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| Product NDC Code | 65649-511 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Proctocort |
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| Type | Brand | ||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | RECTAL | ||||||
| Dosage Form | SUPPOSITORY | ||||||
| RxCUI drug identifier | 1291085, 1291092 |
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| Labeler Name | Salix Pharmaceuticals, Inc | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Drug abuse and dependence
Information about whether the drug is a controlled substance, the types of abuse that can occur with the drug, and adverse reactions pertinent to those types of abuse.DRUG ABUSE AND DEPENDENCE Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.
Overdosage of Proctocort
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE If signs and symptoms of systemic overdosage occur, discontinue use.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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 Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Proctocort ® Suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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 30 mg in a specially blended hydrogenated vegetable oil base. Proctocort Structural Formula
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION For rectal administration. Detach one suppository from strip of suppositories. Remove the foil 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Proctocort ® Suppositories are indicated for use in inflamed hemorrhoids, postirradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.
Spl product data elements
Usually a list of ingredients in a drug product.Proctocort HYDROCORTISONE ACETATE HYDROGENATED PALM OIL SILICON DIOXIDE BUTYLATED HYDROXYANISOLE HYDROCORTISONE ACETATE HYDROCORTISONE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL PRINCIPAL DISPLAY PANEL - PROCTOCORT ® 30 mg Carton Label NDC 65649-511-12 Rx only PROCTOCORT ® Hydrocortisone Acetate Rectal Suppositories For rectal use only. Not for oral use. 30 mg 12 Suppositories carton
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Box of 12 suppositories - 30 mg - NDC 65649-511-12 Box of 24 suppositories - 30 mg - NDC 65649-511-24 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store away from heat. PROTECT FROM FREEZING. Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA Proctocort is a trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2024 Salix Pharmaceuticals, Inc. or its affiliates Rev. 07/2024 9521401
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Do not use Proctocort ® Suppositories 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 anti-bacterial agent should be instituted. If a favorable response does not occur promptly, Proctocort ® Suppositories 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. Proctocort ® 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. Nursing Mothers: 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 Proctocort ® 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API