sul-fa-SAL-a-zeen

• Mild-to-moderate ulcerative colitis or as adjunctive therapy in severe ulcerative colitis.
• Rheumatoid arthritis unresponsive or intolerant to salicylates and/or NSAIDs.

• Locally acting anti-inflammatory action in the colon, where activity is probably a result of inhibition of prostaglandin synthesis.

• Reduction in the symptoms of ulcerative colitis or rheumatoid arthritis.

Absorption: 10–15% absorbed after oral administration.

Distribution: Widely distributed; crosses the placenta and enters breast milk.

Protein Binding: 99%.

Metabolism/Excretion: Split by intestinal bacteria into sulfapyridine and 5-aminosalicylic acid. Some absorbed sulfasalazine is excreted by bile back into intestines; 15% excreted unchanged by the kidneys. Sulfapyridine also excreted mostly by the kidneys.

Half-life: 6 hr.

Contraindicated in:

• Hypersensitivity reactions to sulfonamides, salicylates, or sulfasalazine
• Cross-sensitivity with furosemide, sulfonylurea hypoglycemic agents, or carbonic anhydrase inhibitors may exist
• Glucose-6–phosphate dehydrogenase (G6PD) deficiency (↑ risk of hemolysis)
• Hypersensitivity to bisulfites (mesalamine enema only)
• Urinary tract or intestinal obstruction
• Porphyria.

Use Cautiously in:

• Severe hepatic or renal impairment
• History of porphyria
• Blood dyscrasias
• OB: Neural tube defects have been reported; use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: May compete with bilirubin for binding sites on plasma proteins in the newborn and cause kernicterus; bloody stools or diarrhea reported in breast-fed infants
• Pedi: Children <2 yr (safety not established).

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), EXFOLIATIVE DERMATITIS, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN), rash, photosensitivity, yellow discoloration.

GI: anorexia, diarrhea, nausea, vomiting, drug-induced hepatitis.

GU: crystalluria, infertility, oligospermia, orange-yellow discoloration of urine.

Hemat: AGRANULOCYTOSIS, APLASTIC ANEMIA, blood dyscrasias, eosinophilia, hemolytic anemia, megaloblastic anemia, thrombocytopenia.

Neuro: peripheral neuropathy , headache.

Resp: pneumonitis.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), fever.

Drug-Drug:

• May ↑ action/risk of toxicity from oral hypoglycemic agents, phenytoin, methotrexate, zidovudine, or warfarin.
• ↑risk of drug-induced hepatitis with other hepatotoxic agents.
• ↑risk of crystalluria with methenamine.
• May ↓ metabolism and ↑ effects/toxicity of mercaptopurine or thioguanine.

Drug-Food:

• May ↓ iron and folic acid absorption.

Ulcerative Colitis

• PO (Adults): 1 g every 6–8 hr (may start with 500 mg every 6–12 hr), followed by maintenance dose of 500 mg every 6 hr.
• PO (Children >2 yr): Initial — 6.7–10 mg/kg every 4 hr or 10–15 mg/kg every 6 hr or 13.3–20 mg/kg every 8 hr. Maintenance — 7.5 mg/kg every 6 hr (not to exceed 2 g/day).

Rheumatoid arthritis

• PO (Adults): 500 mg–1 g/day (as delayed-release tablets) for 1 wk, then ↑ by 500 mg/day every wk up to 2 g/day in 2 divided doses; if no benefit seen after 12 wk, ↑ to 3 g/day in 2 divided doses.
• PO (Children 6 yr): 30–50 mg/kg/day in 2 divided doses (as delayed-release tablets); initiate therapy at ¼–1/3 of planned maintenance dose and ↑ every 7 days until maintenance dose is reached (not to exceed 2 g/day).

• Do not confuse sulfasalazine with cefuroxime or sulfadiazine.
  • Varying dosing regimens of sulfasalazine may be used to minimize GI side effects.
• PO: Administer after meals or with food to minimize GI irritation, with a full glass of water. DNC: Swallow enteric-coated tablets whole; do not crush or chew.

