Orata: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Entecavir

Indications/Uses

Chronic HBV infection in adults w/ evidence of active liver inflammation.

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Dosage/Direction for Use

Nucleoside treatment naive Initially 0.5 mg once daily. Lamivudine-refractory (eg, evidence of viraemia while on lamivudine or presence of lamivudine resistance mutations known as YMDD gene) Initially 1 mg once daily. Renal impairment w/ CrCl 30 to <50 mL/min Usual dose: 0.25 mg once daily or 0.5 mg every 48 hr; Lamivudine refractory: 0.5 mg once daily or 1 mg every 48 hr, 10 to <30 mL/min Usual dose: 0.15 mg once daily or 0.5 mg every 72 hr; Lamivudine refractory: 0.3 mg once daily or 1 mg every 72 hr, <10 mL/min Usual dose: 0.05 mg once daily or 0.5 mg every 7 days; Lamivudine refractory: 0.1 mg once daily or 1 mg every 7 days. Patients on hemodialysis or continuous ambulatory peritoneal dialysis Usual dose: 0.05 mg once daily or 0.5 mg every 7 days; Lamivudine refractory: 0.1 mg once daily or 1 mg every 7 days. On hemodialysis days, administer after hemodialysis.

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Overdosage

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Administration

Should be taken on an empty stomach: Take >2 hr before or after a meal.

Contraindications

Hypersensitivity.

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Special Precautions

Not recommend for HIV/HBV co-infected patients unless also receiving highly active antiretroviral therapy regimen. Lactic acidosis & severe hepatomegaly w/ steatosis. Severe, acute exacerbation of hepatitis B upon discontinuation of therapy. Carefully monitor renal function before & during treatment in liver transplant recipient who has received or is receiving immunosuppressant eg, cyclosporine or tacrolimus. Renal impairment. Pregnancy. Not to breastfeed during treatment. Ped & adolescent <16 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Peripheral edema (w/ decompensated liver disease); headache, fatigue, dizziness; skin rash; decreased serum bicarbonate, glycosuria, hyperglycemia; abdominal pain, diarrhea, dyspepsia, increased serum amylase & lipase, unpleasant taste, nausea, vomiting; ascites, increased ALT & serum bilirubin, hepatic encephalopathy & carcinoma; increased serum creatine; URTI; fever; alopecia, anaphylactoid reaction, hepatomegaly, insomnia, lactic acidosis, macular edema, renal failure, thrombocytopenia.

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Drug Interactions

May increase serum conc w/ drugs that reduce renal function or compete for active tubular secretion. Concomitant use w/ other drugs that are renally eliminated or known to affect renal function. Delayed absorption & reduced AUC w/ food.

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Storage

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Description

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Action

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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.

Thai FDA Category

Presentation/Packing

Form

Orata FC tab 0.5 mg

Packing/Price

3 × 10's

Orata

entecavir

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma