more than 99%).


Plasma half-life: The plasma elimination half-life of fenofibric acid is approximately 20 hours.


Metabolism and excretion: No unchanged fenofibrate can be detected in the plasma where the principal metabolite is fenofibric acid. The drug is excreted mainly in the urine. Practically all the drug is eliminated within 6 days. Fenofibrate is mainly excreted in the form of fenofibric acid and its glucuronide conjugate. In elderly patients, the fenofibric acid apparent total plasma clearance is not modified. Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate. Fenofibric acid is not eliminated by haemodialysis.


INDICATIONS
Hypercholesterolaemia and hypertriglyceridaemia alone or combined (types IIa, IIb, IV dyslipidaemias, as well as types III and V dyslipidaemias) in patients unresponsive to dietary and other non-drug therapeutic measures (e.g. weight reduction or increased physical activity), particularly when there is evidence of associated risk. The treatment of secondary hyperlipoproteinaemias is indicated if the hyperlipoproteinaemia persists despite effective treatment of the underlying disease (e.g. dyslipidaemia in diabetes mellitus).

 

Dietary measures initiated before therapy should be continued.


CONTRA-INDICATIONS
LIPANTHYL SUPRA 160 mg is contra-indicated in children, during pregnancy or lactation, in patients with liver insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality), severe renal insufficiency (creatinine clearance < 20ml/min), in patients hypersensitive to fenofibrate and/or excipients, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen, chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia, gallbladder disease.. LIPANTHYL SUPRA 160 mg should not be taken in patients allergic to peanut or arachis oil or soya lecithin or related products due to the risk of hypersensitivity reactions.


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