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Pharmacology of X-vir 0.5mg


X-vir 0.5mg containing Entecavir exhibits its anti-viral activity by prohibiting three steps in viral production; X-vir 0.5mg is an anti-viral medicine, which is guanosine nucleoside analogue effective against HBV infection. X-vir 0.5mg is encounters with natural substrate deoxyguanosine triphosphate. X-vir 0.5mg interfere with three activities of HBV polymerase; 1. Base priming 2. Reverse transcription of negative strand from pregenomic messenger RNA 3. Integration of positive strand of HBV DNA. An X-vir 0.5mg tablet has Entecavir, which is inserting into viral DNA has extreme effect of prohibiting the HBV polymerase activity.

How the body working for X-vir 0.5mg tablets


X-vir 0.5mg tablet, after an oral administration it may undergo ADME properties. The peak plasma concentration time of Entecavir is occurs within 0.5 & 1.5 hours. The steady state of Entecavir is accomplished after 6 to 10 days of single dose administration. X-vir 0.5MG Cmax value is 4.2ng/ml and trough plasma concentration is 0.3ng/ml X-vir 1MG Cmax value is 8.2ng/ml and trough plasma concentration is 0.5ng/ml

Effect of food

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%.

Distribution

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

Metabolism

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

Elimination

Entecavir is eliminated through kidney, in an unchanged form with the range 62% to 73%. The plasma concentration of Entecavir depletes in bi-exponential manner with the mean terminal half life period of relatively 128 to 148 hours.



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X-vir 0.5mg medical benefits


X-vir tablets are used to treat chronic hepatitis B viral infection mostly in adolescent patients with the sign of viral multiplication and other information of enduring elevation of serum aminotransferase or active disease. The important points take into consideration, while starting the therapy with X-vir tablets; Uses of X-vir is based on 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 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.

Brand : X-vir
Ingredients : Entecavir
Strength : 0.5mg
Manufactured : Natco
Package : 30 tablets

X-vir 0.5mgdosing consideration and its usage

X-vir tablets must be administered on an empty stomach (at least 2 hours after a meal or two hours before the next meal). The usual recommended dosage of X-vir 0.5mg tablets;

In compensated cirrhosis

In adults In this condition, the prescribed dosage of X-vir 0.5mg should be administered orally as a single dose for the chronic hepatitis B viral infected patients who have therapy naïve. In history of hepatitis B viremia, since taking lamivudine therapy or known lamivudine or telbivudine resistant alteration; the suggested dosage of X-vir tablets is 1mg should be administered orally as a single dose.

In pediatric

The safety and efficacy of X-vir in children with the age of <2 years has not been established. In nucleoside naïve patients: 2 years or older with >30kg: 0.5mg of X-vir should be recommended as single dose. In lamivudine resistant patients: 2 years and older with >30kg: 1mg of X-vir should be recommended as a single dose.

In decompensated liver cirrhosis

In decompensated condition, the recommended dosage is 1mg of X-vir should be taken as once a day. In renal damaged patients; If creatinine clearance decreased, then the apparent oral clearance of X-vir is also decreased. The dosage recommendation for the patients; With creatinine clearance of less than 50ml/min, Hemodialysis patients and For Continuous ambulatory peritoneal dialysis patients (CAPD)

CrCl ≥50ml/min: 0.5mg of X-vir should be recommended; in lamivudine resistant or decompensated condition 1mg of X-vir is recommend. In 30 to <50ml/min: 0.5mg of X-vir is taken for every 48 hours; in lamivudine resistant or decompensated condition 0.5mg of X-vir as single dose or 1mg of X-vir 0.5mg taken for every 48 hours. In 10 to <30ml/min: 0.5mg of X-vir should be given for every 72 hours; in lamivudine resistant or decompensated condition 1mg of X-vir is recommended for every 72 hours. <10ml/min: & hemodialysis or CAPD: 0.5mg of X-vir is recommended for every 7 days; in lamivudine resistant or decompensated condition 1mg should be given for every 7 days. In hepatic impairment patients, dosage adjustment should not be recommended.

X-vir 0.5mg produces some undesirable effects

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

Entavir precautions

Some precautions should be taken while starting therapy with X-vir 0.5mg;

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 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 should not be suggested to HBV/HIV co infected patients, also not receiving HAART. To overcome this type of condition, patient should be examine 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 is 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 0.5mg .

X-vir 0.5mg interacts with some drugs like

X-vir is not a CYP 450 enzyme substrate, inhibitor or inducers. 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. Since X-vir is majorly eliminated through kidneys, co administration of X-vir tablets with drugs which reduce the renal functions causes increasing the serum concentration of Entecavir and other combined drugs leads to adverse effects of Entecavir. Co administration of X-vir 0.5mg with lamivudine, Adefovir or tenofovir disoproxil fumarate not expels any drug interaction.



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Renal and Hepatic 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. 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 .

X-vir over dosage

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 missed dose

X-vir 0.5mg is used in chronic hepatitis B infection, if dose of Entecavir is fail to take by the patients, must consult with medical practitioner and take the dose within a time. On the other hand the missed dose is avoided and follows the regular schedule.




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