Trade name : Entehep
Active component : Entecavir
Strength : 0.5mg
Manufactured by : Zydus Heptiza
Pack : 30 tablets in a container
Category : Anti-viral drug
Entehep 0.5mg tablets are used as anti-viral medicine, the safety and effectiveness of the Entehep 0.5mg has been established against chronic hepatitis B viral infection. Entehep 0.5mg contains an active compound known as Entecavir. Entehep 0.5mg is a classified as prototype for cyclopentane class of nucleoside or nucleotide long lasting hepatitis B anti-viral drug. Entehep 0.5mg tablets are nor curable, may it used to reduce the amount of HBV virus in the body Entehep 0.5mg diminishing the capability of HBV for multiplication and infecting new liver cells Entehep 0.5mg enhance the condition of liver Entehep 0.5mg used to reduce the chance of getting liver cancer & liver failure due to hepatitis B infection in chronic.
The major usage of Entehep 0.5mg tablets are :
Entehep 0.5mg 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 Entehep 0.5mg tablets, the crucial points should be considered; The evidence of Entehep 0.5mg 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.
The dosage recommendation of Entehep tablets are given below as follows :
In compensated liver disease : The usual dosage of Entehep 0tablet 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 Entehep is 1mg should be given orally as a single dose.
In pediatric patients :
For therapy naïve patients : The recommended dosage of Entehep tablet is 0.5mg should be given as a single dose.
For lamivudine resistance : The prescribed dosage is 1mg of Entehep should be taken as a single dose.
CrCl 50ml/min or greater: The recommended dosage is 0.5mg of Entehep given as a single dose CrCl 30 to less than 50ml/min: The recommended dosage is 0.5mg of Entehep given for every 48 hours CrCl 10ml/min to less than 30ml/min: The prescribed dosage is 0.5mg of Entehep should be given for every 72 hours. CrCl less than 10ml/min & hemodialysis, CAPD: The suggested dosage is 0.5mg of Entehep given for every 7 days.
In lamivudine resistant or decompensated cirrhosis :
CrCl 50ml/min or greater: The recommended dosage is 1mg of Entehep given as a single dose CrCl 30 to less than 50ml/min: The recommended dosage is 0.5mg of Entehep 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 Entehep should be given for every 72 hours. CrCl less than 10ml/min & hemodialysis, CAPD: The suggested dosage is 1mg of Entehep given for every 7 days.
How to administer Entehep 0.5mg tablets :
Entehep 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.
For chronic hepatitis B viral infection, using Entehep 0.5mg tablets after an oral administration undergoes absorption, distribution, metabolism & elimination. Peak plasma concentration time of Entehep 0.5mg is 0.5 hour & 1.5 hours 0.5mg of Entehep 0.5mg 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 Entehep 0.5mg tablet is 128 to 149 hours Entehep 0.5mg is excreted via kidneys with the range of 62% to 73% in unchanged form. Renal clearance value 360ml/min to 471ml/min.
Entehep 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.
There are two major unfavorable conditions may occur during or after discontinuation of therapy with Entehep 0.5mg 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 Entehep 0.5mg , 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 : Nucleoside analogue inclusive of Entehep 0.5mg , 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 patients with HBV/HIV co infection : Entehep 0.5mg usage is not assessed in HBV/HIV co infected patients who are not correspondingly getting anti-retroviral medication. Entehep 0.5mg 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
Entehep 0.5mg causes some effects due to interact with other drugs :
Concurrent use of Entehep 0.5mg with lamivudine, Adefovir or tenofovir disoproxil fumarate cause no serious drug interactions Some drugs 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, Entehep 0.5mg is eliminated after metabolism through kidneys. If co administration of Entehep 0.5mg tablets with drugs reducing the renal function may leads to cause increasing the concentration of Entecavir and produces serious adverse effects.
Entehep 0.5mg tablet should be stored at 20℃ to 25℃ (68℉ to 77℉) Protected away from moisture, heat and light.
EFFECT OF FOOD
While taking Entehep 0.5mg tablet with high fat meal causes reduction of absorption of Entecavir. Entehep 0.5mg must be administered on an empty stomach.
Entehep 0.5mg has no contraindications Some hypersensitivity reactions may occur, if patients are contraindicated to component of Entehep 0.5mg tablets.
Entehep 0.5mg tablets are anti-hepaciviral drug, used only by getting advice from medical practitioner. If patient fail to take the dose of Entehep 0.5mg , should consult with physician and follow the instructions given by them or otherwise swap the missed dose and continue the regular dosing schedule.
Over dosage is not occurred during the therapy using with Entehep 0.5mg 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.
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 :
Abnormal lab test results may occur,
Creatinine value get elevated,
Respiratory tract infection,
Depletion of blood bicarbonate,
Immune system related effects like anaphylactic reaction,
Skin: Alopecia, rash,
Elevation of AST and ALT.
In decompensated cirrhosis :
Peripheral edema, Ascites, Pyrexia, Glycosuria.