Medication info
Durova Tablet 20mg (Leflunomide)

Durova Tablet 20mg (Leflunomide)

Prescription medicationTabletOral
Ingredient · strength
Leflunomide›20mg / 1 tablet
Manufacturer / importer
Jinyang Pharmaceutical Co., Ltd.
Appearance
Light yellow triangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200711114 · Notified 2007.10.08 · Insurance code 650301750

Summary

Main use
Treatment of rheumatoid arthritis in adults; relief of symptoms of active psoriatic arthritis
Who takes it
Adults
Adult dose
Loading dose: Administer 100mg 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. Maintenance dose (rheumatoid arthritis): Administer 20mg once daily. When 25mg once 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 once daily. If the patient’s clinical tolerability is poor, the maintenance dose may be reduced to 10mg once daily. Maintenance dose (psoriatic arthritis): Administer 20mg once daily.

Ingredients

Manufacturer
Jinyang Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Rheumatoid arthritis
  • joint space reduction
  • erosions
  • decreased physical function
  • active psoriatic arthritis
View approved original text

This medication is used for the treatment of rheumatoid arthritis in adult patients. It relieves the signs and symptoms of rheumatoid arthritis and inhibits structural damage such as joint space reduction and erosions observed on X-ray imaging. Furthermore, it aids in improving physical functionality diminished due to rheumatoid arthritis. Additionally, it is used to relieve the symptoms and signs of active psoriatic arthritis. It can be used in combination with aspirin, non-steroidal anti-inflammatory drugs, and low-dose corticosteroids, although sufficient studies have not been conducted for combination with some other medications. This medication is effective for the treatment of rheumatoid arthritis and active psoriatic arthritis.

How to take

Adult dose

Loading dose: Administer 100mg 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. Maintenance dose (rheumatoid arthritis): Administer 20mg once daily. When 25mg once 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 once daily. If the patient’s clinical tolerability is poor, the maintenance dose may be reduced to 10mg once daily. Maintenance dose (psoriatic arthritis): Administer 20mg once daily.

Precautions

This medication contains an active metabolite that remains in the body for a long time, so side effects may occur or persist even after stopping the medication. If severe adverse reactions occur, or if rapid removal of the drug from the body is necessary, specific medications should be used to rapidly eliminate the components of this drug. Since it is metabolized in the liver and poses a risk of hepatotoxicity, patients with impaired liver function should be particularly cautious, and liver function tests should be conducted frequently before and during the initial phases of treatment. When used with other hepatotoxic drugs or immunosuppressants, liver function and blood status must be monitored more stringently. Patients with a history of lung disease or at high risk for pneumonia should consult a specialist before administration and monitor for respiratory symptoms throughout treatment. Because it can suppress immune function, it is not recommended for use in patients with severe infections or immunodeficiency states. Severe allergic skin reactions, ulcers, and wound healing disorders may occur, so if skin abnormalities appear, treatment should be discontinued immediately and a doctor consulted. This medication can pose severe risks to the fetus, so women who are pregnant or may become pregnant should not use it, and men planning to conceive should discontinue use and follow appropriate procedures. Safety and efficacy in children have not been confirmed, so it is advisable not to use it in children. In cases of overdose, symptoms such as diarrhea, abdominal pain, and blood abnormalities may occur, and drug removal treatment may be necessary. Store this medication away from direct sunlight and at appropriate temperatures. There may be drug interactions, so if taking other medications, be sure to consult a physician or pharmacist. Regular blood tests and liver function tests should be conducted during treatment, and any abnormal symptoms should be reported to medical professionals immediately.

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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  • lower back pain
  • hypertension
  • chest pain
  • loss of appetite
  • indigestion
  • gastroenteritis
  • abnormal liver enzyme levels
  • nausea
  • stomach pain
  • oral ulcer
  • vomiting
  • hypokalemia
  • weight loss
  • joint pain
  • muscle cramps
  • joint disorders
  • synovitis
  • tendonitis
  • dizziness
  • headache
  • paresthesia
  • bronchitis
  • increased cough
  • respiratory infection
  • pharyngitis
  • pneumonia
  • rhinitis
  • sinusitis
  • hair loss
  • eczema
  • pruritus
  • skin dryness
  • urinary tract infection
  • cholelithiasis
  • colitis
  • constipation
  • esophagitis
  • bloating
  • gastritis
  • gingivitis
  • hematochezia
  • oral candidiasis
  • salivary gland enlargement
  • stomatitis
  • dental diseases
  • oral mucosal abnormalities
  • elevated liver parameters
  • xerostomia
  • increased blood pressure
  • 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
  • dysgeusia
  • peripheral neuropathy
  • acne
  • contact dermatitis
  • fungal dermatitis
  • hair discoloration
  • hematoma
  • herpes simplex
  • herpes zoster
  • nail disorders
  • 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 infection
  • sepsis
  • asthma
  • dyspnea
  • epistaxis
  • pulmonary disease
  • interstitial lung disease
  • abscess
  • cyst
  • fever
  • hernia
  • fatigue
  • pain
  • cervical pain
  • pelvic pain
  • elevation of creatine phosphokinase
  • peripheral edema
  • hyperglycemia
  • diabetes
  • proteinuria
  • cystitis
  • dysuria
  • hematuria
  • menstrual disorders
  • vaginal candidiasis
  • prostate disease
  • increased urination
  • decreased sperm concentration
  • decreased total sperm count
  • decreased sperm motility
  • arthrosis
  • bursitis
  • myalgia
  • avascular necrosis
  • bone pain
  • tendon rupture
  • hypokalemia
  • hyperlipidemia
  • decreased uric acid
  • hyperthyroidism
  • blurred vision
  • cataract
  • conjunctivitis
  • eye diseases
  • gastrointestinal adverse reactions
  • hepatitis
  • jaundice
  • cholestasis
  • liver failure
  • acute liver necrosis
  • pancreatitis

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

Storage

This medication is light-sensitive, so it should be stored in a dark place, and kept in a tightly sealed container to avoid contact with air. It is advisable to store it at a cool temperature below 25 degrees Celsius.

Appearance and packaging

Appearance

Light yellow triangular 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.