• Mild-to-moderately active ulcerative colitis.

Contraindicated in:

• Hypersensitivity to salicylates or other metabolites.

Use Cautiously in:

• Pyloric stenosis (may have prolonged gastric retention of capsules)
• Renal or hepatic impairment
• Atopic dermatitis or atopic eczema (↑ risk of photosensitivity)
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children.

Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), photosensitivity, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.

GI: abdominal pain, diarrhea, HEPATOTOXICITY.

GU: interstitial nephritis, nephrolithiasis, renal impairment.

Misc: acute intolerance syndrome, hypersensitivity reactions.

Drug-Drug:

• May ↑ myelosuppressive effects of mercaptopurine or azathioprine; avoid concurrent use, if possible.
• Concurrent use with NSAIDs may ↑ risk of nephrotoxicity.

(Generic available)

• Capsules: 750 mg;

• PO (Adults): 2.25 g 3 times daily for 8–12 wk.
• PO (Children 5–17 yrs): 2.25 g 3 times daily for up to 8 wk or 750 mg 3 times daily for up to 8 wk.

Colazal, Giazo

• Drug is metabolized in the colon to mesalamine (5-aminosalicylic acid), which is a local anti-inflammatory.

• Reduction in the symptoms of ulcerative colitis.

Therapeutic Classification: gastrointestinal anti-inflammatories

Absorption: Absorption is low and variable; drug is delivered intact to the colon.

Distribution: Mostly delivered intact to the colon; remainder of distribution unknown.

Protein Binding: ≥99%.

Metabolism/Excretion: Following delivery to the colon, bacteria break balsalazide down into mesalamine (5-aminosalicylic acid) and an inactive metabolite; mostly excreted in feces.

Half-life: Mesalamine: 12 hr (range 2–15 hr).

(decreased symptoms)

• Instruct patient to take balsalazide as directed, even if feeling better. Take missed doses as soon as remembered unless almost time for next dose.
• Advise patient to drink plenty of fluids during therapy.
• Advise patient to notify health care professional if jaundice, skin rash, difficulty breathing, or hives occur.
• Advise patient to avoid sun exposure and wear protective clothing and sunscreen to prevent photosensitivity reactions.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Monitor breastfed infants for diarrhea.
• Instruct patient to notify health care professional if symptoms do not improve after 1–2 mo of therapy.

bal-SAL-a-zide

NDC Code^*

• 0054- West-Ward Pharmaceuticals Corp.
  • 0054-0079- Balsalazide Disodium
    • 0054-0079-28- 280 CAPSULE in 1 BOTTLE (0054-0079-28)

• 42291- AvKARE, Inc.
  • 42291-157- Balsalazide Disodium
    • 42291-157-28- 280 CAPSULE in 1 BOTTLE (42291-157-28)

• 50268- AvPAK
  • 50268-102- Balsalazide Disodium
    • 50268-102-13- 30 BLISTER PACK in 1 BOX (50268-102-13) > 1 CAPSULE in 1 BLISTER PACK (50268-102-11)

• 60429- GSMS, Incorporated
  • 60429-952- Balsalazide Disodium
    • 60429-952-28- 280 CAPSULE in 1 BOTTLE (60429-952-28)

• 60505- Apotex Corp.
  • 60505-2575- Balsalazide Disodium
    • 60505-2575-0- 10 BLISTER PACK in 1 CARTON (60505-2575-0) > 10 CAPSULE in 1 BLISTER PACK

• 60505- Apotex Corp.
  • 60505-2575- Balsalazide Disodium
    • 60505-2575-3- 30 CAPSULE in 1 BOTTLE (60505-2575-3)

• 60505- Apotex Corp.
  • 60505-2575- Balsalazide Disodium
    • 60505-2575-4- 350 CAPSULE in 1 BOTTLE (60505-2575-4)

• 60505- Apotex Corp.
  • 60505-2575- Balsalazide Disodium
    • 60505-2575-7- 280 CAPSULE in 1 BOTTLE (60505-2575-7)

• 65649- Salix Pharmaceuticals, Inc
  • 65649-101- Colazal
    • 65649-101-02- 280 CAPSULE in 1 BOTTLE (65649-101-02)

• 65649- Salix Pharmaceuticals, Inc
  • 65649-102- GIAZO
    • 65649-102-02- 180 TABLET, FILM COATED in 1 BOTTLE (65649-102-02)

• 68682- Oceanside Pharmaceuticals
  • 68682-750- balsalazide disodium
    • 68682-750-02- 280 CAPSULE in 1 BOTTLE (68682-750-02)