Analpram Hc
Hydrocortisone Acetate And Pramoxine Hydrochloride
Sebela Pharmaceuticals Inc.
Human Prescription Drug
NDC 54766-799Analpram Hc also known as Hydrocortisone Acetate And Pramoxine Hydrochloride is a human prescription drug labeled by 'Sebela Pharmaceuticals Inc.'. National Drug Code (NDC) number for Analpram Hc is 54766-799. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Analpram Hc drug includes Hydrocortisone Acetate - 25 mg/g Pramoxine Hydrochloride - 10 mg/g . The currest status of Analpram Hc drug is Active.
Drug Information:
| Drug NDC: | 54766-799 |
| 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: | Analpram Hc |
| 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: | Hydrocortisone Acetate And Pramoxine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sebela Pharmaceuticals Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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 - 25 mg/g
PRAMOXINE HYDROCHLORIDE - 10 mg/g
|
| 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: | UNAPPROVED DRUG OTHER |
| 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: | 07 Aug, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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. |
| 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: | Sebela Pharmaceuticals Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1294025
1362211
|
| 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. |
| UPC: | 0354766799655
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 54766-799-04 | 28.4 g in 1 TUBE, WITH APPLICATOR (54766-799-04) | 07 Aug, 2015 | N/A | No |
| 54766-799-64 | 30 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-64) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36) | 07 Aug, 2015 | N/A | No |
| 54766-799-65 | 12 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-65) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36) | 07 Aug, 2015 | N/A | No |
| 54766-799-71 | 30 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-71) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-33) | 07 Aug, 2015 | N/A | No |
| 54766-799-72 | 12 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-72) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-33) | 07 Aug, 2015 | 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. |
Product Elements:
Analpram hc hydrocortisone acetate and pramoxine hydrochloride stearic acid cetyl alcohol isopropyl palmitate polyoxyl 40 stearate propylene glycol potassium sorbate sorbic acid triethanolamine lauryl sulfate water hydrocortisone acetate hydrocortisone pramoxine hydrochloride pramoxine
Indications and Usage:
Inidcations and usage: topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration:
Dosage and administration : topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. 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.
Contraindications:
Contraindications: topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions:
Adverse reactions: 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 approximate 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
Pediatric Use:
Pediatric use: pediatric patients may demonstrate greater susceptibility to topical corticosteroid induced hpa axis suppression and cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. hypothalamic-pituitary-adrenal (hpa) axis suppression, cushing's syndrome, and intra-cranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of children.
Overdosage:
Overdosage: topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (see precautions.)
Description:
Description: analpram hc ® cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, aquaphor ® , isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. topical corticosteroids are anti-inflammatory and anti-pruritic agents. the structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- c 23 h 32 o 6 ; mol. wt.: 404.50 pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride c 17 h 27 no 3 .hcl; mol. wt.: 329.87 hydrocortisone acetate pramoxinehcl
Clinical Pharmacology:
Clinical pharmacology: topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. the mechanism of anti-inflammatory activity of 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 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.
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 other disease processes in the skin increase percutaneous absorption. 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
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Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, and impairment of fertility: long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. studies to determine mutagenicity with prednisolone and hydro-cortisone have revealed negative results.
How Supplied:
How supplied: analpram hc ® cream 2.5% 1 oz tube (ndc 54766-799-04) 12 x 4 gram tubes (ndc 54766-799-65) 30 x 4 gram tubes (ndc 54766-799-64) 1 oz analpram advanced kit (ndc 54766-732-04) 30 x 4 gram analpram advanced kit (ndc 54766-731-64)
Information for Patients:
Information for the patient: patients using topical corticosteroids should receive the following information and instructions: this medication is to be used as directed by the physician. it is for external use only. avoid contact with the eyes. patients should be advised not to use this medication for any disorder other than for which it was prescribed. the treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. patients should report any signs of local adverse reactions especially under occlusive dressings. parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
Package Label Principal Display Panel:
Principal display panel - ndc 54766-799-04 analpram hc ® cream 2.5% 1 oz carton analpramhc1oz
Principal display panel - ndc 54766-799-65 analpram hc ® cream 2.5% 12 x 4g carton analpramhc12x4g
Principal display panel - ndc 54766-799-64 analpram hc ® cream 2.5% 30 x 4g carton analpramhc30x4g