The use of lamivudine has been expanded
In June, the Food and Drug Administration approved a supplemental new drug application from GlaxoSmithKline expanding the labeled indication to provide for the use of Epivir (lamivudine) once daily for the treatment of HIV infection in combination with other antiretroviral agents, and a new 300 mg tablet. The product label has been modified to reflect these changes. The "Dosage and Administration" section of the label reads:
"Dosage and administration: Adults: The recommended oral dose of Epivir for adults is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents (see description of clinical studies, precautions, microbiology, and clinical pharmacology). If lamivudine is administered to a patient dually infected with HIV and HBV, the dosage indicated for HIV therapy should be used as part of an appropriate combination regimen (see warnings)."
For a copy of the complete product label, go to www.fda.gov/cder/approval/index.htm by clicking "E" in the index and scrolling down to Epivir. Label is dated 6/25/02.
Agenerase product label changed
The labeling has been changed for Agenerase (amprenavir) Capsules and Agenerase (amprenavir) Oral Solution to reflect new precautions related to use of Agenerase with Methadone, and with oral (hormonal) contraceptives.
The new labeling reads:
"Methadone: Coadministration of amprenavir and methadone can decrease plasma levels of methadone. Agenerase may be less effective due to decreased amprenavir plasma concentrations in patients taking these agents together. Alternative antiretroviral therapy should be considered. Dosage of methadone may need to be increased when coadministered with Agenerase. Oral contraceptives: (Ethinyl estradiol/norethindrone). Those taking Agenerase should be instructed not to use hormonal contraceptives because some birth control pills (those containing ethinyl estradiol/norethindrone) have been found to decrease the concentration of amprenavir. This may lead to loss of virologic response and possible resistance to Agenerase. Alternative methods of nonhormonal contraception are recommended."
For the complete Agenerase label, go to www.fda.gov/cder/foi/label/2002/21007s11,21039s10lbl.pdf.
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