X-vir 1mg (Entecavir)

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Natco Pharma Ltd.

X-vir 1mg (Entecavir)

ManufacturerNatco Pharma Ltd.Brand nameX-virInternational trade nameBaracludeActive substanceEntecavirStrength1mgCategoryHEPATITIS B, HIV

Description of X-vir 1mg (Entecavir 1mg)

X-vir 1mg (Entecavir 1mg) tablets are used as anti-viral medicine, the safety and effectiveness of the X-vir 1mg (Entecavir 1mg) has been established against chronic hepatitis B viral infection. X-vir 1mg (Entecavir 1mg) contains an active compound known as Entecavir. X-vir 1mg (Entecavir 1mg) is a classified as prototype for cyclopentane class of nucleoside or nucleotide long lasting hepatitis B anti-viral medicines. X-vir 1mg (Entecavir 1mg) tablets are nor curable, may it used to reduce the amount of HBV virus in the body X-vir 1mg (Entecavir 1mg) diminishing the capability of HBV for multiplication and infecting new liver cells X-vir 1mg (Entecavir 1mg) enhance the condition of liver X-vir 1mg (Entecavir 1mg) used to reduce the chance of getting liver cancer & liver failure due to hepatitis B infection in chronic.

Medical use /Indication of X-vir 1mg (Entecavir 1mg)

The major usage of X-vir 1mg (Entecavir 1mg) tablets are :
X-vir 1mg (Entecavir 1mg) tablets are involved in the treatment of chronic hepatitis B viral infection in adults and pediatric patients with the age of 2 years and older with the sign of active viral production, either constant eminence of serum aminotransferase or histological effective disease. Before initiating the therapy with X-vir 1mg (Entecavir 1mg) tablets, the crucial points should be considered; The evidence of X-vir 1mg (Entecavir 1mg) in adult patients based on the clinical trial data in nucleoside inhibitor therapy for new patients and patient opposed to lamivudine treatment with HBeAg positive and HBeAg negative HBV infection and compensated liver cirrhosis & minor in decompensated cirrhosis. In children with the age of 2 years or older: Used for nucleoside inhibitor therapy naïve, lamivudine resistance patients with HBeAg positive chronic HBV infection and compensated cirrhosis patients.

Works as of  X-vir 1mg (Entecavir 1mg)

X-vir 1mg (Entecavir 1mg) enclose as Entecavir as an active component, a synthetic analogue of 2-deoxyguanosine has anti-viral activity against hepatitis B virus. Entecavir is triggers in-vivo into 5-triphosphate metabolite which is an active form of Entecavir. Successively, the active metabolite triphosphate form strike with natural substrate deoxyguanosine triphosphate dGTP for infusion into viral DNA. Hence infusion of the activated triphosphate metabolite of Entecavir leads to inhibition of reverse transcriptase enzyme. For viral production and transcription RT is required, thus inhibition results as cell lysis.

ADME of X-vir 1mg (Entecavir 1mg)

For chronic hepatitis B viral infection, using X-vir 1mg (Entecavir 1mg) tablets after an oral administration undergoes absorption, distribution, metabolism & elimination. Peak plasma concentration time of X-vir 1mg (Entecavir 1mg) is 0.5 hour & 1.5 hours 0.5mg of X-vir 1mg (Entecavir 1mg) tablets: The steady state occurs at 4.2ng/ml and Ctrough is 0.3ng/ml Bounding of Human plasma protein is 13%. After attaining peak plasma concentration time, the plasma concentration of Entecavir is reduced in bi exponential aspect. The terminal half life period of X-vir 1mg (Entecavir 1mg) tablet is 128 to 149 hours X-vir 1mg (Entecavir 1mg) is excreted via kidneys with the range of 62% to 73% in unchanged form. Renal clearance value 360ml/min to 471ml/min.

Side effects of X-vir 1mg (Entecavir 1mg)

Two major adverse effects occurred after completion of therapy, includes as Lactic acidosis or severe hepatomegaly with steatosis Aggravation of hepatitis B viral infection after anti-hepatitis B viral treatment discontinued. Most common side effects in compensated liver cirrhosis are :

Headache, Fatigue, Dizziness, Hematuria, Abnormal lab test results may occur, Diarrhea, Dyspepsia, Vomiting, Insomnia, Hepatic encephalopathy, Creatinine value get elevated, Hyperglycemia, Respiratory tract infection, Depletion of blood bicarbonate, Renal failure, Hepatorenal syndrome, Gastrointestinal hemorrhage, Hepatocellular cancer, Immune system related effects like anaphylactic reaction, Skin: Alopecia, rash, Elevation of AST and ALT.

In decompensated cirrhosis :

Peripheral edema, Ascites, Pyrexia, Glycosuria.

Precaution of X-vir 1mg (Entecavir 1mg)

There are two major unfavorable conditions may occur during or after discontinuation of therapy with X-vir 1mg (Entecavir 1mg) tablets. It may include as : Hepatitis B aggravation occurs severely after therapy Lactic acidosis or hepatomegaly with steatosis.

In lactic acidosis or hepatomegaly with steatosis :

Nucleoside analogue inclusive of X-vir 1mg (Entecavir 1mg) , using alone or combination with other anti-retroviral medicines, reported has fatal cases like lactic acidosis or hepatomegaly with steatosis. This condition is majorly occurs in women, causes obesity and extended nucleoside inhibitor risk. Discontinue the therapy If this adverse effect occurs or otherwise provide supportive measures.

