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SEBIVO

TELBIVUDINE · by NOVARTIS

ANTIVIRALS FOR SYSTEMIC USE Nucleoside reverse transcriptase inhibitor NOVARTIS

Composition

Tab 600 mg: Telbivudine 600 mg. Soln 20 mg: Per ml: Telbivudine 20 mg.

Indications & Dosage

Treatment of chronic hepatitis B in patients with evidence of viral replication & active liver inflammation: Adults: 600 mg once daily. Renal impairment: CrCI30-49: 600 mg once every 48 hr; CrCI<30 (not requiring dialysis): 600 mg once every 72 hr; End stage renal disease: 600 mg once every 96 hr, administered after haemodialysis.

Contraindications

Hypersensitivity to telbivudine.

Precautions

Lactic acidosis, severe hepatomegaly with steatosis, myopathy, uncomplicated myalgia, renal impairment, patients with antiviral-resistant, HBV infection, liver transplant recipient, elderly.Monitor hepatic function in patients who have discontinued anti-hepatitis B therapy.

Interactions

Interferon alfa.

Pregnancy

Caution advised, avoid

Lactation

Caution advised, avoid

Side Effects

Dizziness, headache, increased blood amylase & lipase, diarrhoea, nausea; increased liver enzymes; increased blood creatine phosphokinase; rash, fatigue.