Entehep 0.5mg containing Entecavir exhibits its anti-viral activity by prohibiting three steps in viral production; Entehep 0.5mg is an anti-viral medicine, which is guanosine nucleoside analogue effective against HBV infection. Entehep 0.5mg is encounters with natural substrate deoxyguanosine triphosphate. Entehep 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 Entehep 0.5mg tablet has Entecavir, which is inserting into viral DNA has extreme effect of prohibiting the HBV polymerase activity.
Entehep 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. Entehep 0.5MG Cmax value is 4.2ng/ml and trough plasma concentration is 0.3ng/ml Entehep 1mg Cmax value is 8.2ng/ml and trough plasma concentration is 0.5ng/ml
Entehep 0.5mg 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 Entehep tablets; Uses of Entehep 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. Entehep 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 : Entehep
Ingredients : Entecavir
Strength : 0.5mg
Manufactured : Zydus Heptiza
Package : 10 tablets in a strip
Entehep 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 Entehep tablets;In compensated cirrhosis
In adults In this condition, the prescribed dosage of Entehep 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 Entehep tablets is 1mg should be administered orally as a single dose.In pediatric
The safety and efficacy of Entehep 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 Entehep should be recommended as single dose. In Lamivudine resistant patients: 2 years and older with >30kg: 1mg of Entehep should be recommended as a single dose.
In decompensated condition, the recommended dosage is 1mg of Entehep should be taken as once a day.
In renal damaged patients;
If creatinine clearance decreased, then the apparent oral clearance of Entehep 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 Entehep should be recommended; in Lamivudine resistant or decompensated condition 1mg of Entehep is recommend. In 30 to <50ml/min: 0.5mg of Entehep is taken for every 48 hours; in Lamivudine resistant or decompensated condition 0.5mg of Entehep as single dose or 1mg of Entehep 0.5mg taken for every 48 hours. In 10 to <30ml/min: 0.5mg of Entehep should be given for every 72 hours; in Lamivudine resistant or decompensated condition 1mg of Entehep is recommended for every 72 hours. <10 ml/min & hemodialysis or CAPD: 0.5mg of Entehep 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.
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
Some precautions should be taken while starting therapy with Entehep 0.5mgIn 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. Entehep 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. Entehep 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 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 Entehep 0.5mg .
Entehep is not a CYP 450 enzyme substrate, inhibitor or inducers. Drug interaction may occur during combination of Entehep 0.5mg with the drugs which metabolized, inhibit or induce by CYP450 enzyme may have chance to alter pharmacokinetic properties of Entecavir. Since Entehep is majorly eliminated through kidneys, co administration of Entehep 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 Entecavir. Co administration of Entehep with lamivudine, Adefovir or tenofovir disoproxil fumarate not expels any drug interaction.