HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE- hydrocortisone acetate and pramoxine hydrochloride suppository

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Hydrocortisone Acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ), Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)

Available from:

Pageview Pharmaceuticals

Administration route:

RECTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Hydrocortisone acetate and pramoxine hydrochloride suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories. If signs and symptoms of systemic overdosage occur, discontinue use.

Product summary:

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 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.

Authorization status:

unapproved drug other

Summary of Product characteristics

HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE- HYDROCORTISONE
ACETATE AND PRAMOXINE HYDROCHLORIDE SUPPOSITORY
PAGEVIEW PHARMACEUTICALS
_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 25 MG AND PRAMOXINE HYDROCHLORIDE 18 MG
SUPPOSITORIES
For Rectal Administration
Rx Only
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.
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.
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.
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.
PRECAUT