Medication info

MTX Injection (Methotrexate)

Prescription medication
Ingredient · strength
Methotrexate›25mg / 1mL
Manufacturer / importer
JW Pharmaceutical Corp.
Appearance
A yellowish injection solution filled in a brown vial
Packaging
2 milliliters × 10 vials, 20 milliliters × 1 vial
Approval status
Active

MFDS item code 197900070 · Notified 1979.01.09 · Insurance code 644901631,644901641

Summary

Main use
Treatment of cancer (such as leukemia and lymphoma), trophoblastic disease, and severe refractory psoriasis
Who uses it
Adults · Children
Adult dosage
1. Leukemia: Administer 5~10 mg orally per day for 3~6 days per week. Adjust the dose according to the patient's tolerance and symptoms. 2. Trophoblastic disease: Administer 10~30 mg orally per day for 5 days as one cycle, then repeat after a 7~12-day rest period. 3. Rheumatoid arthritis: Administer a test dose of 5~10 mg orally once, 1 week before treatment. Administer 7.5~20 mg orally once weekly, or administer 2.5 mg orally 3 times at 12-hour intervals. Do not exceed a total weekly dose of 20 mg; reduce to the minimum dose once a response is achieved. 4. Psoriasis: Administer a test dose of 5~10 mg orally once, 1 week before treatment. Administer 7.5~20 mg orally once weekly, or administer the dose in 3 divided doses at 12-hour intervals. Injection: For the treatment of psoriasis, administer 10~25 mg orally once weekly or by intravenous or intramuscular injection. Adjust the dose according to the patient's response; liver function tests and monitoring are required.
Children's dosage
Leukemia: Administer 1.25~2.5 mg per day to infants and 2.5~5 mg per day to children orally for 3~6 days per week. Injection: In children with meningeal leukemia, administer 12~15 mg/㎡ by intrathecal injection at 1-week intervals. Trophoblastic disease: Administer 10~30 mg/㎡ per day by intramuscular injection for 5 days, then repeat after a 7~12-day rest period.

Ingredients

Manufacturer
JW Pharmaceutical Corp.

Efficacy & effects

Treatment of cancer (such as leukemia and lymphoma), trophoblastic disease, and severe refractory psoriasis

  • Leukemia
  • subjective symptoms of trophoblastic disease
  • objective symptoms of trophoblastic disease
  • rheumatoid arthritis
  • severe refractory psoriasis
  • acute leukemia
  • non-Hodgkin's lymphoma
  • soft tissue sarcoma
  • osteosarcoma
  • breast cancer
  • lung cancer
  • solid tumors of head and neck cancer
View approved original text

This medication in tablet form is used for the treatment of leukemia, rheumatoid arthritis, and severe psoriasis that is unresponsive to other medications. It also helps alleviate subjective and objective symptoms caused by trophoblastic disease. The injection form is effective for various cancer conditions including acute leukemia, non-Hodgkin's lymphoma, sarcomas, as well as solid tumors such as breast cancer, lung cancer, head and neck cancer, and bladder cancer, and for the treatment of trophoblastic disease. Additionally, it is utilized for severe psoriasis that does not respond to other medications, contributing to symptom relief in patients. This drug plays an important role in the treatment of various cancers and treatment-resistant psoriasis.

Dosage and Administration

Adult dosage

1. Leukemia: Administer 5~10 mg orally per day for 3~6 days per week. Adjust the dose according to the patient's tolerance and symptoms. 2. Trophoblastic disease: Administer 10~30 mg orally per day for 5 days as one cycle, then repeat after a 7~12-day rest period. 3. Rheumatoid arthritis: Administer a test dose of 5~10 mg orally once, 1 week before treatment. Administer 7.5~20 mg orally once weekly, or administer 2.5 mg orally 3 times at 12-hour intervals. Do not exceed a total weekly dose of 20 mg; reduce to the minimum dose once a response is achieved. 4. Psoriasis: Administer a test dose of 5~10 mg orally once, 1 week before treatment. Administer 7.5~20 mg orally once weekly, or administer the dose in 3 divided doses at 12-hour intervals. Injection: For the treatment of psoriasis, administer 10~25 mg orally once weekly or by intravenous or intramuscular injection. Adjust the dose according to the patient's response; liver function tests and monitoring are required.

