Barcavir 0.5mg Incepta Treatment for chronic hepatitis B virus infection (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Entecavir
Ingredient Hepatitis B

Ingredient

Composition information	Content
Entecavir	0.5mg

Uses

Indications

Barcavir medicine is indicated in the following cases:

Entecavir is indicated in the treatment of chronic hepatitis B virus infections in adults with significant evidence of the virus's copy activity and or there is a prolonged increase of amino enzyme serum (enzyme alt or AST) or there is an organization manifestation. Some of the following points need to be considered when the treatment starts with Entecavir:

This indication is based on the response to histology, viruses, biochemical and serum after one year of treatment in patients with adults infected with hepatitis B virus (chronic HBV with compensated liver disease, with positive or negative HBeAg test results, and has not been treated with nucleoside and has become resistant to lamivudine).

This indication is also based on more limited data in adult patients infected with HIV/HVB that had previously been treated with Lamivudine.

Pharmacy

Entecavir is a nucleoside homosexual, a guanosine substance with a selective activity resistant to the hepatitis B virus (HBV). Entecavir inhibits the DNA of virus B, which has high efficiency, has not seen drug resistance like Lamivudine.

Entecavir is superior to Lamivudine in terms of the main mark of evaluation of histological improvement (defined as a reduction of 2 points on the Knodell inflammatory scores but does not reduce Knodell fibrosis scores at the 48th week), as well as superior to the valuable assessment measures to reduce virus levels and normalize ALT.

pharmacokinetic

absorption

By oral in healthy volunteers, the peak concentration of Entecavir's plasma is reached within 0.5 - 1.5 hours. In those who take the drug multiple times a day with doses from 0.1 to 1.0mg, CMAX and AUC in a stable state increase proportional to the dosage.

Stable state is achieved after 6 to 10 days of taking the drug once a day with a double accumulation. With a dose of 0.5mg, cmax in a stable state is 4.2ng/ml and the lowest concentration in plasma (CD) is 0.3ng/ml. With a dose of 1mg of oral, CMAX is 8.2ng/ml and the machine is 0.5ng/ml.

In healthy patients, the bioavailability of the pill is 100% compared to oral solution. Oral solution and tablet can be used instead of each other.

The impact of food on oral absorption

Give 0.5mg of Entecavir along with a normal meal of high fat (945 kilocalorie, 54.6g of fat) or a snack (379 kilocalorie, 8.2g of fat), resulting in a result of slowing absorption (1.0-1.5 hours when the abdomen is full compared to 0.75 hours when hungry) reduces CMAX 44-46% and AUC 18-20%. Therefore, BarcaVir (Entecavir) should be used when the stomach is empty (at least 2 hours after eating and 2 hours before the next meal).

distribution

Based on the pharmacokinetic characteristics of Entecavir after drinking, Entecavir is widely distributed into the entire water in the body and tissues. In In vitro surveys, about 13% of Entecavir associated with human serum protein.

metabolism and elimination

There is no oxidation or acetylation metabolic in humans or rats after drinking 14C-toecavir. Small quantities of metabolites phase II (glucuronide and sulfat complex) have been observed.

Entecavir is not a substrate, an inhibitor or active agent of Cytochrome P450 enzyme system (CYP450). After reaching the peak concentration, the Entecavir concentration in plasma decreases with the exponential function with the final selling time of 128 - 149 hours. The index accumulates the drug to be twice as used for a dose a day, which shows the real accumulated half -life time about 24 hours. Entecavir is eliminated mainly through the kidneys.

The number of non -metabolic drugs recovered in urine in a stable state from 62% to 73% of the dose is used. The dialysis does not depend on the dose and ranges from 360 to 471ml/minute, which shows that Entecavir has passed both glomerular filtration and renal tubules.

Special cases

Gender

There is no difference in pharmacokinetics of Entecavir in male and female patients.

Race

There is no difference in pharmacokinetics of entecavir between races.

Older people

Effects of age -active age of Entecavir are assessed at a 1mg dose of oral. In healthy and older volunteers show that Entecavir's AUC in the elderly is 29.3% higher than young people. The difference in the exposure between the elderly and the young people may be due to the difference in renal function. Adjusting the dose should be based on the patient's kidney function rather than based on age.

Children

There is no pharmacokinetic research on young children.

Before taking Barcavir 0.5mg Incepta Treatment for chronic hepatitis B virus infection (1 blister x 10 tablets)

How to use

Take oral use.

Entecavir is used once a day, patients should be used Entecavir when hungry (at least 2 hours after eating and 2 hours before the next meal).

Dosage

Adults and adolescents (16 years old) is infected with chronic hepatitis B virus and has not used nucleoside of 0.5mg used once a day.

Adults and adolescents (16 years old) have a history of hepatitis B blood virus infection while taking lamivudine or is known to have Lamivudine or Telbivudine anti -drug mutations, the dose is 1mg once/day.

Renal function impairment

In patients with impaired renal function, the purification of entecavir through oral routes decreases when creatinine clearance is reduced. Patients with creatinine clearance

Creatinin clearance (ml/min) Dosage (0.5mg)

patients with Lamivudine resistance patients (1mg) 0.5mg/time/day 1mg/time/day 0.5mg every 72 hours 0.3mg/time/day or 1mg every 72 hours 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? In healthy subjects being treated with Entecavir Single dose up to 40mg or a dosage of up to 20mg/day for more than 14 days without increasing the rate of stroke or no unexpected accident.

