Drug interactions- summary -

Drugs that alter renal function-

Because telbivudine is eliminated primarily by renal excretion, the potential for adverse
 reactions is low. However,  coadmin of telbivudine with drugs that alter renal function,may
alter plasma concentration of telbivudine .

Adverse reactions-

CNS-  fatigue    1%           headache  1%

GI - abdominal pain 1%   diarrhea/loose stools  <1%  gastritis  <1%

Musculoskeletal -  arthalgia  <1% muscle related symptoms   2%

Respiratory -   cough    <1%   

Miscellaneous -   pyrexia   1%

Hypersensitivity

Special precautions-

Excaberation of hepatitis- closely monitor hepatic function with both clinical and laboratory
follow-up

Renal function impairment - Dose interval and adjustments is recommended in patients with
Ccr 50mL/min including patients on dialysis .

Hepatic function impairment - monitor renal function before and during treatment with telbivudine

Pregnancy- use telbivudine during pregnancy only if needed.

Lactation- instruct mothers no to breast feed if they receiving telbivudine

Children- safety and efficacy of telbivudine in children have not been established.

Elderly- monitor renal function in elderly patients and institute  dosage adjustment
accordingly

Monitoring- closely monitor hepatic functioon with both clinical and laboratory follow-up
for at least several monthsin patients who discontinue anti-heaptitis B therapy

Monitor patients for any signs of unexplained muscle pain, tenderness, or weakness.
paticularly during upward dosage titration

Indication-

Chronic hepatitis B

Dosage-
Adults and adolescents ( 16 years of age)-
600mg once daily taken with or without food

1. Patients should remain under care of a doctor during treatment

2. Advice patients to promptly report any unexplained musclev weakness, tendrness
   or pain.

3. Advice paients that tebivudine is not a cure for hepatitis B .

4. Inform patients that deterioration of liver disease may occur in some cases if treatment is
   discontinued and that they should discuss any change in dosage regimen with their doctor

5. Inform patients that treatment with telbivudine has not been to reduce the risk of transmission
of HBV to others through sexual contact.

Can be taken with or without food.

Pregnancy-
Use telbivudine during pregnancy only if needed.

Lactation-
Instruct mothers no to breast feed if they receiving telbivudine

Children-
Safety and efficacy of telbivudine in children have not been established.

Elderly-
Monitor renal function in elderly patients and institute  dosage adjustment
accordingly