Azulfidine, Azulfidine EN-tabs

Salazopyrin

Therapeutic Classification: antirheumatics (DMARD), gastrointestinal anti-inflammatories

(Generic available)

• Tablets: 500 mg;
• Delayed-release (enteric-coated) tablets (Azulfidine EN-tabs): 500 mg;

(blood levels)

• Assess patient for allergy to sulfonamides and salicylates. Therapy should be discontinued if rash, difficulty breathing, swelling of face or lips, or fever occur.
• Monitor intake and output ratios. Fluid intake should be sufficient to maintain a urine output of at least 1200–1500 mL daily to prevent crystalluria and stone formation.
• Assess for rash periodically during therapy. May cause SJS, TEN, and DRESS. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia.
• Ulcerative Colitis: Assess abdominal pain and frequency, quantity, and consistency of stools at the beginning of and during therapy.
• Rheumatoid Arthritis: Assess range of motion and degree of swelling and pain in affected joints before and periodically during therapy.

• Monitor urinalysis, BUN, and serum creatinine before and periodically during therapy. May cause crystalluria and urinary cell calculi formation.
• Monitor CBC with differential and liver function tests before and every 2nd wk during first 3 mo of therapy, monthly during the 2nd 3 mo, and every 3 mo thereafter or as clinically indicated. Discontinue sulfasalazine if blood dyscrasias occur.
• Serum sulfapyridine levels may be monitored; concentrations >50 g/mL may be associated with increased incidence of adverse reactions.
• Higher than recommended doses can interfere with a variety of lab assays that use nicotinamide adenine dinucleotide [NAD(H)] or nicotinamide adenine dinucleotide phosphate (CK-MB, AST/ALT, ammonia, thyroxine, glucose).

• Acute pain (Indications).
• Diarrhea (Indications).

• Instruct patient on the correct method of administration. Advise patient to take medication as directed, even if feeling better. Take missed doses as soon as remembered unless almost time for next dose.
• May cause dizziness. Caution patient to avoid driving or other activities that require alertness until response to medication is known.
• Advise patient to notify health care professional if skin rash, sore throat, fever, mouth sores, unusual bleeding or bruising, wheezing, fever, or hives occur.
• Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
• Inform patient that this medication may cause orange-yellow discoloration of urine and skin, which is not significant. May permanently stain contact lenses yellow.
• Instruct patient to notify health care professional if symptoms worsen or do not improve. If symptoms of acute intolerance (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) occur, discontinue therapy and notify health care professional immediately.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, and to avoid breast feeding during therapy. Monitor newborns for kernicterus if mother taking sulfasalazine; monitor breast-fed infants for bloody stool or diarrhea. Inform male patient that sulfasalazine may cause infertility; usually reversible.
• Instruct patient to notify health care professional if symptoms do not improve after 1–2 mo of therapy.

• Decrease in diarrhea and abdominal pain.
• Return to normal bowel pattern in patients with ulcerative colitis. Effects may be seen within 3–21 days. The usual course of therapy is 3–6 wk.
• Maintenance of remission in patients with ulcerative colitis.
• Decrease in pain and inflammation and increase in mobility in patients with rheumatoid arthritis.

NDC Code^*

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-0101- Azulfidine
    • 0013-0101-01- 100 TABLET in 1 BOTTLE (0013-0101-01)

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-0101- Azulfidine
    • 0013-0101-20- 300 TABLET in 1 BOTTLE (0013-0101-20)

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-0102- Azulfidine EN-tabs
    • 0013-0102-01- 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0013-0102-01)

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-0102- Azulfidine EN-tabs
    • 0013-0102-20- 300 TABLET, DELAYED RELEASE in 1 BOTTLE (0013-0102-20)

• 0591- Actavis Pharma, Inc.
  • 0591-0796- Sulfasalazine
    • 0591-0796-01- 100 TABLET in 1 BOTTLE, PLASTIC (0591-0796-01)

• 0591- Actavis Pharma, Inc.
  • 0591-0796- Sulfasalazine
    • 0591-0796-05- 500 TABLET in 1 BOTTLE, PLASTIC (0591-0796-05)

• 0591- Actavis Pharma, Inc.
  • 0591-0796- Sulfasalazine
    • 0591-0796-10- 1000 TABLET in 1 BOTTLE, PLASTIC (0591-0796-10)

• 33261- Aidarex Pharmaceuticals LLC
  • 33261-756- Sulfasalazine
    • 33261-756-00- 100 TABLET in 1 BOTTLE, PLASTIC (33261-756-00)

• 33261- Aidarex Pharmaceuticals LLC
  • 33261-756- Sulfasalazine
    • 33261-756-95- 125 TABLET in 1 BOTTLE, PLASTIC (33261-756-95)

• 43353- Aphena Pharma Solutions - Tennessee, LLC
  • 43353-495- Sulfasalazine
    • 43353-495-53- 60 TABLET in 1 BOTTLE, PLASTIC (43353-495-53)

