Epifoam

Pramoxine Hydrochloride And Hydrocortisone Acetate

Meda Pharmaceuticals
Human Prescription Drug
NDC 0037-6824

Epifoam also known as Pramoxine Hydrochloride And Hydrocortisone Acetate is a human prescription drug labeled by 'Meda Pharmaceuticals'. National Drug Code (NDC) number for Epifoam is 0037-6824. This drug is available in dosage form of Aerosol, Foam. The names of the active, medicinal ingredients in Epifoam drug includes Hydrocortisone Acetate - 100 mg/10g Pramoxine Hydrochloride - 100 mg/10g . The currest status of Epifoam drug is Active.

Drug Information:

Drug NDC:	0037-6824
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Epifoam
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Pramoxine Hydrochloride And Hydrocortisone Acetate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Meda Pharmaceuticals
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Aerosol, Foam
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	HYDROCORTISONE ACETATE - 100 mg/10g PRAMOXINE HYDROCHLORIDE - 100 mg/10g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	25 Aug, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	28 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA086457
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Meda Pharmaceuticals
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	904782 904783
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	3X7931PO74 88AYB867L5
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0037-6824-10	1 CANISTER in 1 CARTON (0037-6824-10) / 10 g in 1 CANISTER	25 Aug, 2014	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Hydrocortisone Acetate Pramoxine Hydrochloride

Pramoxine Hydrochloride And Hydrocortisone Acetate

Cream
Nivagen Pharmaceuticals Inc.
NDC: 75834-197

Epifoam

Pramoxine Hydrochloride And Hydrocortisone Acetate

Aerosol, Foam
Meda Pharmaceuticals
NDC: 0037-6824

Product Elements:

Epifoam pramoxine hydrochloride and hydrocortisone acetate pramoxine hydrochloride pramoxine hydrocortisone acetate hydrocortisone propylene glycol cetyl alcohol glyceryl monostearate peg-100 stearate laureth-23 polyoxyl 40 stearate methylparaben propylparaben trolamine water isobutane propane

Indications and Usage:

Indications and usage topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Warnings:

Warnings not for prolonged use. if redness, pain, irritation or swelling persists, discontinue use and consult a physician. contents of the container are under pressure. do not burn or puncture the aerosol container. do not store at temperatures above 120Â°f (49Â°c). keep this and all medicines out of the reach of children.

General Precautions:

General systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (hpa) axis suppression, manifestations of cushingâs syndrome, hyperglycemia and glucosuria in some patients. conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings. therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of hpa axis suppression by using the urinary free cortisol and acth stimulation tests. if hpa axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. recovery of hpa axis function is generally prompt and complete upon discontinuation of the drug. infrequently, signs and symptoms of steroid withdrawal may occur, r Read more...

equiring supplemental systemic corticosteroids. in pediatric patients absorption may result in higher blood levels and thus more susceptibility to systemic toxicity. (see precautions-pediatric use .) if irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. in the presence of dermatological infections, 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.

Dosage and Administration:

Dosage and administration apply to affected area 3 to 4 times daily. occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. directions for use: 1. shake the container vigorously for 5-10 seconds before each use. 2. while holding container upright, prime the container by pressing down several times on container cap until foam appears. apply a small amount directly to affected area 3-4 times daily depending on severity of the condition. alternatively, dispense a small amount to a pad and apply to affected areas. note: the aerosol container should never be inserted into vagina or anus. 3. the container and cap should be disassembled and rinsed with warm water after use.

Contraindications:

Contraindications topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions:

Adverse reactions to report suspected adverse reactions, contact meda pharmaceuticals inc. at 1-877-848-6610 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. the following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. these reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria

Use in Pregnancy:

Pregnancy corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. the more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. there are no adequate and well-controlled studies in pregnant women of teratogenic effects from topically applied corticosteroids. therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential 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.

Pediatric Use:

Pediatric use pediatric patients may demonstrate greater susceptibilty to topical corticosteroid-induced hpa axis suppression and cushingâs syndrome than mature patients because of a larger skin surface area to body weight ratio. hypothalamic-pituitary-adrenal (hpa) axis suppression, cushingâs syndrome and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisone levels and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Geriatric Use:

Geriatric use reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Overdosage:

Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (see precautions .)

Description:

Description epifoam Â® (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam containing: hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and peg 100 stearate blend, laureth-23, polyoxyl-40 stearate, methylparaben, propylparaben, trolamine, purified water and inert propellants: isobutane and propane. epifoam Â® contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic. hydrocortisone acetate molecular weight: 404.50. solubility of hydrocortisone acetate in water: 1mg/100ml. chemical name: pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11Î²)-. pramoxine hydrochloride molecular weight: 329.86. pramoxine hydrochloride is freely soluble in water. chemical name: morpholine, 4-[3-(4- butoxyphenoxy) propyl]-, hydrochloride. hydrocortisone acetate structural formula pramoxine hydrochloride structural formula

Clinical Pharmacology:

Clinical pharmacology topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. the mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. there is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. pramoxine hydrochloride a surface or local anesthetic which is not chemically related to the âcaineâ types of local anesthetics. its unique chemical structure is likely to minimize the danger of cross-sensitivity reactions in patients allergic to other local anesthetics. pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. topic Read more...

al corticosteroids can be absorbed from normal intact skin. inflammation and/or disease processes in the skin increase the percutaneous absorption of topical corticosteroids. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (see dosage and administration .) once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bile.

Pharmacokinetics:

Pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or disease processes in the skin increase the percutaneous absorption of topical corticosteroids. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (see dosage and administration .) once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. some of the topical corticosteroids and their metabolites ar Read more...

e also excreted into the bile.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, and impairment of fertility long-term animal studies have not been performed to evaluate carcinogenic potential or the effect on fertility of topical corticosteroids. studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

How Supplied:

How supplied epifoam Â® is supplied in 10 g pressurized cans. ndc 0037-6824-10 10 g store upright at controlled room temperature 20Â° â 25Â°c (68Â° â 77Â°f). do not refrigerate. distributed by: meda pharmaceuticals inc. somerset, new jersey 08873-4120 (c)2020 mylan specialty l.p. for medical inquiries, call toll-free 1-877-848-6610 epifoam is a registered trademark of alaven pharmaceutical llc, a mylan company. in-682410-04 141177-1020

Package Label Principal Display Panel:

Principal display panel ndc 0037-6824-10 epifoam Â® (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol rx only meda 10 g net wt description: a topical aerosol foam containing: hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and peg 100 stearate blend, laureth-23, polyoxyl-40 stearate, methylparaben, propylparaben, trolamine, purified water, and inert propellants: isobutene and propane. warnings: contents of the container are under pressure. do not burn or puncture the aerosol container. do not store at temperatures above 120Â°f (49Â°c). directions for use see package insert for full prescribing information. 1. shake the container vigorously for 5-10 seconds before each use. 2. while holding container upright, prime the container by pressing down several times on container cap until foam appears. apply a small amount directly to affected areas 3-4 times daily depending on severity of the condition. alternatively, dispense a small amount to a pad and apply to affected areas. note: the aerosol container should never be inserted into vagina or anus. 3. the container and cap should be disassembled and rinsed with warm water after use. distributed by: meda pharmaceuticals inc. somerset, new jersey 08873-4120 Â©2020 mylan specialty l.p. epifoam is a registered trademark of alaven pharmaceutical llc, a mylan company. keep out of reach of children. for external use only. store upright at controlled room temperature 20Â° - 25Â°c (68Â° - 77Â°f). do not refrigerate. 117611-0720 uc-682410-03 epifoam topical aerosol carton label

Comments/ Reviews:

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