Medication info
Lualba Tablet 10 mg (Leflunomide)

Lualba Tablet 10 mg (Leflunomide)

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

MFDS item code 201403891 · Approved 2014.08.20 · Insurance code 693901390

Summary

Main use
Treatment of rheumatoid arthritis in adults and relief of symptoms of active psoriatic arthritis
Who takes it
Adults
Adult dose
Administer a loading dose of 100 mg once daily for 3 days. For patients with rheumatoid arthritis, administer a maintenance dose of 20 mg once daily. Some patients experienced adverse reactions such as alopecia, weight loss, and increased liver enzyme levels when treated with 25 mg once daily. Therefore, the maintenance dose should not exceed 20 mg once daily. If the patient's clinical tolerability is poor, the maintenance dose may be reduced to 10 mg once daily. For patients with psoriatic arthritis, administer a maintenance dose of 20 mg once daily.

Ingredients

Manufacturer
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of rheumatoid arthritis in adults and relief of symptoms of active psoriatic arthritis

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

This medication provides several positive effects for patients with rheumatoid arthritis. First, it alleviates signs and symptoms such as pain and inflammation caused by arthritis. It also inhibits the progression of structural damage such as narrowing of joint spaces and joint erosion seen on X-rays. This helps prevent the deterioration of joint function and improves physical abilities. Additionally, it plays a role in alleviating symptoms of active psoriatic arthritis. It can be used in conjunction with other anti-inflammatory medications or low-dose corticosteroids, but further studies are needed for co-administration with some antirheumatic drugs. Therefore, this drug is used for the treatment of rheumatoid arthritis and active psoriatic arthritis.

How to take

Adult dose

Administer a loading dose of 100 mg once daily for 3 days. For patients with rheumatoid arthritis, administer a maintenance dose of 20 mg once daily. Some patients experienced adverse reactions such as alopecia, weight loss, and increased liver enzyme levels when treated with 25 mg once daily. Therefore, the maintenance dose should not exceed 20 mg once daily. If the patient's clinical tolerability is poor, the maintenance dose may be reduced to 10 mg once daily. For patients with psoriatic arthritis, administer a maintenance dose of 20 mg once daily.

Precautions

This medication is slowly eliminated from the body, so side effects may appear or persist even after discontinuation. If serious adverse reactions occur, a special medication may need to be used to rapidly eliminate this drug from the body. It can affect liver function, so patients with liver disease or impaired liver function should be particularly cautious when using this drug. Regular liver function tests should be conducted for a certain period before and after administration, and if liver enzymes significantly increase, the dose may need to be reduced or stopped. There may be an increased risk of liver toxicity when used with other specific medications, so consultation with a physician is necessary. Patients with a history of lung disease or pneumonia symptoms require careful evaluation and examination by a doctor before using this drug. This medication can suppress immune function, so if a serious infection occurs, treatment should be stopped and appropriate care should be received. Severe allergic reactions or ulcers may occur, so any unusual symptoms should be reported to healthcare professionals promptly. The administration of this drug may be temporarily suspended before and after surgery as it can affect wound healing. There may be an increased risk of developing malignancies during long-term use, so caution is required. Treatment should be conducted under the supervision of a physician experienced in treating rheumatic diseases, and if any unusual symptoms occur, immediate consultation with a doctor is necessary. Women who are pregnant or may become pregnant should not take this drug, and if pregnancy is confirmed while taking this medication, they should consult a physician immediately. Patients with hereditary lactose intolerance should also not take this drug. Interstitial pneumonia, blood disorders, liver disease, kidney disorders, severe infections, or immunocompromised patients should use this medication cautiously. Safety in children has not been established, and it is not recommended for patients under 18 years of age. In case of overdose, symptoms such as diarrhea, abdominal pain, or liver function abnormalities may occur, and drug removal treatment may be necessary. This drug may interact with other medications, so healthcare providers should be informed of any other medications being taken. Regular blood pressure and blood tests should be conducted while taking this medication, and immediate treatment should be sought if symptoms of infection appear. Nursing women should not take this medication.

Side effects

  • Diarrhea
  • elevation of liver enzymes (ALT, AST)
  • hair loss
  • rash
  • weakness
  • flu-like syndrome
  • upper respiratory infection
  • injury
  • pain
  • abdominal pain
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  • lumbar pain
  • hypertension
  • chest pain
  • loss of appetite
  • indigestion
  • gastritis
  • abnormal liver enzyme levels
  • nausea
  • abdominal pain
  • oral ulcer
  • vomiting
  • hypokalemia
  • weight loss
  • joint pain
  • muscle cramps
  • joint disorders
  • synovitis
  • tendinitis
  • 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
  • bloating
  • gastritis
  • gingivitis
  • bloody stools
  • oral candidiasis
  • salivary gland enlargement
  • stomatitis
  • dental disease
  • oral mucosal abnormalities
  • dry mouth
  • hepatitis
  • jaundice
  • cholestasis
  • liver failure
  • acute liver necrosis
  • pancreatitis
  • hypertension
  • angina pectoris
  • 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
  • taste disorder
  • peripheral neuropathy
  • acne
  • contact dermatitis
  • fungal dermatitis
  • hair discoloration
  • hematoma
  • herpes simplex
  • shingles
  • nail disease
  • skin nodules
  • subcutaneous nodules
  • papulopustular rash
  • skin diseases
  • skin discoloration
  • skin ulcer
  • lupus erythematosus
  • 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 disease
  • interstitial lung disease
  • abscess
  • cyst
  • fever
  • hernia
  • lethargy
  • pain
  • neck pain
  • pelvic pain
  • elevation of creatine phosphokinase
  • peripheral edema
  • hyperglycemia
  • diabetes
  • proteinuria
  • cystitis
  • dysuria
  • hematuria
  • menstrual disorders
  • vaginal candidiasis
  • prostate disease
  • frequent urination
  • reduced semen concentration
  • reduced total sperm count
  • reduced sperm motility
  • arthrosis
  • bursitis
  • myalgia
  • bone necrosis
  • bone pain
  • tendon rupture
  • hypokalemia
  • hyperlipidemia
  • decreased uric acid
  • hyperthyroidism
  • blurred vision
  • cataract
  • conjunctivitis
  • eye disease
  • myocardial infarction

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

Storage

This medication is sensitive to light, so it should be stored in a container that does not allow light to enter. It is also important to store it in a sealed container to avoid contact with air. The storage temperature should be kept cool, below 25 degrees Celsius, to maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White to almost 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.