Adult Dosing
Ulcerative colitis (TABS, ETABS)
- Initial therapy: Start 3-4 g/day in equally divided doses with dosage intervals not exceeding 8 hrs; may start 1-2 g/day PO to reduce possible GI intolerance
- Max: 6 g/day
- Maintenance therapy: 2 g/day PO divided q8 hrs
Rheumatoid arthritis (ETABS)
- 2 g/day in 2 evenly divided doses. May start 0.5-1 g/day to reduce GI intolerance
Crohn's Disease [Non-FDA approved]
Note: Administer after meals. Do not crush or chew ETABS; swallow them whole.
Pediatric Dosing
Ulcerative colitis
6 yrs of age
- 40-60 mg/kg/day PO divided q4-8 hrs
- Max: 6 g/day
- Maintenance therapy: 30 mg/kg/day PO divided q6 hrs
Note:
- Safety and effectiveness in pediatric patients <2 yrs of age with ulcerative colitis have not been established
- Administer after meals
Juvenile rheumatoid arthritis (ETABS)
=>6 yrs of age
- 30-50 mg/kg in 2 evenly divided doses
- To decrease the possible GI intolerance, start with 25%-33% of planned maintenance dose and increase q7 days until the maintenance dose is reached at 1 month
- Max: 2 g/day
Crohn's Disease [Non-FDA approved]
Note:
- Safety and effectiveness in pediatric patients <6 yrs of age have not been established
- Administer after meals. Do not crush or chew ETABS
[Outline]
See Supplemental Patient Information
- Deaths from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and hepatic damage, irreversible neuromuscular and CNS changes, and fibrosing alveolitis have been reported in some cases treated with sulfasalazine
- Periodically perform CBC and urinalysis with careful microscopic examination in patients on sulfasalazine therapy. Discontinue treatment while awaiting the results of blood tests
- Oligospermia and infertility have been observed in men treated with sulfasalazine; these effects appear to be reversible upon withdrawal of the drug
- Serious infections, including fatal sepsis and pneumonia, have been reported. Some infections were associated with agranulo cytosis, neutropenia, or myelosuppression. Discontinue therapy if a patient develops a serious infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment
- Maintain adequate fluid intake to prevent crystalluria and stone formation
- Patients with glucose-6-phosphate dehydrogenase deficiency may have clinically significant hemolysis, which is frequently dose related; observe these patients closely for signs of hemolytic anemia
- Perform CBC including differential white cell count and LFTs prior to initiating therapy and every second wk during first 3 months of therapy, then every month during the next 3 months, followed by once every 3 months thereafter, and as clinically indicated
- Serum SP (sulfapyridine) levels may be useful because concentrations above 50 mcg/mL appear to be associated with an increased incidence of adverse reactions
- Isolated instances of delayed-release tablets being passed undisintegrated have been reported; immediately discontinue use of this dose form if such a reaction occurs
- Sulfasalazine may permanently stain soft contact lenses yellow
- May precipitate acute attacks of porphyria
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Dehydration
- Blood dyscrasias
- Bronchial asthma
- Severe allergy
- Pregnancy near-term
- Breastfeeding
Supplemental Patient Information
- Instruct patients to promptly report any sore throat, fever, pallor, purpura, or jaundice as these may indicate a serious blood disorder
- Caution patients that ulcerative colitis rarely remits completely, and that relapse risks can be significantly reduced by continued administration of sulfasalazine at a maintenance dosage
- Advise patients that sulfasalazine may produce an orange-yellow discoloration of the urine or skin
Pregnancy Category:B
Breastfeeding: Sulfasalazine and its active metabolite mesalamine are poorly excreted into breastmilk. However, rather high levels of mesalamine metabolite N-acetyl-5-ASA appear in breast milk and the effects of these metabolites on breastfed infants are unknown. Carefully observe infants for diarrhea; other agents that do not contain a sulfonamide are preferred. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 14 March 2011). Manufacturer advises caution.
Pricing data from www.DrugStore.com in U.S.A.
- Sulfasalazine 500 MG TBEC [Bottle] (GREENSTONE)
100 mg = $37.99
200 mg = $69.97 - Azulfidine 500 MG TABS [Bottle] (PFIZER U.S.)
100 mg = $68.99
300 mg = $190.97 - Azulfidine EN-tabs 500 MG TBEC [Bottle] (PFIZER U.S.)
100 mg = $85.99
300 mg = $247.39 - Sulfasalazine 500 MG TABS [Bottle] (GREENSTONE)
100 mg = $29.99
200 mg = $49.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
