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How the body working for Entekor tablets


Entekor tablet, after an oral administration it may undergo ADME properties.

Absorption

The peak plasma concentration time of Entekor is occurs within 0.5 & 1.5 hours. The steady state of Entekor is reaches after 6 to 10 days of single dose administration. Entekor 0.5mg Cmax value is 4.2ng/ml and trough plasma concentration is 0.3ng/ml
Effect of food: Oral administration of Entekor 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 largely 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 adequately phosphorylated into an active triphosphate form.

Elimination

Entekor tablets after metabolism get eliminated via kidneys, in an unchanged form with the range 62% to 73%. The plasma concentration of Entekor 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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Brand : Entekor
Ingredients : Entecavir
Strength : 0.5mg
Manufactured : Aprazer
Package : 30 tablets

Entekor dosing consideration and its usage

Entekor tablets should be taken on an empty stomach (partially 2 hours after a meal or two hours earlier to the next meal). The usual prescribed dosage of Entekor tablets;

In compensated cirrhosis

In adults
In this condition, the prescribed dosage of Entekor is 0.5mg should be administered orally as a single dose for the chronic hepatitis B viral infected patients who have newly started with Entekor. In past hepatitis B viremia, since taking lamivudine therapy or known lamivudine or telbivudine resistant alteration; the advised dosage of Entekor tablets is 1mg should be administered orally as a single dose.

In pediatric

The safety and efficacy of Entekor 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 Entekor should be recommended as single dose. In lamivudine resistant patients: 2 years and older with >30kg: 1mg (2 tablet of 0.5mg Entekor) of Entekor should be recommended as a single dose.

In decompensated liver cirrhosis

In decompensated condition, the suggested dosage is 1mg of Entekor should be taken as once a day.

In renal damaged patients

If creatinine clearance decreased, then the apparent oral clearance of Entekor 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 Entekor should be recommended; in lamivudine resistant or decompensated condition 1mg of Entekor is recommend.

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

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

Entekor precautions

Some precautions should be taken while starting therapy with Entekor

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. Entekor 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. Entekor 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 Entekor 0.5mg.

Entekor 0.5mg interacts with some drugs like

Entekor 0.5mg is not a CYP 450 enzyme substrate, inhibitor or inducers. Since Entekor 0.5mg is majorly eliminated through kidneys, co administration of Entekor tablets with drugs which reduce the renal functions causes increasing the serum concentration of Entecavir and other combined drugs leads to adverse effects of Entekor.

Drug interaction may occur during combination of Entekor 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 Entekor 0.5mg with lamivudine, Adefovir or tenofovir disoproxil fumarate not expels any drug interaction.



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Warning of Entekor 0.5mg tablets

The most serious disadvantageous obtaining in the patients after the therapy who are getting Entecavir, include as Serious aggravation of hepatitis B viral infection in HIV/HBV co infected patients. Severe hepatomegaly with steatosis & lactic acidosis: This condition is reported with the use nucleoside analogs or concomitant with other anti-retroviral. There is a chance of arising resistance to HIV nucleoside reverse transcriptase inhibitors, if Entekor tablet is used in the treatment of chronic hepatitis B infection in HIV patients, not actually treated. Treatment with Entekor tablets should not be recommended for HIV-1/HBV co infected patients, not receiving highly active anti-retroviral therapy (HAART).

Entekor 0.5mg 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.

Entekor missed dose

Entekor 0.5mg is used in chronic hepatitis B infection, if dose of Entecavir is failing 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.




abdominal pain
abdominal pain
concluded as death
concluded as death
dark urine
dark urine
fatigue
fatigue
flu like syndrome
flu like syndrome
loss of apetite
loss of apetite
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loss of weight


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