HYDROCORTISONE ACETATE suppository

HYDROCORTISONE ACETATE by

Drug Labeling and Warnings

HYDROCORTISONE ACETATE by is a Prescription medication manufactured, distributed, or labeled by GRAXCELL PHARMACEUTICAL, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Graxcell Pharmaceutical, llc. Disclaimer: This drug has not been found by FDA to be safe and effective, and this labelling has not been approved by FDA. Hydrocortisone acetae, 25mg. Rectal suppositories.

Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula:

Each rectal suppository contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable oil 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 vasconstrictive action.

INDICATIONS & USAGE

Hydrocortisone acetate suppositories are indicated for the 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 puritus ani.

CONTRAINDICATIONS

Hydrocortisone Acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or 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, the corticosteroid should be discontinued until the infection has been adequately controlled.

Carcinogenic: No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

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 suspected adverse reactions, contact

Graxcell pharmaceutical, llc.

1-888-266-8818 or

FDA @ 1-800-FDA-1088 or

www.fda.gov/medwatch

OVERDOSAGE

If signs and symptoms of systemic overdosage occur, discontinue use.

DOSAGE & ADMINISTRATION

Usual Dosage: 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 in six to eight weeks or less, according to the response of the individual case.

Rx only.

OPENING INSTRUCTIONS

Avoid excessive handling of the suppository. It is designed to melt at body temperature.

1. Separate plastic film at top opening and pull downward.

2. Continue pulling downward to almost the full length of the suppository.

3. Gently remove the suppsitory from the film pocket.

HOW SUPPLIED

Hydrocortisone Acetate suppositories 25mg are white,cyclinder shaped, with one end tapered.

Package of 12 NDC: 70795-2412-1

and

Package of 24 NDC: 70795-2412-2

STORAGE AND HANDLING

Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. Store away from heat. Protect from freezing.

Manufactured for:

Graxcell pharmaceutical, LLC.

130 knickerbocker ave,Bohemia, NY 11716

Manufactured by:

Graxcell pharmaceutical, llc.

136 OAk Drive,

syosset, NY 11791

1-888-266-8818.

DRUG ABUSE AND DEPENDENCE

Drug abuse and dependece have not been reported in patients treated with Hydrocortisone acetate suppositories.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE ACETATE 
hydrocortisone acetate suppository

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70795-2412
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	25 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)

Product Characteristics
Color	yellow (off-white)	Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70795-2412-1	12 in 1 CARTON; Type 0: Not a Combination Product	10/18/2017
2	NDC: 70795-2412-2	24 in 1 CARTON; Type 0: Not a Combination Product	10/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/18/2017

Labeler - GRAXCELL PHARMACEUTICAL, LLC. (056556923)

Registrant - GRAXCELL PHARMACEUTICAL, LLC. (080805631)

Establishment
Name	Address	ID/FEI	Business Operations
GRAXCELL PHARMACEUTICAL, LLC.		056556923	relabel(70795-2412)

Establishment
Name	Address	ID/FEI	Business Operations
GRAXCELL PHARMACEUTICAL, LLC.		080805631	manufacture(70795-2412)