Sulfasalazine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]
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Overview
Sulfasalazine is a Sulfonamide that is FDA approved for the treatment of mild to moderate ulcerative colitis, as adjunctive therapy in severe ulcerative colitis, for the prolongation of the remission period between acute attacks of ulcerative colitis, rheumatoid arthritis and for pediatric patients with polyarticular-course juvenile rheumatoid arthritis.. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Ulcerative Colitis
The dosage of AZULFIDINE EN-tabs Tablets should be adjusted to each individual's response and tolerance. Patients should be instructed to take AZULFIDINE EN-tabs in evenly divided doses, preferably after meals, and to swallow the tablets whole.
Initial Therapy
- 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.
- If daily doses exceeding 4 g are required to achieve the desired therapeutic effect, the increased risk of toxicity should be kept in mind.
Maintenance Therapy
- 2 g daily
Rheumatoid Arthritis
- 2 g daily in two evenly divided doses.
- It is advisable to initiate therapy with a lower dosage of AZULFIDINE EN-tabs, e.g., 0.5 to 1.0 g daily, to reduce possible gastrointestinal intolerance.
- Careful monitoring is recommended for doses over 2 g per day.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sulfasalazine in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfasalazine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Ulcerative Colitis
The dosage of AZULFIDINE EN-tabs Tablets should be adjusted to each individual's response and tolerance. Patients should be instructed to take AZULFIDINE EN-tabs in evenly divided doses, preferably after meals, and to swallow the tablets whole.
Initial Therapy
- 40 to 60 mg/kg of body weight in each 24-hour period, divided into 3 to 6 doses.
- Six years of age and older
Maintenance Therapy
- 30 mg/kg of body weight in each 24-hour period, divided into 4 doses.
- Six years of age and older
Juvenile Rheumatoid Arthritis, Polyarticular-Course
- 30 to 50 mg/kg of body weight daily in two evenly divided doses.
- 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.
- Six years of age and older
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sulfasalazine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfasalazine in pediatric patients.
Contraindications
- Hypersensitivity to sulfasalazine, its metabolites, sulfonamides or salicylates.
- Patients with intestinal or urinary obstruction,
- Patients with porphyria, as the sulfonamides have been reported to precipitate an acute attack.
Warnings
- Only after critical appraisal should AZULFIDINE EN-tabs Tablets be given to patients with hepatic or renal damage or blood dyscrasias.
- Deaths associated with the administration of sulfasalazine have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and liver damage, irreversible neuromuscular and central nervous system changes, and fibrosing alveolitis.
- The presence of clinical signs such as sore throat, fever, pallor, purpura or jaundice may be indications of serious blood disorders or hepatotoxicity.
- Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving AZULFIDINE EN-tabs.
- Discontinue treatment with sulfasalazine while awaiting the results of blood tests.
- 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.
- Discontinue AZULFIDINE EN-tabs if a patient develops a serious infection. *Closely monitor patients for the development of signs and symptoms of infection during and after treatment with AZULFIDINE EN-tabs.
- For a patient who develops a new infection during treatment with AZULFIDINE EN-tabs, perform a prompt and complete diagnostic workup for infection and 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.
- Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of sulfasalazine.
- Patients are at highest risk for these events early in therapy, with most events occurring within the first month of treatment.
- Sulfasalazine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
- Severe, life-threatening, systemic hypersensitivity reactions such as drug rash with eosinophilia and systemic symptoms have been reported in patients taking sulfasalazine.
- Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
- If such signs or symptoms are present, the patient should be evaluated immediately.
- Sulfasalazine should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Sulfasalazine Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Sulfasalazine Postmarketing Experience in the drug label.
Drug Interactions
- Reduced absorption of folic acid and digoxin have been reported when those agents were administered concomitantly with sulfasalazine.
- When daily doses of sulfasalazine 2 g and weekly doses of methotrexate 7.5 mg were coadministered to 15 rheumatoid arthritis patients in a drug-drug interaction study, the pharmacokinetic disposition of the drugs was not altered.
- Daily doses of sulfasalazine 2 g (maximum 3 g) and weekly doses of methotrexate 7.5 mg (maximum 15 mg) were administered alone or in combination to 310 rheumatoid arthritis patients in two controlled 52-week clinical studies.
- The overall toxicity profile of the combination revealed an increased incidence of gastrointestinal adverse events, especially nausea, when compared to the incidence associated with either drug administered alone.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Sulfasalazine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sulfasalazine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Sulfasalazine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Sulfasalazine in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Sulfasalazine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Sulfasalazine in geriatric settings.
Gender
There is no FDA guidance on the use of Sulfasalazine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Sulfasalazine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Sulfasalazine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Sulfasalazine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sulfasalazine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Sulfasalazine in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
Monitoring
- Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving AZULFIDINE EN-tabs.
- Closely monitor patients for the development of signs and symptoms of infection during and after treatment with AZULFIDINE EN-tabs.
IV Compatibility
There is limited information regarding the compatibility of Sulfasalazine and IV administrations.
Overdosage
There is limited information regarding Sulfasalazine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Sulfasalazine Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Sulfasalazine Mechanism of Action in the drug label.
Structure
There is limited information regarding Sulfasalazine Structure in the drug label.
Pharmacodynamics
There is limited information regarding Sulfasalazine Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Sulfasalazine Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Sulfasalazine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Sulfasalazine Clinical Studies in the drug label.
How Supplied
There is limited information regarding Sulfasalazine How Supplied in the drug label.
Storage
There is limited information regarding Sulfasalazine Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Sulfasalazine Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Sulfasalazine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Sulfasalazine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Sulfasalazine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.