Balsalazide Disodium
Pronunciation: (bal-SAL-a-zide die-SO-dee-um)Class: GI agent
Trade Names:
Colazal
- Capsule 750 mg
Pharmacology
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Reduces inflammation of colon by preventing local production of substances such as arachidonic acid that are involved in inflammatory process.
Pharmacokinetics
Absorption
Very low systemic absorption. T max is approximately 1 to 2 h.
Distribution
At least 99% protein bound.
Metabolism
In the colon, bacterial azoreductases cleave the balsalazide compound to release 5-aminosalicylic acid (5-ASA) (active) and 4-aminobenzoyl-beta-alanine.
Elimination
UrineLess than 1% as parent compound, 5-ASA, or 4-aminobenzoyl-beta-alanine; up to 25% as N-acetylated metabolites.
Feces65% as 5-ASA, 4-aminobenzoyl-beta-alanine, and N-acetylated metabolites; less than 1% as parent compound.
Special Populations
Ulcerative colitisMay have increased AUC.
Indications and Usage
Treatment of mildly to moderately active ulcerative colitis.
Contraindications
Hypersensitivity to salicylates, or any of the components of balsalazide capsules, or balsalazide metabolites.
Dosage and Administration
AdultsPO 2.25 g (eg, three 750 mg capsules) 3 times daily (eg, 6.75 g/day) for 8 wk; some patients may require up to 12 wk of treatment.
General Advice
- Capsules can be opened and contents sprinkled on applesauce. Entire mixture should be swallowed immediately and not stored for future use. If necessary, contents may be chewed.
Storage/Stability
Store at 59° to 86°F.
Drug Interactions
None well documented.
Laboratory Test Interactions
None well documented.
Adverse Reactions
CNS
Headache (8%); fatigue, insomnia (2%); dizziness (1%).
EENT
Pharyngitis, rhinitis (2%).
GI
Abdominal pain (6%); diarrhea, nausea (5%); vomiting (4%); anorexia, dyspepsia, flatulence, rectal bleeding (2%); constipation, dry mouth, frequent stools (1%).
Genitourinary
UTI (1%).
Hepatic
Cholestatic jaundice, cirrhosis, hepatocellular damage (including liver necrosis and liver failure), hepatotoxicity (including elevated ALT, AST, gamma-glutamyl-transferase, LDH), jaundice, Kawasaki-like syndrome that included hepatic function changes (postmarketing).
Musculoskeletal
Arthralgia (4%); back pain (2%); myalgia (1%).
Respiratory
Respiratory infection (4%); coughing (2%); sinusitis (1%).
Miscellaneous
Fever, pain (2%); cramps, flu-like disorder (1%).
Precautions
MonitorAssess patient's colitis symptoms, including the following: rectal bleeding, stool frequency and character, abdominal pain, and overall functional status. |
Pregnancy
Category B .
Lactation
Undetermined.
Children
Safety and efficacy not established.
Renal Function
Use with caution in patients with known renal function impairment or history of renal disease.
Colitis exacerbation
Some patients may develop exacerbation of colitis symptoms.
Pyloric Stenosis
Patients with pyloric stenosis may have prolonged gastric retention of capsules.
Overdosage
Symptoms
No case of overdose has occurred.
Patient Information
- Advise patient that capsules can be opened and contents sprinkled on applesauce. Entire mixture should be swallowed immediately and not stored for future use. If necessary, contents may be chewed.
- Advise patient that usual course of therapy is 8 to 12 wk.
- Advise patient to report worsening of colitis symptoms to health care provider.
- Advise patients to inform the health care provider if experiencing adverse reactions such as headache, stomach pain, nausea, or diarrhea.
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Balsalazide Disodium Side Effects
balsalazide - Includes detailed dosage instructions.
Compare Balsalazide Disodium with other medications for the treatment of:
Ulcerative Colitis, Crohn's Disease, Ulcerative Colitis, Active
