Fenoflex drug 160mg United treatment of hyperliglyceride severe blood triglycerides (3 blisters x 10 tablets)

Through the activation of ppara, fenofibrat increases lipid decomposition and exemplarity of plasma -rich sub -fertilizers from plasma by activating liporotein lipase and reducing the production of apoprotein ClLL. The activation of Ppara also increases the synthesis of AI apoprotein and all.

The above starting efficiency for lipoprotein leads to reduction in LDL and VLDL containing lipoprotein B, and increases HDL containing AI apoprotein and all. In addition, through the synthesis and catabolic changes of the VLDL components, Fenofibrat increases the LDL clearance and reduces the low density LDL. LDL's concentration is often increasing in risks (arteriosclerosis caused by blood lipids).

In clinical trials with fenofibrat, total cholesterol decreased by about 20-25%, triglycerides decreased by about 40-55%and HDL increased by 10 - 30%.

In patients with hypercholesterolemia, when LDL-cholesterol levels increase by about 20-35%, the overall effect of cholesterol creates a decrease in the total cholesterol ratio compared to HDL-Cholesterol, LDL-Cholesterol compared to HDL-Cholesterol, or APO B compared to AI AI. All of this creates the risk of arteriosclerosis.

So far, in long -term control tests has not seen the results of fenofibrat in preventing complications of atherosclerotic or secondary atherosclerosis.

The condensation of the vasoconstrictor of cholesterol: tendons or tumors in yellow tumors (tuberous xanthoma) may be significantly reduced, even completely lost when treated with fenofibrat.

Patients with high fibrinogen levels are treated with fenofibrat that this parameter is significantly reduced as well as high LP (A) people. The physical expression for inflammation such as C Reactive Protein also decreases when treated with fenofibrat.

The effect of increasing urinary uric acid export of fenofibrat leads to a reduction of uric acid by about 25% - also a very beneficial supportive effect in patients with lipid disorders accompanied by hyperuricemia. Fenofibrat has anti -platelet gathering effect on animal and clinical trials, reducing platelet aggregation created by ADP, arachidonic acid and epinephrin.

Accord research also shows that combination of fenofibrat with simvastatin reduces the rate of diabetic diabetic diabetic disease progression of 36.3% (6.5% compared to 10.2%, P = 0.006); reducing general protein at 14.6% (10.5% compared to 12.3%, P = 0.03); decreased microscopic protein 8.1% (38.2% compared to 41.6%, p = 0.01) compared to therapy only using simvastatin.

In Field research, Fenofibrat reduces spending without injury by 35.7% (0.9% compared to 1.4%, P = 0.02) compared to the control group.

Pharmacokinetics

absorption

Maximum concentration in plasma (cmax) reaches 4-5 hours after drinking. The concentration of drugs in plasma is stable when treated continuously in all individuals. Fenofibrat increases absorption when taken at meals.

Distribution

Fenofibric acid is strongly linked to plasma albumme (> 99%).

Metabolism and elimination

After drinking, fenofibric is quickly hydrolyzed through the catalyst of the esterase so that the active chemical substance is fenofibric acid. Not found in fenofibrate plasma has not metabolized. Fenofibrat is not the substrate of CYP3A4. There is no metabolism through the liver microphone.

This drug is excreted mainly through urine. In fact, all the amount of medicine used is eliminated within 6 days. Fenofibrat is excreted mainly in the form of fenofibric acid and glucuronid complex. For elderly patients, the whole purification of fenofibric acid in plasma has not changed.

Research on dynamics after drinking single doses and continuous treatment has shown that this drug is not accumulated.

Fenofibric acid is not excreted through dialysis. The sale time of fenofibric acid from plasma is about 20 hours.

In patients with renal impairment: In patients with severe renal impairment (creatinine clearance

Based on these findings, Fenofibrat should be avoided in patients with severe renal impairment and need to reduce the dose in patients with medium renal failure. (See dosage, usage and sugar).

No need to adjust the dose with elderly patients without renal failure.

Patients with renal failure

Need to adjust the dose according to creatinine clearance (CRCI):

Fenofibrat 160 mg is not recommended for patients with liver failure because there is no enough data.