If an overdose occurs, the patient should be monitored to see if there is any manifestation of poisoning and using appropriate treatments. With a single dose of 1mg, about 13% of the dose will be eliminated within 4 hours of blood separator.

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 Barcavir medicine, you may experience unwanted effects (ADR).

Most serious side effects occur with the ratio (

The adverse effects have been reported including

Digestive system: diarrhea, digestive disorders, nausea, vomiting.

overall: fatigue.

Nervous system: Dizziness, drowsiness.

Mental: Insomnia.

Immune system disorders: Anaphylaxis.

Skin and subcutaneous tissue disorders: rashes.

After stopping treatment: there is a seriousness of hepatitis.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Barcavir medicine is contraindicated in the following cases:

Has a history of hypersensitivity to Entecavir or any ingredient of the drug.

Children under 16 years old.

Precautions when using

Acute hepatitis B is severe

There have been reports on the case of hepatitis B, which becomes serious in patients who have stopped anti -hepatitis B therapy, including treatment with Entecavir. The liver function where patients stopped against hepatitis B should be closely observed by monitoring both clinically and in the laboratory for at least a few months,

Patients with HIV and HBV infected

has not yet evaluated Entecavir in HIV/HBV co -infected patients but not HIV treatment. There is less experience foresting, showing the ability to increase resistance to HIV nucleoside reversible inhibitors if using Entecavir to treat HIV virus infection. Therefore, it is not recommended to use Entecavir for patients with HIV/HBV co -infected patients. Before treatment with Entecavir, HIV antibodies should be tested in all patients. There is no study using Entecavir for HIV -infected patients.

Lactic acid and severe fatty liver, including death, have been reported when used alone as nucleoside or combined with anti -virus drugs. Most of these cases occur in women. Obesity and prolonged nucleoside use may be potential risks. Especially need to be cautious when using nucleoside in any patient with elements of liver disease. Entecavir should be discontinued in patients with lactic acid hyperplasia or clearly manifest liver toxicity on clinical. Patients need to be indicated that Entecavir has not yet proved to reduce the risk of HBV transmission to others through sexual contact or blood transmission.

Renal function impairment

The adjustment of the dentecavir is recommended for patients with creatinine clearance

Patients with liver transplantation: The safety and effectiveness of Entecavir for patients with liver transplant unknown. If Entecavir is determined to be necessary for patients with liver transplantations that have or are taking immunosuppressant drugs that can affect kidney function, such as cyclosporine or tacrolimus, the kidney function must be carefully monitored both before and during treatment with enterecavir.

used for children

The safety and effectiveness of Entecavir in the treatment of children under 16 years old has not been established.

used for the elderly

Entecavir is mainly discharged from the kidneys and the risk of poisoning may be larger in patients with impaired renal function. Because older patients are more likely to be impaired renal function, so cautious when choosing the dosage and need to monitor the kidney function.

The ability to drive and operate machinery

No report.

Pregnancy

There are no appropriate surveys and strict tests in pregnant women. Because reproductive surveys in animals do not necessarily predict the response in humans, Enterecavir should only be used during pregnancy when it is really necessary and after careful consideration of the risks and benefits of the drug.

during labor and childbirth

There has been no survey on women and no data on the effects of Entecavir on HBV transmission from mother to child. Therefore, challenging intervention measures are used to prevent the suffering of HBV in the newborn period.

Breastfeeding period

Entecavir is excreted in the milk of mice. It is not known whether this drug is excreted in human milk or not. Mothers need to be instructed not to breastfeed while taking entecavir.

Drug interaction

The metabolism of Entecavir has been assessed in in vitro and in the body. Entecavir does not activate the Cytochrome P450 enzyme system (CYP450). At a concentration of up to approximately 10,000 times higher than the concentration in humans, Entecavir does not inhibit one of the main CYP450 enzymes of humans: 1A2, 2C9, 2C19, 2D6, 3A4, 2B6 and 2E1. At concentration up to approximately 340 times higher than the observation concentration in humans, Entecavir does not activate the CYP450 enzymes of people 1A2, 2C9, 2C19, 3A4, 3A5 and 2B6.

The pharmacokinetic properties of Entecavir will almost not be affected by the common use of the agents transformed by or have the effect of inhibiting or activating the CYP450 system. Also, the pharmacokinetics of CYP substrates that have been known will not be affected by the common use with Entecavir.

Pharmacokinetics in the stable state of Entecavir and of non -changing shared drugs in drug interaction surveys between Entecavir and Lamivudine, Adefovir Dipivoxil and Tenofovir Disproxil Fumarate.

Because Entecavir is mainly discharged through the kidneys, the use of drugs that impaired kidney function or competing drugs with Entecavir to discharge in the renal tubules can increase the serum concentration of Entecavir or of the shared drugs.

The consequences of adecavir sharing with other drugs are eliminated through the kidneys or knowing that it affects the renal function that has not been evaluated, so the patient should be closely monitored on the harmful effects of the drug when using entecavir with these drugs.

Storage

Keep the drug in a dry place, temperature below 30 ° C. Avoid light and damp.

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