TKV

TKV

entecavir

Manufacturer:

Kalbe Farma
Full Prescribing Info
Contents
Entecavir monohydrate.
Action
Entecavir is a nucleoside analog which is selective to hepatitis B virus and inhibits the synthesis and replication of hepatitis B virus DNA.
Indications/Uses
Management of chronic hepatitis B.
Dosage/Direction for Use
Once-daily dosing is recommended, with or without food.
Contraindications
Hypersensitivity to entecavir or any component of the product.
Special Precautions
Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue entecavir therapy. It is not recommended for administration of entecavir to patient with hiv. Need a dosage adjustment of entecavir for patients with renal disorders (creatinine clearance <50 mL/min, and on hemodialysis).
Use in Children: TKV should not be used in children <16 years.
Use In Pregnancy & Lactation
TKV should not be used during pregnancy or lactation. There is no adequate experience in pregnant women.
Adverse Reactions
In general is headache, fatigue, dizziness, and nausea.
Drug Interactions
There is a quite strong interaction between entecavir and immunosupressan like cyclosporine and tacrolimus.
Storage
Store at room temperature (below 30°C). Protect from light.
MIMS Class
ATC Classification
J05AF10 - entecavir ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
FC tab 0.5 mg x 3 x 10's.
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