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NDC 16477-0201-24 Hemmorex-HC 25 mg/1 Details
Hemmorex-HC 25 mg/1
Hemmorex-HC is a RECTAL SUPPOSITORY in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Laser Pharmaceuticals, LLC. The primary component is HYDROCORTISONE ACETATE.
MedlinePlus Drug Summary
Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum). It is also used to relieve itching and swelling from hemorrhoids and other rectal problems. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Related Packages: 16477-0201-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Rectal
Product Information
| NDC | 16477-0201 |
|---|---|
| Product ID | 16477-201_c74432dc-6d37-98c0-e053-2995a90a8b99 |
| Associated GPIs | 89100010105230 |
| GCN Sequence Number | 006858 |
| GCN Sequence Number Description | hydrocortisone acetate SUPP.RECT 25 MG RECTAL |
| HIC3 | Q3A |
| HIC3 Description | RECTAL PREPARATIONS |
| GCN | 27941 |
| HICL Sequence Number | 002863 |
| HICL Sequence Number Description | HYDROCORTISONE ACETATE |
| Brand/Generic | Generic |
| Proprietary Name | Hemmorex-HC |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | hydrocortisone acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUPPOSITORY |
| Route | RECTAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | HYDROCORTISONE ACETATE |
| Labeler Name | Laser Pharmaceuticals, LLC |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 16477-0201-24 (16477020124)
| NDC Package Code | 16477-201-24 |
|---|---|
| Billing NDC | 16477020124 |
| Package | 4 BLISTER PACK in 1 BOX (16477-201-24) / 6 SUPPOSITORY in 1 BLISTER PACK |
| Marketing Start Date | 2013-11-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL db67f724-c78c-4280-9c2e-6abbaeaef42d Details
SPL UNCLASSIFIED SECTION
DESCRIPTION:
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.
INDICATIONS AND USAGE:
CONTRAINDICATIONS:
PRECAUTIONS:
Do not use Hemmorex-HC™ 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 antibacterial agent should be instituted. If a favorable response does not occur promptly, Hemmorex-HC™ 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. Hemmorex-HC™ 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 Hemmorex-HC™ 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:
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.
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein.
HOW SUPPLIED:
STORAGE:
INGREDIENTS AND APPEARANCE
| HEMMOREX-HC
hydrocortisone acetate suppository |
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| Labeler - Laser Pharmaceuticals, LLC (614417132) |