In hepatitis B reactivation :

This side effect occurs mostly after the stopping of anti-hepatitis B viral therapy frequently. Hepatic or liver function test should be periodically taken for the patients To avoid this condition, The patients who are getting hepatitis B infection after the treatment, recurrently will get Anti-hepatitis B viral therapy

In patients with HBV/HIV co infection : 

X-vir 1mg (Entecavir 1mg) usage is not assessed in HBV/HIV co infected patients who are not correspondingly getting anti-retroviral medication. X-vir 1mg (Entecavir 1mg) tablets used to treat chronic hepatitis B infection in HIV infected patients that are not being used if there is a possible to get advancement of resistance to HIV nucleoside reverse transcriptase inhibitors. Patient must investigate by checking the HIV antibody before starting therapy with Entecavir

X-vir 1mg (Entecavir 1mg) causes some effects due to interact with other medicines:

Concurrent use of X-vir 1mg (Entecavir 1mg) with lamivudine, Adefovir or tenofovir disoproxil fumarate cause no serious medicines interactions Some medicines may cause some effects while concomitant with Entecavir, it may follow as; Chlorpheniramine Ginkgo Biloba Aspirin Lamivudine Metoprolol Valproate sodium Paracetamol, Sorafenib, KCl in sodium chloride Hence, X-vir 1mg (Entecavir 1mg) is eliminated after metabolism through kidneys. If co administration of X-vir 1mg (Entecavir 1mg) tablets with medicines reducing the renal function may leads to cause increasing the concentration of Entecavir and produces serious adverse effects.

Over dosage of X-vir 1mg (Entecavir 1mg)

Over dosage is not occurred during the therapy using with X-vir 1mg (Entecavir 1mg) tablets. If over dosage occurs, the patients must be confirmed with toxicity and monitored the signs and symptoms. Patients should be provided with supportive measures For single dose of 1mg of Entecavir, after 4hours of hemodialysis clears 13% of Entecavir dose from the body.

Contraindication of X-vir 1mg (Entecavir 1mg)

X-vir 1mg (Entecavir 1mg) has no contraindications Some hypersensitivity reactions may occur, if patients are contraindicated to component of X-vir 1mg (Entecavir 1mg) tablets.

Pregnancy of X-vir 1mg (Entecavir 1mg)

Pregnancy category of X-vir 1mg (Entecavir 1mg) tablet C

X-vir 1mg (Entecavir 1mg) used in pregnancy condition, only after knowing the risk arising to the fetus.

X-vir 1mg (Entecavir 1mg) is recommended for pregnancy condition and it should be used only by getting advice from the medical practitioner.

Lactation of X-vir 1mg (Entecavir 1mg)

While In animal data, excreted in animal milk, whereas human data is not applicable. However, breast feeding should not be recommended during the therapy.

Dosage of X-vir 1mg (Entecavir 1mg)

The dosage recommendation of X-vir 1mg (Entecavir 1mg) tablets are given below as follows :

In compensated liver disease :

The usual dosage of  X-vir 1mg (Entecavir 1mg) tablet for this condition in adults is 0.5mg should be recommended as a single dose.

In decompensated cirrhosis:

In chronic hepatitis B viral infected patients, the prescribed dosage of X-vir is 1mg should be given orally as a single dose.

In pediatric patients :

For therapy naïve patients :

The recommended dosage of X-vir 1mg (Entecavir 1mg) tablet is 0.5mg should be given as a single dose.

For lamivudine resistance :

The prescribed dosage is 1mg of  X-vir 1mg (Entecavir 1mg) should be taken as a single dose.

For renal impairment patients :

CrCl 50ml/min or greater: The recommended dosage is 0.5mg of X-vir 1mg (Entecavir 1mg) given as a single dose CrCl 30 to less than 50ml/min: The recommended dosage is 0.5mg of X-vir 1mg (Entecavir 1mg) given for every 48 hours CrCl 10ml/min to less than 30ml/min: The prescribed dosage is 0.5mg of X-vir 1mg (Entecavir 1mg) should be given for every 72 hours. CrCl less than 10ml/min & hemodialysis, CAPD: The suggested dosage is 0.5mg of X-vir 1mg (Entecavir 1mg) given for every 7 days.

In lamivudine resistant or decompensated cirrhosis :

CrCl 50ml/min or greater: The recommended dosage is 1mg of X-vir 1mg (Entecavir 1mg) given as a single dose CrCl 30 to less than 50ml/min: The recommended dosage is 0.5mg of X-vir 1mg (Entecavir 1mg) given as a single dose or 1mg for every 48 hours. CrCl 10ml/min to less than 30ml/min: The prescribed dosage is 1mg of X-vir 1mg (Entecavir 1mg) should be given for every 72 hours. CrCl less than 10ml/min & hemodialysis, CAPD: The suggested dosage is 1mg of X-vir 1mg (Entecavir 1mg) given for every 7 days.

How to administer X-vir 1mg (Entecavir 1mg) tablets :

X-vir 1mg (Entecavir 1mg) tablet should be given for chronic hepatitis B viral infected patients, taken in an empty stomach i.e., partially 2 hours after a meal and 2 hours earlier the next meal.

Storage of X-vir 1mg (Entecavir 1mg)

X-vir 1mg (Entecavir 1mg) tablet should be stored at 20℃ to 25℃ (68℉ to 77℉) Protected away from moisture, heat and light.

Missed dose of X-vir 1mg (Entecavir 1mg)

X-vir 1mg (Entecavir 1mg) tablets are anti-hepaciviral medicines, used only by getting advice from medical practitioner. If patient fail to take the dose of X-vir 1mg (Entecavir 1mg) , should consult with physician and follow the instructions given by them or otherwise swap the missed dose and continue the regular dosing schedule.

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Natco Pharma Ltd
30 Tablet
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