• 43353- Aphena Pharma Solutions - Tennessee, LLC
  • 43353-495- Sulfasalazine
    • 43353-495-70- 120 TABLET in 1 BOTTLE, PLASTIC (43353-495-70)

• 43353- Aphena Pharma Solutions - Tennessee, LLC
  • 43353-495- Sulfasalazine
    • 43353-495-80- 180 TABLET in 1 BOTTLE, PLASTIC (43353-495-80)

• 50090- A-S Medication Solutions
  • 50090-0086- Sulfasalazine
    • 50090-0086-3- 30 TABLET in 1 BOTTLE (50090-0086-3)

• 50090- A-S Medication Solutions
  • 50090-2013- Sulfasalazine
    • 50090-2013-3- 30 TABLET in 1 BOTTLE (50090-2013-3)

• 50090- A-S Medication Solutions
  • 50090-2013- Sulfasalazine
    • 50090-2013-4- 90 TABLET in 1 BOTTLE (50090-2013-4)

• 50268- AvPAK
  • 50268-730- Sulfasalazine
    • 50268-730-15- 50 BLISTER PACK in 1 BOX (50268-730-15) > 1 TABLET in 1 BLISTER PACK (50268-730-11)

• 59762- Greenstone LLC
  • 59762-0104- Sulfasalazine
    • 59762-0104-1- 100 TABLET, DELAYED RELEASE in 1 BOTTLE (59762-0104-1)

• 59762- Greenstone LLC
  • 59762-0104- Sulfasalazine
    • 59762-0104-2- 300 TABLET, DELAYED RELEASE in 1 BOTTLE (59762-0104-2)

• 59762- Greenstone LLC
  • 59762-5000- Sulfasalazine
    • 59762-5000-1- 100 TABLET in 1 BOTTLE (59762-5000-1)

• 59762- Greenstone LLC
  • 59762-5000- Sulfasalazine
    • 59762-5000-2- 300 TABLET in 1 BOTTLE (59762-5000-2)

• 63629- Bryant Ranch Prepack
  • 63629-5688- Sulfasalazine
    • 63629-5688-1- 30 TABLET in 1 BOTTLE (63629-5688-1)

• 63629- Bryant Ranch Prepack
  • 63629-5688- Sulfasalazine
    • 63629-5688-2- 60 TABLET in 1 BOTTLE (63629-5688-2)

• 63629- Bryant Ranch Prepack
  • 63629-5688- Sulfasalazine
    • 63629-5688-3- 90 TABLET in 1 BOTTLE (63629-5688-3)

• 63629- Bryant Ranch Prepack
  • 63629-5688- Sulfasalazine
    • 63629-5688-4- 120 TABLET in 1 BOTTLE (63629-5688-4)

• 68071- NuCare Pharmaceuticals,Inc.
  • 68071-4215- Sulfasalazine
    • 68071-4215-1- 100 TABLET in 1 BOTTLE (68071-4215-1)

• 68788- Preferred Pharmaceuticals, Inc
  • 68788-9021- SULFASALAZINE
    • 68788-9021-1- 120 TABLET in 1 BOTTLE, DISPENSING (68788-9021-1)

• 68788- Preferred Pharmaceuticals, Inc
  • 68788-9021- SULFASALAZINE
    • 68788-9021-3- 30 TABLET in 1 BOTTLE, DISPENSING (68788-9021-3)

• 68788- Preferred Pharmaceuticals, Inc
  • 68788-9021- SULFASALAZINE
    • 68788-9021-6- 60 TABLET in 1 BOTTLE, DISPENSING (68788-9021-6)

• 68788- Preferred Pharmaceuticals, Inc
  • 68788-9021- SULFASALAZINE
    • 68788-9021-9- 90 TABLET in 1 BOTTLE, DISPENSING (68788-9021-9)

• 70518- REMEDYREPACK INC.
  • 70518-0185- Sulfasalazine
    • 70518-0185-0- 30 TABLET in 1 BLISTER PACK (70518-0185-0)

• 70518- REMEDYREPACK INC.
  • 70518-1829- Sulfasalazine
    • 70518-1829-0- 270 TABLET in 1 BOTTLE, PLASTIC (70518-1829-0)

• 70518- REMEDYREPACK INC.
  • 70518-2342- Sulfasalazine
    • 70518-2342-0- 270 TABLET in 1 BOTTLE, PLASTIC (70518-2342-0)