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 language | English (US) |
|---|---|
| Pages (from-to) | 1444-1449 |
| Number of pages | 6 |
| Journal | American Journal of Obstetrics and Gynecology |
| Volume | 177 |
| Issue number | 6 |
| DOIs | |
| State | Published - 1997 |
| Externally published | Yes |
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Keywords
- Abortion
- Methotrexate
- Misoprostol
- Pharmacokinetics
- Renal clearance
ASJC Scopus subject areas
- Medicine(all)
- Obstetrics and Gynecology
Cite this
Methotrexate pharmacokinetics and effects in women receiving methotrexate 50 mg and 60 mg per square meter for early abortion. / Creinin, Mitchell D; Krohn, M. A.
In: American Journal of Obstetrics and Gynecology, Vol. 177, No. 6, 1997, p. 1444-1449.Research output: Contribution to journal › Article
}
TY - JOUR
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
UR - http://www.scopus.com/inward/record.url?scp=0031459242&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0031459242&partnerID=8YFLogxK
U2 - 10.1016/S0002-9378(97)70089-9
DO - 10.1016/S0002-9378(97)70089-9
M3 - Article
C2 - 9423749
AN - SCOPUS:0031459242
VL - 177
SP - 1444
EP - 1449
JO - American Journal of Obstetrics and Gynecology
JF - American Journal of Obstetrics and Gynecology
SN - 0002-9378
IS - 6
ER -