Pharmacokinetics and tolerance of zidovudine in preterm infants

Edmund V. Capparelli; Mark Mirochnick; Wayne M. Dankner; Suzette Blanchard; Lynne Mofenson; George D. McSherry; Hannah Gay; Gregory Ciupak; Betsy Smith; James D. Connor; Elmer David; Richard Stephens; Tzong Jer Wei; Mary Jo Hoyt; Beth Barlow; Sondra Sadler; Stacee Naylor; Ann Petru; Ross McKinney; Lori Ferguson; Megan Valentine; Jean Hurwitz; Janet Squires; George Johnson; Moya Clarken; Andrea Kovacs; Steven Pelton; Ann Melvin; Lisa Frenkel; Kathleen Mohan; Mary Jo O'Hara; Nancy Wade; Martha Lepow; Patricia Hughes; Michael Horgan; Louis Levy; F. Moncrief Dobson; Laura Clarke-Steffen; Janice Piatt; Coleen Cunningham; Kathie Contello; Emily Barr; Maureen Famiglietti; John Sleasman; Mobeen Rathmore; Abeer Khayat; Michelle Eagle; Saniyyah Mahmoudi; Eleanor Jimenez; Janet Englund; Pamela Lofton; Christine Elsen; Ronda Oram

doi:10.1067/mpd.2003.mpd0335

Pharmacokinetics and tolerance of zidovudine in preterm infants

Edmund V. Capparelli, Mark Mirochnick, Wayne M. Dankner, Suzette Blanchard, Lynne Mofenson, George D. McSherry, Hannah Gay, Gregory Ciupak, Betsy Smith, James D. Connor, Elmer David, Richard Stephens, Tzong Jer Wei, Mary Jo Hoyt, Beth Barlow, Sondra Sadler, Stacee Naylor, Ann Petru, Ross McKinney, Lori FergusonMegan Valentine, Jean Hurwitz, Janet Squires, George Johnson, Moya Clarken, Andrea Kovacs, Steven Pelton, Ann Melvin, Lisa Frenkel, Kathleen Mohan, Mary Jo O'Hara, Nancy Wade, Martha Lepow, Patricia Hughes, Michael Horgan, Louis Levy, F. Moncrief Dobson, Laura Clarke-Steffen, Janice Piatt, Coleen Cunningham, Kathie Contello, Emily Barr, Maureen Famiglietti, John Sleasman, Mobeen Rathmore, Abeer Khayat, Michelle Eagle, Saniyyah Mahmoudi, Eleanor Jimenez, Janet Englund, Pamela Lofton, Christine Elsen, Ronda Oram

Research output: Contribution to journal › Article › peer-review

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Abstract

Objective: To determine zidovudine pharmacokinetics and tolerance in premature human human immunodeficiency virus-exposed infants. Study design: Pediatric AIDS Clinical Trials Group Study 331 was a multicentered prospective, open-label study of the use of zidovudine in premature infants. Thirty-eight infants <35 weeks' gestational age (GA) were studied while receiving zidovudine 1.5 mg/kg every 12 hours until 2 weeks of age, then 2.0 mg/kg every 8 hours until 6 weeks of age. Population pharmacokinetics were evaluated at 1, 2, and 4 weeks' postnatal age; zidovudine doses were adjusted to maintain troughs <3 οM. Results: Zidovudine clearance was lower than reported in term infants at similar postnatal ages. Nine premature infants required dose reduction because of high levels (7/19 <30 weeks' and 2/19 ≥30 weeks' CA). Postnatal age, CA, serum creatinine, and furosemide use independently predicted zidovudine clearance. Zidovudine was generally well tolerated in this high-risk population. Conclusions: Zidovudine clearance is greatly reduced in premature infants. We recommend the following zidovudine dosing schedule in this population: 1.5 mg/kg (intravenous) or 2.0 mg/kg (oral) every 12 hours increased to every 8 hours at 2 weeks of age (≥30 weeks' CA) or at 4 weeks (<30 weeks' GA).

Original language	English (US)
Pages (from-to)	47-52
Number of pages	6
Journal	Journal of Pediatrics
Volume	142
Issue number	1
DOIs	https://doi.org/10.1067/mpd.2003.mpd0335
State	Published - Jan 1 2003

All Science Journal Classification (ASJC) codes

Pediatrics, Perinatology, and Child Health

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1067/mpd.2003.mpd0335

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Capparelli, E. V., Mirochnick, M., Dankner, W. M., Blanchard, S., Mofenson, L., McSherry, G. D., Gay, H., Ciupak, G., Smith, B., Connor, J. D., David, E., Stephens, R., Wei, T. J., Hoyt, M. J., Barlow, B., Sadler, S., Naylor, S., Petru, A., McKinney, R., ... Oram, R. (2003). Pharmacokinetics and tolerance of zidovudine in preterm infants. Journal of Pediatrics, 142(1), 47-52. https://doi.org/10.1067/mpd.2003.mpd0335

