HYDROCORTISONE ACETATE- 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:

Paddock Laboratories, LLC

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:

Hydrocortisone Acetate Suppositories are easy to open, color coded and available in cartons of: Store at controlled room temperature 15°- 30° C (59° - 86° F).

Authorization status:

unapproved drug other

Summary of Product characteristics

HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY
PADDOCK LABORATORIES, LLC
_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 30 MG
DESCRIPTION
Each Hydrocortisone Acetate Suppository for rectal administration
contains 30 mg hydrocortisone
acetate in a hydrogenated cocoglyceride 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 C
H O 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.
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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.
CARCINOGENES IS
No long-term