Medication info
Durova Tablet 10mg (Leflunomide)

Durova Tablet 10mg (Leflunomide)

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

MFDS item code 200808310 · Notified 2008.08.01 · Insurance code 650301770

Summary

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

Ingredients

Manufacturer
JinYang 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
  • reduction in joint space
  • erosions
  • impaired bodily function
  • 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, relieving the signs and symptoms of arthritis. It also protects joints by inhibiting structural damage such as joint space reduction and erosions visible on X-rays. Additionally, it helps improve bodily functions impaired due to rheumatoid arthritis. Furthermore, it is used to relieve symptoms and signs of active psoriatic arthritis. This drug may generally be administered in combination with aspirin, non-steroidal anti-inflammatory drugs, or low-dose corticosteroids. However, sufficient studies have not been conducted regarding its use in combination with antimalarials, gold preparations, D-penicillamine, azathioprine, or methotrexate. Therefore, this drug is used to improve the symptoms of rheumatoid arthritis and active psoriatic arthritis.

How to take

Adult dose

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

Precautions

This drug contains active metabolites that remain in the body for a long time, which may cause side effects to appear or persist even after discontinuation. If serious side effects occur or if rapid elimination of the drug from the body is necessary, special drugs (cholestyramine or activated charcoal) should be administered to quickly eliminate this drug. Patients with impaired liver function or a history of liver disease should undergo liver function tests before using this drug and monitor their liver condition regularly during treatment. If liver enzyme levels rise, the dosage may need to be reduced or the medication discontinued, as serious liver damage may occur. The risk of hepatotoxicity may increase when used concomitantly with certain other medications (e.g., methotrexate), so frequent liver function tests are necessary. Patients with pulmonary issues or a history of lung disease should be evaluated by a physician before starting this drug and pay attention to pulmonary symptoms during treatment. As it may suppress immune function, it is not recommended for patients with severe infections or immunodeficiency. Serious skin reactions may occur, so if symptoms such as rash or skin ulcers appear, discontinue use immediately and consult a physician. This drug should not be administered to pregnant women or women of childbearing potential, and if pregnancy is confirmed during treatment, the physician should be notified immediately. Patients with genetic lactose metabolism disorders should not take this drug. No special dosage adjustment is needed for elderly patients over 65 years old, but it is not recommended for use in children under 18 years old. Overdosage may cause diarrhea, abdominal pain, hematological abnormalities, etc., in which case the drug can also be eliminated by administering cholestyramine or activated charcoal. This drug may interact with other medications, so if other drugs are being taken, it is essential to inform the physician or pharmacist. Regular blood tests and liver function tests should be performed during treatment, and medical consultation should be sought immediately if any abnormal symptoms occur. Moreover, as this drug has immunosuppressive effects, care should be taken to prevent infections, and vaccination should be discussed with a physician as necessary. It is advisable to store this drug away from direct sunlight and at a temperature below 25 degrees Celsius.

Side effects

  • Diarrhea
  • increased liver enzyme levels (ALT, AST)
  • hair loss
  • rash
  • weakness
  • flu-like syndrome
  • upper respiratory infection
  • injury
  • pain
  • abdominal pain
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  • low back pain
  • hypertension
  • chest pain
  • loss of appetite
  • indigestion
  • gastritis
  • abnormal liver enzyme levels
  • nausea
  • abdominal discomfort
  • 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
  • eczema
  • pruritus
  • skin dryness
  • urinary tract infection
  • agranulocytosis
  • anemia
  • petechiae
  • leukopenia
  • thrombocytopenia
  • eosinophilia
  • pancytopenia
  • anxiety
  • depression
  • insomnia
  • neuralgia
  • neuritis
  • sleep disorders
  • sweating
  • drowsiness
  • taste disorders
  • peripheral neuropathy
  • acne
  • contact dermatitis
  • fungal dermatitis
  • hair discoloration
  • hematoma
  • herpes simplex
  • shingles
  • nail diseases
  • skin nodules
  • subcutaneous nodules
  • papulovesicular rash
  • skin diseases
  • skin discoloration
  • skin ulcers
  • skin erythema lupus
  • pustular psoriasis
  • worsening of psoriasis
  • drug reaction DRESS
  • urticaria
  • anaphylactic reaction
  • Stevens-Johnson syndrome
  • epidermal necrolysis
  • necrotizing vasculitis
  • severe infection
  • sepsis
  • asthma
  • dyspnea
  • epistaxis
  • lung disease
  • interstitial lung disease
  • abscess
  • cyst
  • fever
  • hernia
  • fatigue
  • pain
  • neck pain
  • pelvic pain
  • increased creatine phosphokinase
  • peripheral edema
  • hyperglycemia
  • diabetes
  • proteinuria
  • cystitis
  • dysuria
  • hematuria
  • menstrual disorders
  • vaginal candidiasis
  • prostate disease
  • frequent urination
  • reduced sperm concentration
  • reduced total sperm count
  • reduced sperm motility
  • arthrosis
  • bursitis
  • myalgia
  • osteonecrosis
  • bone pain
  • tendon rupture
  • hypokalemia
  • hyperlipidemia
  • decreased uric acid
  • hyperthyroidism
  • blurred vision
  • cataract
  • conjunctivitis
  • eye disorders
  • myocardial infarction

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

Storage

This drug is sensitive to light and should be stored in a container that does not allow light to enter. It should also be kept in a sealed container to prevent air from entering, and maintaining a storage temperature below 25 degrees Celsius is essential.

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.