Fenostad 200 STADA treatment for hyperglyceride severe blood triglyceride (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Fenofibrate
Ingredient
| Composition information | Content |
| Fenofibrate | 200mg |
Uses
Indications
fenostad is indicated to support diets and other non -drug treatments (such as exercise, weight loss):
Pharmacology
Fenofibrate is a derivative of fibric acid that adjusts lipids in people through intermediaries to activate PPAR PPAR α (PPARα). Through the activation of PPARα, Fenofibrate increases lipid resolution and eliminates triglyceride particles from plasma by activating lipoprotein lipase and reducing the production of apoprotein C - III. Activation of pparα also increases the synthesis of apoprotein A - I and A - II.
There is evidence that fibrate treatment may reduce the factors of coronary artery disease but do not show reducing all causes of death in primary or secondary prevention of cardiovascular disease.
Studies with fenofibrate always show a decrease in the concentration of LDL - cholesterol. HDL - cholesterol usually increases. Triglyceride concentration also decreases. This leads to a decrease in the rate of LDL and VLDL compared to HDL, correlating with a decrease in the risk of atherosclerosis in epidemiological studies. Apoliprotein - A and Apoliprotein - B are changed corresponding to the levels of HDL and LDL, VLDL.
Foreign cholesterol accumulation (yellow tumors in tendons and tumors) can be significantly reduced or even completely removed during fenofibrate treatment.
Plasma acid levels increased by about 20% in patients with hyperlipidemia, especially in type IV patients.
Fibrinogen patients treated with fenofibrate have shown a significant decrease in this parameter, which is similar to LP (A) increase. Other inflammatory substances such as protein C reacts when treated with fenofibrate.
The effect of increasing urinary uric acid of fenofibrate leads to a reduction in uric acid levels by about 25% more beneficial in patients with blood lipid disorders with hyperuricemia.
Fenofibrate has anti -platelet aggregation effect in animals and in a clinical study, this shows the effect of reducing platelet aggregation caused by ADP, Arachidonic Acid and Epinephrine.
Data in children is limited. The effect of fenofibrate in children with blood lipid disorders has been studied in two small clinical trials and in a long -term monitoring registration with 76 children with hypercholesterolemia from 3 to 18 years old, Fenofibrate from 1 to 11 years. However, due to limited data and lack of methodology, no end results can be drawn about the use of fenofibrate in children with blood lipid disorders.
Unwanted effects have been reported in children similar to adults: leukopenia, abnormal liver function tests, muscular elimination, kidney failure, liver failure, jaundice, muscle inflammation and muscle pattern.
Mechanism of action
fenofibrate is a derivative of fibric acid, the substance is reported to have the effect of changing lipid levels in humans through activating peroxisome ProLiferator Activated Receptor Type α (PPARα).
Through the activation of PPARα, Fenofibrate increases the hydrolysis and elimination of triglycerides -rich sub -fertilizers from plasma by activating lipoprotein lipase and reducing the production of apoprotein C - III. The activation of pparα also increases the synthesis of apoprotein A I and A II.
The above starting efficiency for lipoprotein leads to reducing LDL and VLDL containing Apoprotein B and increases HDL containing Apoprotein A I and A II.
In addition, through the synthesis and catabolic changes of components of VLDL, Fenofibrate, increasing LDL clearance and low density LDL reduction, these substances are often high in the forms of atherosclerotic lipoprotein in vascular disorders, a common disorder in patients at risk of coronary artery disease.
Pharmacokinetics
absorption
Maximum concentration in plasma (cmax) is achieved within 4-5 hours after drinking. The concentration in plasma is stable during continuous treatment in any individual.
Fenofibrate absorption is increased when used with food.
Distribution
fenofibric acid has a strong link to plasma albumin (over 99%).
Metabolism and elimination
After drinking, fenofibrate is quickly hydrolyzed by esterases into metabolites with fenofibric acid activity.
No discovery of unchanged fenofibrate in plasma. Fenofibrate is not the substrate of CYP3A4. There is no metabolism of the liver.
The drug is excreted mainly in urine. In fact all drugs are eliminated within 6 days. Fenofibrate is mainly eliminated in the form of fenofibric acid and glucuronide.
In the elderly, the total clearance of fenofibric acid in plasma does not change.
Dynamic studies after the only dose and continuous treatment have shown no drug accumulation.
fenofibric acid is not eliminated through hemolysis.
Semi -selling time in the plasma of fenofibric acid is about 20 hours.
