Methotrexate pharmacokinetics and effects in women receiving methotrexate 50 mg and 60 mg per square meter for early abortion

Mitchell D Creinin, M. A. Krohn

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

OBJECTIVE: Our goal was to evaluate the pharmacokinetics and safety of methotrexate in doses of 50 mg/m2 and 60 mg/m2 in regimens for early abortion. STUDY DESIGN: A randomized controlled trial was performed in women requesting an abortion at ≤49 days' gestation. Twenty women were treated with intramuscular methotrexate 50 mg/m2 (group 1) or 60 mg/m2 (group 2). Methotrexate levels were determined serially for the first 24 hours, then every 24 hours for 7 days. On the seventh day misoprostol 800 μg was administered vaginally. The misoprostol dose was repeated 24 hours later if abortion did not occur. RESULTS: Complete abortion occurred in 9 of 10 (90%, 95% confidence interval 56% to 100%) patients in group 1 and all 10 (100%, 95% confidence interval 69% to 100%; p = 0.99) in group 2. Methotrexate levels peaked within 1 to 2 hours and were nondetectable within 48 hours in all patients in group 1 and 72 hours in group 2. Both the maximum concentration of methotrexate and the area under the curve were significantly greater for group 2. Methotrexate clearance rates were 7.89 ± 1.98 L/hr and 5.55 ± 0.83 L/hr (p = 0.003), respectively. CONCLUSIONS: The serum levels of intramuscular methotrexate with 50 mg/m2 and 60 mg/m2 regimens indicate that these are safe treatment doses. Methotrexate 50 mg/m2 intramuscularly has the same clearance rates when administered during pregnancy as in a nonpregnant state, and maximum concentrations do not reach sustained toxic levels.

Original languageEnglish (US)
Pages (from-to)1444-1449
Number of pages6
JournalAmerican Journal of Obstetrics and Gynecology
Volume177
Issue number6
DOIs
StatePublished - 1997
Externally publishedYes

Fingerprint

Methotrexate
Pharmacokinetics
Misoprostol
Confidence Intervals
Pregnancy
Poisons
Area Under Curve
Randomized Controlled Trials
Safety
Serum

Keywords

  • Abortion
  • Methotrexate
  • Misoprostol
  • Pharmacokinetics
  • Renal clearance

ASJC Scopus subject areas

  • Medicine(all)
  • Obstetrics and Gynecology

Cite this

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title = "Methotrexate pharmacokinetics and effects in women receiving methotrexate 50 mg and 60 mg per square meter for early abortion",
abstract = "OBJECTIVE: Our goal was to evaluate the pharmacokinetics and safety of methotrexate in doses of 50 mg/m2 and 60 mg/m2 in regimens for early abortion. STUDY DESIGN: A randomized controlled trial was performed in women requesting an abortion at ≤49 days' gestation. Twenty women were treated with intramuscular methotrexate 50 mg/m2 (group 1) or 60 mg/m2 (group 2). Methotrexate levels were determined serially for the first 24 hours, then every 24 hours for 7 days. On the seventh day misoprostol 800 μg was administered vaginally. The misoprostol dose was repeated 24 hours later if abortion did not occur. RESULTS: Complete abortion occurred in 9 of 10 (90{\%}, 95{\%} confidence interval 56{\%} to 100{\%}) patients in group 1 and all 10 (100{\%}, 95{\%} confidence interval 69{\%} to 100{\%}; p = 0.99) in group 2. Methotrexate levels peaked within 1 to 2 hours and were nondetectable within 48 hours in all patients in group 1 and 72 hours in group 2. Both the maximum concentration of methotrexate and the area under the curve were significantly greater for group 2. Methotrexate clearance rates were 7.89 ± 1.98 L/hr and 5.55 ± 0.83 L/hr (p = 0.003), respectively. CONCLUSIONS: The serum levels of intramuscular methotrexate with 50 mg/m2 and 60 mg/m2 regimens indicate that these are safe treatment doses. Methotrexate 50 mg/m2 intramuscularly has the same clearance rates when administered during pregnancy as in a nonpregnant state, and maximum concentrations do not reach sustained toxic levels.",
keywords = "Abortion, Methotrexate, Misoprostol, Pharmacokinetics, Renal clearance",
author = "Creinin, {Mitchell D} and Krohn, {M. A.}",
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T1 - Methotrexate pharmacokinetics and effects in women receiving methotrexate 50 mg and 60 mg per square meter for early abortion

