Teviral Syrup

• Chronic Hepatitis B Virus (HBV) Infection: Used for the treatment of CHB with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease in patients 2 years and older.

By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt): Base priming, Reverse transcription of the negative strand from the pregenomic messenger RNA, and Synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity.

Adult Dose:

• Nucleoside inhibitor-naïve (compensated liver disease): 0.5 mg PO qDay.
• Lamivudine-refractory (or telbivudine resistance): 1 mg PO qDay.
• Decompensated liver disease: 1 mg PO qDay.

Child Dose (≥2 years, ≥10 kg): Under 16 years: 0.015-0.03 mg/kg; 16 years: as adult.

Renal Dose:

• CrCl ≥50 mL/min: No dosage adjustment required
• CrCl 30-49 mL/min: 0.25 mg/day or 0.5 mg q48hr
• CrCl 10-29 mL/min: 0.15 mg/day or 0.5 mg q72hr
• CrCl <10 mL/min (dialysis/CAPD): 0.05 mg/day or 0.5 mg q7days

Common Side Effects:

• Headache
• Dizziness
• Tiredness
• Nausea

Use in Pregnancy: Entecavir may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Consult your doctor.

Precautions:

• Entecavir may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.
• Take it on an empty stomach (at least 2 hours after or before a meal).
• Entecavir may cause dizziness or sleepiness. Do not drive or do anything requiring concentration until you know how it affects you.
• You may still develop infections or other illnesses associated with viral infection while taking this medication.
• During treatment and for at least six months after stopping this medicine, regular blood tests are needed to monitor your liver function, level of hepatitis B virus and blood cells in your blood.

Overdose: No experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.

Storage: Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.