HYDROCORTISONE ACETATE- hydrocortisone acetate_suppository

In normal subjects, about 26 percent of hydrocortisone acetate is absorbed when the hydrocortisone acetate suppository is applied to the rectum. Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces. Topical steroids are primarily effective because of their antien dashinflammatory, antien dashpruritic and vasoconstrictive action.

Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, posten dashirradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.

Dosage and Administration
One suppository in the rectum morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to the response of the individual case. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equivalency testing. No representation is made as to generic status or bioequivalency.
Opening Instructions
Avoid excessive handling of the suppository. Separate plastic film at top opening and pull downward. Continue pulling downward to almost the full length of the suppository. Gently remove the suppository from the film pocket. Manufactured by: Manufactured for: I144 0321R0 Revised 03/2021 Figure Figure Figure.

The following local adverse reactions have been reported with hydrocortisone suppositories: Burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergy contact dermatitis, secondary infection. To report suspected adverse reactions, contact Vitruvias Therapeutics at 1en dash844en dash451en dash5944 or FDA @ 1en dash800en dashFDAen dash1088 or www.fda.gov/medwatch.

Hydrocortisone suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.

In laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels. There are no adequate and wellen dashcontrolled studies in pregnant women. Hydrocortisone suppositories should only be used during pregnancy if the potential benefit justifies the risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. It is not known whether this drug is excreted in human milk, and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocortisone suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Carcinogenic
No longen dashterm studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.
Overdosage
If signs and symptoms of systemic overdosage occur, discontinue use.

Vitruvias Therapeutics

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