Leflunomide - Drug Information

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General Information on Leflunomide

Generic Name : Leflunomide

Pronunciation : le-FLOO-noe-mide

Latest prescription information about Leflunomide. Learn how to pronounce the drug's name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
ICD Code : Y45.4 | Therapeutic Classification : Antirheumatics

Why is Leflunomide Prescribed? (Indications)

This medication is a pyrimidine synthesis inhibitor, prescribed for rheumatoid arthritis. The medication reduces joint damage and enhances physical activity.  It blocks certain enzymes responsible for abnormal tissue development or growth.

When should Leflunomide not to be taken? (Contraindications)

Contraindicated in patients with liver impairment, pregnancy, breast feeding, uncontrolled infection and hypersensitivity.

Pregnancy Category

A B C D X

Category X :

Animal and/or human studies have demonstrated fetal injury and potential risks outweigh the benefits of the drug in pregnancy. These drugs are found to be harmful when taken during pregnancy, and should not be used.

What is the dosage of Leflunomide?

Adult: Oral- Rheumatoid arthritis; Psoriatic arthritis- Loading dose: 100 mg/day for 3 days. Maintenance: 10-20 mg/day.

How should Leflunomide be taken?

It comes as a tablet to take by mouth with or without food.

What are the warnings and precautions for Leflunomide?

Caution should be exercised in patients with history of immune system disorders, infection, cancer, blood disorders, heart, lung, kidney, liver diseases, alcohol abuse, elderly, children, during pregnancy and breastfeeding.
It may cause dizziness, drowsiness, or blurred vision, do not drive a car or operate machinery while taking this medication.
Avoid vaccination, alcohol consumption while taking this medication.
It may affect blood clot events, avoid bruising or injury.
TB test should be done before the treatment.

What are the side effects of Leflunomide?

  Body as a Whole: Pus, cyst, fever, hernia, uneasiness, neck pain and pelvic pain.
  Heart: Chest pain, headache, palpitation, fast heart rate and dilatation/inflammation of blood vessels.
  Gastrointestinal: Gallstone, constipation, flatulence, inflammation of gastrointestinal tract, blood in stool, mouth infection, salivary gland enlargement and tooth disorder.
  Blood: Anemia and skin discoloration.
  Metabolic: Increased sugar/cholesterol/liver enzymes and swelling in the extremities.
  Musculoskeletal: Joint/muscle pain, gangrene, bone pain, joint inflammation, muscle cramps and tendon rupture.
  Central Nervous System: Anxiety, depression, dry mouth, sleeplessness, nerve pain, increased sweating and fainting.
  Respiratory: Asthma, difficulty in breathing, nose bleed and lung disorder.
  Skin: Pimples, inflammation, hair discoloration, blood clot, infection, rash, nail disorders, skin discoloration, skin nodule, subcutaneous nodule, skin ulcer and worsening psoriasis.
  Eye and ENT: Blurred vision, cataract, inflammation of conjunctiva, eye disorder and taste perversion.
  Genitourinary: Inflammation of bladder, painful urination, blood in urine, menstrual disorder, prostate disorder, urinary frequency and vaginal infection.

What are the other precautions for Leflunomide?

Patient may develop with serious liver or lung problem, monitor liver or lung function, complete blood counts during the treatment.

What are the storage conditions of Leflunomide?

Store it at controlled temperature (25C).

♦ Safety Labeling Changes Approved By FDA

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