Medication info

Pfizer Methotrexate Injection 25mg/mL

Prescription medicationInjections
Ingredient · strength
Methotrexate›25mg / 1mL
Manufacturer / importer
Pfizer Pharmaceuticals Korea Limited
Appearance
A clear vial containing a yellow clear liquid injection.
Packaging
50mg/2mL x 5 vials, 500mg/20mL x 1 vial
Approval status
Active

MFDS item code 200210231 · Notified 2002.07.15 · Insurance code 648903011,648903013

Summary

Main use
Treatment of cancer and trophoblastic diseases (leukemia, etc.), severe refractory psoriasis, and rheumatoid arthritis
Who uses it
Adults · Children
Adult dosage
1. Leukemia: Administer 5~10 mg of methotrexate orally per day for 3~6 days per week. 2. Trophoblastic disease: Administer 10~30 mg orally per day. Use a 5-day treatment cycle, and repeat after a drug-free period of 7~12 days. 3. Rheumatoid arthritis: Administer 7.5~20 mg orally once weekly, or administer 2.5 mg orally 3 times at 12-hour intervals. The total weekly dose should not exceed 20 mg. 4. Psoriasis: Administer 7.5~20 mg orally once weekly, or orally in 3 divided doses at 12-hour intervals. Adult dosing for injectable formulation: It is recommended to administer a test dose of 5~10 mg orally once, 1 week before treatment, to test for idiosyncratic adverse reactions. For patients with severe, refractory psoriasis, 10~25 mg may be administered orally once weekly or by intravenous/intramuscular injection. Adjust the dose according to the patient's response.
Children's dosage
1. 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. Pediatric dosing for injectable formulation: - Meningeal leukemia: Administer 12~15 mg/㎡ (0.4~0.5 mg per kg of body weight) by intrathecal injection at 1-week intervals until the cerebrospinal fluid returns to normal. - Trophoblastic disease: Administer 10~30 mg/㎡ per day by intramuscular injection for 5 days, followed by a drug-free period of 7~12 days. The cycle may be repeated 3~5 times.

Ingredients

Importer
Pfizer Pharmaceuticals Korea Limited

Efficacy & effects

Treatment of cancer and trophoblastic diseases (leukemia, etc.), severe refractory psoriasis, and rheumatoid arthritis

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

The tablet form of the drug is used to treat leukemia, rheumatoid arthritis, and severe resistant psoriasis when other medications are ineffective. It also helps relieve subjective and objective symptoms of trophoblastic disease such as chorionic carcinoma, destructive hydatidiform mole, and hydatidiform mole. The injectable form is used for extensive treatment of conditions such as acute leukemia, non-Hodgkin lymphoma, sarcomas including soft tissue sarcoma and osteosarcoma, as well as various solid tumors including breast cancer, lung cancer, head and neck cancer, and bladder cancer. This injection is also used for the treatment of resistant severe psoriasis.

Dosage and Administration

Adult dosage

1. Leukemia: Administer 5~10 mg of methotrexate orally per day for 3~6 days per week. 2. Trophoblastic disease: Administer 10~30 mg orally per day. Use a 5-day treatment cycle, and repeat after a drug-free period of 7~12 days. 3. Rheumatoid arthritis: Administer 7.5~20 mg orally once weekly, or administer 2.5 mg orally 3 times at 12-hour intervals. The total weekly dose should not exceed 20 mg. 4. Psoriasis: Administer 7.5~20 mg orally once weekly, or orally in 3 divided doses at 12-hour intervals. Adult dosing for injectable formulation: It is recommended to administer a test dose of 5~10 mg orally once, 1 week before treatment, to test for idiosyncratic adverse reactions. For patients with severe, refractory psoriasis, 10~25 mg may be administered orally once weekly or by intravenous/intramuscular injection. Adjust the dose according to the patient's response.

Children's dosage

1. 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. Pediatric dosing for injectable formulation: - Meningeal leukemia: Administer 12~15 mg/㎡ (0.4~0.5 mg per kg of body weight) by intrathecal injection at 1-week intervals until the cerebrospinal fluid returns to normal. - Trophoblastic disease: Administer 10~30 mg/㎡ per day by intramuscular injection for 5 days, followed by a drug-free period of 7~12 days. The cycle may be repeated 3~5 times.

