quinta-feira, janeiro 06, 2005
Crixivan não recomendado para mulheres grávidas
FDA 27.12.04
Crixivan (Indinavir) Label Revised -- Not Recommended for HIV-Infected Pregnant Patients
The Clinical Pharmacology section of the Crixivan (indinavir) label has been revised to include pharmacokinetic data from a study (PACTG 358) in HIV-infected pregnant women. Results from this study show substantially reduced indinavir concentrations in women at 30-32 weeks gestation compared to postpartum. Based on these data, the Precautions Section now states that indinavir is not recommended in HIV-infected pregnant patients.
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Crixivan (Indinavir) Label Revised -- Not Recommended for HIV-Infected Pregnant Patients
The Clinical Pharmacology section of the Crixivan (indinavir) label has been revised to include pharmacokinetic data from a study (PACTG 358) in HIV-infected pregnant women. Results from this study show substantially reduced indinavir concentrations in women at 30-32 weeks gestation compared to postpartum. Based on these data, the Precautions Section now states that indinavir is not recommended in HIV-infected pregnant patients.
...