Hafenthyl 145mg Hasan Treatment of Lipoprotein disorders (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Fenofibrate

Ingredient

Composition information	Content
Fenofibrate	145mg

Uses

Indications

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

Pharmacokic

fenofibrat, also known as the derivative of fibric acid, is an intermediary blood lipid drug through interaction 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 decreases triglycerides by stimulating through pparα intermediaries of fatty acid oxidation, increasing the synthesis of lipoprotein lipase, and reducing the expression of APOC-LLL.

Increased 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-L and APOA-LL.

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 statin should use (HMG-CA Reductase inhibitors) 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.

pharmacokinetic

absorption

Fenofibrat is well absorbed in the digestive tract. The maximum concentration in plasma (CMAX) reached 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 through 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 sale time is about 20 hours but this time increases greatly in patients with kidney disease and fenofibric acid accumulated significantly in patients with kidney failure Fenofibrat daily, in elderly patients, the total clearance of fenofibric acid in plasma is unchanged.

Research on dynamics after drinking single dose and continuous treatment shows that this drug is not accumulated.

Before taking Hafenthyl 145mg Hasan Treatment of Lipoprotein disorders (3 blisters x 10 tablets)

How to use

The drug is used by oral. The time of use can be at any time of the day, during meals or outside meals.

Should swallow the whole tablet with a cup of water.

Dosage

Adults

Take 145mg fenofibrat/time/day.

Patients who are using fenofibrat 200mg capsules (micro -seeds) or Fenofibrat 160mg film tablets can be switched to treatment with Hafenthyl films 145mg 1 tablet/day without dosage.

Children

Contraindicated dose of 145 mg.

Patients with renal failure

Dosage reduction in patients with renal failure (EGFR from 30-59 ml/min/1.73m2).

Recommended the use of low -level tablets for these patients (100mg or 67mg fenofibrat).

Elderly patients

No dose adjustment.

What to do when overdose?

Overdose

There are no reports related to 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

Common

Stomach disorders;

anorexia;

increased serum transaminase;

weight gain;

dizziness;

headache; Rarely

Hypoglycemia;

Anemia;

leukopenia;

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

Too hypersensitivity to fenofibrat or any component of the drug. honey.

Children.

Be cautious when using

necessarily explore the patient's liver and kidney function before starting to use Fibrat.

For patients with anticoagulant drugs: When starting to use fibrat, it is necessary to reduce the anticoagulant dose to only one third of the old dose and adjust the dose if necessary. Need to monitor more frequent amount of blood prothrombin. Adjust the anticoagulant dose during use and after stopping Fibrat 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 with the liver.

File complications occur in patients with bile or gallstones.

Periodically monitor the concentration of creatinine kinase in patients with side effects. Stop treatment if the high serum creatinine concentration is noticeable or the patient is diagnosed or suspected of muscle or muscle disease.

If after a few months of taking the drug (3-6 months) that the amount of lipid in the blood changes is not significant, it is necessary to consider other therapeutic (additional or other).

The ability to drive and operate machines

fenofibrat does not have or have a negligible effect 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.

Breastfeeding period

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.

Medicinal interaction

Anticoagulant, oral (Warfarin): Extend the time of PT/INR: Need to reduce anticoagulant dose (equal to one -third of the original dose and adjust the next dose when necessary), and monitor PT/INR periodically until stable.

HMG-CAA Reductase inhibitors and other fibrats: The risk of serious muscle poisoning increases when using simultaneously fenofibrat with HMG-CAA Reductase inhibitors 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 reduced HDL-cholesterol paradox have been recovered when used simultaneously fenofibrat with Glitazon. Therefore, HDL-cholesterol should be monitored when combining drugs and stopping one of the two drugs if the HDL-cholesterol level 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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