Precautions

This drug should only be taken once a week for the treatment of rheumatoid arthritis or psoriasis, as dosing errors can lead to serious side effects. Combination therapy with certain anticancer drugs is risky, so caution is advised under a doctor's supervision. High-dose use with proton pump inhibitors may increase toxicity, so caution is necessary. Patients who are hypersensitive to any component of this drug, have poor kidney or liver function, are pregnant or may become pregnant, and nursing mothers should not be administered this medication. Patients with diarrhea, stomatitis, gastric ulcers, blood disorders, infections, etc., should be administered with caution, and children and elderly patients should also be closely monitored. During administration, various severe adverse reactions such as shock, gastrointestinal bleeding, pneumonia, hepatitis, and renal failure can occur, so symptoms should be reported to medical staff immediately. Regular monitoring of bone marrow function, liver and kidney function, and blood tests is essential to detect any abnormalities early and respond accordingly. This drug affects reproductive function and poses a serious risk to the fetus during pregnancy; hence, women who are pregnant or planning to become pregnant should avoid use, and men should also use contraception for a certain period during and after treatment. This drug interacts with many other medications, so caution is required when taken together, especially when drugs that may delay renal excretion and increase toxicity are involved. In case of overdose, an antidote should be administered immediately, and appropriate medical treatment is necessary; it cannot be removed by hemodialysis, so careful management is required. This medication should be stored out of reach of children and should not be transferred to another container.

Side effects

  • Shock
  • symptoms of anaphylaxis
  • hemorrhagic colitis
  • necrotizing colitis
  • abdominal pain
  • diarrhea
  • nausea
  • vomiting
  • stomatitis
  • loss of appetite
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  • glossitis
  • papular rash
  • gastrointestinal ulcer
  • bleeding
  • hematochezia
  • bowel obstruction
  • pancreatitis
  • interstitial pneumonia
  • pulmonary fibrosis
  • fever
  • cough
  • dyspnea
  • alveolar hemorrhage
  • acute pulmonary edema
  • headache
  • drowsiness
  • blurred vision
  • aphasia
  • incomplete paralysis
  • paralysis
  • seizures
  • coma
  • dementia
  • cervical and lumbar rigidity
  • back pain
  • sensory disturbances
  • sensory impairment
  • increased cerebrospinal fluid pressure
  • acute idiopathic multifocal neuropathy
  • azoospermia
  • ovarian dysfunction
  • menstrual disorders
  • infertility
  • miscarriage
  • fetal malformations
  • azotemia
  • defects in oogenesis
  • defects in spermatogenesis
  • vaginitis
  • vaginal ulcers
  • pancytopenia
  • agranulocytosis
  • anemia
  • leukopenia
  • thrombocytopenia
  • sepsis
  • hypogammaglobulinemia
  • lymphoproliferative diseases
  • severe hepatitis
  • liver dysfunction
  • jaundice
  • fatty liver
  • hepatic tissue necrosis
  • fulminant hepatitis
  • liver failure
  • hepatic tissue fibrosis
  • cirrhosis
  • renal failure
  • cystitis
  • hematuria
  • elevated BUN
  • elevated creatinine
  • acute renal failure
  • tubular necrosis
  • severe kidney disease
  • consciousness disorders
  • hypotension
  • tachycardia
  • paresthesia
  • sneezing
  • dyspnea
  • chest discomfort
  • cold and sweating
  • skin and mucous membrane syndrome
  • toxic epidermal necrolysis
  • photosensitivity reactions
  • fever
  • rash
  • urticaria
  • itching
  • erythematous rash
  • erythema
  • pigmentation
  • depigmentation
  • subcutaneous purpura
  • acne
  • hair loss
  • capillary telangiectasia
  • ulcer
  • conjunctival congestion
  • dermatitis
  • cystitis
  • arthritis
  • myalgia
  • diabetes
  • sudden death
  • edema
  • spinal disease
  • symptoms of acute chemical arachnoiditis
  • subacute spinal disease

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

Storage

This medication should be stored in a sealed container to prevent air entry and kept in a cool place below 25 degrees Celsius, protected from direct sunlight.

Appearance and packaging

Appearance

A clear vial containing a yellow clear liquid injection.

Package unit

50mg/2mL x 5 vials, 500mg/20mL x 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.