Hafenthyl 300 Hasan treats lipoprotein disorders (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Fenofibrat

Ingredient

Composition information	Content
Fenofibrat	300mg

Uses

indications

Hafenthyl 300 is indicated in the following cases:

Lipoprotein disorders of IIA, IIB, III, IV and V Types in patients do not respond to diets and other non -drug treatments. The diet must still be maintained during medication.

Pharmacology

fenofibrat, derivative of fibric acid, is an intermediary blood lipid that interacts with Peroxisom hyperactive receptor (PPAR). The three types of ppar participating in this process are α, β and γ. Fibrat associated with pparα mainly in the liver and adipose tissue, less in the kidneys, heart and skeletal muscles.

Fibrat reduces triglycerides by stimulating through pparα intermediaries of fatty acid oxidation, increasing lipoprotein lipase synthesis, and reducing APOC - LLL's expression. The increase in lipoprotein lipase will increase the clearance of triglycerides rich in lipoprotein. The reduction of APOC - LLL production in the liver will increase the clearance of lipoprotein very low density (VLDL) and low density lipoprotein (LDL). The fibrats increase the high density lipoprotein level (HDL) due to the activation of pparα, increasing the synthesis of APOA - I and APOA - II.

Fenofibrat can reduce 20-25% of total cholesterol and 40-50% of triglycerides in the blood. Fenofibrat treatment needs to be continuous. There is a decrease in cholesterol of low density and very low density lipoprotein (LDL, VLDL) which are the ingredients that cause atherosclerosis and increase the cholesterol of high density lipoprotein (HDL). The relationship between hyperchemical hyperkemin and atherosclerosis has been established, and the relationship between atherosclerosis and the risk of coronary artery. HDL concentration is associated with high coronary risk. High triglyceride concentration is also associated with increased cardiovascular risk.

There is evidence that the treatment of fibrats may reduce the risk of coronary artery events, but have not yet noticed a decrease in death in the first or secondary prevention of cardiovascular disease. Although fibrats can reduce the risk of coronary events in humans with low HDL - cholesterol or high triglycerides, the first statin (HMG inhibitor) should be used first. Fibrats are only the leading treatment for patients with blood triglycerides higher than 10 mmol/iodine or non -tolerated persons.

Fenofibrat also reduces blood uric acid in normal people and people with hyperuricemiaemia due to increased urine elimination of urine.

Fenofibrat can also reduce platelet aggregation and reduce blood uric acid.

Pharmacokinetics

absorption

Fenofibrat is well absorbed in the digestive tract. The maximum concentration in plasma (CMAX) reaches 2-4 hours after taking the drug. The concentration of drugs in plasma is stable when treated continuously in all individuals. The peak concentration in plasma and the total exposure of Fenofibrat does not depend on the meal. Therefore, it is possible to take the medicine regardless of the meal.

Distribution

about 99% fenofibrate in the blood combined with plasma proteins.

Metabolism

After drinking, Fenofibrat is quickly hydrolyzed by esterase into active metabolites of fenofibric acid, mainly in combination with glucuronic acid. Fenofibrat does not metabolize through the liver microsom. There is no metabolic form in plasma. Fenofibrat is not the substrate of CYP3A4.

Elimination

Fenofibrat is eliminated in the urine (60%) in the form of metabolites and feces (about 25%) all drugs are eliminated within 6 days, in people with normal kidney function, the selling time is about 20 hours but this time increases greatly in patients with kidney disease and fenofibric acid accumulated in patients with fenofibrat drinks daily, in the elderly patient, the total amount Fenofibric in plasma does not change. Research on dynamics after drinking single dose and continuous treatment shows that this drug is not accumulated.

Before taking Hafenthyl 300 Hasan treats lipoprotein disorders (3 blisters x 10 tablets)

How to use

Take medicine at meals.

Need to take medicine in combination with a low -fat diet and exercise.

Do not arbitrarily stop the drug without a doctor's opinion or when the drug makes you feel bad because the abnormal concentration of fat in the blood needs long -term treatment.

There is no special requirement on drug treatment after use.

Do not throw away drugs in wastewater or domestic waste. Consult the pharmacist how to quit unused. These measures will help protect the environment.

Dosage

Adults: 1 tablet recommended dose (300 mg fenofibrat)/day.

Children> 10 years old: The maximum recommended dose is 5 mg/kg/day. In some special cases (very high increase in blood lipids accompanied by clinical signs of atherosclerosis, parents with cardiovascular manifestations due to atherosclerosis before 40 years old ...) can be used higher doses but must be indicated by specialized physicians.