Before taking Fenostad 200 STADA treatment for hyperglyceride severe blood triglyceride (3 blisters x 10 tablets)
How to use
still have to continue the diet used before treatment. Monitoring the treatment response by determining serum lipid value.
If not appropriate response after a few months (3 months) should consider additional treatments or other treatments.
fenostad should take whole tablets with meals.
Dosage
Adults
recommended dose is 200 mg/day (1 tablet fenostad 67 x 3 times/day or 1 tablet fenostad 100 x 2 times/day).
If necessary, the dose can be adjusted up to 267 mg/day (1 fenostad 67 x 4 times/day). This dose is not recommended when combined with statin.
200 mg or 160 mg: The recommended starting dose is 1 tablet/day with the main meal. Patients who are taking a fenofibrat 200 mg capsule can be changed to a Fenofibrat 160 mg tablet without additional adjustment.
Elderly (≥ 65 years)
No dose adjustment.
Dosage recommended, except for patients with impaired renal function at estimated glomerular filtration rate (EGFR)
kidney failure
Do not use fenofibrate in patients with severe renal failure, with EGFR
Fenofibrate dose does not exceed 100 mg or 67 mg Micronized x 1 time/day if EGFR is from 30 - 59 ml/min/1.73 m2.
Stop using fenofibrate if during EGFR treatment continues to decrease to
Hepatic failure
It is not recommended to use fenostad in patients with liver failure due to lack of data.
Children
recommended dose for children is 1 tablet fenofibrate (67 mg) micronised/day/20 kg body weight.
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? There is no specific antidote. If suspected of overdose, symptomatic treatment and appropriate support measures when needed. Hematopathy does not eliminate fenofibrat.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting a 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.
Side Effects
When using the drug, you may experience unwanted effects (ADR).
Common (1/100 ≤ ADR
Uncommon (1/1,000 ≤ ADR
Liver: gallstones. Skin and subcutaneous tissue: Hypersensitivity due to skin (such as rash, itching, urticaria). Testing indicators (research): increased blood creatinine. Rare (1/10,000 ≤ ADR Hepatitis: Hepatitis. Skin and subcutaneous tissue: Hair loss, light -sensitive reaction. Notify the doctor with unwanted effects when using the drug. Instructions on how to handle ADR With minor adverse reactions, usually just stop the drug. In case of severe sensitivity or allergic reactions, supportive treatment (airy keeping and using epinephrin, oxygen breathing, antihistamine, corticoid ...).
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
contraindicated drugs in the following cases:
Hepatic failure (including cholestasis and long -term liver function abnormalities).
Severe renal failure (the rate of glomerular filtration is estimated
Acute or chronic pancreatitis, except for acute pancreatitis due to severe hyperglyceremia. secondary causes of hyperlipidemia Secondary cause of hyperlipidemia, such as type 2 diabetes uncontrolled, thyroid failure, nephrotic syndrome, blood protein disorders, obstructive liver disease, pharmacological treatment, alcoholism should be fully treated before using fenofibrate. Secondary cause of hematuria hyperkemops related to pharmacological treatment can be seen in diuretics, beta blocker, estrogen, progestogen, oral contraceptives used in combination, immune inhibitors and protease. In these cases, it is necessary to determine the cause of hyperlipidemia is primary or secondary (these treatment agents may increase lipid value). Liver function Like other lipid remedies, increasing transaminase levels in some patients have also been reported. In most cases, increased transient, mild and asymptomatic. Advice to monitor Transaminase concentration every 3 months in the first 12 months of treatment and periodic treatment. Pay attention to patients who progress to increase transaminase concentration and stop treatment if AST (SGOT) and ALT (SGPT) concentration exceeds 3 times normal. Stop using fenofibrate when symptoms of hepatitis (such as jaundice, itching), and have been diagnosed with tests. pancreatic gland Pancreatitis has been reported in patients using fenofibrate. This may represent the ineffective of drugs in patients with severe triglycerides, giving a direct effect of the drug, or for a secondary phenomenon from the formation of mud or bile duct stones with bile duct obstruction. muscle disease Mechanical toxicity, including rare cases of pattern, have or without kidney failure, have been reported when using fibrates and other lipid medications. The incidence of this disorder increases in cases of decreased blood albumin and kidney failure. Patients with factors leading to muscle disease and/or muscle pattern, including over 70 years old, a history of patients or families with genetic disorders, kidney failure, hypothyroidism and drinking a lot of alcohol, can also increase the risk of progression of muscle panoda. For these patients, careful consideration of the benefits and risks of fenofibrate therapy. Muscle poisoning is suspected in patients manifesting muscle pain, muscle inflammation, muscle spasm and/or/or increased creatine phosphokinase (CPK) (exceeding 5 times). Stop using fenofibrate in these