X-vir 0.5mg

X-vir 0.5mg tablets are used as anti-viral medicine, the safety and effectiveness of the X-vir 0.5mg has been established against chronic hepatitis B viral infection. X-vir 0.5mg contains an active compound known as Entecavir. X-vir 0.5mg is a classified as prototype for cyclopentane class of nucleoside or nucleotide long lasting hepatitis B anti-viral drug. Entecavir is coordinate with development of minimal resistance in long term therapy of nucleoside naïve patients.

Entecavir

X-vir

0.5mg

Natco




X-vir INDICATED FOR

The critical points take into consideration, while starting the therapy with X-vir 0.5mg tablets; Indication of X-vir 0.5mg is established by clinical trial data in nucleoside inhibitor-therapy naïve and lamivudine resistant patients with HBeAg positive and HBeAg negative HBV infection and compensated liver cirrhosis & decompensated cirrhosis. X-vir 0.5mg is used in pediatric patients with 2 years of age or older, with treatment naïve, lamivudine resistant with HBeAg positive HBV infection & compensated liver cirrhosis.

Main indication:
X-vir 0.5mg tablets are used to treat chronic hepatitis B viral infection commonly in adolescent patients with the sign of viral multiplication and other information of lasting elevation of serum aminotransferase or active disease.

X-vir 0.5mg MECHANISM OF ACTION

X-vir 0.5mg 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.

Consecutively, the active metabolite triphosphate form collides with natural substrate deoxyguanosine triphosphate dGTP for insertion into viral DNA. Thus, the inclusion of the activated triphosphate metabolite of Entecavir causes prohibition of reverse transcriptase enzyme.

RT is responsible for viral production and transcription, thus inhibition results as cell lysis.



ADME Properties

X-vir 0.5mg tablet, after an oral administration it may undergo ADME properties. The peak plasma concentration time of X-vir 0.5mg is occurs within 0.5 & 1.5 hours. The steady state of X-vir 0.5mg is reaches after 6 to 10 days of single dose administration. X-vir 0.5mg Cmax value is 4.2ng/ml and trough plasma concentration are 0.3ng/ml



Oral administration of X-vir 0.5mg with high fat meal causes decreasing the absorption, depletes Cmax of 44 to 46%, decreases AUC of 18 to 20%.

The volume of distribution is exuberance of total body water; Entecavir is largely distributed into tissues. The binding of Entecavir with serum proteins occurs relatively 13%.

Entecavir should not be considering as cytochrome P450 enzymes substrate, inhibitor or inducers, which is adequately phosphorylated into an active triphosphate form.

X-vir 0.5mg tablets after metabolism get eliminated via kidneys, in an unchanged form with the range 62% to 73%. The plasma concentration of X-vir 0.5mg depletes in bi-exponential manner with the mean terminal half life period of relatively 128 to 148 hours and the phosphorylated metabolite half life is 15 hours.

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X-vir-0.5mg
Brand X-vir
Ingredients Entecavir
Strength 0.5mg
Manufactured Natco
Rating

X-vir 0.5mg DOSAGE AND ADMINISTRATION

The dosage recommendation of X-vir tablets are given below as follows;

In compensated liver disease

The usual dosage of X-vir tablet for this condition in adults is 0.5mg should be recommended as a single dose. History of hepatitis B viremia in patients: At the time of getting lamivudine or well-known lamivudine or telbivudine opposed substitutions like rtM204I/V with or without rtL180M, rtL80I/v, or rtV173L, in this situation the recommended dosage of X-vir 0.5mg is 1mg should be administered 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 tablet is 0.5mg should be given as a single dose.

For lamivudine resistance

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

In lamivudine resistant or decompensated cirrhosis

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

How to administer X-vir 0.5mg tablets

X-virtablet 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.

The most common adverse reaction occurs during or after the treatment

• Severe aggravation of hepatitis B infection
• Lactic acidosis
• Hepatomegaly with steatosis

The common side effects like

Dyspepsia, Alopecia, Rash, Elevation of transaminase, Headache, Fatigue, Anaphylactic reactions, Dizziness, Diarrhea, Nausea, Vomiting, Somnolence, Insomnia, Hepatic failure, Gastrointestinal hemorrhage, Hepatocellular carcinoma

X-vir 0.5mg PRECAUTIONS

Some precautions should be taken while starting therapy with X-vir;

In severe acute aggravation of hepatitis B

This adverse may occur after discontinuation of anti-hepatitis B therapy. In this condition patient should be monitored frequently with liver functions and other laboratory follow ups. Continue the anti-hepatitis B therapy, if required.

