Label: RECTACORT - HC- hydrocortisone acetate suppository
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Contains inactivated NDC Code(s)
NDC Code(s): 68784-108-12, 68784-108-24 - Packager: Acino Products, LLC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated June 19, 2014
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- Official Label (Printer Friendly)
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DESCRIPTION:
HYDROCORTISONE ACETATE, 25 mg
Rectal Suppositories
DESCRIPTION: 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.
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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 AND USAGE:
- CONTRAINDICATIONS:
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PRECAUTIONS:
Do not use hydrocortisone acetate suppositories unless a 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.
Carcinogenesis: No long term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.
Pregnancy Category C: In laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels. There are no adequate and well controlled studies in pregnant women. Hydrocortisone acetate suppositories should only be used during pregnancy if the potential benefit justifies the risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
It is not known whether this drug is excreted in human milk and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocortisone acetate suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
- ADVERSE REACTIONS:
- DRUG ABUSE AND DEPENDENCE:
- OVERDOSAGE:
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DOSAGE AND ADMINISTRATION:
For rectal administration. Detach one suppository from strip of suppositories. Remove the wrapper. Avoid excessive handling of the suppository which is designed to melt at body temperature. Insert suppository into the rectum with gentle pressure, 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.
- HOW SUPPLIED:
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Rectacort-HC Product Label
NDC 68784-108-12
Rectacort - HC
25-mg Suppositories
(Hydrocortisone Acetate in a Hydrogenated Cocoglyceride Base)
Caution: Federal Law prohibits dispensing without prescription.
Place Rx Label Here
Acino Products
12 SUPPOSITORIES
DESCRIPTION: Each suppository contains hydrocortisone acetate 25 mg in a hydrogenated cocoglyceride base.
DIRECTIONS:
1. Detach one suppository from the strip of suppositories.
2. Remove wrapper before inserting into the rectum as follows: Hold suppository upright and carefully separate foil by inserting tip of fingernail at the foil split.
3. Peel slowly and evenly down both sides, exposing suppository.
4. Avoid excessive handling of suppository which is designed to melt at body temperature.
5. Insert one suppository rectally as directed in dosage and administration.
Store below 30°C (86°F). Avoid freezing
DOSAGE AND ADMINISTRATION:
Usual Dosage: One suppository in the rectum morning and night for two weeks, in nonspecific procititis. In more severe cases, one suppository three times daily; or two suppositories twice daily in factitial proctitis, recommended therapy is six to eight weeks or less, according to response. For full prescribing information, see packet insert.
ACINO PRODUCTS Hamilton, NJ 08619
- Rectacort - HC Package Insert
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INGREDIENTS AND APPEARANCE
RECTACORT - HC
hydrocortisone acetate suppositoryProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68784-108 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68784-108-12 12 in 1 BOX 1 1 in 1 BLISTER PACK 2 NDC:68784-108-24 24 in 1 BOX 2 1 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/01/2006 Labeler - Acino Products, LLC. (019385518) Registrant - Acino Products, LLC. (019385518) Establishment Name Address ID/FEI Business Operations Acino Products, LLC. 019385518 manufacture(68784-108)