@article{1deb734cd5ef45b2ba805e021fdb18cd,

title = "Pharmacokinetics and tolerance of zidovudine in preterm infants",

abstract = "Objective: To determine zidovudine pharmacokinetics and tolerance in premature human human immunodeficiency virus-exposed infants. Study design: Pediatric AIDS Clinical Trials Group Study 331 was a multicentered prospective, open-label study of the use of zidovudine in premature infants. Thirty-eight infants <35 weeks' gestational age (GA) were studied while receiving zidovudine 1.5 mg/kg every 12 hours until 2 weeks of age, then 2.0 mg/kg every 8 hours until 6 weeks of age. Population pharmacokinetics were evaluated at 1, 2, and 4 weeks' postnatal age; zidovudine doses were adjusted to maintain troughs <3 οM. Results: Zidovudine clearance was lower than reported in term infants at similar postnatal ages. Nine premature infants required dose reduction because of high levels (7/19 <30 weeks' and 2/19 ≥30 weeks' CA). Postnatal age, CA, serum creatinine, and furosemide use independently predicted zidovudine clearance. Zidovudine was generally well tolerated in this high-risk population. Conclusions: Zidovudine clearance is greatly reduced in premature infants. We recommend the following zidovudine dosing schedule in this population: 1.5 mg/kg (intravenous) or 2.0 mg/kg (oral) every 12 hours increased to every 8 hours at 2 weeks of age (≥30 weeks' CA) or at 4 weeks (<30 weeks' GA).",

author = "Capparelli, {Edmund V.} and Mark Mirochnick and Dankner, {Wayne M.} and Suzette Blanchard and Lynne Mofenson and McSherry, {George D.} and Hannah Gay and Gregory Ciupak and Betsy Smith and Connor, {James D.} and Elmer David and Richard Stephens and Wei, {Tzong Jer} and Hoyt, {Mary Jo} and Beth Barlow and Sondra Sadler and Stacee Naylor and Ann Petru and Ross McKinney and Lori Ferguson and Megan Valentine and Jean Hurwitz and Janet Squires and George Johnson and Moya Clarken and Andrea Kovacs and Steven Pelton and Ann Melvin and Lisa Frenkel and Kathleen Mohan and O'Hara, {Mary Jo} and Nancy Wade and Martha Lepow and Patricia Hughes and Michael Horgan and Louis Levy and Dobson, {F. Moncrief} and Laura Clarke-Steffen and Janice Piatt and Coleen Cunningham and Kathie Contello and Emily Barr and Maureen Famiglietti and John Sleasman and Mobeen Rathmore and Abeer Khayat and Michelle Eagle and Saniyyah Mahmoudi and Eleanor Jimenez and Janet Englund and Pamela Lofton and Christine Elsen and Ronda Oram",

year = "2003",

month = jan,

day = "1",

doi = "10.1067/mpd.2003.mpd0335",

language = "English (US)",

volume = "142",

pages = "47--52",

journal = "Journal of Pediatrics",

issn = "0022-3476",

publisher = "Mosby Inc.",

number = "1",

}

Capparelli, EV, Mirochnick, M, Dankner, WM, Blanchard, S, Mofenson, L, McSherry, GD, Gay, H, Ciupak, G, Smith, B, Connor, JD, David, E, Stephens, R, Wei, TJ, Hoyt, MJ, Barlow, B, Sadler, S, Naylor, S, Petru, A, McKinney, R, Ferguson, L, Valentine, M, Hurwitz, J, Squires, J, Johnson, G, Clarken, M, Kovacs, A, Pelton, S, Melvin, A, Frenkel, L, Mohan, K, O'Hara, MJ, Wade, N, Lepow, M, Hughes, P, Horgan, M, Levy, L, Dobson, FM, Clarke-Steffen, L, Piatt, J, Cunningham, C, Contello, K, Barr, E, Famiglietti, M, Sleasman, J, Rathmore, M, Khayat, A, Eagle, M, Mahmoudi, S, Jimenez, E, Englund, J, Lofton, P, Elsen, C & Oram, R 2003, 'Pharmacokinetics and tolerance of zidovudine in preterm infants', Journal of Pediatrics, vol. 142, no. 1, pp. 47-52. https://doi.org/10.1067/mpd.2003.mpd0335

TY - JOUR

T1 - Pharmacokinetics and tolerance of zidovudine in preterm infants

AU - Capparelli, Edmund V.

AU - Mirochnick, Mark

AU - Dankner, Wayne M.

AU - Blanchard, Suzette

AU - Mofenson, Lynne

AU - McSherry, George D.

