Medication info
Yuhan Methotrexate Tablets

Yuhan Methotrexate Tablets

Prescription medicationTablet
Ingredient · strength
Methotrexate›2.5mg / 1 tablet
Manufacturer / importer
(Yuhan Corporation)
Appearance
This medication is a yellow, round tablet.
Packaging
100 tablets/PTP (10 tablets/PTP x 10)
Approval status
Active

MFDS item code 197900145 · Notified 1979.11.19 · Insurance code 642101470

Summary

Main use
Treatment of rheumatoid arthritis, severe refractory psoriasis, and cancer and trophoblastic disease (such as leukemia)
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 for 5 days as one treatment cycle, then repeat after a 7~12-day drug-free interval. 3. Rheumatoid arthritis: One week before treatment, administer a single 5~10 mg test dose orally and assess for adverse reactions. Then administer 7.5~20 mg orally once weekly, or divide the dose into 3 doses administered orally at 12-hour intervals. 4. Psoriasis: One week before treatment, administer a single 5~10 mg test dose orally and assess for adverse reactions. Then administer 7.5~20 mg orally once weekly, or divide the dose into 3 doses administered orally at 12-hour intervals. For the injectable product—psoriasis: Administer 10~25 mg once weekly orally or by intravenous or intramuscular injection, adjusting the dose according to the patient's response. For the injectable product—breast cancer, lung cancer, head and neck cancer, bladder cancer, osteosarcoma, and non-Hodgkin lymphoma: The dose administered by intravenous injection or infusion varies according to the type of cancer.
Children's dosage
Leukemia: Administer 1.25~2.5 mg orally per day for 3~6 days per week. For the injectable product—meningeal leukemia in children: Administer 12~15 mg/㎡ by intrathecal injection at 1-week intervals. For the injectable product—trophoblastic disease: Administer 10~30 mg/㎡ by intramuscular injection daily for 5 days, then repeat after a 7~12-day drug-free interval.

Ingredients

Manufacturer
(Yuhan Corporation)

Efficacy & effects

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

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

This medicine is used in tablet form for the relief of subjective and objective symptoms associated with leukemia, rheumatoid arthritis, refractory severe psoriasis, and hydatidiform mole. In injectable form, it is utilized for the treatment of various solid tumors such as acute leukemia, non-Hodgkin's lymphoma, sarcoma, breast cancer, lung cancer, head and neck cancer, and bladder cancer, as well as for the treatment of hydatidiform mole. In both formulations, it is also used to treat severe refractory psoriasis when other therapies have been ineffective. This drug is effective for the treatment of various cancers and inflammatory diseases, and it aids in alleviating symptoms.

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 for 5 days as one treatment cycle, then repeat after a 7~12-day drug-free interval. 3. Rheumatoid arthritis: One week before treatment, administer a single 5~10 mg test dose orally and assess for adverse reactions. Then administer 7.5~20 mg orally once weekly, or divide the dose into 3 doses administered orally at 12-hour intervals. 4. Psoriasis: One week before treatment, administer a single 5~10 mg test dose orally and assess for adverse reactions. Then administer 7.5~20 mg orally once weekly, or divide the dose into 3 doses administered orally at 12-hour intervals. For the injectable product—psoriasis: Administer 10~25 mg once weekly orally or by intravenous or intramuscular injection, adjusting the dose according to the patient's response. For the injectable product—breast cancer, lung cancer, head and neck cancer, bladder cancer, osteosarcoma, and non-Hodgkin lymphoma: The dose administered by intravenous injection or infusion varies according to the type of cancer.

Children's dosage

Leukemia: Administer 1.25~2.5 mg orally per day for 3~6 days per week. For the injectable product—meningeal leukemia in children: Administer 12~15 mg/㎡ by intrathecal injection at 1-week intervals. For the injectable product—trophoblastic disease: Administer 10~30 mg/㎡ by intramuscular injection daily for 5 days, then repeat after a 7~12-day drug-free interval.

