^Description
Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene 3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy–(11b) with the following structural formula:
Pramoxine Hydrochloride is a topical anesthetic agent designed chemically as 4-(3-(butoxyphenoxy)propyl)morpholine hydrochoride with the following structural formula:
Each suppository for rectal administration contains hydrocortisone acetate, USP 25 mg and pramoxine hydrochloride, USP 18 mg in a specially blended hydrogenated vegetable base.
^Overdosage
If signs and symptoms of systemic overdosage occur, discontinue use.
^Dosage And Administration
FOR RECTAL ADMINISTRATION. Detach one suppository from strip of suppositories.
Hold suppository upright and carefully separate tabs at top opening and pull downward from the pointed end to expose the suppository. Remove the suppository from the pocket. Avoid excessive handling of suppository which is designed to melt at body temperature. Insert one suppository rectally, pointed end first. Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.
^Principal Display Panel - Suppository Blister Pack Box
NDC 73028-401-12
PAGEVIEWPHARMACEUTICALS
Hydrocortisone Acetate 25 mgPramoxine Hydrochloride 18 mgSuppositories
FOR RECTAL USE ONLY
MADE INUSA
12 SuppositoriesUnit Dose
Rx Only
^Drug Abuse And Dependence
Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.
^How Supplied
Hydrocortisone acetate 25mg and Pramoxine Hydrochloride 18 mg Suppositories are off-white, smooth surfaced and bullet shaped with one pointed end.
Box of 12 suppositories, NDC 73028-401-12
^Indications And Usage
Hydrocortisone acetate and pramoxine hydrochloride suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.
^Adverse Reactions
The following local adverse reactions have been reported with hydrocortisone acetate suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.
To report an adverse event, please contact Pageview Pharmaceuticals, LLC at 1-636-399-9417.
^Carcinogenesis
No long term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.
^Contraindications
Hydrocortisone acetate and pramoxine hydrochloride suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.
^Storage
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°-30°C (59°-86°F). Store away from heat. Protect from freezing. Avoid contact with eyes.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
PHARMACIST: This product is not an Orange Book rated product, therefore all prescriptions using this product shall be subject to state and federal statutes as applicable. This product has not been subjected to FDA therapeutic or other equivalency testing. There are no claims of bioequivalence or therapeutic equivalence. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information contained within the enclosed prescribing information.
^Clinical Pharmacology
In normal subjects, about 26% of hydrocortisone acetate is absorbed when the 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, anti-pruritic and vasoconstrictive action.
Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.
^Precautions
Do not use hydrocortisone acetate and pramoxine hydrochloride suppositories 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 should be discontinued until the infection has been adequately controlled.