AU - Gay, Hannah

AU - Ciupak, Gregory

AU - Smith, Betsy

AU - Connor, James D.

AU - David, Elmer

AU - Stephens, Richard

AU - Wei, Tzong Jer

AU - Hoyt, Mary Jo

AU - Barlow, Beth

AU - Sadler, Sondra

AU - Naylor, Stacee

AU - Petru, Ann

AU - McKinney, Ross

AU - Ferguson, Lori

AU - Valentine, Megan

AU - Hurwitz, Jean

AU - Squires, Janet

AU - Johnson, George

AU - Clarken, Moya

AU - Kovacs, Andrea

AU - Pelton, Steven

AU - Melvin, Ann

AU - Frenkel, Lisa

AU - Mohan, Kathleen

AU - O'Hara, Mary Jo

AU - Wade, Nancy

AU - Lepow, Martha

AU - Hughes, Patricia

AU - Horgan, Michael

AU - Levy, Louis

AU - Dobson, F. Moncrief

AU - Clarke-Steffen, Laura

AU - Piatt, Janice

AU - Cunningham, Coleen

AU - Contello, Kathie

AU - Barr, Emily

AU - Famiglietti, Maureen

AU - Sleasman, John

AU - Rathmore, Mobeen

AU - Khayat, Abeer

AU - Eagle, Michelle

AU - Mahmoudi, Saniyyah

AU - Jimenez, Eleanor

AU - Englund, Janet

AU - Lofton, Pamela

AU - Elsen, Christine

AU - Oram, Ronda

PY - 2003/1/1

Y1 - 2003/1/1

N2 - Objective: To determine zidovudine pharmacokinetics and tolerance in premature human human immunodeficiency virus-exposed infants. Study design: Pediatric AIDS Clinical Trials Group Study 331 was a multicentered prospective, open-label study of the use of zidovudine in premature infants. Thirty-eight infants <35 weeks' gestational age (GA) were studied while receiving zidovudine 1.5 mg/kg every 12 hours until 2 weeks of age, then 2.0 mg/kg every 8 hours until 6 weeks of age. Population pharmacokinetics were evaluated at 1, 2, and 4 weeks' postnatal age; zidovudine doses were adjusted to maintain troughs <3 οM. Results: Zidovudine clearance was lower than reported in term infants at similar postnatal ages. Nine premature infants required dose reduction because of high levels (7/19 <30 weeks' and 2/19 ≥30 weeks' CA). Postnatal age, CA, serum creatinine, and furosemide use independently predicted zidovudine clearance. Zidovudine was generally well tolerated in this high-risk population. Conclusions: Zidovudine clearance is greatly reduced in premature infants. We recommend the following zidovudine dosing schedule in this population: 1.5 mg/kg (intravenous) or 2.0 mg/kg (oral) every 12 hours increased to every 8 hours at 2 weeks of age (≥30 weeks' CA) or at 4 weeks (<30 weeks' GA).

AB - Objective: To determine zidovudine pharmacokinetics and tolerance in premature human human immunodeficiency virus-exposed infants. Study design: Pediatric AIDS Clinical Trials Group Study 331 was a multicentered prospective, open-label study of the use of zidovudine in premature infants. Thirty-eight infants <35 weeks' gestational age (GA) were studied while receiving zidovudine 1.5 mg/kg every 12 hours until 2 weeks of age, then 2.0 mg/kg every 8 hours until 6 weeks of age. Population pharmacokinetics were evaluated at 1, 2, and 4 weeks' postnatal age; zidovudine doses were adjusted to maintain troughs <3 οM. Results: Zidovudine clearance was lower than reported in term infants at similar postnatal ages. Nine premature infants required dose reduction because of high levels (7/19 <30 weeks' and 2/19 ≥30 weeks' CA). Postnatal age, CA, serum creatinine, and furosemide use independently predicted zidovudine clearance. Zidovudine was generally well tolerated in this high-risk population. Conclusions: Zidovudine clearance is greatly reduced in premature infants. We recommend the following zidovudine dosing schedule in this population: 1.5 mg/kg (intravenous) or 2.0 mg/kg (oral) every 12 hours increased to every 8 hours at 2 weeks of age (≥30 weeks' CA) or at 4 weeks (<30 weeks' GA).

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UR - http://www.scopus.com/inward/citedby.url?scp=0037238447&partnerID=8YFLogxK

U2 - 10.1067/mpd.2003.mpd0335

DO - 10.1067/mpd.2003.mpd0335

M3 - Article

C2 - 12520254

AN - SCOPUS:0037238447

SN - 0022-3476

VL - 142

SP - 47

EP - 52

JO - Journal of Pediatrics

JF - Journal of Pediatrics

IS - 1

ER -

Pharmacokinetics and tolerance of zidovudine in preterm infants

Abstract

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