Sulfasalazine

What is Sulfasalazine?

• Sulfasalazine (Azulfidine; Azulfidine EN-tabs) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), may be related to the anti-inflammatory and/or immunomodulatory properties.
• Sulfasalazine (Azulfidine) is used to treat ulcerative colitis and also to maintain improvement of ulcerative colitis symptoms.
• Sulfasalazine delayed-release (Azulfidine EN-tabs) is also used to treat rheumatoid arthritis in adults whose disease has not responded well to other medications or could not be tolerated.
• Sulfasalazine delayed-release (Azulfidine EN-tabs) is also used to treat polyarticular juvenile idiopathic arthritis (PJIA) in children who have not been helped by other medications.

Sulfasalazine

Sulfasalazine

What are the uses of this medicine?

Sulfasalazine (Azulfidine) is indicated:

• in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
• for the prolongation of the remission period between acute attacks of ulcerative colitis.

Sulfasalazine delayed-release (Azulfidine EN-tabs)tablets are indicated:

• in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis
• for the prolongation of the remission period between acute attacks of ulcerative colitis
• in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); and
• in the treatment of pediatric patients with polyarticular juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.

How does this medicine work?

• The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), may be related to the anti-inflammatory and/or immunomodulatory properties.
• Sulfasalazine is a modified sulfonamide composed of sulfapyridine that is covalently linked to 5-aminosalacyclic acid (5-ASA).
• Sulfasalazine is poorly absorbed, but its azo bond is broken by bacteria in the bowel lumen releasing sulfapyridine that is absorbed and 5-ASA, which reaches high levels and acts locally decreasing inflammation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• intestinal or urinary obstruction
• porphyria
• hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• digoxin (Lanoxin), folic acid, and methotrexate (Trexall, Xatmep)

Is this medicine FDA approved?

• Sulfasalazine was approved for clinical use in the United States in 1950 and is still commonly used.

How should this medicine be used?

Recommended dosage:

Ulcerative Colitis: Initial Therapy:

• Adults:
• 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours.
• It may be advisable to initiate therapy with a lower dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance.

• Children, six years of age and older:
• 40 to 60 mg/kg of body weight in each 24-hour period, divided into 3 to 6 doses.

Maintenance Therapy:

• Adults:
• 2 g daily.

• Children, six years of age and older:
• 30 mg/kg of body weight in each 24-hour period, divided into 4 doses.

Adult Rheumatoid Arthritis:

• 2 g daily in two evenly divided doses.
• It is advisable to initiate therapy with a lower dosage of sulfasalazine delayed release tablets, e.g., 0.5 to 1.0 g daily, to reduce possible gastrointestinal intolerance.

Juvenile Rheumatoid Arthritis - polyarticular course Children, six years of age and older:

• 30 to 50 mg/kg of body weight daily in two evenly divided doses.
• Typically, the maximum dose is 2 g per day.
• To reduce possible gastrointestinal intolerance, begin with a quarter to a third of the planned maintenance dose and increase weekly until reaching the maintenance dose at one month.

Administration: Sulfasalazine comes as regular and delayed-release tablets. It usually is taken 3 to 6 times a day in evenly spaced doses throughout the day so that no more than 8 hours separates any two doses, if possible. For treatment of rheumatoid arthritis or polyarticular juvenile idiopathic arthritis, sulfasalazine delayed-release tablets are usually taken twice a day in evenly spaced doses throughout the day. Take sulfasalazine after a meal or with a light snack, then drink a full glass of water. Swallow delayed-release tablets whole; do not crush or chew them. Drink plenty of fluids while taking sulfasalazine.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets contain sulfasalazine, 500 mg, for oral administration.
• Sulfasalazine delayed release tablets contain sulfasalazine, formulated in a delayed release tablet (enteric-coated), 500 mg, for oral administration.

This medicine is available in fallowing brand namesː

• Azulfidine; Azulfidine EN-tabs

What side effects can this medication cause?

The most common side effects of this medicine include: In ulcerative colitis:

• anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia.
• Less frequent adverse reactions are pruritus, urticaria, rash, fever, Heinz body anemia, hemolytic anemia, and cyanosis.

In adult rheumatoid arthritis:

• nausea, dyspepsia, rash, headache, abdominal pain, vomiting, fever, dizziness, stomatitis, pruritis, abnormal liver function tests, leukopenia, and thrombocytopenia.

In juvenile rheumatoid arthritis:

• Similar to those seen in patients with adult rheumatoid arthritis except for a high frequency of serum sickness-like syndrome.

What special precautions should I follow?

• Oligospermia and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects.
• Serious infections, including fatal sepsis and pneumonia, have been reported. Some infections were associated with agranulocytosis, neutropenia, or myelosuppression. Caution should be exercised when considering the use of sulfasalazine in patients with a history of recurring or chronic infections or with underlying conditions or concomitant drugs which may predispose patients to infections.
• Severe hypersensitivity reactions may include internal organ involvement, such as hepatitis, nephritis, myocarditis, mononucleosis-like syndrome (i.e., pseudomononucleosis), hematological abnormalities (including hematophagic histiocytosis), and/or pneumonitis including eosinophilic infiltration.
• Severe, life-threatening, systemic hypersensitivity reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients taking sulfasalazine. Discontinue sulfasalazine delayed release tablets if an alternative etiology for the signs or symptoms cannot be established.
• Other severe cutaneous adverse reactions, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of sulfasalazine. Discontinue sulfasalazine delayed release tablets at the first appearance of signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
• Sulfasalazine delayed release tablets should be given with caution to patients with severe allergy or bronchial asthma. If toxic or hypersensitivity reactions occur, sulfasalazine delayed release tablets should be discontinued immediately.
• Patients should be informed of the possibility of adverse effects and of the need for careful medical supervision. The occurrence of sore throat, fever, pallor, purpura, or jaundice may indicate a serious blood disorder. Should any of these occur, the patient should seek medical advice.
• Patients should be instructed to take sulfasalazine delayed release tablets in evenly divided doses, preferably after meals, and to swallow the tablets whole. Additionally, patients should be advised that sulfasalazine may produce an orange-yellow discoloration of the urine or skin.
• Plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Sulfasalazine may make your skin sensitive to sunlight.
• Sulfasalazine is a rare, but well known cause of idiosyncratic liver injury.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• nausea, vomiting, gastric distress, and abdominal pains
• In more advanced cases, central nervous system symptoms such as drowsiness, convulsions, etc., may be observed.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Gastric lavage or emesis plus catharsis as indicated.
• Alkalinize urine.
• If kidney function is normal, force fluids.
• If anuria is present, restrict fluids and salt, and treat appropriately.
• Catheterization of the ureters may be indicated for complete renal blockage by crystals.
• The low molecular weight of sulfasalazine and its metabolites may facilitate their removal by dialysis.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of sulfasalazine in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• SULFASALAZINE

Inactive ingredients:

• MAGNESIUM STEARATE
• POVIDONE, UNSPECIFIED
• SILICON DIOXIDE
• STARCH, CORN

Who manufactures and distributes this medicine?

Azulfidine:

• PFIZER LABORATORIES DIV PFIZER INC.

sulfasalazine delayed release tablets:

• GREENSTONE® BRAND

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).

• Dailymed label info on Sulfasalazine
• FDA Sulfasalazine

Sulfasalazine Resources
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• Sulfasalazine
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• Sulfisoxazole