If blood lipid concentration does not decrease much after 3-6 months of fenofibrat treatment, it is necessary to change the therapy (additional therapy or other therapy).

What to do when overdose?

How to handle: There is no specific antidote. Symptomatic treatment should be treated and taken supportive measures in cases of overdose. Hemorrhage does not have the effect of eliminating the body from the body.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Hafenthyl 300 often has unwanted effects (ADR), the side effects are usually mild and less common.

Common

Digestive disorders, epigastric area, nausea, bloating, mild diarrhea; floating skin, urticaria, not specific; increased serum transaminase; muscle aches.

rarely

headache, dizziness, dizziness, fatigue, rash, itching, light sensitivity, hair loss, bile stones, losing sex and impotence, reducing sperm, leukopenia.

Instructions on how to handle ADR

Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Hafenthyl 300 is contraindicated in the following cases:

Hypersensitivity to fenofibrat or any ingredients of the drug.

Be cautious when using

necessarily explore the patient's liver and kidney function before treatment with fenofibrat.

In patients with anticoagulant drugs: When starting to use fenofibrat, it is necessary to reduce the anticoagulant dose to a third of the old dose and adjust if needed. Need to monitor more often prothrombin in the blood. Adjust the anticoagulant dose during use and after stopping fenofibrat 8 days.

Armor weakness can be a factor that increases the likelihood of side effects in muscle.

Need to measure transaminase every 3 months, in the first 12 months of taking the drug.

Must suspend the drug if sgpt (ALT)> 100 international units.

Do not combine fenofibrat with drugs that have a toxic effect on the liver. If after 3 - 6 months of treatment, the amount of blood lipids changes significantly, other treatments (supplements or other) must be considered).

File complications occur in people with bile cirrhosis or gallstones.

Do not use 300 mg tablets for children, only use tablets with this content for patients who need a dose of 300 mg fenofibrat/day.

The ability to drive and operate machines

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

Pregnancy

should not be used for pregnant women. Animal research does not see teratogenic effects. However, observed signs of poison for pregnancy at the poisonous doses for the mother animal. However, it has not yet determined the potential risk in humans.

The period of breastfeeding

There is no data on the excretion of fenofibrat and or the metabolites of this drug through breast milk. However, because of safety, should not be used for breastfeeding women.

Interactive drug

anticoagulant, orally (warfarin): extends the time of PT/INR. It is necessary to reduce the anticoagulant dose (about one third of the original dose and adjust the next dose when necessary), and monitor PT/INR periodically until stable.

HMG inhibitors - CoA Reductase and other fibrats: The risk of serious muscle poisoning increases when using simultaneously fenofibrat with HMG inhibitors - CoA Reductase or other fibrats, need to be cautious when combining drugs and patients should be closely monitored by signs of muscle poisoning. Currently there is no evidence that Fenofibrat has an effect on the pharmacokinetics of Simvastatin.

Bile acid -mounted plastic (Cholestyramin, Colestipol): reduces fenofibrat absorption.

Cyclosporin: Increased risk of kidney toxicity (impaired renal function).

Glitazon: Some cases of HDL - cholesterol paradoxical reduction have been reported when used simultaneously fenofibrat with glitazon. Therefore, it is necessary to monitor HDL - cholesterol when combining the drug and stop one of the two drugs if the HDL - cholesterol concentration is too low.

Cytochrom P450 enzyme: In vitro studies use human liver microsom indicated that fenofibrat and fenofibric acid do not inhibit cytochrom (CYP) P450 such as CYP3A4, CYP2D6, CYP2E1 or CYP1A2; weak inhibitors CYP2C19 and CYP2A6; Mild to medium inhibition CYP2C9 at treatment concentration.

Patients with simultaneous use of fenofibrat with metabolic drugs through CYP2C19, CYP2A6 and especially CYP2C9 have a narrow treatment index, should be carefully monitored and adjusted if necessary.

Do not use a combination of poison with liver (Mao inhibitors, Perhexilin Maleat ...) with fenofibrat.

Similar to other fibrats, fenofibrat stimulates the multifunctional oxidation enzymes of mitochondria related to the metabolism of fatty acids in rodents and can interact with the drugs metabolized through these enzymes.

Storage

Store in closed packaging, dry place, avoid moisture, temperature below 30 ° C.

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