Children's dosage

Leukemia: Administer 1.25~2.5 mg per day to infants and 2.5~5 mg per day to children orally for 3~6 days per week. Injection: In children with meningeal leukemia, administer 12~15 mg/㎡ by intrathecal injection at 1-week intervals. Trophoblastic disease: Administer 10~30 mg/㎡ per day by intramuscular injection for 5 days, then repeat after a 7~12-day rest period.

Precautions

This medication should be taken only once a week when treating rheumatoid arthritis or psoriasis, and strict adherence to the dosage instructions is crucial as serious side effects may occur if not followed properly. Co-administration of this medication with specific anticancer drugs can be risky and should always be conducted under a doctor's supervision. When used with proton pump inhibitors, this medication's blood concentration may increase, leading to toxicity, so caution is needed. Patients who have had allergic reactions to this medication, those with poor kidney or liver function, patients with specific blood disorders or immune deficiencies, pregnant women, and nursing mothers should not use this medication. Patients with diarrhea, stomatitis, gastric ulcers, infections, etc., should use this medication with caution, and special care is needed for children and the elderly. This medication can cause various serious side effects such as shock, gastrointestinal bleeding, pneumonia, neurological abnormalities, reproductive issues, blood disorders, liver impairment, kidney impairment, and skin reactions, so any symptoms that arise should be immediately discussed with medical personnel. During long-term use, regular monitoring of bone marrow function, liver, and kidney function is necessary, and attention should be paid to the risk of infections and bleeding. Women who are pregnant or could become pregnant should not take this medication, and men should avoid conception during and for some time after treatment. This medication has multiple drug interactions, so it is essential to consult with healthcare providers regarding any concurrent medications, especially when used with drugs that hinder renal excretion, as this can increase the risk of side effects. In case of overdose, immediate detoxification therapy is necessary, and this medication cannot be removed by hemodialysis or peritoneal dialysis, thus requiring specialized treatment. When storing, keep it out of reach of children and do not transfer it to another container.

Side effects

Shock, anaphylactic symptoms, hemorrhagic colitis, necrotizing colitis, abdominal pain, diarrhea, nausea, vomiting, stomatitis, anorexia, glossitis, papular rash, gastrointestinal ulcers, hemorrhage, hematochezia, intestinal obstruction, pancreatitis, interstitial pneumonia, pulmonary fibrosis, fever, cough, shortness of breath, alveolar hemorrhage, acute pulmonary edema, headache, drowsiness, blurred vision, aphasia, incomplete paralysis, paralysis, convulsions, coma, dementia, neck and pelvic tension, back pain, sensory abnormalities, decreased sensation, increased intracranial pressure, acute idiopathic multiple neuropathy, azoospermia, ovarian dysfunction, menstrual disorders, infertility, miscarriage, fetal malformations, azotemia, oocyte production deficiency, sperm production deficiency, vaginitis, vaginal ulcers, pancytopenia, agranulocytosis, anemia, leukopenia, thrombocytopenia, sepsis, hypogammaglobulinemia, lymphoproliferative disorders, severe hepatitis, liver dysfunction, jaundice, fatty liver, hepatic necrosis, fulminant hepatitis, liver failure, liver fibrosis, cirrhosis, renal failure, cystitis, hematuria, elevated BUN, elevated creatinine level, acute renal failure, tubular necrosis, severe nephropathy, consciousness disorder, hypotension, tachycardia, numbness, sneezing, shortness of breath, chest discomfort, cold sweats, skin and mucous membrane syndrome, toxic epidermal necrolysis, photosensitivity reaction, fever, rash, urticaria, pruritus, erythematous lesions, erythema, pigmentation, depigmentation, subcutaneous petechiae, acne, hair loss, capillary dilation, ulcer, ocular congestion, skin peeling, exfoliative dermatitis, Pneumocystis carinii pneumonia, pneumonia, sepsis, cytomegalovirus infection, herpes zoster, osteoporosis, decreased bone density, jawbone necrosis, malaise, parotitis, conjunctivitis, cystitis, arthritis, myalgia, diabetes mellitus, sudden death, edema, myelopathy, symptoms of acute chemical meningoencephalitis, subacute myelopathy

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a sealed container that can block light and kept at room temperature between 1°C and 30°C. Proper storage can help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

A yellowish injection solution filled in a brown vial

Package unit

2 milliliters × 10 vials, 20 milliliters × 1 vial

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.