Agicarvir 0.5mg Agimexpharm Treatment Treatment of Virus B infection (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Entecavir
Ingredient Hepatitis B

Ingredient

Composition information	Content
Entecavir	0.5mg

Uses

Indications

Agicarvir 0.5 mg drug is indicated in the following cases:

Treatment of chronic liver B virus infection in adults has evidence of virus copy activity and/or there is a prolonged increase in liver enzymes (aminotransferase in serum (ALT or AST)) or showing an organization, including resistant patients with Lamivudine.

Pharmacological

Entecavir is homogeneous, a guanosine nucleoside has the selective activity of antiviral antiviral hepatitis B (HBV). Entecavir is a new generation pill to treat chronic hepatitis B. Entecavir inhibits CCCDNA of virus Belves highly effective, has not seen drug resistance such as Lamivudine, effective for new patients for treatment as well as patients with anti -drug mutations.

Dynamic pharmacokinetics

After drinking, the peak concentration of Entecavir in plasma of healthy objects achieved after 0.5 to 1.5 hours.

For healthy, bioavailable patients of pills is 100% compared to oral solution. Oral solution and tablet can be used instead of each other.

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

Based on the pharmacokinetics analysis of entecavir after a dose, the apparent distribution integral is estimated to be more than the total amount of water in the body, which shows that Entecavir is widely distributed into the tissues.

There is no metabolic or acetylation in humans and rats after drinking 14*C - Entecavir. Small quantities of metabolites phase II (glucuronide and sulfate complex) have been found. 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 last semi -exhaust time of about 128 - 149 hours. The accumulation index of the drug is twice as long as the dose once a day, this shows that the semi -cancellation time is actually accumulated about 24 hours.

Entecavir is eliminated mainly through the kidneys. The number of non -metabolic drugs recovered in urine in a stable state is from 62% to 73% of the dose used. The dialysis does not depend on the dose used and fluctuates from 360 temples 471 ml/min, which implies that Entecavir has passed the filtration process in glomerular and excreted through the sub -network.

Before taking Agicarvir 0.5mg Agimexpharm Treatment Treatment of Virus B infection (3 blisters x 10 tablets)

How to use

should take the drug when hungry (at least 2 hours after eating and 2 hours before the next meal).

Dosage

recommended doses for adults and adolescents aged 16 and older infected with chronic hepatitis B virus and have not used nucleosid

Take 0.5 mg x 1 time/day.

recommended doses for adults and adolescents aged 16 and older with a history of hepatitis B virus infection while taking lamivudine or with Lamivudine anti -drug mutations

Take 1 mg x 1 time/day.

Patients should take drugs when hungry (at least 2 hours after eating and 2 hours before the next meal).

Renal function impairment

The dose adjustments for patients with creatinine clearance are needed Use medication after dialysis. For the dose less than 0.5 mg of patients should take the drug in the form of solution.

Liver function impairment

No need to adjust the dosage for patients with liver function reduction.

used for children

The safety and effectiveness of Entecavir for children under 16 years old have not been established.

used for the elderly

Clinical studies about Entecavir do not have enough subjects aged 65 and above to be able to determine whether they have a different response to younger subjects.

Treatment time: Optimal treatment time with Agicarvir for patients with chronic hepatitis B virus and the relationship between treatment with long -term consequences such as cirrhosis and unknown liver cancer.

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 do

do when overdose? On healthy volunteers, single dose of Entecavir up to 40 mg or multiple doses to 20 mg/day for up to 14 days, there is no increase in extra effects or extra extra effects.

If an overdose occurs, the patient must be monitored with manifestations of poisoning, and if the standard support treatment is required. After using entecavir 1 mg of single dose, hemorrhage for 4 hours has eliminated about 13% of entecavir.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using 0.5 mg Agicarvir, you may experience unwanted effects (ADR).

No frequency determination, ADR> 1/100

Metabolism: Blood lactic acid infection.

digestive: slight nausea, vomiting, diarrhea, indigestion.

Mile liver: jaundice, yellow eyes, dark urine, clay feces.

Body: Stunned, faint, tired or very weak, mild fever, temporary hair loss, red skin, numbness or cold limbs.

muscle muscle: muscle weakness or muscle pain.

Respiratory: Difficulty breathing.

nerve: headache, insomnia.

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

Agicarvir 0.5 mg contraindicated drug in the following cases:

Patients with a history of hypersensitivity to Entecavir or any ingredients of the drug.

Caution when used

The seriousness of hepatitis after stopping treatment: There has been a report on the case of hepatitis B becoming acute serious in patients who have stopped treating hepatitis B anti -hepatitis B, including treatment with Entecavir. The liver function of patients who stop treatment with hepatitis B anti -hepatitis must be closely monitored in the clinical and laboratory at least a few months. If appropriate, it may be possible to start treating with hepatitis b.

Patients with HIV and HBV: Entecavir have not been the price in patients with HIV and HBV co -infected patients but not effective HIV treatment at the same time. A little clinical experience shows the potential to develop resistance of enzyme inhibitors that transcription of HIV nucleosides if Entecavir is used for patients with chronic hepatitis B virus but not treated HIV.

Therefore Entecavir is not recommended to use treatment for patients with HIV/HBV co -infected patients but are not treated under Haart therapy. Before starting treatment with Entecavir, it is necessary to perform HIV antibody tests for all patients. Entecavir has not been studied for HIV treatment and is not recommended for this indication.

Serious liver lactic acid and liver with fatty fatty: There have been reports on cases of serious lagoon and liver acid with fatty fatty, including deaths, when using individual nucleoside substances or antiviral antibiotics. Most cases occur in women. Obesity and long -term contact with nucleoside can be risk factors.

It is necessary to be particularly cautious when prescribing nucleoside medications for patients who have known to have risk factors for liver disease. Entacavir treatment must be temporarily suspended when the patient has clinical results and tests for blood lactic acid infection or liver toxicity (may include large liver and fatty even without increased liver enzymes).

Renal functional decline: Agicarvir adjustment is recommended for patients with creatinine clearance

Liver disease can deteriorate in some cases if treatment and patients should discuss with their doctor about any change in therapeutic regime.

Patients need to be indicated that the treatment with Agicarvir has not shown to reduce the risk of HBV transmission to others through sexual contact or blood transmission.

Entervavir is excreted mainly in the kidneys and the risk of drug poisoning may be higher in patients with impaired renal function. Because older patients have a higher impairment of renal function, be cautious when choosing the dosage and the monitoring of kidney function can be helpful.

The ability to drive and operate machinery

The drug can cause headaches, dizziness, fatigue, drowsiness. Should be cautious when driving and operating machinery.

pregnancy

Entecavir should only be used during pregnancy when it is really necessary and after careful consideration of the risks and benefits of the drug.

The period of breastfeeding

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

Drug interaction

Because Entecavir is excreted mainly through the kidneys, it is common to use with drugs that impaired renal function or eliminating drugs compete with Agicarvir in the renal tubules that can increase the serum concentration of entecavir or of the shared drugs.

Concomitance entity of Entecavir with Lamivudine, Adefovir Dipovoxil, or Tenofovir Disoproxil Fumarate does not cause significant drug interactions. The consequences of being used with drugs that are eliminated through other kidneys or are known to affect the kidney function are currently not evaluated, so the patient must be closely monitored the harmful effects of the drug when used with these drugs.

Storage

In a dry place, avoid light, store no more than 30 ° C.

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