HYDROCORTISONE ACETATE suppository

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Marlex Pharmaceuticals, Inc.

Administration route:

RECTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Hydrocortisone Acetate Suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components. Drug abuse and dependence have not been reported in patients treated with Hydrocortisone Acetate Suppositories.

Product summary:

25mg (12 count) NDC 10135-0751-12 25mg (24 count) NDC 10135-0751-24 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store away from heat. Protect from freezing. Manufactured for/ Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 07/22 ID

Authorization status:

unapproved drug other

Summary of Product characteristics

HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY
MARLEX PHARMACEUTICALS, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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HYDROCORTISONE ACETATE SUPPOSITORIES
RX ONLY
DESCRIPTION
Each Hydrocortisone Acetate Suppository for rectal administration
contains
hydrocortisone acetate USP in a hydrogenated palm kernel oil base.
Hydrocortisone acetate is a corticosteroid. The molecular weight of
hydrocortisone
acetate is 404.50. Chemically, hydrocortisone acetate is
pregn-4-ene-3, 20 dione, 21-
(acetyloxy)-11, 17-dihydroxy-, (11β)- with an empirical formula of
C23 H32O6 and the
following structural formula:
CLINICAL PHARMACOLOGY
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
anti-inflammatory, antipruritic
and vasoconstrictive action.
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.
CONTRAINDICATIONS
Hydrocortisone Acetate Suppositories are contraindicated in those
patients with a
history of hypersensitivity to any of the components.
PRECAUTIONS
Do not use unless adequate proctologic examination is made.
If irritation develops, the product should be discontinued, and
appropriate therapy
instituted.
In the presence of an infection, the use of an appropriate antifungal
or antibacterial
agent should be instituted. If a favorable response does not occur
promptly,
Hydrocortisone Acetate Suppositories should be discontinued until the
infection has
been adequately controlled.
CARCINOGENESIS
No long-te