Medication info

Pfizer Methotrexate Injection 1 g

Prescription medicationInjections
Ingredient · strength
Methotrexate›1g / 1 vial
Manufacturer / importer
Pfizer Pharmaceuticals Korea Limited
Appearance
A clear solution injection contained in a transparent vial with a yellow to orange clear liquid
Packaging
1 g/10mL X 1 vial
Approval status
Active

MFDS item code 200210230 · Notified 2002.07.15 · Insurance code 648902971

Summary

Main use
Treatment of cancer and trophoblastic diseases (leukemia, lymphoma, etc.), 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 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. The total weekly dose should not exceed 20 mg. 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 orally in 3 divided doses at 12-hour intervals. Injectable formulation: 1) Trophoblastic disease: Use a 5-day treatment cycle and administer 10~30 ㎎/㎡ per day by intramuscular injection for 5 days. Allow a drug-free period of 7~12 days. The cycle may be repeated 3~5 times. 2) Breast cancer: Administer 10~60 ㎎/㎡ intravenously. 3) Lung cancer: Administer 20~100 ㎎/㎡ by intravenous infusion or injection. 4) Head and neck cancer: Administer 240~1,080 ㎎/㎡ by intravenous infusion, followed by leucovorin calcium rescue therapy. 5) Bladder cancer: Administer up to 100 mg intravenously by injection or infusion every 1 or 2 weeks. 6) Osteosarcoma: Administer 600~9,000 ㎎/㎡ by intravenous infusion, followed by leucovorin calcium rescue therapy. 7) Non-Hodgkin lymphoma: Administer 90~900 ㎎/㎡ by intravenous injection or infusion, followed by high-dose leucovorin calcium. Administration for psoriasis: Administer a test dose of 5~10 mg orally once, 1 week before treatment. For severe, uncontrolled psoriasis refractory to existing therapy, administer 10~25 ㎎ orally once weekly or by intravenous or intramuscular injection. Adjust the dose according to the patient's response.
Children's dosage
1. Leukemia: Administer methotrexate 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. Injectable formulation: 1) Meningeal leukemia in children: Administer 12~15 ㎎/㎡ (0.4~0.5 ㎎ per kg) by intrathecal injection at 1-week intervals until the cerebrospinal fluid returns to normal.

Ingredients

Importer
Pfizer Pharmaceuticals Korea Limited

Efficacy & effects

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

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

This oral tablet is used to alleviate both subjective and objective symptoms of leukemia, gestational trophoblastic disease (choriocarcinoma, destructive hydatidiform mole, hydatidiform mole), is also helpful for the treatment of rheumatoid arthritis and severe refractory psoriasis that do not respond to other medications. The injectable form is utilized for various cancer conditions, including acute leukemia, non-Hodgkin lymphoma, soft tissue sarcoma, and osteosarcoma, as well as for widespread treatment of solid tumors such as breast cancer, lung cancer, head and neck cancer, bladder cancer, and gestational trophoblastic diseases. In addition, the injectable form is also used to treat severe refractory psoriasis. This medication is effective in treating various cancers, autoimmune diseases, and skin conditions, improving symptoms and enhancing treatment efficacy.

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 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. The total weekly dose should not exceed 20 mg. 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 orally in 3 divided doses at 12-hour intervals. Injectable formulation: 1) Trophoblastic disease: Use a 5-day treatment cycle and administer 10~30 ㎎/㎡ per day by intramuscular injection for 5 days. Allow a drug-free period of 7~12 days. The cycle may be repeated 3~5 times. 2) Breast cancer: Administer 10~60 ㎎/㎡ intravenously. 3) Lung cancer: Administer 20~100 ㎎/㎡ by intravenous infusion or injection. 4) Head and neck cancer: Administer 240~1,080 ㎎/㎡ by intravenous infusion, followed by leucovorin calcium rescue therapy. 5) Bladder cancer: Administer up to 100 mg intravenously by injection or infusion every 1 or 2 weeks. 6) Osteosarcoma: Administer 600~9,000 ㎎/㎡ by intravenous infusion, followed by leucovorin calcium rescue therapy. 7) Non-Hodgkin lymphoma: Administer 90~900 ㎎/㎡ by intravenous injection or infusion, followed by high-dose leucovorin calcium. Administration for psoriasis: Administer a test dose of 5~10 mg orally once, 1 week before treatment. For severe, uncontrolled psoriasis refractory to existing therapy, administer 10~25 ㎎ orally once weekly or by intravenous or intramuscular injection. Adjust the dose according to the patient's response.

Children's dosage

1. Leukemia: Administer methotrexate 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. Injectable formulation: 1) Meningeal leukemia in children: Administer 12~15 ㎎/㎡ (0.4~0.5 ㎎ per kg) by intrathecal injection at 1-week intervals until the cerebrospinal fluid returns to normal.

