sulfasalazine (Rx)Brand and Other Names:Azulfidine, Azulfidine EN

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 500mg

tablet, enteric coated (delayed release)

  • 500mg
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Ulcerative Colitis

Mild to moderate cases, adjunctive therapy in severe cases, and prolongation of remission

3-4 g/day PO divided TID after meals; may start 1-2 g qDay

Rheumatoid Arthritis

Inadequate response or intolerance to salicylates or other NSAIDs

Enteric coated: 2-3 g/day PO divided TID after meals; may start 0.5-1 g qDay

Crohn Disease (Off-label)

3-6 g/day PO divided TID after meals

Administration

Take after meals

Administer in equally divided doses

Dosage Forms & Strengths

tablet

  • 500mg

tablet, enteric coated (delayed release)

  • 500 mg
more...

Ulcerative Colitis

Mild to moderate cases, adjunctive therapy in severe cases, and prolongation of remission

<6 years old: Safety and efficacy not established

6 years or older

  • Initial: 40-60 mg/kg/day PO divided q4-8hr after meals 
  • Maintenance: 30 mg/kg/day PO divided q6hr after meals

Juvenile Rheumatoid Arthritis

Polyarticular course with inadequate response to salicylates or other NSAIDs

<6 years old: Safety and efficacy not established

6 years or older: Gradually titrate at weekly intervals up to 30-50 mg/kg/day PO divided BID after meals; not to exceed 2 g/day 

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Interactions

Interaction Checker

sulfasalazine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Anorexia (~33%)

            Headache (~33%)

            Nausea (~33%)

            Vomiting (~33%)

            Gastric distress (~33%)

            Apparently reversible oligospermia (~33%)

            <1%

            Skin rash

            Pruritus

            Urticaria

            Fever

            Heinz body anemia

            Hemolytic anemia

            Cyanosis

            Postmarketing Reports

            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), 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: Anaphylaxis

            Metabolism and nutrition system disorders: Folate deficiency

            Renal and urinary disorders: Nephrolithiasis

            Respiratory, thoracic and mediastinal disorders: Oropharyngeal pain

            Skin and subcutaneous tissue disorders: Angioedema, purpura

            Vascular disorders: Pallor

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            Warnings

            Contraindications

            Hypersensitivity to sulfasalazine or its metabolites, to sulfonamides, or to salicylates

            Intestinal or urinary tract obstruction

            Porphyria

            Cautions

            Severe allergy or bronchial asthma

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

            Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis

            Severe hypersensitivity reported; may include internal organ involvement, such as hepatitis, nephritis, myocarditis, mononucleosis-like syndrome (ie, pseudomononucleosis), hematological abnormalities (including hematophagic histiocytosis), and/or pneumonitis including eosinophilic infiltration

            Anemia

            Gout

            Hepatic/renal impairment

            Hypochlorhydria

            Hypoprothrombinemia

            Thyrotoxicosis

            Vitamin K deficiency

            Ensure adequate hydration to prevent crystalluria

            May cause orange discoloration of the urine or skin

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            Pregnancy & Lactation

            Pregnancy category: B; D if used for prolonged periods or near term; increased potential for kernicterus in the newborn

            Oral sulfasalazine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation and protection from neural tube defects

            Lactation: Excreted into human breast milk; caution with breastfeeding, some reports of bloody stools or diarrhea in human milk fed infants of mothers taking sulfasalazine

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Sulfasalazine is a prodrug that is metabolized to its active components, sulfapyridine and 5-aminosalicylic acid (5-ASA; mesalamine); beneficial effects are predominantly from the anti-inflammatory properties of 5-ASA, which inhibits leukotriene synthesis and lipoxygenase

            Absorption

            Bioavailability: <15% of parent drug; 60% (sulfapyridine); 10-30% (5-ASA)

            Peak plasma time: 6 hr; 10 hr (sulfapyridine and 5-ASA)

            Peak plasma concentration: 6 mcg/mL

            Distribution

            Protein bound: >99% to albumin; 70% (sulfapyridine)

            Vd: 7.5 L

            Metabolism

            Approximately 90% of sulfasalazine is converted by colon bacteria into its active components, sulfapyridine and mesalamine

            Elimination

            Half-life: 10.4-14.8 hr (sulfapyridine)

            Renal clearance: 37%

            Excretion: Urine (systematically absorbed sulfapyridine and 5-ASA); feces (majority of 5-ASA)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
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            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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