Product Description.:
APO, B750
capsule , white , oblong oblong
OpaqueRed ink
Balsalazide disodium is a stable, odorless orange to yellow microcrystalline powder. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents.
Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. The sodium content of each capsule is approximately 86 mg.
INDICATIONS AND USAGE
COLAZAL is indicated for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of COLAZAL beyond 12 weeks has not been established.
CONTRAINDICATIONS
COLAZAL is contraindicated in patients with hypersensitivity to salicylates or to any of the components of COLAZAL capsules or balsalazide metabolites.
PRECAUTIONS
Of the 259 patients treated with COLAZAL 6.75 grams/day in controlled clinical trials of active disease, exacerbation of the symptoms of colitis, possibly related to drug use, has been reported by 3 patients.
General
Patients with pyloric stenosis may have prolonged gastric retention of COLAZAL capsules.
Drug Interactions
No drug interaction studies have been conducted for COLAZAL, however, the use of orally administered antibiotics could, theoretically, interfere with the release of mesalamine in the colon.