Giazo Tablets
Name: Giazo Tablets
Indications and Usage for Giazo Tablets
GIAZO 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 GIAZO in the treatment of female patients was not demonstrated in clinical trials [see Clinical Trials (14.1)]. • Safety and effectiveness of GIAZO therapy beyond 8 weeks have not been established.Giazo Tablets Dosage and Administration
The dose is three 1.1 g Giazo Tablets to be taken 2 times a day with or without food (6.6 g per day) for up to 8 weeks.
Dosage Forms and Strengths
GIAZO is available as yellow, oval, film-coated tablets containing 1.1 g balsalazide disodium, with BZT debossed on one side of the tablet.
Drug Interactions
Based on in vitro studies, balsalazide and its metabolites [5‑aminosalicylic acid (5-ASA), N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), 4‑aminobenzoyl-ß-alanine (4-ABA), and N-acetyl-4-aminobenzoyl-ß-alanine (N‑Ac‑4‑ABA)] are not expected to inhibit the metabolism of other drugs that are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5.
Overdosage
No case of overdose has been reported with GIAZO. GIAZO is an aminosalicylate, and symptoms of salicylate toxicity include: hematemesis, tachypnea, hyperpnea, tinnitus, deafness, lethargy, seizures, confusion, or dyspnea. Severe intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) involvement. There is no specific antidote for balsalazide overdose. 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.
References
1. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mild to moderately active ulcerative colitis: a randomized study. N Engl J Med. 1987;317:1625-9.