Entecavir Stella 0.5mg Treatment of chronic hepatitis B (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Entecavir

Ingredient

Composition information	Content
Entecavir	0.5mg

Uses

indications

Entecavir is indicated in the following cases:

Treatment of chronic hepatitis B in adults with liver disease also has evidence of the copy activity of the virus, there is a prolonged increase in liver enzyme values and showing historical diseases, including cases of resistance to lamivudin. Guanosin has HBV polymerase resistance, which is effective by phosphorylation into a triphosphate form that is active with the semi -discharged time in cells of 15 hours. Due to the competition with the natural substrate Deoxyguanosin Triphosphate, the function of Entecavir Triphosphate inhibits all 3 activity of HBV Polymerase (enzyme copied backward):

Provide base. It is a weak inhibitor of DNA polymerase of alpha, beta, delta and DNA polymerase (gamma) DNA with ki value in the range of 18 to> 160µm.

pharmacokinetic

absorption

The peak concentration of Entecavir in plasma in healthy objects achieved in the range of 0.5 - 1.5 hours after drinking.

The effect of food on oral absorption: drink 0.5mg entecavir along with a normal meal of high fat or a snack leads to slow absorption (1.0 - 1.5 hours when the abdomen is full compared to 0.75 hours when hungry belly) reduces CMAX 44 - 46% and AUC 8 - 20%.

Distribution

Based on the pharmacokinetics records of Entecavir after oral, the apparent distribution integral is estimated to be more than the total amount of water in the body, which shows that Entecavir is distributed in tissue.

On In vitro, about 13% of Entecavir associated with human serum protein.

Metabolism and elimination

There is no oxidation or acetylation metabolite in humans after drinking 14C-toecavir. Observations are not significant amounts of stage II metabolites (glucuronid and sulfate complex). Entecavir is not a substrate, an inhibitor or an induction of the cytochrom P450 enzyme system (CYP450).

After reaching the peak concentration, the Entecavir concentration in plasma decreases with the second -order exponential function with the last selling time of about 128 - 149 hours. The accumulation index of observation is about 2 times at a dose 1 time/day, this shows that the semi -cancellation time is actually about 24 hours.

Entecavir is mainly eliminated through the kidney with non -metabolic drugs recovered in urine in a stable state of 62 - 73% of the dose. The dialysis does not depend on the dose and ranges from 360 - 471ml/min, which shows that Entecavir has passed both glomerular filtration processes and sub -sub -secretion.

Before taking Entecavir Stella 0.5mg Treatment of chronic hepatitis B (3 blisters x 10 tablets)

How to use

Take oral use.

Entecavir is used when hungry stomach (at least 2 hours after eating and 2 hours before the next meal).

Dosage

Entrepreneurial dose of Entecavir for adults and adolescents ≥ 16 years old with chronic and untreated hepatitis B virus and untreated with nucleosid

0.5mg x 1 time/day.

Entrance of Entecavir for adults and adolescents (≥ ≥ 16 years old) with a history of hepatitis B virus infection in the blood while taking lamivudine or with lamivudine anti -drug mutations

1mg x 1 time/day.

Patients with renal failure

Creatinin purification Common doses used Time/day 1 mg x 1 time/day Time/day (Capd).

Hepatic failure

No need to adjust the dose for patients with liver failure.

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? Healthy objects have used Entecavir a single dose of up to 40mg or a dosage of up to 20mg/day for more than 14 days without increasing or unexpected accident. If there is an overdose of the drug, the patient must be monitored with signs of poisoning, and if necessary, the standard support treatment must be applied.

After taking entecavir 1mg of single dose, a hemorrhage in 4 hours is about 13% of the dosecavir.

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 close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using Entecavir, you may experience unwanted effects (ADR).

The most unwanted unwanted effects of Entecavir are headaches, fatigue, dizziness and nausea. Other undesirable effects include diarrhea, indigestion, insomnia, drowsiness and vomiting. Increased liver enzyme levels may occur and reported on the serious condition of hepatitis after stopping treatment with Entecavir. Lactic acid infections, often accompanied by large liver and severe fatty, is associated with single treatment with nucleosid -similar drugs or with antacids.

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

Entecavir drugs contraindicated in the following cases:

Patients with hypersensitivity to Entecavir or any ingredient of the drug.

Caution when using

Lactic acid infection and severe liver fatty liver, including deaths, are reported when using single nucleosid substances or in combination with retrovirus resistance drugs.

There have been reports on the case of acute hepatitis B, which becomes serious in patients who have stopped hepatitis B anti -hepatitis, including Entecavir. Should continue to closely monitor the liver function on both clinical and experimental for at least a few months in patients who have stopped taking anti -hepatitis B treatment.

The adjustment of the Entecavir dose is recommended for patients with creatinine purification

The safety and effectiveness of Entecavir in liver transplant patients are not known. If the treatment with Entecavir is necessary for patients with liver transplantation or taking an immunosuppressant that can affect kidney function, such as cyclosporin or tacrolimus, renal function should be carefully monitored both before and during treatment with Entecavir.

The ability to drive and operate machinery

No research shows the effect of the drug affects the ability to drive and operate machinery. Dizziness, fatigue and drowsiness are unwanted effects that can affect the ability to drive and operate machinery.

Pregnancy

There are no complete and well -controlled studies in pregnant women. Because animal reproductive studies do not always predict to meet humans, only entecavir should be used during pregnancy if really necessary and after careful consideration of risks and benefits.

There are no studies in pregnant women and there is no data on the influence of Entecavir on the transmission of HBV from mother to child. Therefore, it is advisable to use appropriate interventions to prevent the suffering from HBV in infants.

Breastfeeding period

It is not known whether this drug is excreted in breast milk or not. Need to guide the mother should not breastfeed while taking entecavir.

Drug interaction

Because Entecavir is excreted mainly through the kidneys, the use of Entecavir with drugs that impaired kidney function or active excretion with Entecavir in the renal tubules can increase the concentration of the server of Enterecavir or of the commonly used drugs.

Concomitance the ENTECAVIR use with lamivudin, adefovir dipivoxil or Tenofovir Disoproxil Fumarat does not cause significant drug interactions. The consequences of adecavir sharing with drugs that are eliminated through the kidneys or are known to affect the kidney function have not been evaluated, so patients should be closely monitored on the harmful effects of Entecavir when the drug is used with these drugs.

Storage

In closed packaging, dry place. The temperature does not exceed 30 ° C.

Expiry date: 24 months from the date of manufacture. Do not use overdue drugs stated on the packaging.

Manufacturer: LD Stellapharm Co., Ltd.

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