dose of nevirapine prophylaxis in newborn endep

We hypothesized that the administration, in addition to zidovudine, of a single dose of oral nevirapine to mothers during labor and to neonates would further reduce transmission of HIV. 2002 The administration of single-dose nevirapine to women in labor and their infants can prevent HIV-1 mother-to-child transmission. /recap/928835 Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

Available for Android and iOS devices. Diseases; Fogarty International Center. Indicated for treatment of HIV-1 infection in combination with other antiretrovirals; also used for prevention of maternal-fetal HIV transmission in women with no prior antiretroviral treatmentIf no rash, increase to 200 mg q12hr; if rash occurs wait until it is resolved before increasingPrevention of maternal-fetal HIV transmission: 200 mg PO as a single dose at onset of labor, in combination with IV zidovudineBased on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine should not be initiated in adult females with CD4+ cell counts >250 cells/mm³ or in adult males with CD4+ cell counts >400 cells/mm³ unless the benefit outweighs the riskThe 14-day lead-in period with immediate-release dosing must be strictly followed; it has been demonstrated to reduce the frequency of rashIf nevirapine extended-release interrupted >7 days, restart with lead-in dosing with immediate-release nevirapineIf mild-to-moderate rash (without constitutional symptoms) occurs during 14-day lead-in period, do not increase immediate-release dose or initiate extended-release regimen until the rash has resolved; duration of the lead-in dosing should not exceed 28 days, at which point an alternative regimen should be chosen; discontinue also if severe rash develops or rash with elevated hepatic transaminases or with constitutional symptoms occurIndicated for treatment of HIV-1 infection in combination with other antiretroviralsAdditional prophylaxis with nevirapine is needed for HIV-exposed infants of women who did not receive antepartum ART (NIH perinatal guidelines July 2012)Administer 3 doses in the first week of life; 1st dose 48 hr after birth, give 2nd dose 48 hr after 1st dose, and 3rd dose 96 hr after 2nd doseRecommended in combination with 6 weeks of zidovudineThe 14-day lead-in period with immediate-release dosing must be strictly followed; it has been demonstrated to reduce the frequency of rashIf nevirapine extended-release interrupted >7 days, restart with lead-in dosing with immediate-release nevirapineIf mild-to-moderate rash (without constitutional symptoms) occurs during 14-day lead-in period, do not increase immediate-release dose or initiate extended-release regimen until the rash has resolved; duration of the lead-in dosing should not exceed 28 days, at which point an alternative regimen should be chosenPotentially fatal hepatotoxicity (fulminant hepatitis, cholestatic hepatitis, hepatic failure, hepatic necrosis)Body as a whole: Fever, somnolence, drug withdrawal, redistribution/accumulation of body fatLiver and biliary: Jaundice, fulminant and cholestatic hepatitis, hepatic necrosis, hepatic failureHematology: Anemia, eosinophilia, neutropenia Investigations: decreased serum phosphorusMusculoskeletal: Arthralgia, rhabdomyolysis associated with skin and/or liver reactionsSkin and appendages: Allergic reactions including anaphylaxis, angioedema, bullous eruptions, ulcerative stomatitis and urticaria have all been reported; hypersensitivity syndrome and hypersensitivity reactions with rash associated with constitutional findings (eg, fever, blistering, oral lesions, conjunctivitis, facial edema, muscle or joint aches, general malaise, fatigue, or significant hepatic abnormalities, drug reaction with eosinophilia and systemic symptoms [DRESS])Monitoring during the first 18 wk of therapy essential; extra vigilance warranted during first 6 wk of therapy (period of greatest risk)Moderate or severe hepatic impairment (Child-Pugh class B or C)Coadministration with drugs (eg, CYP inducers) where significant decreases in nevirapine plasma concentrations may occur, which may result in loss of virologic response and possible resistance and cross-resistance to other NNRTIsUse as part of postexposure prophylaxis (PEP) regimensDo not restart therapy following severe skin rash, skin rash combined with increased transaminases or other symptoms, or hypersensitivity reactionRisk of severe, life threatening skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivityDiscontinue if severe rash or any rash accompanied by constitutional findings occursRisk of immune reconstitution syndrome if used in combination with other antiretroviral drugsRedistribution/accumulation of body fat may occur (cushingoid appearance)Limited human data are insufficient to determine risk of infertility in humans; based on results from animal fertility studies conducted in rats, therapy may reduce fertility in females of reproductive potential; not known if these effects on fertility are reversibleThere is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263Available data from the APR show no difference in risk of overall major birth defects for nevirapine compared with background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP); rate of miscarriage is not reported in the APRSevere hepatic events, including fatalities, reported in pregnant women receiving chronic therapy as part of combination treatment of HIV-1 infection; regardless of pregnancy status, women with CD4+ cell counts greater than 250 cells/mm3 should not initiate therapy unless benefit outweighs risk; it is unclear if pregnancy augments risk observed in non-pregnant womenThe Centers for Disease Control and Prevention recommend that HIV-1 infected mothers in the United States not breastfeed infants to avoid risking postnatal transmission of HIV-1 infection; published data report that nevirapine is present in human milk; there are limited data on effects of nevirapine on breastfed infant; there is no information on effects of nevirapine on milk production; because of potential for (1) HIV-1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) serious adverse reactions in nursing infants, mothers should not breastfeed if they are receiving therapy; published literature indicates that rash and hyperbilirubinemia have been seen in infants exposed to nevirapine through breastmilkA: Generally acceptable.

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