EPIVIR-HBV ORAL SOLUTION Rx

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EPIVIR-HBV ORAL SOLUTION

Viral infections
Only 4 drugs may be compared at once

Generic Name and Formulations:

Lamivudine 5mg/mL; strawberry-banana flavor.

Company:

GlaxoSmithKline

Select therapeutic use:

Indications for EPIVIR-HBV ORAL SOLUTION:

Chronic hepatitis B associated with viral replication and active liver inflammation.

Adult:

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.

Children:

<2yrs: not recommended. 2–17yrs: 3mg/kg (max 100mg) once daily. Renal impairment: consider dose reduction.

Contraindications:

Concomitant zalcitabine.

Warnings/Precautions:

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). Suspend if lactic acidosis or hepatotoxicity (eg, hepatomegaly and steatosis) occurs. Risk factors for liver disease. Women, obesity, or prolonged nucleoside exposure: increased risk of toxicity. Post-treatment exacerbation of hepatitis B; monitor closely during and for several months after treatment. Emergence of resistance-associated HBV substitutions: monitor ALT and HBV DNA levels during treatment. Diabetes (oral soln). Reevaluate annually. Pregnancy. Nursing mothers.

Interactions:

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).

See Also:

EPIVIR-HBV

Pharmacological Class:

Nucleoside analogue (reverse transcriptase inhibitor).

Adverse Reactions:

Ear, nose, and throat infections, sore throat, diarrhea; rare: lactic acidosis, severe hepatomegaly with steatosis, emergence of viral mutations.

Note:

Register pregnant patients exposed to lamivudine by calling (800) 258-4263.

Generic Availability:

Tabs (YES); Soln (NO)

How Supplied:

Tabs—60; Soln—240mL