Patient Information

SULFASALAZINE
 Azulfidine


DOSING IN  ADULTS

Ulcerative colitis
Initially 1 g 3-4 times/day, 2 g/day maintenance in divided doses; may initiate therapy with 0.5-1 g/day

Since sulfasalazine impairs folate absorption, provide1 mg/day folate supplement.


DOSING IN  RENAL IMPAIRMENT

Administer once daily.


DOSING IN  HEPATIC IMPAIRMENT
 Avoid use


DOSAGE FORMS
 

Tablet: 500 mg
  Azulfidine®, Sulfazine: 500 mg
Tablet, delayed release, enteric coated: 500 mg


SIGNIFICANT
 ADVERSE REACTIONS

Headache (33%)
Photosensitivity
Vomiting
Reversible oligospermia (33%)
Alopecia, anaphylaxis
Aplastic anemia


CONTRAINDICATIONS
 

 Hypersensitivity to sulfasalazine, sulfa drugs, salicylates, or any component of the formulation  such as sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid).; porphyria; GI or GU obstruction; pregnancy (at term)


DRUG INTERACTIONS


Azathioprine, mercaptopurine, sulfasalazine: May increase the risk of myelosuppression (due to TPMT inhibition).
Cyclosporine concentrations may be decreased; monitor levels and renal function
Digoxin's absorption may be decreased
Hypoglycemics: Increased effect of oral hypoglycemics (rare, but severe); monitor blood sugar
Methotrexate-induced bone marrow suppression may be increased
NSAIDs and salicylates: May increase sulfonamide concentrations
PABA (para-aminobenzoic acid - may be found in some vitamin supplements): Interferes with the antibacterial activity of sulfonamides; avoid concurrent use
Sulfinpyrazone: May increase sulfonamide concentrations
Thiazide diuretics: May increase the incidence of thrombocytopenia purpuraUricosuric agents: Actions of these agents are potentiated
Warfarin and other oral anticoagulants: Anticoagulant effect may be increased; decrease dose and monitor INR closely


PREGNANCY RISK FACTOR
 — B/D


LACTATION
 — Enters breast milk/use caution.