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Tricor 160mg 30 Tabs, Fenofibrate

Tricor 160mg 30 Tabs, Fenofibrate
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Tricor 160mg 30 Tabs, Fenofibrate


THERAPEUTIC INDICATIONS: Hypercholesterolemia and hypertriglyceridemia alone or in combination (dyslipidemia type IIa, IIb and IV dyslipidemias and type III and V [although the proportion of patients with the latter two types of dyslipidemia have been treated with fenofibrate during clinical trials has been less]) in patients unresponsive to dietary measures and pharmacological (eg, weight loss or increased physical activity), particularly when there is evidence of risk factors. Treatment of secondary hyperlipoproteinemia is indicated if the hyperlipoproteinaemia persists despite effective treatment of the underlying disease (eg dyslipidaemia in diabetes mellitus).

Should be continued nonpharmacologic measures before treatment started. Pharmacokinetics in Humans: Pharmacokinetics CONTROLIP is a 160 mg capsule contains 160 mg of micronized fenofibrate and is suprabioavailable (high bioavailability) compared with previous formulations. Absorption: Maximum plasma concentrations (Cmax) occur within 4 to 5 hours after oral administration. Plasma concentrations are stable during continuous treatment in any individual. The absorption of fenofibrate is increased when administered with food. Distribution: fenofibric acid binds strongly 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 plasma, since the main metabolite is fenofibric acid. The drug is excreted mainly in urine. Practically all the drug is eliminated within 6 days. Fenofibrate is mainly excreted as fenofibric acid and its glucuronide conjugate. In elderly patients, total clearance of fenofibric acid in plasma is not altered. Kinetic studies after administration of a single dose and the continuous treatment have shown that the drug does not accumulate. Fenofibric acid is not removed by hemodialysis. Pharmacodynamics: Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of receptor activator of peroxisome proliferator-alpha (PPARa, for its acronym in English). Through activation of PPARa, fenofibrate increases lipolysis and removal of triglyceride-rich particles from the plasma by activating lipoprotein lipase and to reduce the production of apolipoprotein CIII. Activation of PPARa also induces an increase in the synthesis of apo AI and AII.

The above mentioned effects on lipoproteins fenofibrate produce a reduction in cholesterol fractions of low and very low density (LDL and VLDL) containing apoprotein B and an increase in the fraction of HDL cholesterol (HDL) containing apoprotein AI and AII. Additionally, by modulating the synthesis and catabolism of VLDL fractions, fenofibrate increases clearance of LDL and reduces the proportion of the dense LDL particles and small levels of the latter are elevated in the atherogenic phenotype lipoprotein, a common disorder in patients at risk for coronary heart disease. During clinical trials with fenofibrate, total cholesterol was reduced from 20 to 25%, triglycerides by 40-55% and HDL cholesterol increased from 10 to 30%.

In hypercholesterolemic patients, in which reduced LDL cholesterol levels 20 to 35%, the overall effect on cholesterol resulted in a decrease in the ratios of total cholesterol / HDL cholesterol, LDL cholesterol / HDL cholesterol or Apo B / Apo AI, all of which are markers of atherogenic risk. Due to its significant effect on LDL cholesterol and triglycerides, treatment with fenofibrate should be beneficial in hypercholesterolemic patients with or without hypertriglyceridemia, including secondary hyperlipoproteinaemia such as type 2 diabetes mellitus. Currently there are no results from controlled clinical studies demonstrating long-term 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 completely eliminated during treatment with fenofibrate. Patients with elevated levels of fibrinogen treated with fenofibrate have shown significant reductions in this parameter, such as those with elevated Lp (a). Other inflammatory markers such as CRP are reduced with treatment based on fenofibrate. The uricosuric effect of fenofibrate leading to reduced approximately 25% of uric acid levels and this should be an additional beneficial effect in dyslipidemic patients with hyperuricemia. Fenofibrate has been shown to have an antiplatelet effect on platelets in animals and clinical studies, which have shown a reduction in platelet aggregation induced by ADP, arachidonic acid and epinephrine.

In fenofibrate-treated rats was observed 80% inhibition of the activity of HMG-CoA in liver microsomes. This phenomenon could partly explain the mechanism of action of fenofibrate in man. Contraindications • Hepatic impairment (including biliary cirrhosis). • Kidney failure. • Children. • Hypersensitivity to fenofibrate or any component of the formula. • History of photoallergic or phototoxic reaction during treatment with fenofibrate and ketoprofen. • gallbladder disease. Use during pregnancy and lactation: See Restrictions on use during pregnancy and lactation.

PRECAUTIONS: Liver function: As with other lipid lowering agents, have reported increases in transaminase levels in some patients. In most cases these elevations were transient, mild and asymptomatic. It is recommended to monitor transaminase levels every 3 months during the first 12 months of treatment. Attention should be paid to patients who develop increased transaminase levels and should be discontinued if the levels of AST and ALT levels increase to more than three times the upper limit of normal range or 100 IU Muscle: Muscle toxicity has been reported, including rare cases of rhabdomyolysis, with administration of fibrates and other lipid lowering agents. The incidence of this disorder increases in cases of hypoalbuminaemia and previous renal insufficiency.

Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis, muscle spasms and weakness and / or marked increases in CPK (levels exceeding 5 times the normal range). In these cases treatment with fenofibrate should be discontinued.

