|Important Safety Information|
Do not break or use partial Orapred ODT tablets.
Orapred ODT is contraindicated in patients with systemic fungal infections. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered, however, the response to such vaccines cannot be predicted. Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison’s disease. Orapred ODT may cause mood swings. Adverse effects of Orapred ODT include the following: endocrine (including development of cushingoid state, increased requirements for insulin or oral hypoglycemic agents in diabetic patients, manifestations of latent diabetes mellitus); fluid and electrolyte disturbances (including fluid retention, hypertension); gastrointestinal (including peptic ulcer with possible perforation and hemorrhage); increased appetite; and weight gain.
For additional safety information:
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Manufactured for Shionogi Inc. Florham Park, NJ 07932
by CIMA LABS INC., Eden Prairie, MN 55344