Balsalazide Disodium (3 brand names, 2 dosage forms, 1 route)
Available dosage forms: TABLET, CAPSULE.
Routes of administration: ORAL.
Brand Names
- BALSALAZIDE DISODIUM
- COLAZAL
- GIAZO
Indications and Usage
Balsalazide disodium tablets is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. Limitations of Use: Effectiveness of balsalazide disodium tablets in the treatment of female patients was not demonstrated in clinical trials [seeClinical Trials (14)]. Safety and effectiveness of balsalazide disodium tablets therapy beyond 8 weeks have not been established.
Dosage and Administration
The recommended dosage is 3.3 g (three 1.1 g tablets) orally twice daily with or without food [see Clinical Pharmacology (12.3)] for up to 8 weeks. Drink an adequate amount of fluids [see Warnings and Precautions (5.7)].
Contraindications
Balsalazide disodium tablets is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates or their metabolites, or to any of the components of balsalazide disodium tablets [see Warnings and Precautions (5.3), Description (11)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in labeling: Renal Impairment [ see Warnings and Precautions (5.1)] Mesalamine-Induced Acute Intolerance Syndrome [ seeWarnings and Precautions (5.2)] Hypersensitivity Reactions [seeWarnings and Precautions (5.3)] Hepatic Failure [seeWarnings and Precautions (5.4)] Severe Cutaneous Adverse Reactions [seeWarnings and Precautions (5.5)] Photosensitivity [ seeWarnings and Precautions (5.6)] Nephrolithiasis [seeWarnings and Precautions (5.7)]
Mechanism of Action
Balsalazide is a prodrug of mesalamine (5-aminosalicylic acid, 5-ASA). The mechanism of action of 5-ASA is not fully understood, but appears to be a local anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with ulcerative colitis, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites in the colon.
Overdosage
Balsalazide Disodium is an aminosalicylate, and symptoms of salicylate toxicity include: nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe intoxication with salicylates may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) damage. There is no specific antidote for balsalazide overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent further absorption. Proper medical care should be sought immediately with appropriate supportive care, including the possible use of emesis, cathartics, and activated charcoal to prevent further absorption. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.