- X-vir 1mg tablet is used as an antiviral medicine, the safety and effectiveness of X-vir 1mg has been established against chronic viral hepatitis B infection.
- X-vir 1mg contains an active compound known as Entecavir . X-vir 1mg is classified as a prototype for the class of nucleoside cyclopentane or long-lasting nucleotide against antiviral hepatitis B.
- X-vir 1mg tablets are not curable, they can be used to reduce the amount of HBV virus in the body. X-vir decreasing the ability of HBV to multiply and infect new liver cells. X-vir 1mg It is used to reduce the chance of getting liver cancer and liver failure due to chronic hepatitis B infection.

INDICATION
The main use of X-vir 1mg tablets is:
- X-vir 1mg tablet is involved in the treatment of chronic viral hepatitis B infection in adults and pediatric patients aged 2 years or older with the sign of active viral production, either constant eminence of serum amino transferase or effective histological disease. Before starting therapy with X-vir 1mg tablet , the crucial points should be considered; The evidence of X-vir 1mg in adult patients based on data from clinical trials in therapy with nucleoside inhibitors for new patients and patients opposed to lamivudine treatment with HBeAg infection HBV positive and HBeAg negative and liver cirrhosis compensated and minor in cirrhosis decompensatedIn children 2 years of age or older: used for therapy with nucleoside inhibitors, patients with lamivudine resistance without prior treatment with chronic HBeAg HBV infection and patients with compensated cirrhosis.
PROMOTE ME
- For chronic viral hepatitis B infection, the use of X-vir 1mg tablet after oral administration is subject to absorption, distribution, metabolism and elimination.
- The maximum plasma concentration time of X-vir 1 mg is 0.5 hours and 1.5 hours 0.5 tablets of X-vir 1mg : the steady state occurs at 4.2 ng / ml and Ctrough is 0 , 3 ng / ml. The concentration of human plasma protein is 13%. After reaching the maximum plasma concentration time, the plasma concentration of Entecavir is reduced in a bi-exponential aspect.
- The terminal half-life period of the X-vir 1mg tablet is 128 to 149 hours. X-vir 1mg is excreted through the kidneys with a range of 62% to 73% unchanged. Renal clearance value 360 ml / min at 471 ml / min.
HE WORKS AS
- X-vir is included as Entecavir as an active component, a synthetic analogue of 2-deoxyguanosine has antiviral activity against hepatitis B virus.
- Entecavir is triggered in vivo in the metabolite 5-triphosphate, which is an active form of Entecavir. Successively, the active metabolite forms triphosphate hits with the natural substrate deoxyguanosine triphosphate dGTP for infusion into viral DNA.
- Therefore, infusion of the activated metabolite triphosphate of Entecavir leads to inhibition of the enzyme reverse transcriptase. RT is required for viral production and transcription, so the inhibition results as cell lysis.
DOSE
Dosage recommendations for X-vir tablets are given below as follows:
- In compensated liver disease: the usual dose of X-vir 1mg tablet for this condition in adults is 0.5 mg, it should be recommended as a single dose.
- In decompensated cirrhosis: in patients with chronic viral hepatitis B viral infection, the prescribed dose of X-vir is 1 mg should be administered orally as a single dose.
In pediatric patients:
- For patients without prior treatment: the recommended dose of the X-vir 1mg tablet is 0.5 mg should be administered as a single dose.
- For lamivudine resistance: the prescribed dose is 1 mg of X-vir as a single dose.
- For patients with renal impairment: CrCl 50 ml / min or more: the recommended dose is 0.5 mg of X-vir administered as a single dose of CrCl 30 at less than 50 ml / min: the recommended dose is 0.5 X-vir mg for every 48 hours CrCl 10 ml / min at less than 30 ml / min: the prescribed dose is X-vir 1mg should be administered every 72 hours. CrCl less than 10 ml / min and hemodialysis, CAPD: the suggested dose is 0.5 mg of X-vir for every 7 days.
In lamivudine-resistant or decompensated cirrhosis:
- CrCl 50 ml / min or more: the recommended dose is 1 mg of X-vir administered as a single dose of CrCl 30 at less than 50 ml / min: the recommended dose is 0.5 mg of X-vir administered as a dose single or 1 mg for every 48 hours CrCl 10 ml / min at less than 30 ml / min: the prescribed dose is 1 mg of X-vir for every 72 hours. CrCl less than 10 ml / min and hemodialysis, CAPD: the suggested dose is 1 mg of X-vir for every 7 days.
