Tecavir

Tecavir

entecavir

Manufacturer:

Aristopharma

Distributor:

KTZ
Full Prescribing Info
Contents
Entecavir.
Description
Each film-coated tablet contains entecavir monohydrate INN equivalent to entecavir 0.5 g and 1 mg, respectively.
Action
Pharmacology: Entecavir is a guanosine nucleoside analogue with potent and selective activity against HBV polymerase. For pharmacological action, it is phosphorylated to the active triphosphate (TP) form. Entecavir triphosphate functionally inhibits all 3 activities of the viral polymerase; priming of the HBV polymerase, reverse transcription of the negative strand from the pregenomic messenger RNA and synthesis of the positive strand HBV DNA.
Indications/Uses
Chronic hepatitis B virus infection in adults with compensated liver disease, evidence of viral replication and histologically documented active liver inflammation or fibrosis. It is also effective in decompensated cirrhosis.
Dosage/Direction for Use
Adults over 16 years: Not Previously Treated with Nucleoside Analogues: 0.5 mg once daily.
Adults over 16 years: Lamivudine or Telbivudine Resistant Chronic Hepatitis B: 1 mg once daily.
Renal Impairment: Dose adjustment is recommended for patients with creatinine clearance <50 mL/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPO) as shown in the table. (See table.)

Click on icon to see table/diagram/image

Administration: Taken in an empty stomach (at least 2 hrs before or 2 hrs after meal).
Contraindications
Hypersensitivity to any component of Tecavir.
Special Precautions
Monitor liver function tests every 3 months, and viral and serological markers for hepatitis B every 3-6 months. Discontinue if deterioration in liver function, hepatic steatosis, progressive hepatomegaly or unexplained lactic acidosis. Recurrent hepatitis may occur on discontinuation.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Entecavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether entecavir is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking entecavir.
Use in children: Safety and effectiveness of entecavir in pediatric patients <16 years have not been established.
Use in the elderly: Entecavir is significantly excreted by the kidney and the risk of toxic reactions to Tecavir may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
Use In Pregnancy & Lactation
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Entecavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether entecavir is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking entecavir.
Adverse Reactions
The most common adverse reactions are headache, fatigue, dizziness and nausea.
Drug Interactions
Since entecavir is predominantly eliminated by the kidney, co-administration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentration of either drug.
Storage
Store 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 1 x 10's. 1 mg x 1 x 10'S.
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