Leflunomide 20 mg Tablets

Adult dosage

1. Loading dose Given the long half-life of this medicine and the recommended dosing interval of 24 hours, treatment is generally initiated with a loading dose to reach steady-state plasma concentrations more rapidly. The loading dose is 100mg once daily for 3 days. 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 The maintenance dose for patients with rheumatoid arthritis is 20mg daily. Some patients experienced adverse reactions such as hair loss, weight loss, and elevated liver enzyme levels when treated with 25mg daily. Therefore, the maintenance dose should not exceed 20mg daily and may be reduced to 10mg daily if the patient has poor clinical tolerability. The maintenance dose for patients with psoriatic arthritis is 20mg daily. Monitor liver enzyme levels; dose adjustment may be necessary. (See Warnings - Hepatotoxicity.) Because the half-life of the active metabolite of this medicine is prolonged, it may take several weeks for metabolite levels to decrease. Therefore, monitor patients carefully after reducing the dose.

This medication includes an active metabolite that remains in the body for an extended period, so adverse reactions may continue even after discontinuing the medication. If serious adverse reactions occur or if there is a need to rapidly eliminate the drug from the body, specific antidotes should be used to quickly expel the medication. It can affect liver function, so patients with impaired liver function should use it with caution, and it is not recommended for patients with severe liver damage. Liver function tests should be performed regularly both before and during administration to closely monitor liver status. When taken with other medications, the risk of liver toxicity may increase, especially when combined with methotrexate, necessitating frequent liver function tests. Patients with a history of pulmonary disease or those at risk of pneumonia should assess their lung status before administering this medication and carefully monitor pulmonary symptoms during treatment. This medication can suppress immune function, so it is not recommended for patients with severe infections or immunodeficiency, and if an infection occurs, the medication should be stopped immediately. Severe skin reactions may rarely occur; if skin rash or ulcers develop, treatment should be discontinued immediately, and a physician should be consulted. Women who are pregnant or may become pregnant should not take this medication, and if pregnancy occurs during treatment, it poses a serious risk to the fetus; they should consult a physician immediately. Patients with certain specific metabolic disorders should not use this medication. Elderly patients can use it without special dosage adjustments, but safety in pediatric patients has not been established. In case of overdose, symptoms such as diarrhea, abdominal pain, and blood abnormalities may occur, and even in this case, an antidote should be used to eliminate the medication. This medication can interact with various drugs, so those taking other medications should consult a physician or pharmacist. During treatment, regular checks on health status, including blood pressure and blood tests, should be conducted, and any unusual symptoms should be reported to healthcare personnel immediately. This medication should be stored in a light-protected container in a cool place, and clinical use should be conducted under the supervision of qualified medical professionals.

• Diarrhea
• elevation of liver enzymes (ALT, AST)
• hair loss
• rash
• asthenia
• flu-like syndrome
• upper respiratory tract infection
• injury accident
• pain
• abdominal pain

This medication is sensitive to light and should be stored in a light-protected container. It is also important to keep it sealed to avoid contact with air. The storage temperature should be maintained at a cool place below 25 degrees.

Appearance

Pale yellow triangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle