Hyperchol

Fenofibrate (200 M: micronized).

HYPERCHOL 100: Each capsule contains Fenofibrate 100 mg.
HYPERCHOL 300: Each capsule contains Fenofibrate 300 mg.
HYPERCHOL 200 M: Each capsule contains Fenofibrate micronized 200 mg.

Fenofibrate can reduce blood cholesterol levels up to 20-25% and blood triglyceride levels up to 40-50%.
It produces reductions in the low density atherogenic fractions of cholesterol (VLDL and LDL), thus improving cholesterol distribution in plasma. Fenofibrate reduces the total cholesterol/HDL cholesterol ratio, this ratio increases during atherogenic hyperlipidemia conditions.
The rapid increase of LDL in liver cells is a result of the inhibition of HMG-CoA reductase, a condition that can be improved by Fenofibrate.
Fenofibrate increases apolipoprotein A1 levels and reduces apolipoprotein B levels, thereby improving the apo A1/apo B ratio, the indicator for atherogenic risk.
Extravascular cholesterol reserves (xanthum tendinosum and tuberosum) can experience significant regression or can disappear completely on prolonged effective usage of the drug.
Increased urinary excretion of uric acid, which plays an important role in reducing mean blood uric acid levels up to 25% has been observed in hyperlipidemic patients.
An antiaggregation effect has been observed in clinical studies. It was the result of reduction of aggregation related to ADP, arachidonic acid and epinephrine.

Hypercholesterolemia (type IIa), endogenous hypertriglyceridemia whether isolated (type IV) or associated (type IIb and III); when therapeutic response to diet alone has been inadequate, when blood cholesterol level remains high in spite of the diet alone has been inadequate and/or when there is a relating risk factor involved. It is important, however, to continue with diet.

Hyperchol: Adults: Treatment: 3 x 100 mg or 1 x 300 mg daily. When after the diet cholesterol level stands above 4 g/L, the dosage may reach 4 x 100 mg daily. The initial dosage must be maintained until cholesterol levels gets back to normal. Once it is normalized, dosage of 2 x 100 mg daily can be advised providing that cholesterol is checked every 3 months. Go back to dosage 3 x 100 mg or 1 x 300 mg daily in case of a new increase of the level of the lipidic parameters.
Hyperchol 200 M: For adult patient the recommended initial dose is 1 capsule of HYPERCHOL 200 M per day. If cholesterol level is ≥4 g/L after tight diet, it is advisable to give 1 capsule HYPERCHOL 100 and 1 capsule HYPERCHOL 200 M per day may be increased to 400 mg (2 capsules HYPERCHOL 200 M per day) and should be maintained until the cholesterol level return to normal, a maintenance dose of 1 capsule HYPERCHOL 200 M per day and the serum lipid levels should be monitored. As the absorption of Fenofibrate is increased when administered with food, HYPERCHOL should be given with meals. The dosage must be increased to 300 mg per day if there is a rise in blood cholesterol level.

HYPERCHOL is contraindicated in patients who exhibit hypersensitivity to Fenofibrate.
HYPERCHOL is contraindicated in children and in patients with hepatic or renal dysfunction, including biliary disease.

If after several months (3-6 months) of treatment, no adequate reduction in serum lipid levels are achieved, a different therapy (combination or use of a different drug) should be considered. Transient increases in serum transaminases have been reported in some patients, therefore it is recommended to:
Regular monitoring of transaminase levels every 3 months, should be performed for more than 12 months of initial therapy.
Therapy should be discontinued temporarily, if SGPT level rises above 100 IU.
Avoid hepatotoxic substances such as perhexillin maleate and MAOI when using Fenofibrate.

HYPERCHOL is not recommended for pregnant women and nursing mothers.
Pregnancy: No teratogenic effect was found in preclinical studies; at present there are no adequate and well-controlled studies on the teratogenic effect of Fenofibrate in human, therefore the use of the drug in pregnant women is not recommended.
Lactation: Although there is no information on excretion of Fenofibrate in the milk, the drug should not be used in nursing mothers.

Adverse events reported are mild and occur seldom.
Reported adverse events include: Mild gastrointestinal disturbances (dyspeptic type). Allergic reactions. Myalgia accompanied by increased Creatine Phosphokinase. Modest rise (transient) in serum transaminase levels. Hematology: anemia, leukopenia and thrombocytopenia have been reported. Alopaecia. Sexual asthenia.

Caution should be exercised when anticoagulants are given in concomitant with Fenofibrate. The dosage of the anticoagulants should be reduced to maintain the prothrombin time at the normal level to prevent bleeding complications. Prothrombin time monitoring is advisable until it has been determined that the prothrombin time has stabilized at normal levels. In concurrent therapy with resin, it is recommended to take the resin at an interval of 2 hours prior to administration of HYPERCHOL. The combined use of Fibrate and derivates and HMG-CoA reductase inhibitors may produce myopathy. So far there is no proof of clinical interactions of Fenofibrate with other drugs. As with other fibrate derivatives, it is advisable to monitor the concurrent use with oral hypoglycemic agents.

Store below 30°C.

Dyslipidaemic Agents

C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.

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