Precautions

This medication should be taken only once a week during treatment for rheumatoid arthritis or psoriasis, and the method of administration and dosage must be strictly adhered to in order to prevent serious side effects. Co-administration of this drug with certain chemotherapy drugs poses risks, so treatment must be conducted under the supervision of a physician, and medical facilities prepared for emergencies and experienced doctors are required. Care must be taken when using this drug in high doses with proton pump inhibitors, as its concentration may increase and lead to toxicity. Patients with allergies to this drug's components, or with kidney or liver function issues, pregnant or potentially pregnant women, or nursing mothers should not use this medication. Patients with specific conditions such as diarrhea, mucositis, blood disorders, infections, mental disorders, children, the elderly, etc. should use this drug with caution, and immediate consultation with medical personnel is necessary if abnormal symptoms occur. During administration, various side effects may occur, including allergic reactions, gastrointestinal issues, respiratory problems, neurological abnormalities, reproductive problems, blood disorders, and liver and kidney function decline, so the patient's condition should be monitored frequently. This medication has immunosuppressive effects, so caution against infections is necessary, and care is also required during vaccinations. Taking this drug during pregnancy significantly increases the risk of miscarriage and birth defects, so women who are pregnant or planning to become pregnant should strictly avoid it, and pregnancy should be avoided for at least six months after treatment. Men are also advised to avoid pregnancy during and for six months after taking this medication. This medication should be administered to children and the elderly with greater caution, and liver and kidney function should be tested regularly. Due to interactions when used with other medications, the toxicity of this drug may increase, so if you are taking other medications, you must consult with a physician or pharmacist. In case of overdose, immediate treatment at a medical institution is necessary, and special treatment may be required to reduce the toxicity of this drug. This medication should be stored in a place out of reach of children, not transferred to other containers, and should be used promptly after dilution.

Side effects

  • Shock
  • anaphylactic symptoms
  • hemorrhagic enteritis
  • necrotizing enteritis
  • abdominal pain
  • diarrhea
  • nausea
  • vomiting
  • stomatitis
  • loss of appetite
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  • glossitis
  • papular edema
  • gastrointestinal ulcer
  • bleeding
  • bloody stool
  • intestinal obstruction
  • pancreatitis
  • interstitial pneumonia
  • pulmonary fibrosis
  • fever
  • cough
  • dyspnea
  • alveolar hemorrhage
  • acute pulmonary edema
  • headache
  • drowsiness
  • blurred vision
  • aphasia
  • incomplete paralysis
  • paralysis
  • convulsions
  • coma
  • dementia
  • neck and buttock rigidity
  • back pain
  • sensory disturbances
  • sensory impairment
  • increased cerebrospinal fluid pressure
  • acute idiopathic polyneuropathy
  • azoospermia
  • ovarian insufficiency
  • menstrual disorders
  • infertility
  • miscarriage
  • fetal malformation
  • nitrogenemia
  • oocyte formation deficiency
  • sperm production deficiency
  • vaginitis
  • vaginal ulcer
  • pancytopenia
  • agranulocytosis
  • anemia
  • leukopenia
  • thrombocytopenia
  • sepsis
  • hypogammaglobulinemia
  • lymphoproliferative disorder
  • severe hepatitis
  • liver dysfunction
  • jaundice
  • fatty liver
  • liver tissue necrosis
  • fulminant hepatitis
  • liver failure
  • liver tissue fibrosis
  • cirrhosis
  • renal failure
  • cystitis
  • hematuria
  • elevated BUN
  • elevated creatinine
  • acute renal failure
  • tubular necrosis
  • severe nephropathy
  • consciousness disturbance
  • hypotension
  • tachycardia
  • sensation of paralysis
  • sneezing
  • dyspnea
  • chest discomfort
  • cold sweat
  • skin and mucous membrane syndrome
  • toxic epidermal necrolysis
  • phototoxic reaction
  • fever
  • rash
  • urticaria
  • pruritus
  • erythematous rash
  • erythema
  • pigmentation
  • depigmentation
  • subcutaneous purpura
  • acne
  • hair loss
  • capillary dilation
  • ulcer
  • conjunctival congestion
  • cystitis
  • arthritis
  • myalgia
  • diabetes
  • sudden death
  • edema
  • myelopathy
  • acute chemical arachnoiditis symptoms
  • subacute myelopathy

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

Storage

This medication should be stored in a tightly sealed container to prevent air exposure and kept in a dark place to avoid light exposure. Additionally, it is important to store it at a cool temperature below 25 degrees Celsius to maintain the drug's effectiveness.

Appearance and packaging

Appearance

A clear solution injection contained in a transparent vial with a yellow to orange clear liquid

Package unit

1 g/10mL X 1 vial

Same-ingredient medicines

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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.