Sulfasalazine (Azulfidine EN)

Generic Name: Sulfasalazine

Sulfasalazine is used to treat a certain type of bowel disease called ulcerative colitis. This medication does not cure this condition, but it helps decrease symptoms such as fever, stomach pain, diarrhea, and rectal bleeding. After an attack is treated, sulfasalazine is also used to increase the amount of time between attacks. Sulfasalazine works by reducing irritation and swelling in the large intestines. In addition, delayed-release tablets of sulfasalazine are used to treat rheumatoid arthritis. Sulfasalazine helps to reduce joint pain, swelling, and stiffness. Early treatment of rheumatoid arthritis with sulfasalazine helps to reduce/prevent further joint damage so you can do more of your normal daily activities. This medication is used with other drugs, rest, and physical therapy in patients who have not responded to other medications (salicylates, nonsteroidal anti-inflammatory drugs-NSAIDs).

Sulfasalazine may also be used to treat another type of bowel disease called Crohn's disease.

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The mechanism of action is not clear, but it appears that sulfasalazine and its metabolites have immunosuppressive, antibacterial, and anti-inflammatory effects. It also appears to inhibit the cystine-glutamate antiporter.

lfasalazine is used in the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn's disease. It is also indicated for use in rheumatoid arthritis and used in other types of inflammatory arthritis (e.g. psoriatic arthritis and reactive arthritis).

It is usually not given to children under 2 years of age.

Common side effects of sulfasalazine include:
  • Loss of appetite
  • Headache
  • Nausea
  • Vomiting
  • Gastric distress/stomach upset
  • Temporary, reversible male infertility
  • Diarrhea
  • Ringing in your ears (tinnitus)
  • Dizziness
  • Spinning sensation (vertigo)
  • Unusual tiredness
  • White patches or sores inside your mouth or on your lips
  • Sleep problems (insomnia)

Less common side effects of sulfasalazine include:

  • Skin rash
  • Itching
  • Hives
  • Fever
  • Heinz body anemia
  • Hemolytic anemia
  • Cyanosis

Serious side effects of sulfasalazine include:

  • Sun sensitivity
  • Hearing changes
  • Mental/mood changes
  • Painful urination
  • Blood in the urine
  • Changes in the amount of urine
  • New lump or growth in the neck (goiter)
  • Numbness or tingling of the hands or feet
  • Signs of low blood sugar (e.g., hunger, cold sweat, blurred vision, weakness, fast heartbeat)
  • Swollen glands

Postmarketing side effects of sulfasalazine reported include:

  • Blood dyscrasias: Pseudomononucleosis
  • Cardiac disorders: Myocarditis
  • Hepatobiliary disorders: reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), yellowing skin and eyes (jaundice), cholestatic jaundice, cirrhosis, hepatitis cholestatic, cholestasis and possible hepatocellular damage including liver necrosis and liver failure; some of these cases were fatal; 1 case of Kawasaki-like syndrome
  • Immune system disorders: Severe allergic reaction (anaphylaxis)
  • Metabolism and nutrition system disorders: Folate deficiency
  • Renal and urinary disorders: Nephrolithiasis
  • Respiratory, thoracic and mediastinal disorders: Mouth and throat pain
  • Skin and subcutaneous tissue disorders: Angioedema, red or purple spots on the skin (purpura)
  • Vascular disorders: Pale skin (pallor)

Adult and Pediatric Dosage Forms and Strengths

Tablet

  • 500 mg

Tablet, enteric coated (delayed release)

  • 500 mg

Dosage Considerations – Should be Given as Follows:

Ulcerative Colitis

  • Mild to moderate cases, adjunctive therapy in severe cases, and prolongation of remission
  • Adult: 3-4 g/day orally divided three times daily after meals; may start 1-2 g once/day
  • Children under 6 years old: Safety and efficacy not established
  • Children 6 years or older
    • Initial: 40-60 mg/kg/day orally divided every 4-8 hours after meals
    • Maintenance: 30 mg/kg/day orally divided every 6 hours after meals

Rheumatoid Arthritis

  • Inadequate response or intolerance to salicylates or other nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Enteric coated: 2-3 g/day orally divided three times daily after meals; may start 0.5-1 g once/day

Juvenile Rheumatoid Arthritis

  • Polyarticular course with inadequate response to salicylates or other nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Children under 6 years old: Safety and efficacy not established
  • Children 6 years or older: Gradually titrate at weekly intervals up to 30-50 mg/kg/day orally divided twice daily after meals; not to exceed 2 g/day

Crohn's Disease (Off-label)

  • 3-6 g/day orally divided three times daily after meals

Administration

  • Take after meals
  • Administer in equally divided doses

If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first.

Sulfasalazine has no known severe interactions with other drugs.

Serious interactions of sulfasalazine include:

  • ketorolac
  • ketorolac intranasal
  • measles, mumps, rubella and varicella vaccine, live
  • methotrexate
  • pemetrexed
  • varicella virus vaccine live

Sulfasalazine has moderate interactions with at least 215 different drugs.

Sulfasalazine has mild interactions with at least 124 different drugs.

Severe allergy or bronchial asthma.

Blood dyscrasias; serious infections reported, including fatal sepsis and pneumonia; some infections were associated with agranulocytosis, neutropenia, or myelosuppression.

This medication contains sulfasalazine. Do not take Azulfidine or Azulfidine EN if you are allergic to sulfasalazine or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

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