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Pharmacologic classification: folate analog
Therapeutic classification: antidote
Pregnancy risk category: C
AVAILABLE FORMS
Single-use vial: 50 mg
INDICATIONS AND DOSAGES
To diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists after high-dose methotrexate therapy in osteosarcoma--
Adults with methotrexate level 10 micromolar at 24 hours, 1 micromolar at 48 hours, and less than 0.2 micromolar at 72 hours after methotrexate administration: 7.5 mg I.V. every 6 hours for 60 hours (10 doses starting 24 hours after start of methotrexate).
Adults with methotrexate level remaining about 0.2 micromolar at 72 hours and more than 0.05 micromolar at 96 hours after methotrexate administration: Continue 7.5 mg I.V. every 6 hours until methotrexate level is less than 0.05 micromolar.
Adults with methotrexate level 50 micromolar or more at 24 hours, or 5 micromolar or more at 48 hours after administration, or a 100% or greater increase in creatinine level at 24 hours after methotrexate administration: 75 mg I.V. every 3 hours until methotrexate is less that 1 micromolar, then 7.5 mg I.V. every 3 hours until methotrexate is less than 0.5 micromolar.
Adults having inadvertent methotrexate overdose: 7.5 mg I.V. every 6 hours, beginning within 24 hours of overdosage and continuing until methotrexate levels are within nontoxic range.
CONTRAINDICATIONS AND CAUTIONS
Contraindicated in those allergic to folic acid or folinic acid.
Use cautiously in pregnant or breast-feeding patients and in those who take anticonvulsants.
INTERACTIONS
Drug-drug.
Fluorouracil: May increase risk of fluorouracil toxicity. Avoid using together or, if this combination must be used, monitor patient closely for enterocolitis, diarrhea, and dehydration.
Phenobarbital, phenytoin, primidone: May decrease anticonvulsant effect. Use together cautiously.
Trimethoprim-sulfamethoxazole: May increase risk of treatment failure for Pneumocystis carinii pneumonia in patients with HIV infections. Avoid using together.
ADVERSE REACTIONS
CNS: confusion, neuropathy.
GI: nausea, vomiting, stomatitis, diarrhea, dyspepsia, taste perversion.
GU: renal dysfunction.
Respiratory: dyspnea.
Skin: dermatitis.
Other: allergic reactions.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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levoleucovorin