Adult Dosing

Ulcerative Colitis

balsalazide (generic), Colazal

• 2.25 gm PO tid x 8-12 wks
• Max: 6.75 g/day x 12 wks

Giazo

• 3.3 g PO bid x up to 8 wks
• Max: 6.6 g/day x 8 wks

Pediatric Dosing

Ulcerative Colitis

balsalazide (generic), Colazal

• 5-17 yrs: 2.25 g PO tid X 8 wks; alt: 750 mg PO tid x 8 wks
• Max: 6.75 g/day, 8 wks

Giazo

• Safety and efficacy for pediatric dosing has not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of mild to moderately active ulcerative colitis

• Hypersensitivity to salicylates or any components of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined; caution advised

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Exacerbation of the symptoms of ulcerative colitis has occurred in patients. Observe patients closely for worsening of these symptoms while on treatment
• Prolonged gastric retention of balsalazide capsules have occurred in patients with pyloric stenosis

Cautions: Use cautiously in

• Renal dysfunction
• History of renal disease

Supplemental Patient Information

• Advise patient to consult physician if diagnosed with pyloric stenosis and renal dysfunction

Pregnancy Category:B

Breastfeeding: Safety unknown; no published data. Balsalazide is metabolized to active drug mesalamine; A few cases of diarrhea have been reported in infants exposed to mesalamine. If breastfeeding is continued during therapy; monitor the infants for diarrhea. This information is based upon data from LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 03 February 2011).

• CNS: Headache, fatigue, insomnia
• GI: Ulcerative colitis exacerbation, abdominal pain, diarrhea, nausea, vomiting, rectal bleeding, flatulence, dyspepsia, anorexia, dry Mouth, constipation
• GU: Urinary tract infection
• HEMA: Anemia
• EENT: Rhinitis, pharyngitis
• RESP: Respiratory infection, coughing
• MUSC: Arthralgia, myalgia, cramps, back pain
• MISC: Fever, flu-like disorder

• Gastrointestinal agent; Exact mechanism of action of is unknown; 5-ASA reduces inflammation by blocking production of arachidonic acid metabolites in the colon through cyclooxygenase and lipoxygenase pathways
• Excretion: feces; urine (<1% unchanged) balsalazide is broken down into mesalamine (5-aminosalicylic acid) and an inactive metabolite
• Half-life: Unknown

US Trade Name(s)

• Colazal
• Giazo

US Availability

balsalazide (generic)

• CAPS: 750 mg

Colazal

• CAPS: 750 mg

Giazo

• TABS: 1.1 g

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Colazide

UK Availability

Colazide

• CAPS: 750 mg

Australian Trade Name(s)

• Colazide

Australian Availability

Colazide

• CAPS: 750 mg

[Outline]

Gastrointestinal

5-aminosalicylates (GI)

Pricing data from www.DrugStore.com in U.S.A.

• Colazal 750 MG CAPS [Bottle] (SALIX PHARMACEUTICALS)
  INC. mg = $280
  mg = $560

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.

Drug Name: Balsalazide disodium 750 MG Oral Capsule

Ingredient(s): Balsalazide

Imprint: 54;795

Color(s): Orange

Shape: Capsule

Size (mm): 1.00

Score: 1

Inactive Ingredient(s): ammonia / silicon dioxide / fd&c blue no. 1 / fd&c red no. 40 / fd&c yellow no. 6 / gelatin / ferrosoferric oxide / isopropyl alcohol / magnesium stearate / butyl alcohol / propylene glycol / shellac / titanium dioxide

Drug Label Author:
Roxane Laboratories, Inc

DEA Schedule:
Non-Scheduled

Drug Name: Colazal 750 MG Oral Capsule

Ingredient(s): Balsalazide

Imprint: CZ

Color(s): White

Shape: Capsule

Size (mm): 23.00

Score: 1

Inactive Ingredient(s): colloidal silicon dioxide / magnesium stearate

Drug Label Author:
Salix Pharmaceuticals, Inc.

DEA Schedule:
Non-Scheduled