Drug interactions- summary

Drugs affected by renal functionimpairment -
coadministration of drugs that reduce renal function or compete for active tubular secretion
may increase serum concentration of either entacavir or the coadministred drug

Chronic hepatitis B

Adverse reactions-

CNS -   diarrhoea   < 1%   fatigue 1%   headache 2 %  insomnia <1% somnolence <1%

GI - diarrhea   <1%   dyspepsia <1%   nausae <1%   vomiting <1%

 Special precautions-

Severe acute excaberation of hepatitis B-  closely monitor hepatic function with clinical
laboratory follow-up for at least several months in patients who discontinue antihepatic B
therapy

Patients co-infected with HIV and HBV - not recommended for this use.

Lactic acid acidosis -lactic acid acidosis and severe hepatomegaly, including fatal cases
have been reported with the use of neucloside analogs alone or in combination with
antiretrovirals

Liver transplant recipients - renal function must be carefully monitored before and during
treatment with entecavir

Pregnancy- use entecavir in pregnancy only if clearly needed, after considering the risk
and benefits

Lactation- decide whether to discontinue nursing or the drug taking into considedration
of the importance of the drug to the mother.

Children- safety and efficacy for use inchildren below 16 years of age have not been
established

Elderly- elderly patients are more likely to have decreased renal function, take care of
dose selection and monitor liver function.

Monitoring- periodic monitoring of renal function is recommended. Monitor patients for
signs and symptoms of laactic acid acidosis/hepatomegaly

Indication-

Chronic hepatitis B

Dosage-
0.5mg once daily in adults and adolescents 16 years of age

1. Advice patients to take entecavir on an empty stomach at least 2 hours after a meal and
    2 hours before the next meal

2. Inform patients of the deterioation of liver disease may occur in some cases if treatment
    is discontinued and tell them to discuss any change in regimen with their doctor

3. Advice patients that treatment with entecavir has not been shown to reduce the risk of
    transmission of HBV to others, through sexual contact or blood contamination

4. Instruct patients using oral solution to hold dosing spoon in a vertical position and fill it
    gradually to the mark corrsponding to the prescribed dose

5. Inform patients that if they have HIV  infection and not receiving effective HIV infections
   and receiving effective HIV treatment, entacavir can increase the chance of HIV resistence
   to HIV medication

Pregnancy-
Use entecavir in pregnancy only if clearly needed, after considering the risk
and benefits

Lactation-                                                                                                                            Decide whether to discontinue nursing or the drug taking into considedration
of the importance of the drug to the mother.

Children-
Safety and efficacy for use inchildren below 16 years of age have not been
established

Elderly-
Elderly patients are more likely to have decreased renal function, take care of
dose selection and monitor liver function.