MYTREX F
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MYTREX F (MYTREX F).
Methylprednisolone is a corticosteroid that inhibits phospholipase A2, reducing prostaglandin and leukotriene synthesis, and suppresses immune cell activity.
| Metabolism | Hepatic metabolism via CYP3A4, primarily to inactive metabolites. |
| Excretion | Renal: 90% unchanged; biliary/fecal: 10% as metabolites. |
| Half-life | 3.5 hours (terminal); prolonged to 8-12 hours in renal impairment. |
| Protein binding | 99% (primarily to albumin). |
| Volume of Distribution | 0.2 L/kg; indicates low tissue distribution, primarily in plasma. |
| Bioavailability | Oral: 80-90% (immediate-release); 70-80% (extended-release). |
| Onset of Action | Oral: 1-2 hours; IV: immediate (5-15 minutes). |
| Duration of Action | 4-6 hours; extended-release formulations up to 12 hours. |
Oral methotrexate 7.5-25 mg once weekly; subcutaneous methotrexate 7.5-25 mg once weekly; intravenous methotrexate 50-200 mg/m² every 2-3 weeks for oncology indications.
| Dosage form | CREAM |
| Renal impairment | GFR 60-90 mL/min: no adjustment; GFR 30-59 mL/min: reduce dose by 50%; GFR <30 mL/min: contraindicated (do not use). |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated (do not use). |
| Pediatric use | For juvenile idiopathic arthritis: 10-15 mg/m² orally or subcutaneously once weekly; for leukemia: 15-30 mg/m² orally or intramuscularly once weekly. |
| Geriatric use | Initiate at lowest recommended adult dose due to reduced renal and hepatic function; monitor closely for toxicity; adjust based on renal function (see renal adjustment). |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MYTREX F (MYTREX F).
| Breastfeeding | Methotrexate is excreted into breast milk in low concentrations; M/P ratio approximately 0.08. Due to potential for accumulation and adverse effects (bone marrow suppression, gastrointestinal toxicity) in the neonate, breastfeeding is contraindicated during MYTREX F therapy. |
| Teratogenic Risk | MYTREX F contains methotrexate, a known teratogen. First trimester: high risk of neural tube defects, craniofacial anomalies, and limb malformations (FDA Category X). Second and third trimesters: risk of fetal growth restriction, skeletal abnormalities, and neurodevelopmental delays. Contraindicated in pregnancy. |
■ FDA Black Box Warning
Corticosteroids may increase the risk of serious and potentially fatal infections. Live or live attenuated vaccines are contraindicated in patients receiving immunosuppressive doses of corticosteroids.
| Serious Effects |
["Systemic fungal infections (except when used for specific indications)","Hypersensitivity to methylprednisolone or any component","Live or live attenuated vaccines (in immunosuppressive doses)","Idiopathic thrombocytopenic purpura (intramuscular use only)"]
| Precautions | ["Immunosuppression and increased risk of infections","Adrenal insufficiency with rapid withdrawal after prolonged therapy","Masking of signs of infection and new infections during use","Gastrointestinal perforation (especially in patients with IBD or diverticulitis)","Osteoporosis with long-term use","Cushing's syndrome with prolonged therapy","Psychiatric disturbances (including depression, euphoria, psychosis)","Kaposi's sarcoma has been reported in patients receiving corticosteroids","Exacerbation of systemic fungal infections; avoid in active untreated infections"] |
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| Fetal Monitoring | For inadvertent pregnancy exposure: serial fetal ultrasound for structural anomalies, detailed anatomy scan, and fetal echocardiography. Monitor maternal liver function, renal function, and complete blood count (CBC) weekly. Measure methotrexate levels if toxicity suspected. |
| Fertility Effects | Methotrexate can cause reversible oligospermia and menstrual dysfunction. Preclinical studies show impaired spermatogenesis and folliculogenesis. Contraceptive counseling is recommended for both males and females of reproductive potential. Effect on fertility may persist for several months after discontinuation. |