In HBV/HIV-1 co infected patients

Entecavir has not assessed in HIV/HBV co infected patients who are not concurrently taking effective anti-retroviral therapy. X-vir 0.5mg tablet used for HBV infection in patients who are infected with HIV, produce resistant to HIV nucleoside reverse transcriptase inhibitors, not exist to treat. X-vir 0.5mg should not be suggested to HBV/HIV co infected patients, also not receiving HAART. To overcome this type of condition, patient should be examining with HIV antibody testing before the therapy.

In lactic acidosis & hepatomegaly with steatosis

This condition may occur due to the combination of nucleoside analog with anti-retroviral agents, this may happen mostly in women. The major fatal cases of this condition are obesity and extended nucleoside exposure. Lactic acidosis frequently occurs in decompensated liver cirrhosis patients, the only way to reduce this adverse is discontinuing the treatment with X-vir.


X-vir 0.5mg INTERACTS WITH SOME DRUGS LIKE

  • X-vir 0.5mg is not a CYP 450 enzyme substrate, inhibitor or inducers.

  • Since X-vir 0.5mg is majorly eliminated through kidneys, co administration of X-vir 0.5mg tablets with drugs which reduce the renal functions causes increasing the serum concentration of Entecavir and other combined drugs leads to adverse effects of X-vir.

  • Drug interaction may occur during combination of X-vir 0.5mg with the drugs which metabolized, inhibit or induce by CYP450 enzyme may have chance to alter pharmacokinetic properties of Entecavir.

  • Co administration of X-vir 0.5mg with lamivudine, Adefovir or tenofovir disoproxil fumarate not expels any drug interaction.

X-vir 0.5mg CONTRAINDICATION


No contraindication is acquired in the therapy using with X-vir 0.5mg tablets. Any hypersensitivity reaction occurs, if patients who are contraindicated to the ingredients present in X-vir 0.5mg tablets.

X-vir 0.5mg usage in

Pregnancy

The pregnancy category of X-vir 0.5mg tablets is C X-vir 0.5mg tablets should not be used in pregnancy condition. X-vir 0.5mg used in pregnancy for necessary condition, if risk and benefits are clearly known.

Renal impairment

Depending upon creatinine clearance, the dosage of Entecavir is suggested for patients who are having renal damage. They may follow the dosage adjustments. The safety and effectiveness of Entecavir in hepatic impaired patients has not been evaluated.

Pediatric

In pediatric patient age of less than 2 years, the potency of X-vir 0.5mg has not been assured. Care should be taken while using in pediatric patients.

Lactation

In animal clinical studies reveals that Entecavir is excreted in human milk, but human data is not applicable. Breast feeding should be avoided, because most of the drugs are eliminated in human milk. To avoid problems related to Entecavir, it should be taken into consideration.

Hepatic impairment

If X-vir 0.5mg is necessary to take in hepatic impairment patients, who are already receiving Immuno suppressant like cyclosporine, Tacrolimus or sirolimus causes affecting the renal function. Patient must examine periodically before or after the therapy using with X-vir 0.5mg

Geriatric

In geriatric patient who have renal impairment, while taking X-vir 0.5mg caution should be taken because it is renal eliminated medicine. In elder patients’ renal functions are mostly decreased.



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X-vir 0.5mg tablets should be stores at below 30°C Keep away from light, moisture and heat. The shelf life of X-vir tablets is 2 years from the date of manufacture.

If over dosage of Entecavir occurs, confirmation of toxicity should be taken and provide supportive measures. Following 1mg of Entecavir, nearly 13% of Entecavir dose should be eliminated by hemodialysis method.

X-vir 0.5mg tablets are anti-hepaciviral drug, used only by getting advice from medical practitioner.

If patient fail to take the dose of X-vir, must consult with physician and follow the instructions given by them. On the other hand, skip the missed dose and follow the regular dosing schedule.




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