Clobetasol Propionate
Novel Laboratories, Inc.
Human Prescription Drug
NDC 40032-096Clobetasol Propionate is a human prescription drug labeled by 'Novel Laboratories, Inc.'. National Drug Code (NDC) number for Clobetasol Propionate is 40032-096. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Clobetasol Propionate drug includes Clobetasol Propionate - .5 mg/g . The currest status of Clobetasol Propionate drug is Active.
Drug Information:
| Drug NDC: | 40032-096 |
| 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: | Clobetasol Propionate |
| 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: | Clobetasol Propionate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Novel Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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: | CLOBETASOL PROPIONATE - .5 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: | 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 Nov, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 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: | ANDA208841 |
| 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: | Novel Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 861448
|
| 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: | 0340032096603
|
| UPC stands for Universal Product Code. |
| UNII: | 779619577M
|
| 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 |
|---|
| 40032-096-60 | 1 TUBE in 1 CARTON (40032-096-60) / 15 g in 1 TUBE | 25 Nov, 2016 | N/A | No |
| 40032-096-61 | 1 TUBE in 1 CARTON (40032-096-61) / 30 g in 1 TUBE | 25 Nov, 2016 | N/A | No |
| 40032-096-62 | 1 TUBE in 1 CARTON (40032-096-62) / 60 g in 1 TUBE | 25 Nov, 2016 | 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:
Clobetasol propionate clobetasol propionate clobetasol propionate clobetasol propylene glycol sorbitan sesquioleate petrolatum off-white
Indications and Usage:
Indications and usage clobetasol propionate ointment usp is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. use in pediatric patients under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Dosage and Administration:
Dosage and administration apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely (see indications and usage ). clobetasol propionate ointment is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. clobetaol propionate ointment should not be used with occlusive dressings. geriatric use: in studies where geriatric patients (65 years of age or older, see precautions ) have been treated with clobetasol propionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
Contraindications:
Contraindications clobetasol propionate ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Adverse Reactions:
Adverse reactions in controlled clinical trials, the most frequent adverse events reported for clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia. cushing syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. the following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. these reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.
Pediatric Use:
Pediatric use: safety and effectiveness of clobetasol propionate ointment in pediatric patients have not been established. use in pediatric patients under 12 years of age is not recommended. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing syndrome when they are treated with topical corticosteroids. they are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. hpa axis suppression, cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to acth stimulation. manifestations of intracranial hypertension incl
Read more...ude bulging fontanelles, headaches, and bilateral papilledema.
Geriatric Use:
Geriatric use: a limited number of patients at or above 65 years of age have been treated with clobetasol propionate ointment (n = 101) in us and non-us clinical trials. while the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. based on available data, no adjustment of dosage of clobetasol propionate ointment in geriatric patients is warranted.
Overdosage:
Overdosage topically applied clobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description clobetasol propionate ointment usp, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. chemically, clobetasol propionate is (11Ã, 16Ã)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1, 4-diene-3, 20-dione, and it has the following structural formula: clobetasol propionate has the molecular formula c 25 h 32 cifo 5 and a molecular weight of 467. it is a white or almost white crystalline powder insoluble in water. clobetasol propionate ointment usp, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. structure
Clinical Pharmacology:
Clinical pharmacology like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. the mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. however, corticosteroids are thought to act by the induction of phospholipase a 2 inhibitory proteins, collectively called lipocortins. it is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. arachidonic acid is released from membrane phospholipids by phospholipase a. pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96
Read more... hours markedly enhances penetration. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin may increase percutaneous absorption. studies performed with clobetasol propionate ointment indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
Pharmacokinetics:
Pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin may increase percutaneous absorption. studies performed with clobetasol propionate ointment indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
How Supplied:
How supplied clobetasol propionate ointment usp, 0.05% is a white to off white ointment and supplied in: 15-g tubes (ndc 40032-096-60) 30-g tubes (ndc 40032-096-61) 60-g tubes (ndc 40032-096-62) store at 20° to 25°c (68° to 77°f) excursions permitted between 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. manufactured by: novel laboratories, inc. somerset, nj 08873 pi0960000102 rev. 05/2016
Information for Patients:
Information for patients: 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. this medication should not be used for any disorder other than that for which it was prescribed. the treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. patients should report any signs of local adverse reactions to the physician.
Package Label Principal Display Panel:
Package label.principal display panel 15 g â container label 60 g â carton label 15 g - container 60 g - carton