Monograph Details
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Infections & Infestations
> Viral infections
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EPIVIR-HBV |
| Manufacturer |
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GlaxoSmithKline Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Nucleoside analogue (reverse transcriptase inhibitor). |
| Generic Name |
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Lamivudine 100mg; tabs. |
| Also |
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• EPIVIR-HBV ORAL SOLUTION
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| Indications |
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Chronic hepatitis B associated with viral replication and active liver inflammation. |
| Children |
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<2years: not recommended. 2–17years: 3mg/kg (max 100mg) once daily. Renal impairment: consider dose reduction. |
| Adults |
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100mg once daily. Renal impairment: CrCl 30–49mL/min: 100mg for 1st dose then 50mg once daily; CrCl 15–29mL/min: 100mg for 1st dose then 25mg once daily; CrCl 5–14mL/min: 35mg for 1st dose then 15mg once daily; CrCl <5mL/min: 35mg for 1st dose then 10mg once daily. |
| Contraindications |
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Concomitant zalcitabine. |
| Precautions |
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Unrecognized or untreated HIV infection (do HIV testing and counseling before and periodically during treatment). Not for treatment of HIV and HBV co-infections (use doses appropriate for HIV). Discontinue if pancreatitis (increased risk in pediatric HIV patients) or lactic acidosis or hepatotoxicity occurs. Women, obesity, or prolonged nucleoside exposure: increased risk of toxicity (eg, lactic acidosis, steatosis). Risk of hepatitis B reactivation. Diabetes (oral soln). Monitor closely during and for several months after treatment. Reevaluate annually. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Caution with drugs eliminated by active organic cationic secretion (eg, trimethoprim). Increased lamivudine absorption with TMP/SMX; increased zidovudine levels with lamivudine (clinical significance unknown). |
| Adverse Reactions |
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See literature. Rare: Lactic acidosis, severe hepatomegaly with steatosis, post-treatment exacerbation of hepatitis, pancreatitis, emergence of viral mutations. |
| Extra Text |
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Note: Register pregnant patients exposed to lamivudine by calling (800) 258-4263. |
| How Supplied |
Tabs—60
Soln—240mL |
| Additional Resources |
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• Related Prescribing Note |
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