The risk of muscle toxicity may be increased if the drug is administered with another fibrate or HMG-CoA reductase, especially in cases of pre-existing muscular disease. Consequently, the coprescripción of fenofibrate with a statin should be reserved for patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscle disease. This combination treatment should be used with caution and patients should be monitored closely by if signs of muscle toxicity.

For hyperlipidaemic patients taking oestrogens or contraceptives containing estrogen, confirm whether the hyperlipidaemia is of primary or secondary nature (possible elevation of lipid values ​​caused by oral estrogen). If after a period of administration of 3 to 6 months has not obtained a satisfactory reduction of serum lipid levels, consider the use of additional or different therapeutic measures. Fenofibrate should not be combined with hepatotoxic substances, such as perhexiline maleate or MAO inhibitors. Pancreas:

There have been reports of pancreatitis in patients who were treated with fenofibrate. However, not established a causal link. Use in Pregnancy and Lactation: No adequate data on the use of fenofibrate in pregnant women. Animal studies have not demonstrated any teratogenic effect. Embryotoxic effects were observed at doses in the range of maternal toxicity (see

PRECAUTIONS effects related to carcinogenesis, mutagenesis, teratogenesis and on fertility). It is not known the potential risk to humans. No data on the excretion of fenofibrate and / or its metabolites in breast milk, so it is recommended not using the product during lactation.

ADVERSE REACTIONS: The most commonly reported adverse reactions include: Gastrointestinal Disorders Digestive, gastric or intestinal moderate severity (abdominal pain, nausea, vomiting, diarrhea and flatulence). Skin reactions may occur such as rashes, pruritus, urticaria or photosensitivity reactions; in individual cases (even after several months of uncomplicated use) cutaneous photosensitivity may occur with erythema, vesiculation or nodulation on parts of skin exposed to light sunlight or artificial UV light (eg sunlamp).

Less frequently reported adverse reactions: Liver: You can get to find mildly elevated serum transaminases in some patients (see Precautions). Have been reported very rarely episodes of hepatitis. When symptoms are indicative of the occurrence of an hepatitis (jaundice, pruritus), you must perform tests to confirm this state and fenofibrate discontinued, if necessary (see Precautions). Muscle: As with other lipid-lowering agents have been reported some cases of muscle toxicity (diffuse myalgia, myositis, muscular cramps and weakness) in very rare cases of rhabdomyolysis. These effects are usually reversible when the drug is discontinued (see Precautions). In rare cases, have reported the following effects: cholelithiasis (but any causal relationship remains inconclusive) sexual asthenia and alopecia. There were also increases in serum creatinine and urea, which are generally mild, and also a slight decrease in hemoglobin and leukocytes. DRUG

INTERACTIONS AND OTHER GENDER: Oral anticoagulants: Fenofibrate increases the effect of oral anticoagulants and may increase the risk of bleeding. It is recommended that the dose of anticoagulants is reduced by one third at the start of treatment and then gradually adjust if necessary, according to the monitoring of INR (English acronym for International Standard Ratio). Cyclosporine have been reported some severe cases of reversible alteration in renal function during concomitant administration of fenofibrate and cyclosporin. Therefore, the renal function of these patients should be monitored closely and should be discontinued if fenofibrate severe alterations in laboratory parameters.

CHANGES IN RESULTS OF LABORATORY TESTS: See PRECAUTIONS and ADVERSE REACTIONS. PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, Impairment of Fertility: Chronic toxicity studies have yielded little information relevant to the specific toxicity of fenofibrate. The mutagenicity of fenofibrate have been negative. We found liver tumors in rats and mice at high doses, which is attributed to the proliferation of perixomas. These changes are specific to small rodents and has been observed that does not happen in other animal species. This is not relevant for therapeutic use in man. Studies in rats, mice and rabbits revealed no teratogenic effects. Embryotoxic effects were observed at doses in the range of maternal toxicity. At high doses, there was prolongation of the gestation period and difficulties during childbirth. No evidence has been detected any effect on fertility.

DOSAGE AND ADMINISTRATION: Adults: The recommended dose is one capsule containing 160 mg fenofibrate once daily. Patients who are currently taking a capsule of 250 mg CONTROLIP can be changed to a 160 mg capsule without making other adjustments. Elderly patients: The recommended dose in adults. Patients with renal impairment: Fenofibrate is contraindicated in patients with renal insufficiency. Children:

The use of the dosage form of 160 mg is contraindicated in children. Liver disease has not been studied using this dose in patients with liver disease. After starting treatment with fenofibrate should continue dietary measures started before drug treatment. If after several months of the administration of fenofibrate (eg 3 months) serum levels of lipids have not been successfully reduced, it should consider additional or different therapeutic measures. Method of administration: The capsules should be swallowed intact during meals.

REPRESENTATIONS AND MANAGEMENT Overdosage: No reports of overdose. There is no known specific antidote. If overdose is suspected, you must treat symptomatically and institute supportive measures as required. Fenofibrate can not be removed by hemodialysis.

Name of medicine: Controlip
Comparable patent medicine: Tricor
Active ingredient: Fenofibrate
Presentation: Capsules
Concentration: 160 mg
Lab: abbott laboratories Mexico
Box: 30 pills
Made in: France           

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