For intrathecal and high-dose methotrexate therapy, use the preservative-free formulation of methotrexate.Use the preservative-free formulation of methotrexate in neonates.For intrathecal and high-dose methotrexate therapy, use the preservative-free formulation of methotrexate. The actual mechanism of action is unknown.In a 6-month double-blind, placebo-controlled trial of 127 pediatric patients with juvenile rheumatoid arthritis (JRA) (mean age, 10.1 years; age range, 2.5 to 18 years; mean duration of disease, 5.1 years) on background nonsteroidal anti-inflammatory drugs (NSAIDs) and/or prednisone, methotrexate given weekly at an oral dose of 10 mg/mTwo Pediatric Oncology Group studies (one randomized and one non-randomized) demonstrated a significant improvement in relapse-free survival in patients with non-metastatic osteosarcoma, when high-dose methotrexate with leucovorin rescue was used in combination with other chemotherapeutic agents following surgical resection of the primary tumor. Impaired renal function, as well as concurrent use of drugs such as weak organic acids that also undergo tubular secretion, can markedly increase methotrexate serum levels. For cancer, methotrexate competitively inhibits dihydrofolate reductase (DHFR), an enzyme that participates in the tetrahydrofolate synthesis. Trimethoprim/sulfamethoxazole has been reported rarely to increase bone marrow suppression in patients receiving methotrexate, probably by decreased tubular secretion and/or an additive antifolate effect.The use of nitrous oxide anesthesia potentiates the effect of methotrexate on folate-dependent metabolic pathways, resulting in the potential for increased toxicity such as stomatitis, myelosuppression, and neurotoxicity. The combination of methotrexate and mercaptopurine may therefore require dose adjustment.Oral antibiotics such as tetracycline, chloramphenicol, and nonabsorbable broad spectrum antibiotics, may decrease intestinal absorption of methotrexate or interfere with the enterohepatic circulation by inhibiting bowel flora and suppressing metabolism of the drug by bacteria.Penicillins may reduce the renal clearance of methotrexate; increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with high and low dose methotrexate.

Methotrexate for Injection, USP (preservative free) is supplied in a 1 gram, single-dose vial of lyophilized powder containing 1 gram methotrexate as the base in the following package strength: NDC 0143-9367-01 1 gram Vial (individually boxed)

With the exception of alopecia, photosensitivity, and “burning of skin lesions” (each 3% to 10%), the adverse reaction rates in these reports were very similar to those in the rheumatoid arthritis studies. This results in a prolonged terminal plasma half-life and unexpected toxicity. Renal tubular transport is also diminished by probenecid; use of methotrexate with this drug should be carefully monitored.In the treatment of patients with osteosarcoma, caution must be exercised if high-dose methotrexate is administered in combination with a potentially nephrotoxic chemotherapeutic agent (e.g., cisplatin).Methotrexate increases the plasma levels of mercaptopurine. The use of methotrexate may permit the return to conventional topical therapy, which should be encouraged.Methotrexate for injection should be reconstituted with an appropriate sterile, preservative free medium such as 5% dextrose solution, USP or sodium chloride injection, USP. They are available in bottles of 30 tablets. In controlled clinical trials in rheumatoid arthritis (n=128), leukopenia (WBC <3000/mmIn psoriasis and rheumatoid arthritis, methotrexate should be stopped immediately if there is a significant drop in blood counts. You may also report side effects at https://www.fda.gov/medwatch. Anaphylactoid reactions have been reported.The approximate incidences of methotrexate-attributed (i.e., placebo rate subtracted) adverse reactions in 12 to 18 week double-blind studies of patients (n=128) with rheumatoid arthritis treated with low-dose oral (7.5 to 15 mg/week) pulse methotrexate, are listed below. High CSF concentrations of the drug may be attained by intrathecal administration.In dogs, synovial fluid concentrations after oral dosing were higher in inflamed than uninflamed joints. A twenty fold difference between highest and lowest peak levels (C-After intravenous administration, the initial volume of distribution is approximately 0.18 L/kg (18% of body weight) and steady-state volume of distribution is approximately 0.4 to 0.8 L/kg (40 to 80% of body weight). Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate. Tell your This condition can be progressive and even fatal.Pulmonary symptoms (especially a dry nonproductive cough) or a non-specific pneumonitis occurring during methotrexate therapy may be indicative of a potentially dangerous lesion and require interruption of treatment and careful investigation. FOR INTRATHECAL AND HIGH-DOSE THERAPY, USE THE PRESERVATIVE-FREE FORMULATION OF METHOTREXATE. Be ready to tell or show what was Methotrexate causes embryotoxicity, abortion, and fetal defects in humans. The aqueous solubility of 7-hydroxymethotrexate is 3 to 5 fold lower than the parent compound.

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