Medication info
Lemod Tablet 10 mg (Leflunomide)

Lemod Tablet 10 mg (Leflunomide)

Prescription medicationTablet
Ingredient · strength
Leflunomide›10mg / 1 tablet
Manufacturer / importer
Aliko Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202101188 · Approved 2021.02.08 · Insurance code 652607010,656005710

Summary

Main use
Treatment of rheumatoid arthritis in adults; relief of active psoriatic arthritis
Who uses it
Adults
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.

Ingredients

Manufacturer
Aliko Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of rheumatoid arthritis in adults; relief of active psoriatic arthritis

  • Signs of rheumatoid arthritis
  • symptoms of rheumatoid arthritis
  • narrowing of joint space
  • erosion
  • symptoms of active psoriatic arthritis
  • signs of active psoriatic arthritis
View approved original text

This medication is used for the treatment of rheumatoid arthritis in adults, helping to relieve the signs and symptoms of arthritis. It also inhibits structural damage, such as narrowing of joint space and joint erosion observed in X-rays, thereby slowing the progression of the disease. Improvement of impaired physical function due to rheumatoid arthritis can also be expected. Additionally, it is used to relieve symptoms and signs of active psoriatic arthritis. This medication can be used in combination with aspirin, non-steroidal anti-inflammatory drugs, and low-dose corticosteroids; however, studies on its combination with certain immunosuppressants and antimalarials are still insufficient. Therefore, it is indicated for rheumatoid arthritis and active psoriatic arthritis.

Dosage and Administration

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.

Precautions

This medication contains active metabolites that can remain in the body for a long time, so side effects may continue to appear even after discontinuation. If serious side effects occur or if rapid removal of the drug is necessary, specific antidotes should be used to expel the drug quickly from the body. It may affect liver function; therefore, patients with liver disease or impaired liver function should use this medication with particular caution and regular liver function tests are necessary. The risk of hepatotoxicity may increase when co-administered with other medications, so consultation with a doctor about the concomitant drugs is essential. It can affect the lungs, so it should be administered cautiously in patients with a history of lung disease or symptoms of pneumonia. It may suppress immune function, thus it is not recommended for patients with severe infections or immunocompromised states. Serious reactions on the skin may occur, so if symptoms such as rash or skin ulcers appear, discontinue use immediately and consult a physician. Women who are pregnant or may become pregnant should not take this medication as it may pose a risk to the fetus, and if they become pregnant while taking it, they should consult a physician immediately. Nursing mothers are also advised not to take this medication, and safety in children has not been established, so it is not administered to those under 18 years of age. Regular blood tests and liver function tests should be conducted while taking the medication, and any abnormal symptoms should be reported to medical personnel immediately. In case of overdose, symptoms such as diarrhea, abdominal pain, and hematological abnormalities may occur, and antidote therapy may be required. This medication can interact with other drugs, so it is crucial to inform healthcare providers of any other medications being taken. When storing this medication, it should be kept out of direct sunlight and at a stable temperature.

Side effects

Diarrhea

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

Storage

This medication is sensitive to light, so it should be stored away from direct sunlight. Additionally, it should be stored in a sealed container to prevent contact with air, and it is important to maintain the storage temperature below 25 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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.

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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.