Children

Contraindicated dose of this 160 mg division for children.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

No reports related to overdose. There is no specific antidote. If the overdose is suspected, symptomatic treatment should be treated and taken supportive measures when needed. Fenofibrat is not excluded when dialysis.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Be cautious when used

In case of secondary cholesterol hyperplasia such as uncontrolled type 2 diabetes, thyroid failure, kidney syndrome, blood protein disorders, obstructive liver disease being treated, alcoholism, should be treated adequately before using Fenofibrate therapy.

Monitoring treatment response by determining serum lipid value (total cholesterol, ldl-cholesterol, triglyceride), if fully responded, is not achieved after a few months (such as 3 months), should consider additional or use other alternative therapy.

For patients with high blood fat using estrogen or contraceptives containing estrogen, it is clear that increased blood fat is primary or secondary (maybe increased blood fat is due to drinking.

Liver function

As well as other lipid medications, there have been reports on increased transaminase levels in some patients. Most of these cases only increase fleeting, few and almost asymptomatic. It is recommended to monitor Transaminase concentration every 3 months in the first 12 months of treatment and then periodically check. Pay attention to patients with increased transaminase concentration and need to stop treating if ASAT (SGOT) and ALAT (SGPT) concentration increases more than 3 times the upper limit of normal levels.

Pancreatitis

There have been cases of pancreatitis recorded in patients using fenofibrat. This may indicate the failure of these drugs in patients with serious triglycerides, or the secondary treatment phenomenon due to bile stones or sedimentation in the bile duct.

muscle

There have been a report on muscle toxicity, including rare Myoglobulin when taking fenofibrat and other lipid medications. This disorder rate increases in the case of lowering blood albumin and renal failure. An increased risk of urinary globulin may be increased in patients with favorable factors for muscle diseases and/or myoglobulin, including: over 70 years old, personal history or family with genetic disorders, kidney failure, reducing thyroid activity, drinking a lot of alcohol. Must consider the benefits and risks when treating with fenofibrat for these patients.

It is necessary to think about toxicity to muscles when the patient appears muscle pain, muscle inflammation with muscle seizures, cramps and muscle weakness, and/or increasing signs on CPK (concentration of more than 5 times normal). Stop treatment with fenofibrat in these cases.

Increased risk of muscle toxicity when the drug is used simultaneously with other fibrats or HMG-CoA Reductase inhibitors, especially in the case of previous muscle diseases. Therefore, it is necessary to be careful when prescribing fenofibrat with HMG-Coa Reductase or other fibrat inhibitors for patients without a history of muscle disease but there is severe hyperglycemic disorder accompanied by a high risk of cardiovascular disease. Need to strictly check the ability of muscle toxicity.

Kidney function

Cause treatment in case of increased creatinine concentration above 50% of ULN (normal limits of normal). Consider measuring creatinine in the first 3 months of treatment.

Seruminin

Increased serum creatinine levels have been reported in patients using fenofibrat. Creatinine concentration will return to normal when stop using fenofibrat. The clinical significance of these reports is unclear. In Field research, serum creatinine in the group using fenofibrat maintains an average higher than 10 - 12 micromol/l compared to the placebo group after use 4 months until the end of the study.

Measure creatinine levels during the first 3 months at the beginning of treatment and periodically. Creatinine concentration should be monitored in patients with fenofibrat at risk of renal failure such as elderly people, people with diabetes. It is necessary to stop treating when creatinine concentration> 50% of the limit of normal levels.

Causing the secret stasis

Fenofibrat is like clofibrat and gemfibrozil, which can increase the secretion of cholesterol into bile, leading to gallstones. If the gallstones are suspected, gallbladder checks. Fenofibrat should be stopped if you find gallstones.

Venous thrombosis

In Field research, pulmonary embolism (PE) and deep vein thrombosis (DVT) have a higher incidence in the group using fenofibrat compared to the placebo group. Of the 9,795 patients participating in Field research, 4,900 people in the placebo group and 4,895 patients use Fenofibrat. There are 48 cases (1%) in the placebo group and 67 cases (1.4%) in the group using fenofibrat (p = ó, 074) with deep vein thrombosis; 32 cases (0.7%) in the placebo group and 53 cases (1.1%) in the group using fenofibrat (P = 0.022) have symptoms of pulmonary embolism.

blood changes

There is a mitigation of hemoglobin, hematocrit and leukocytes that have been observed in patients after starting treatment with fenofibrat. However, this concentration is maintained stable when taking the drug for a long time. Platelets and leukopenia have been reported in patients treated with fenofibrat. Need to check the number of red blood cells and white blood cells in the first 12 months of treatment.

Hypersensitivity reactions

Acute hypersensitivity reactions such as Stevens-Johnson syndrome and poisoned epidermal necrosis need to be hospitalized and steroid treatment have been reported in some cases of fenofibrat treatment. In a controlled test, the urticaria appeared in the group using fenofibrat and the placebo group was 1.3% compared to 0% and the rash at 1.5% compared to 0.8%.

The opposite HDL-C reduction effect

There has been a report after circulation and clinical trial report of a serious reduction in HDL-C levels (the smallest is 2 mg/dl) occurs in patients with diabetes and no diabetes when starting with fibrate. The reduction of HDL-C is reflected by the reduction of apolipoprotein A1. This decline appears within 2 weeks to the years after starting fibrat treatment. HDL-C concentration remains low until stopping with fibrat; Reaction to stop using Fibrat quickly and stable.

Clinical significance of HDL-C reduction is unknown. HDL-C levels should be checked for the first few months after starting with fibrat treatment. If you see a significant reduction in HDL-C level, it is necessary to stop treating with fibrat, and monitor the concentration of HDL-C until you return to normal, and should not continue to use Fibrat.

Use the same anticoagulant drugs

Be cautious when taking Coumarin anticoagulants along with fenofibrat because of the possibility of Coumarin anticoagulants that extend prothrombin/international standard ratio (PT/INR). To prevent bleeding complications, regularly check PT/INR and need to adjust the dose of anticoagulants until PT/INR is stable (see interaction, cavalry of the drug).

The ability to drive and operate machinery

fenofibrat does not have or have a significant impact on the ability to drive and operate machinery.

Pregnancy

There is no enough data using fenofibrat in pregnant women. Animal research does not see teratogenic effects. However, it has been observed signs of toxic fetuses at a toxic dose for maternal animal. However, the potential risk in people is unknown. Therefore, fenofibrate should only be used during pregnancy when carefully evaluated about benefits/risks.

Lactation period

There is no data on the excretion of fenofibrat and/or of the metabolites of the drug through breast milk. Risks for breastfed babies have not been excluded. So do not use fenofibrat for mothers during breastfeeding.

Interactive drug

Anticertal oral drugs

Do not recommend combining fenofibrat and anticoagulant oral medication. Fenofibrat increases the effects of anticoagulant oral medications and may increase the risk of bleeding. However, if this combination is mandatory, the advice is to reduce 1/3 of the dose with anticoagulant drugs at the time of the beginning of treatment and then gradually adjust it if necessary compared to the INR (international standardization rate).

cyclosporin

A few cases of reversible renal function impaired have been recorded when used simultaneously fenofibrat and cyclosporin. The kidney function in these patients should be closely monitored and stopped treating fenofibrat in cases of serious changes in testing indicators.

HMG-CoA Reductase inhibitors and other fibrats

may increase the risk of muscle poisoning if the drug is combined with other fibrats or HMG-CAA Reductase inhibitors. Very careful with these combination treatments and patients should be closely monitored by the signs of muscle poisoning.

Cytochrom P450 enzymes: Research in the laboratory using human liver criteria shows that fenofibrat and fenofibric acid do not inhibit cytochrom (CYP) P450 isomers such as CYP3A4, CYP2D6, CYP2E1 or CYP1A2. At the treatment concentration, the inhibitors are CYP2C19 and CYP2A6, which inhibits light to medium -sized mildly with CYP2C9. Closely monitor patients to use simultaneously fenofibrat and metabolic drugs via CYP2C19, CYP2á6, especially CYP2C9, with accurate treatment index. Recommended adjustment of the dose of these drugs if necessary.

Glitazon

Some reversible decreases with HDL-cholesterol recovery have been recorded when using simultaneously fenofibrat and glitazon. However, it is recommended to monitor HDL-cholesterol levels if using this combination and stop treatment if HDL-cholesterol is too low.

Bile acid -mounted resin

Because the resin is attached to bile acid can be attached to other drugs when used simultaneously, patients should take fenofibrat at least 1 hour or 4 - 6 hours after using the bile acid -attaching resin to avoid obstructing absorption.

colchicin

Cases of muscle disease, including muscle pepper, have been reported when using fenofibrat simultaneously with colchicin, and should be cautious when prescribing fenofibrat with colchicin.