What is Bezafibrate 200mg?

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1. Uses of the drug Bezafibrate 200mg

1.1. Indications "What disease is Bezafibrate?". Bezafibrate 200mg medicine contains the active ingredient Bezafibrate which is used in the treatment of the following conditions:
Treatment of hyperlipoproteinemia type IIa, IIb, III, IV and V in patients who do not respond to diet as well as other measures. other appropriate treatment; Treatment of severe hypertriglyceridemia with or without low HDL cholesterol. 1.2. Pharmacodynamics Bezafibrate is the active ingredient of fibric acid derivatives with therapeutic effects against dyslipidemia. The mechanism of action of the drug has been shown to inhibit cholesterol biosynthesis in the liver, enhance cholesterol excretion into bile and inhibit bile acid synthesis. The main effect of the drug is to reduce low and very low density lipoproteins (LDL and VLDL), increase the concentration of high density lipoprotein (HDL). Therefore, the drug significantly improves the distribution of cholesterol in the blood plasma.
Bezafibrat has the effect of lowering blood triglycerides and cholesterol, so the drug is used in the treatment of hyperlipoproteinemia type IIa, IIb, III, IV and V in combination with a low-fat diet.
1.3. Pharmacokinetics Absorption: Bezafibrate is well absorbed from the gastrointestinal tract after oral administration, but is poorly absorbed on an empty stomach and the extent of absorption is greatly reduced after overnight fasting. Peak plasma concentrations are reached 2 to 4 hours after dosing. The bioavailability of the extended-release formulation is approximately 70% of that of the standard formulation.
Distribution: Bezafibrate is widely distributed and concentrated in the kidneys, liver and intestines. Approximately 95% of the drug is bound to plasma proteins (mostly to albumin). Due to the high rate of drug binding to plasma albumin, the drug has the ability to displace vitamin K antagonists from their plasma protein binding sites. The volume of distribution of Bezafibrate is 0.2 liters/kg.
Metabolism: The drug is easily hydrolyzed into active substances and metabolism takes place in the liver. Elimination: Approximately 60-90% of an oral dose is excreted in the urine, of which 50% is unchanged, 20% is conjugated with glucuronic acid, and the remainder is as metabolites. other chemical. Approximately 3% of the remaining dose is excreted in the feces. Bezafibrate is not increased in excretion except when taken with diuretics, is not eliminated by hemodialysis. The half-life of the drug (t1/2) is 2.1 hours.

2. Dosage of Bezafibrate

"What is Bezafibrate and what is a reasonable dose?". Accordingly, the dose of Bezafibrate depends on the age and condition of the patient, specifically as follows:
Adults: Take the drug during or immediately after a meal, combined with a fat-restricted diet. The usual dosage is as follows:
Take 200mg/time x 3 times/day with meals or immediately after eating. Patients can also take a single dose of 400mg/time/day at the main meal or right after the main meal (the dose of 400mg is not suitable in patients with renal failure); Incorporate periodic monitoring of blood cholesterol and blood triglycerides during treatment with Bezafibrate. In case the treatment results are not achieved after 3-4 months, it is necessary to choose another treatment regimen; In case of taking Bezafibrate with cholestyramine, it is necessary to take 3 hours between the two doses. Children: Not recommended for use in children.
Special subjects:
Patients with renal impairment : Adjust dose according to the degree of renal failure. Specifically, for patients with serum creatinine level of 135 micromol/liter or less, the dose is 200mg/time x 3 times/day. For patients with serum creatinine level from 136 to 226 micromol/liter, the dose is 200mg/time x 2 times/day. For patients with serum creatinine level from 226 to 530 micromol/liter, the dose is 200mg x times/day. For patients with serum creatinine level greater than 530 micromol/liter, use a dose of 200mg/time and repeat the dose every 3 days; Elderly: Dosage is adjusted based on serum creatinine concentration and creatinine clearance.

3. Side effects when using Bezafibrate 200mg

Some possible side effects when taking Bezafibrate 200mg are as follows:
Common side effects: Nausea, indigestion, digestive disorders, mild diarrhea and decreased appetite.
Uncommon side effects:
Dizziness, headache; Acute renal failure, biliary obstruction, increased blood transaminase levels; Itching, urticaria, hair loss, photosensitivity reaction, rash; Muscle weakness, muscle aches, muscle cramps; Mild elevation of serum creatinine not related to renal function; Anaphylaxis and other hypersensitivity reactions; Constipation, abdominal distension, erectile dysfunction, cholestasis. Rare side effects:
Thrombocytopenia, decreased blood hemoglobin concentration, leukopenia, thrombocytopenic purpura; Loss of libido, impotence; Stevens-Johnson syndrome, toxic epidermal necrolysis; Psychosis, peripheral neuropathy, insomnia, depression; Gallstone disease, rhabdomyolysis, pancreatitis, interstitial lung disease.

4. Notes when using the drug Bezafibrate

4.1. Contraindications Contraindicated to use Bezafibrate drug for the following subjects:
People who are sensitive to any component of the drug Bezafibrate; Patients with severe liver failure; People with hypoalbuminemia; Patients with primary biliary cirrhosis; People without gallstones or gallbladder disease; Patients with nephrotic syndrome, patients on dialysis, severe renal failure (serum creatinine level greater than 135 micromol/l or creatinine clearance less than 60 ml/min, patients on dialysis; contraindicated). Concomitant use of Bezafibrate with HMG - CoA reductase inhibitors in patients with predisposing factors for myopathy; People who are allergic to light due to fibrates or known to have toxic reactions to light 4.2. When using Bezafibrate medicine Some notes when using Bezafibrate 200mg are as follows:
General notes:
Caution when using Bezafibrate 200mg in patients with renal failure Because the dose is not correct or the concentration is not correct. The gradual increase in serum creatinine may lead to rhabdomyolysis; When co-administering bezafibrate and cholestyramine, it must be taken 3 hours between the two doses; Patients on anticoagulant therapy if bezafibrate must be reduced by 1.3 doses. anticoagulants; Do not take Bezafibrate with hepatotoxic drugs such as perhexi lin, an MAO inhibitor; Drugs that change the composition of bile; Bezafibrate should be considered in patients taking estrogen as well as estrogen-containing contraceptives; Take 2 hours apart when combining Bezafibrate with ion exchange resin. Caution for pregnant women: Use in pregnant women is not recommended due to lack of evidence for safety.
Note for lactating women: The drug is not recommended for use in lactating women.
Drivers and operators: The drug may cause dizziness, mild to moderate influence on the ability to drive or use machines. Therefore, patients should not drive or use machines in case of these side effects.
Bezafibrate 200mg drug contains the active ingredient Bezafibrate, indicated in the treatment of hyperlipoproteinemia type IIa, IIb, III, IV and V in patients who have not responded to diet and other appropriate measures. To ensure the effectiveness of treatment and avoid side effects, patients need to take medicine according to prescription or consult a doctor, pharmacist for advice.
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