cases. The risk of muscle poisoning may increase if the drug is used simultaneously with another fibrate or a HMG - coa reductase inhibitor, especially when there is a muscle disease before. Therefore, the indication of using fenofibrate with a HMG - coa reductase or another fibrate inhibitor should be reserved for patients with serious mixed blood lipid disorders and high cardiovascular risks without any history of muscle disease and closely monitoring muscle toxicity signs. Kidney function fenostad is contraindicated in severe renal failure. fenostad should be used carefully in patients with mild to medium renal failure. The dose should be adjusted in patients with glomerular filtration estimated from 30 - 59 ml/min/1.73 m2. Increased serum creatinine has been reported in patients using single -treatment fenofibrate or coordinated with statin. High concentration of serum creatinine is often stable over time without continuing to increase when long -term treatment and tend to return to normal when stopping treatment. In clinical trials, the proportion of patients increased by more than 30 μmol/l Creatinin compared to the original level when used in combination with fenofibrate and simvastatin is 10% compared to when using statin monatlyners is 4.4%. 0.3% of patients use simultaneously fenofibrate and statin with high creatinine, over 200 μmol/l. Stop treatment when creatinine concentration is 50% higher than normal. Reconcalation recommendations for creatinine in the first 3 months of treatment and regular monitoring. Children Only genetic disease (hyperemia family lipids) need early treatment, and the true nature of hyperlipidemia must be determined by genetic studies and laboratories. Should start treatment with controlled diets for at least 3 months. Continuing medication treatment should only be considered after medical advice and clinical signs in severe form such as atherosclerosis and/or yellow tumors and/or in the case of patients with atherosclerosis before 40 years old. excipients The drug contains sucrose (Sugar Spheres). This medication should not be used for patients with rare genetic problems that are fructose intolerance, Glucose - Galactose or SUCRASE - Isomaltase. fenostad does not have or negligible on the ability to drive and operate machinery. pregnancy There is no adequate data on the use of fenofibrate in pregnant women. Animal studies have not proven any teratogenic effects. The fetal toxicity effect has appeared within the range of toxic doses for the mother. Potential risks for unknown people. Therefore, Fenostad should only be used during pregnancy after careful evaluation of benefits and risks. Reproduction The effects of reproductive recovery have been observed in animals. There is no clinical data for fertility when using fenofibrate. Breastfeeding period It is unknown whether fenofibrate and/or its metabolites are excreted into breast milk or not. Can not rule out the risk for breastfeeding. Therefore, Fenofibrate should not be used for nursing women. Oral anticoagulant drugs Fenofibrate increases the effects of oral anticoagulants and may increase the risk of bleeding. The dose should be reduced by about 1/3 in patients who start treatment with oral anticoagulants and dose adjustments if needed depending on the control of INR (international standardized ratio). cyclosporin Some severe cases of recovery renal function have been reported when used simultaneously fenofibrate and cyclosporin simultaneously. Therefore, the kidney function in these patients must be closely monitored and stop using fenofibrate in case of serious changes in testing indicators. HMG inhibitors - CoA Reductase or other fibrates The risk of severe muscle poisoning increases if used simultaneously fenofibrate with HMG - COA Reductase inhibitors or other fibrates. This combination therapy should be used carefully and patients should be closely monitored by signs of muscle poisoning. There is no evidence that fenofibrate affects the pharmacokinetics of simvastatin. Glitazones Some cases of HDL - cholesterol recovery reduction have been reported when used simultaneously fenofibrate and glitazones. Therefore, HDL - cholesterol should be monitored if they use these two drugs simultaneously and stop treating either if HDL - cholesterol is too low. enzyme cytochrome p450 In vitro studies use human liver microsome shows that fenofibrate and fenofibric acid are not Cytochrome inhibitors (CYP) P450 CYP3A4 form, CYP2D6, CYP2E1, or CYP1A2. They are weak inhibitors CYP2C19 and CYP2A6, and mild to medium inhibitors CYP2C9 at treatment concentration. In patients with simultaneous use of fenofibrate with drugs with narrow treatment metabolized through CYP2C19, CYP2A6 and especially CYP2C9, should carefully monitor and adjust these drugs if needed. Other As other fibrates in general, fenofibrate induction oxidation microsom enzymes with a mixed function related to the metabolism of fatty acids in rodent and can interact with drugs metabolic by these enzymes. Be cautious when using
The ability to drive and operate machinery
During pregnancy and lactation
Interactive drug
Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
To be out of reach of children.
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