balsalazide

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.

Adv. Reactions/Side Effects ⬆ ⬇

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

Interactions ⬆ ⬇

Drug-drug:

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

Availability ⬆ ⬇

(Generic available)

Capsules: 750 mg

Route/Dosage ⬆ ⬇

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.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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

Therapeutic effects:

Reduction in the symptoms of ulcerative colitis.

Classifications ⬆ ⬇

Therapeutic Classification: gastrointestinal anti-inflammatories

Pharmacokinetics ⬆ ⬇

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).

Time/Action Profile ⬆ ⬇

(decreased symptoms )

ROUTE	ONSET	PEAK	DURATION
PO	unknown	up to 8 wk	unknown

Patient/Family Teaching ⬆ ⬇

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.

Pronunciation ⬆ ⬇

Code ⬆

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)

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Indications ⬇

Contraind./Precautions ⬆ ⬇