Monograph Details
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Infections & Infestations
> Viral infections
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EPIVIR ORAL SOLUTION |
| 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 10mg/mL; strawberry-banana flavor; contains sucrose 3g/15mL. |
| Also |
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• EPIVIR
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| Indications |
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HIV infection. |
| Adults and Children |
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≤3months: not recommended. 3months–16years: 4mg/kg (max 150mg) twice daily; renal impairment: reduce dose or prolong dosing interval. ≥16years, CrCl ≥50mL/min: 300mg once daily or 150mg twice daily; CrCl 30–49mL/min: 150mg once daily; CrCl 15–29mL/min: 150mg for 1st dose then 100mg once daily; CrCl 5–14mL/min: 150mg for 1st dose then 50mg once daily; CrCl <5mL/min: 50mg for 1st dose then 25mg once daily. |
| Contraindications |
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Concomitant zalcitabine. |
| Precautions |
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Discontinue if pancreatitis (increased risk in pediatric patients) or lactic acidosis occurs. Suspend therapy if hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Women, obesity, or prolonged nucleoside exposure: increased risk of toxicity (ie, lactic acidosis, steatosis). Hepatitis B (monitor for post-treatment exacerbation). Other liver disease risk factors. Diabetes (oral soln). Children with prior antiretroviral nucleoside exposure, history of pancreatitis or risk factors for pancreatitis. 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 (clinical significance unknown). Triple therapy (once daily regimen) with abacavir + tenofovir or with didanosine + tenofovir: high rate of early viral non-response (see literature). Monitor for treatment-associated toxicities with interferon-alpha with or without ribavirin. |
| Adverse Reactions |
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Adults: headache, malaise, fever, GI upset, neuropathy, dizziness, sleep or depressive disorders, rash, respiratory effects, musculoskeletal pain, lactic acidosis, severe hepatomegaly with steatosis, fat redistribution, neutropenia, abnormal liver function tests. Children: pancreatitis, paresthesias, peripheral neuropathy, fever, rash, respiratory effects, neutropenia, anemia, abnormal liver function tests. |
| Extra Text |
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Note: Register pregnant patients exposed to lamivudine by calling (800) 258-4263. |
| How Supplied |
Tabs 150mg—60
Tabs 300mg—30
Soln—240mL |
| Additional Resources |
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• Related Prescribing Note |
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