Hydrocortisone Acetate
Generic: HYDROCORTISONE ACETATE
Basic Information
Manufacturer
Marlex Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
RECTAL
FDA Set ID
e60473f7-fd00-a477-e053-2a95a90ad4dd
Indications & Usage
INDICATIONS AND USAGE Hydrocortisone Acetate Suppositories are indicated for use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.
Adverse Reactions
ADVERSE REACTIONS The following local adverse reactions have been reported with Hydrocortisone Acetate Suppositories: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, and secondary infection.
To report SUSPECTED ADVERSE REACTIONS, contact Marlex Pharmaceuticals at 1-888-582-1953 or drugsafety@marlexpharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
To report SUSPECTED ADVERSE REACTIONS, contact Marlex Pharmaceuticals at 1-888-582-1953 or drugsafety@marlexpharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.