Entecavir Stella

Entecavir Stella

entecavir

Manufacturer:

Stellapharm

Marketer:

Stadpharm
Concise Prescribing Info
Contents
Entecavir monohydrate
Indications/Uses
Chronic HBV infection in adults w/ evidence of active viral replication & either evidence of persistent elevations in serum aminotransferases (ALT/AST) or histologically active disease.
Dosage/Direction for Use
Compensated liver disease Nucleoside-naive patient 0.5 mg once daily. Lamivudine-refractory patient 1 mg once daily. Decompensated liver disease 1 mg once daily.
Administration
Should be taken on an empty stomach: For patients w/ decompensated liver disease & lamivudine-refractory patients w/ compensated liver disease, take 2 hr before or 2 hr after meals. In nucleoside-naive patients w/ compensated liver disease, may administer w/ meals if necessary.
Special Precautions
Discontinue use if rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/lactic acidosis of unknown aetiology occur. Not to be used for HIV/HBV co-infected patients not receiving highly active antiretroviral therapy. Not to be used to reduce risk of HBV transmission. Not recommended for HIV infection. Lactic acidosis associated w/ severe hepatomegaly & hepatic steatosis. Co-infection w/ hepatitis C or D; HIV w/ low CD4 cell counts (<200 cells/mm3). May affect ability to drive & use machines. Renal impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation. Ped & adolescents <16 yr.
Adverse Reactions
Insomnia; headache, dizziness, somnolence; vomiting, diarrhoea, nausea, dyspepsia; increased transaminases; fatigue.
Drug Interactions
Increased serum conc w/ drugs reducing renal function or competing for active tubular secretion.
MIMS Class
Antivirals
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
Form
Entecavir Stella FC tab 0.5 mg
Packing/Price
3 × 10's
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