How to administer X-vir 1mg tablets:
- X-vir 1mg tablet should be administered to patients with viral viral infection of chronic hepatitis B, taken on an empty stomach, that is, partially 2 hours after a meal and 2 hours before the next meal.
PRECAUTIONS
- There are two main unfavorable conditions that may occur during or after discontinuation of therapy with the X-vir 1mg tablet . It can include as; Worsening hepatitis B occurs severely after lactic acidosis therapy or hepatomegaly with steatosis.
In lactic acidosis or hepatomegaly with steatosis:
- The nucleoside analog that includes X-vir 1mg , used alone or in combination with other antiretroviral drugs, reported fatal cases such as lactic acidosis or hepatomegaly with steatosis. This condition occurs mainly in women, causes obesity and an extended risk of nucleoside inhibitor. Stop therapy if this adverse effect occurs or provide supportive measures.
- In the reactivation of hepatitis B: this side effect occurs mainly after the interruption of viral hepatitis B therapy frequently. A liver or liver function test should be performed periodically for patients. To avoid this condition, patients who get hepatitis B after treatment will receive recurrent viral hepatitis B therapy.
- In patients with HBV / HIV coinfection: the use of X-vir 1mg in patients with HBV / HIV infection who do not receive the corresponding antiretroviral medication is not evaluated . 1-mg X-vir tablets are used to treat chronic hepatitis B infection in HIV-infected patients that are not used if there is a possibility of advancing resistance to HIV nucleoside reverse transcriptase inhibitors. The patient should investigate by checking the HIV antibody before starting Entecavir therapy.
X-vir 1mg causes some effects due to interaction with other drugs:
- Concomitant use of X-vir 1mg with lamivudine, adefovir or tenofovir disoproxil fumarate does not cause serious drug interactions. Some medications may cause some effects, while concomitant with Entecavir , they may continue as; Chlorpheniramine Ginkgo Biloba Aspirin Lamivudine Metoprolol Sodium valproate Paracetamol, Sorafenib, KCl in sodium chloride Therefore, X-vir 1mg is eliminated after metabolism through the kidneys. If co-administration of X-vir 1 mg tablets with drugs that reduce renal function may cause an increase in the concentration of Entecavir and cause serious adverse effects.
STORAGE
- X-vir 1mg tablet should be stored at 20-20 to 25 ℃ (68 77 to 77 ℉) Protected from moisture, heat and light.
EFFECT OF THE FOOD
- While taking X-vir 1mg tablet with high-fat food causes the reduction of Entecavir absorption. X-vir 1mg should be administered on an empty stomach.
CONTRAINDICATIONS
- X-vir 1mg has no contraindications Some hypersensitivity reactions may occur, if patients are contraindicated with the component of X-vir 1mg tablets.
LOST DOSE
- X-vir 1mg tablet is an anti-hepaciviral drug, used only by medical advice.
- If the patient does not take the dose of X-vir 1mg , he should consult with the doctor and follow the instructions given by them or change the missed dose and continue with the regular dosing schedule.
Overdose
- An overdose does not occur during therapy with X-vir 1 mg tablets. If an overdose occurs, the toxicity of the patients must be confirmed and the signs and symptoms monitored. Support measures should be provided to patients. For a single dose of 1 mg of Entecavir , after 4 hours of hemodialysis, 13% of the dose of Entecavir is eliminated from the body.

SIDE EFFECTS
- Two important adverse effects occurred after the end of therapy, including lactic acidosis or severe hepatomegaly with steatosis. Aggravation of viral hepatitis B infection after discontinuation of viral hepatitis B treatment. The most common side effects in compensated liver cirrhosis are: headache, fatigue, dizziness, hematuria, abnormal laboratory test results, diarrhea, dyspepsia, vomiting, insomnia, hepatic encephalopathy, increased creatinine value, hyperglycemia, infection of the respiratory tract, bicarbonate blood depletion, renal failure, hepatorenal syndrome, gastrointestinal bleeding, hepatocellular cancer, effects related to the immune system such as anaphylactic reaction, skin: alopecia, rash, AST and ALT elevation.
In decompensated cirrhosis:
- Peripheral edema, ascites, pyrexia, glycosuria.
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