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NDC 73028-0401-12 Hydrocortisone Acetate Pramoxine Hydrochloride 25; 18 mg/1; mg/1 Details
Hydrocortisone Acetate Pramoxine Hydrochloride 25; 18 mg/1; mg/1
Hydrocortisone Acetate Pramoxine Hydrochloride is a RECTAL SUPPOSITORY in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pageview Pharmaceuticals. The primary component is HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE.
Product Information
| NDC | 73028-0401 |
|---|---|
| Product ID | 73028-401_d4f8a1fa-dcd1-4363-8df2-da07a5c162a6 |
| Associated GPIs | 89991002315201 |
| GCN Sequence Number | 083363 |
| GCN Sequence Number Description | hydrocortisone/pramoxine SUPP.RECT 25 MG-18MG RECTAL |
| HIC3 | Q3I |
| HIC3 Description | HEMORRHOID PREP,ANTI-INFLAM STEROID-LOCAL ANESTHET |
| GCN | 52299 |
| HICL Sequence Number | 015163 |
| HICL Sequence Number Description | HYDROCORTISONE ACETATE/PRAMOXINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Hydrocortisone Acetate Pramoxine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydrocortisone Acetate and Pramoxine Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUPPOSITORY |
| Route | RECTAL |
| Active Ingredient Strength | 25; 18 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE |
| Labeler Name | Pageview Pharmaceuticals |
| 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 | 2023-12-31 |
Package
Package Images
NDC 73028-0401-12 (73028040112)
| NDC Package Code | 73028-401-12 |
|---|---|
| Billing NDC | 73028040112 |
| Package | 2 BLISTER PACK in 1 BOX (73028-401-12) / 6 SUPPOSITORY in 1 BLISTER PACK (73028-401-01) |
| Marketing Start Date | 2022-01-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ac9617e7-0487-4ec8-8714-edcf967e9e50 Details
DESCRIPTION
Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene 3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy–(11b) with the following structural formula:
Pramoxine Hydrochloride is a topical anesthetic agent designed chemically as 4-(3-(butoxyphenoxy)propyl)morpholine hydrochoride with the following structural formula:
Each suppository for rectal administration contains hydrocortisone acetate, USP 25 mg and pramoxine hydrochloride, USP 18 mg in a specially blended hydrogenated vegetable base.
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.
Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.
INDICATIONS AND USAGE
CONTRAINDICATIONS
PRECAUTIONS
Do not use hydrocortisone acetate and pramoxine hydrochloride 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, 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 and pramoxine hydrochloride 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 and pramoxine hydrochloride 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
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 an adverse event, please contact Pageview Pharmaceuticals, LLC at 1-636-399-9417.
DRUG ABUSE AND DEPENDENCE
DOSAGE AND ADMINISTRATION
FOR RECTAL ADMINISTRATION. Detach one suppository from strip of suppositories.
Hold suppository upright and carefully separate tabs at top opening and pull downward from the pointed end to expose the suppository. Remove the suppository from the pocket. Avoid excessive handling of suppository which is designed to melt at body temperature. Insert one suppository rectally, 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
Hydrocortisone acetate 25mg and Pramoxine Hydrochloride 18 mg Suppositories are off-white, smooth surfaced and bullet shaped with one pointed end.
Box of 12 suppositories, NDC 73028-401-12
STORAGE
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°-30°C (59°-86°F). Store away from heat. Protect from freezing. Avoid contact with eyes.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
PHARMACIST: This product is not an Orange Book rated product, therefore all prescriptions using this product shall be subject to state and federal statutes as applicable. This product has not been subjected to FDA therapeutic or other equivalency testing. There are no claims of bioequivalence or therapeutic equivalence. 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 contained within the enclosed prescribing information.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 12 Suppository Blister Pack Box
INGREDIENTS AND APPEARANCE
| HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE
hydrocortisone acetate and pramoxine hydrochloride suppository |
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| Labeler - Pageview Pharmaceuticals (117003305) |