Orata

Orata

entecavir

Manufacturer:

Unison

Distributor:

Medline

Marketer:

F.C.P.
Concise Prescribing Info
Contents
Entecavir
Indications/Uses
Chronic HBV infection in adults w/ evidence of active liver inflammation.
Dosage/Direction for Use
HBV infection Nucleoside treatment naive: 0.5 mg once daily. Lamivudine-refractory: 1 mg once daily.
Administration
Should be taken on an empty stomach: Take at least 2 hr before or after a meal.
Contraindications
Hypersensitivity.
Special Precautions
Lactic acidosis & severe hepatomegaly w/ steatosis. Severe, acute exacerbation of hepatitis B may occur upon discontinuation of therapy. May result into HIV resistance in chronic hepatitis B patients w/ unrecognized or untreated HIV infection. Renal impairment. Liver transplant recipients.
Adverse Reactions
Peripheral edema, headache, fatigue, dizziness, skin rash, decreased serum bicarbonate, glycosuria, hyperglycemia, abdominal pain, diarrhea, dyspepsia, increased serum amylase & lipase, nausea, vomiting, ascites, increased ALT & serum bilirubin, hepatic encephalopathy, hepatic carcinoma, upper resp tract infection.
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
Form
Orata FC tab 1 mg
Packing/Price
3 × 10's
Form
Orata FC tab 0.5 mg
Packing/Price
3 × 10's
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