Precautions

This drug is used to treat rheumatoid arthritis or psoriasis and should only be taken once a week. Strict adherence to the dosing regimen is crucial, as failure to comply may lead to serious side effects. Combination therapy with this drug and other anticancer agents is risky and must be managed under the supervision of a physician. Adequate medical facilities and an experienced physician are also necessary. Patients with allergies to any component of this drug, impaired kidney or liver functions, patients with pleural effusion or ascites, certain blood disorders, immunodeficiency, alcohol dependence, women who are pregnant or potentially pregnant, breastfeeding mothers, and patients with specific genetic disorders should not use this drug. Patients with diarrhea, stomatitis, gastric ulcers, blood abnormalities, bone marrow suppression, varicella infections, infections, mental disorders, children, and the elderly should use this medication cautiously. This drug may rarely cause severe allergic reactions, such as shock or anaphylaxis, and any unusual symptoms during treatment should prompt immediate discontinuation and hospital consultation. Gastrointestinal side effects may include hemorrhagic enteritis, nausea, vomiting, stomatitis, abdominal pain, diarrhea, and pancreatitis should also be monitored. Respiratory side effects may manifest as pneumonia or pulmonary fibrosis; thus, immediate examination and treatment are required if fever, cough, or shortness of breath occur. Neurological effects may include headache, drowsiness, blurred vision, and seizures. Reproductive system side effects such as infertility, menstrual irregularities, and fetal malformations have been reported. Hematologic side effects may include anemia, leukopenia, and thrombocytopenia indicating bone marrow suppression, necessitating regular blood testing. The drug may affect liver and kidney function, so regular monitoring and observation of conditions are critical, and use should be discontinued if abnormalities are found. Skin reactions such as severe rashes, skin desquamation, and photosensitivity reactions may occur and should be carefully observed. The risk of infections may increase, and treatment should be sought immediately if symptoms of infection arise. Bone health issues, such as osteoporosis, may also develop, thus regular assessments during long-term use are necessary. This drug can interact with various medications, so it is crucial to consult a doctor or pharmacist if taking other medications concurrently. Women who are pregnant or may become pregnant must avoid this medication, as it poses serious risks to the fetus; it should not be administered while breastfeeding as well. Children and the elderly may be more susceptible to side effects of this medication, so caution is warranted during administration. In case of overdose, seek immediate medical attention for appropriate detoxification treatment, and keep this medication out of the reach of children.

Side effects

  • Shock
  • anaphylactic symptoms
  • hemorrhagic colitis
  • necrotizing colitis
  • abdominal pain
  • diarrhea
  • nausea
  • vomiting
  • stomatitis
  • loss of appetite
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  • glossitis
  • papular swelling
  • gastrointestinal ulcer
  • hemorrhage
  • hematochezia
  • intestinal 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
  • neck and buttock rigidity
  • back pain
  • sensory disturbance
  • sensory loss
  • azoospermia
  • ovarian dysfunction
  • menstrual dysfunction
  • infertility
  • miscarriage
  • fetal malformation
  • azotemia
  • oocyte development deficiency
  • spermatogenesis deficiency
  • vaginitis
  • vaginal ulcer
  • pancytopenia
  • agranulocytosis
  • anemia
  • leukopenia
  • thrombocytopenia
  • sepsis
  • hypogammaglobulinemia
  • lymphoproliferative disorders
  • 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 nephropathy
  • consciousness disorder
  • hypotension
  • tachycardia
  • numbness
  • sneezing
  • dyspnea
  • chest discomfort
  • cold and sweating
  • skin and mucous membrane syndrome
  • toxic epidermal necrolysis
  • photosensitivity reaction
  • fever
  • rash
  • urticaria
  • itching
  • erythematous eruption
  • erythema
  • pigmentation
  • depigmentation
  • subcutaneous petechiae
  • acne
  • hair loss
  • capillary dilation
  • ulcer
  • conjunctival congestion
  • cystitis
  • arthritis
  • myalgia
  • diabetes
  • sudden cardiac death
  • edema
  • reactivation of hepatitis B

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

This medication is a yellow, round tablet.

Package unit

100 tablets/PTP (10 tablets/PTP x 10)

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.

Questions about this medicine

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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.