Myungmoon Leflunomide Tablet 20mg

Adult dose

1. Loading dose In view of this medicine's long half-life and the recommended 24-hour dosing interval, treatment is generally initiated with a loading dose to achieve steady-state plasma concentrations more rapidly. Administer 100mg per dose, once daily for 3 days as the loading dose. In patients with rheumatoid arthritis, omitting the loading dose may reduce the risk of adverse reactions (see section ‘5. General Precautions 9)’). 2. Maintenance dose Administer 20mg once daily as the maintenance dose to patients with rheumatoid arthritis. When a dose of 25mg daily was administered, some patients experienced adverse reactions such as hair loss, weight loss, and elevated liver enzyme levels. Therefore, the maintenance dose should not exceed 20mg daily, and may be reduced to 10mg daily in patients with poor clinical tolerability. Administer 20mg daily as the maintenance dose to patients with psoriatic arthritis. Monitor liver enzyme levels; dose adjustment may be necessary. (See Warning - Hepatotoxicity.) Because the half-life of this medicine's active metabolite is prolonged, it may take several weeks for metabolite levels to decrease. Therefore, monitor patients carefully after reducing the dose.

This medication contains an active metabolite that remains in the body for a long time, so adverse reactions may occur even after stopping the medication. If serious adverse reactions occur, special drugs may be required to expedite the elimination of this medication from the body. It may affect liver function, so patients with liver disease or compromised liver function should be especially cautious. Regular liver function tests should be conducted before and during administration, and dosage adjustment or discontinuation may be necessary if liver enzyme levels rise. It can suppress the immune system, increasing the risk of infections, and if serious infections occur, the medication should be stopped immediately. Those with a history of lung disease should be carefully assessed due to the risk of pneumonia or interstitial pneumonia worsening. Severe allergic reactions or ulcers on the skin may occur, so any abnormal symptoms should be reported to a doctor immediately. Women who are pregnant or may become pregnant should not take this medication due to risks to the fetus, and consultation with healthcare providers is essential if pregnancy occurs during treatment. Patients with lactose intolerance should not take this medication. Regular blood tests are necessary to monitor for abnormalities such as anemia or leukopenia. Caution is required when using with other hepatotoxic drugs or immunosuppressants due to an increased risk of adverse reactions. There may be drug interactions between this medication and certain others, so inform your healthcare provider if you are taking other medications. In cases of overdose, symptoms may include diarrhea, abdominal pain, and liver function abnormalities, necessitating prompt drug removal treatment. Store this medication away from direct sunlight and below 25 degrees Celsius, and special care is needed when administering to children or the elderly.

Diarrhea, elevation of liver enzyme levels (ALT, AST), hair loss, rash, hypersensitivity reactions, weakness, flu-like syndrome, upper respiratory infection, injury, pain, abdominal pain, lumbar pain, hypertension, chest pain, loss of appetite, dyspepsia, gastroenteritis, abnormal liver enzyme levels, nausea, gastric pain, oral ulcer, vomiting, hypokalemia, weight loss, joint pain, muscle cramps, joint dysfunction, synovitis, tendonitis, dizziness, headache, paresthesia, bronchitis, increased cough, respiratory infection, pharyngitis, pneumonia, rhinitis, sinusitis, hair loss, eczema, pruritus, dry skin, urinary tract infection, cholelithiasis, colitis, constipation, esophagitis, flatulence, gastritis, gingivitis, bloody stools, oral candidiasis, salivary gland enlargement, stomatitis, dental disease, oral mucosal abnormalities, hepatitis, jaundice, cholestasis, liver failure, acute liver necrosis, pancreatitis, elevated blood pressure, angina pectoris, migraine, palpitations, tachycardia, vasculitis, vasodilation, varicose veins, pulmonary hypertension, agranulocytosis, anemia, petechiae, leukopenia, thrombocytopenia, eosinophilia, pancytopenia, anxiety, depression, insomnia, neuralgia, neuritis, sleep disorders, sweating, drowsiness, taste disturbances, peripheral neuropathy, acne, contact dermatitis, fungal dermatitis, hair discoloration, hematoma, herpes simplex, herpes zoster, nail disorders, skin nodules, subcutaneous nodules, maculopapular rash, skin diseases, skin discoloration, skin ulcer, cutaneous lupus erythematosus, pustular psoriasis, exacerbation of psoriasis, drug reaction DRESS, urticaria, anaphylactic reaction, Stevens-Johnson syndrome, epidermal necrolysis, necrotizing vasculitis, severe infection, sepsis, asthma, dyspnea, epistaxis, pulmonary disease, interstitial lung disease, abscess, cyst, fever, hernia, malaise, pain, cervical pain, pelvic pain, elevated creatine phosphokinase, peripheral edema, hyperglycemia, diabetes mellitus, proteinuria, cystitis, dysuria, hematuria, menstrual disorders, vaginal candidiasis, prostate disease, frequent urination, decreased sperm concentration, reduced total sperm count, decreased sperm motility, arthrosis, bursitis, myalgia, osteonecrosis, bone pain, tendon rupture, hypokalemia, hyperlipidemia, decreased uric acid, hyperthyroidism, blurred vision, cataract, conjunctivitis, eye diseases, myocardial infarction

This medication should be stored in a sealed container that blocks light and prevents air from entering. For domestic use, it is advisable to store it in a cool place below 25 degrees Celsius. Export medications should be stored at temperatures not exceeding 30 degrees Celsius to ensure safety and efficacy.

Appearance

Yellow to yellowish-brown triangular film-coated tablets

Package unit

For domestic use - 30 tablets/bottle, for export - 30 tablets/box [(10 tablets/PTP × 3)]