Label: HYDROCORTISONE ACETATE suppository
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Contains inactivated NDC Code(s)
NDC Code(s): 70795-2412-1, 70795-2412-2 - Packager: GRAXCELL PHARMACEUTICAL, LLC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated December 21, 2021
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- 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.
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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
- CONTRAINDICATIONS
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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, 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.
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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
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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
- STORAGE AND HANDLING
- DRUG ABUSE AND DEPENDENCE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE ACETATE
hydrocortisone acetate suppositoryProduct 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)
