Rectacort - Hc
Product Images NDC 68784-108

This is a medication information for Rectacort-HC, a hydrocortisone acetate suppository for rectal use. The package contains 12 suppositories and it should be stored below 60 degrees Fahrenheit. The directions suggest removing the wrapper before inserting the suppository into the rectum for relief of discomfort caused by inflammation or allergy. The usual dosage is one suppository inserted into the rectum once or twice a day, as recommended by a healthcare provider. There is a caution related to federal law that prohibits dispensing without a prescription. The remaining text appears to be inaccurate and not available for a useful description.*

Hydrocortisone Acetate suppositories are designed to be used in the treatment of various inflammatory conditions of the anorectum and pruritus ani, as well as inflamed hemorrhoids, post-irradiation (factitial) proctitis, chronic ulcerative colitis, and cryptitis. Each rectal suppository contains hydrocortisone acetate, USP 25 mg in specially blended hydrogenated vegetable oil base. The clinical pharmacology of the drug suggests that about 26% of hydrocortisone acetate is absorbed when the suppository is applied to the rectum. Absorption may vary across abraded or inflamed surfaces. The product is contraindicated in patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. Adequate proctologic examination is advised before using hydrocortisone acetate suppositories. If irritation develops, the product should be discontinued, and proper therapy should be instituted. The carcinogenic potential of corticosteroid suppositories has not been evaluated through long term studies in animals.*

Hydrocortisone acetate suppositories are pregnancy category C drugs that should only be used if the benefits outweigh the risk to the fetus, as laboratory animals have shown an increase in fetal abnormalities with exposure. They are not recommended for use on pregnant patients for long periods of time or in large amounts. It is not known whether the drug is excreted in human milk, and the potential for serious adverse reactions in nursing infants means that a decision should be made whether to stop nursing or discontinue the drug, accounting for the importance of the drug to the mother. Local adverse reactions have been reported, along with possible systemic overdosage signs and symptoms. The administration of Hydrocortisone acetate suppositories involves inserting one pointed end first into the rectum twice daily, one suppository for two weeks, or more if required, under medical supervision. The suppositories come in off-white, smooth surfaced, and rod-shaped, and are packaged in a box of 12, 24, 50, or 100 suppositories. They can be stored between 15°-30°C (59°-86°F), with protection from freezing, and dispensing without prescription is prohibited by Federal law.*