The following Structured Product Label (SPL) was submitted to the FDA by Graxcell Pharmaceutical, Llc. for the product Hydrocortisone Acetate (NDC 70795-2412). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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., clinical pharmacology, indications & usage, contraindications, precautions, adverse reactions, overdosage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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.
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.
Hydrocortisone Acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components
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.
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
If signs and symptoms of systemic overdosage occur, discontinue use.
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.
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
Store at 20°-25°C (68°-77°F) [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 dependece have not been reported in patients treated with Hydrocortisone acetate suppositories.
* Please review the disclaimer below.
