Yuhan Methotrexate Injection 25 mg/mL

Adult dosage

1. Leukemia: Administer 5～10 mg of methotrexate orally per day for 3～6 days per week. Adjust the dose according to the patient's tolerance and the severity of symptoms. 2. Gestational trophoblastic disease: Administer 10～30 mg orally per day. A treatment cycle consists of 5 days, followed by a drug-free period of 7～12 days, after which treatment is repeated. Withhold treatment if adverse reactions occur. 3. Rheumatoid arthritis: A test dose of 5～10 mg orally once one week beforehand is recommended to assess adverse reactions. 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: A test dose of 5～10 mg orally once one week beforehand is recommended to assess adverse reactions. Administer 7.5～20 mg orally once weekly, or administer the dose orally in 3 divided doses at 12-hour intervals. Injection doses: - Gestational trophoblastic disease: Administer 10～30 ㎎/㎡ intramuscularly once daily for 5 days, as a 5-day treatment cycle. Allow a drug-free period of 7～12 days or until adverse reactions subside. The cycle may be repeated 3～5 times. - Breast cancer: Administer 10～60 ㎎/㎡ intravenously. - Lung cancer: Administer 20～100 ㎎/㎡ by intravenous infusion or injection. - Head and neck cancer: Administer 240～1,080 ㎎/㎡ by intravenous infusion, followed by leucovorin calcium rescue therapy. - Bladder cancer: Administer up to 100 mg by intravenous injection or infusion every 1 or 2 weeks. - Osteosarcoma: Administer 600～9,000 ㎎/㎡ by intravenous infusion, followed by leucovorin calcium rescue therapy. - Non-Hodgkin lymphoma: Administer 90～900 ㎎/㎡ by intravenous injection or infusion, followed by high-dose leucovorin calcium. Injection treatment for psoriasis: For severe psoriasis unresponsive to conventional therapy, administer 10～25 ㎎ orally once weekly or by intravenous or intramuscular injection, adjusting the dose according to the patient's response. Perform liver function tests periodically during treatment and exercise caution regarding the risk of hepatotoxicity.

Children's dosage

1. Leukemia: Administer methotrexate orally per day for 3～6 days per week at a dose of 1.25～2.5 mg for infants and 2.5～5 mg for children. Adjust the dose according to the patient's tolerance and the severity of symptoms. Injection doses: - Pediatric meningeal leukemia: Administer 12～15 ㎎/㎡ (0.4～0.5 ㎎ per kg of body weight) by intrathecal injection at 1-week intervals until the cerebrospinal fluid returns to normal.

This medication should be taken only once a week for the treatment of rheumatoid arthritis or psoriasis, and serious side effects may occur if the dosage instructions are not followed. This drug is included in high-risk therapies and requires strict supervision by a physician during and for a certain period after administration. Particularly, caution is necessary when using this medication at high doses in conjunction with gastrointestinal drugs known as proton pump inhibitors, as it can increase the blood concentration of this drug and increase toxicity. This medication should not be used in patients with poor kidney or liver function, blood disorders, women who are pregnant or potentially pregnant, or nursing mothers. It should be administered with caution to patients with symptoms like diarrhea, stomatitis, gastric ulcers, infections, as well as to children and the elderly, and immediate consultation with a physician is required if any abnormal symptoms occur. There can be various serious side effects associated with this drug, such as gastrointestinal bleeding, pneumonia, hepatitis, renal failure, skin rashes, and blood abnormalities, thus regular monitoring of the patient's condition is necessary. During administration, regular tests on bone marrow function, liver and kidney function, and blood tests should be performed to detect any abnormal signs early and take appropriate actions. This drug may affect reproductive function, so it is advised to avoid pregnancy for at least six months during and after treatment, and males should also use contraception. Furthermore, this medication has immunosuppressive effects that can diminish the effectiveness of vaccines, and severe reactions may occur if used with live vaccines, necessitating caution. There are many interactions with other medications that can alter the effects or side effects of this drug; hence, it is essential to consult a physician or pharmacist. In cases of overdose, the antidote leucovorin should be administered immediately, and prompt medical intervention is required. When storing, keep out of reach of children and do not transfer to other containers, ensure it is sealed to avoid exposure to air and light, and use the diluted solution immediately while discarding any leftover liquid.

• Shock
• symptoms of anaphylaxis
• hemorrhagic enteritis
• necrotizing enteritis
• abdominal pain
• diarrhea
• nausea
• vomiting
• stomatitis
• loss of appetite

This medication should be stored in a sealed container to prevent exposure to air and light, and it is important to avoid direct sunlight and keep it in a cool room temperature.

Appearance

Clear, yellowish transparent injection solution

Package unit

2ml/vial x 1, 20ml/vial x 1