AU - Creinin, Mitchell D

AU - Krohn, M. A.

PY - 1997

Y1 - 1997

N2 - OBJECTIVE: Our goal was to evaluate the pharmacokinetics and safety of methotrexate in doses of 50 mg/m2 and 60 mg/m2 in regimens for early abortion. STUDY DESIGN: A randomized controlled trial was performed in women requesting an abortion at ≤49 days' gestation. Twenty women were treated with intramuscular methotrexate 50 mg/m2 (group 1) or 60 mg/m2 (group 2). Methotrexate levels were determined serially for the first 24 hours, then every 24 hours for 7 days. On the seventh day misoprostol 800 μg was administered vaginally. The misoprostol dose was repeated 24 hours later if abortion did not occur. RESULTS: Complete abortion occurred in 9 of 10 (90%, 95% confidence interval 56% to 100%) patients in group 1 and all 10 (100%, 95% confidence interval 69% to 100%; p = 0.99) in group 2. Methotrexate levels peaked within 1 to 2 hours and were nondetectable within 48 hours in all patients in group 1 and 72 hours in group 2. Both the maximum concentration of methotrexate and the area under the curve were significantly greater for group 2. Methotrexate clearance rates were 7.89 ± 1.98 L/hr and 5.55 ± 0.83 L/hr (p = 0.003), respectively. CONCLUSIONS: The serum levels of intramuscular methotrexate with 50 mg/m2 and 60 mg/m2 regimens indicate that these are safe treatment doses. Methotrexate 50 mg/m2 intramuscularly has the same clearance rates when administered during pregnancy as in a nonpregnant state, and maximum concentrations do not reach sustained toxic levels.

AB - OBJECTIVE: Our goal was to evaluate the pharmacokinetics and safety of methotrexate in doses of 50 mg/m2 and 60 mg/m2 in regimens for early abortion. STUDY DESIGN: A randomized controlled trial was performed in women requesting an abortion at ≤49 days' gestation. Twenty women were treated with intramuscular methotrexate 50 mg/m2 (group 1) or 60 mg/m2 (group 2). Methotrexate levels were determined serially for the first 24 hours, then every 24 hours for 7 days. On the seventh day misoprostol 800 μg was administered vaginally. The misoprostol dose was repeated 24 hours later if abortion did not occur. RESULTS: Complete abortion occurred in 9 of 10 (90%, 95% confidence interval 56% to 100%) patients in group 1 and all 10 (100%, 95% confidence interval 69% to 100%; p = 0.99) in group 2. Methotrexate levels peaked within 1 to 2 hours and were nondetectable within 48 hours in all patients in group 1 and 72 hours in group 2. Both the maximum concentration of methotrexate and the area under the curve were significantly greater for group 2. Methotrexate clearance rates were 7.89 ± 1.98 L/hr and 5.55 ± 0.83 L/hr (p = 0.003), respectively. CONCLUSIONS: The serum levels of intramuscular methotrexate with 50 mg/m2 and 60 mg/m2 regimens indicate that these are safe treatment doses. Methotrexate 50 mg/m2 intramuscularly has the same clearance rates when administered during pregnancy as in a nonpregnant state, and maximum concentrations do not reach sustained toxic levels.

KW - Abortion

KW - Methotrexate

KW - Misoprostol

KW - Pharmacokinetics

KW - Renal clearance

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JO - American Journal of Obstetrics and Gynecology

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