Medication info
Myungmoon Leflunomide Tablet 10mg

Myungmoon Leflunomide Tablet 10mg

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

MFDS item code 201404855 · Approved 2014.10.23 · Insurance code 649806710

Summary

Main use
Treatment of rheumatoid arthritis; relief of symptoms of active psoriatic arthritis
Who takes it
Adults
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.

Ingredients

Manufacturer
Myungmoon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of rheumatoid arthritis; relief of symptoms of active psoriatic arthritis

  • Signs of rheumatoid arthritis
  • symptoms of rheumatoid arthritis
  • reduction of joint space
  • erosive disease
  • 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. It alleviates the signs and symptoms of arthritis caused by rheumatoid arthritis and inhibits structural damage such as joint space reduction and erosion seen on X-ray. It also helps improve physical function decreased due to arthritis. Additionally, it is effective in relieving symptoms and signs of active psoriatic arthritis. It can be administered in conjunction with aspirin, nonsteroidal anti-inflammatory drugs, and low-dose corticosteroids during treatment, but studies on the combination with some other medications are still insufficient. This medication is used to relieve symptoms of rheumatoid arthritis and active psoriatic arthritis and to improve joint function.

How to take

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.

Precautions

This medication has an active metabolite that remains in the body for a long time, and adverse effects may occur or persist even after discontinuation. If serious adverse effects occur, rapid treatment to remove the medication may be necessary under specialist direction. This medication is metabolized and excreted by the liver, so patients with impaired liver function require special caution and should not use it if there is a history of liver damage. Liver function tests should be frequently monitored before and during medication, and if liver enzyme levels rise significantly, dosage adjustment or discontinuation may be necessary. This medication can suppress immune function and is not recommended for patients with serious immune deficiency or infections. Patients with a history of pulmonary disease or symptoms of pneumonia must receive medical evaluation before taking this medication, and respiratory symptoms should be monitored during use. Serious allergic reactions or ulcers may occur on the skin; if such symptoms occur, the medication should be stopped immediately, and medical advice should be sought. Women who are pregnant or may become pregnant should not take this medication, and if pregnancy is confirmed during use, immediate consultation with a physician is required. Patients with genetically lactose intolerance should not take this medication. Regular blood tests and liver function tests should be performed during medication, particularly for patients with bone marrow function suppression. This medication can increase the risk of adverse effects when used with other hepatotoxic drugs or immunosuppressants, so consultation with a physician is required. In case of overdose, symptoms such as diarrhea, abdominal pain, and blood abnormalities may occur, and treatment to remove the medication may be necessary. This medication should be stored in a container that blocks light below 25 degrees Celsius, and can be used for children or elderly patients without special dosage adjustments. This medication may increase sensitivity to infections due to its immunosuppressive action; if symptoms of infection appear, immediate consultation with healthcare professionals is necessary. Blood pressure should be regularly monitored during use, and if any unusual symptoms arise, immediate consultation with a physician is required. This medication can have severe effects on the fetus during pregnancy; therefore, women planning to become pregnant must consult with a physician before use.

Side effects

  • Diarrhea
  • elevated liver enzymes (ALT, AST)
  • hair loss
  • rash
  • hypersensitivity reactions
  • asthenia
  • flu-like syndrome
  • upper respiratory infections
  • injuries
  • pain
Show 149 more
  • abdominal pain
  • lumbar pain
  • hypertension
  • chest pain
  • loss of appetite
  • dyspepsia
  • gastroenteritis
  • abnormal liver enzyme levels
  • nausea
  • abdominal discomfort
  • oral ulcers
  • vomiting
  • hypokalemia
  • weight loss
  • arthralgia
  • muscle cramps
  • joint disorders
  • synovitis
  • tendinitis
  • dizziness
  • headache
  • paresthesia
  • bronchitis
  • increased cough
  • respiratory infections
  • pharyngitis
  • pneumonia
  • rhinitis
  • sinusitis
  • hair loss
  • eczema
  • pruritus
  • dry skin
  • urinary tract infections
  • nausea
  • cholelithiasis
  • colitis
  • constipation
  • esophagitis
  • bloating
  • gastritis
  • gingivitis
  • bloody stools
  • oral candidiasis
  • salivary gland enlargement
  • stomatitis
  • dental diseases
  • oral mucosa abnormalities
  • xerostomia
  • hepatitis
  • jaundice
  • cholestasis
  • liver failure
  • acute liver necrosis
  • pancreatitis
  • elevated blood pressure
  • angina
  • migraine
  • palpitations
  • tachycardia
  • vasculitis
  • vasodilation
  • varicose veins
  • pulmonary hypertension
  • agranulocytosis
  • anemia
  • petechial hemorrhage
  • leukopenia
  • thrombocytopenia
  • eosinophilia
  • pancytopenia
  • anxiety
  • depression
  • insomnia
  • neuralgia
  • neuritis
  • sleep disorders
  • sweating
  • drowsiness
  • dysgeusia
  • peripheral neuropathy
  • acne
  • contact dermatitis
  • fungal dermatitis
  • hair discoloration
  • hematoma
  • herpes simplex
  • herpes zoster
  • nail diseases
  • skin nodules
  • subcutaneous nodules
  • papulovesicular rash
  • skin diseases
  • skin discoloration
  • skin ulcers
  • skin erythema lupus
  • pustular psoriasis
  • exacerbation of psoriasis
  • drug reaction DRESS
  • urticaria
  • anaphylactic reaction
  • Stevens-Johnson syndrome
  • epidermal necrolysis
  • necrotizing vasculitis
  • severe infections
  • sepsis
  • asthma
  • dyspnea
  • epistaxis
  • lung diseases
  • interstitial lung diseases
  • abscess
  • cysts
  • fever
  • hernia
  • malaise
  • pain
  • cervical pain
  • pelvic pain
  • elevated creatine phosphokinase
  • peripheral edema
  • hyperglycemia
  • diabetes
  • proteinuria
  • cystitis
  • dysuria
  • hematuria
  • menstrual disorders
  • vaginal candidiasis
  • prostate diseases
  • polyuria
  • reduced semen concentration
  • total sperm count reduction
  • decreased sperm motility
  • arthrosis
  • bursitis
  • myalgia
  • bone necrosis
  • bone pain
  • tendon rupture
  • hypokalemia
  • hyperlipidemia
  • reduced uric acid
  • hyperthyroidism
  • blurred vision
  • cataracts
  • conjunctivitis
  • eye diseases
  • myocardial infarction

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

Storage

This medication is sensitive to light and should be stored in a container that blocks light. Additionally, it is important to store it in a cool place below 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 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.