Hydrocortisone Valerate

Glenamrk Pharmaceuticals Inc., Usa
Human Prescription Drug
NDC 68462-575

Hydrocortisone Valerate is a human prescription drug labeled by 'Glenamrk Pharmaceuticals Inc., Usa'. National Drug Code (NDC) number for Hydrocortisone Valerate is 68462-575. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Hydrocortisone Valerate drug includes Hydrocortisone Valerate - 2 mg/g . The currest status of Hydrocortisone Valerate drug is Active.

Drug Information:

Drug NDC:	68462-575
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:	Hydrocortisone Valerate
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 Valerate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Glenamrk Pharmaceuticals Inc., Usa
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 VALERATE - 2 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:	15 Oct, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	27 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:	ANDA211129
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:	Glenamrk Pharmaceuticals Inc., USA
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1370754
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:	0368462575475 0368462575178
UPC stands for Universal Product Code.
UNII:	68717P8FUZ
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
68462-575-17	15 g in 1 TUBE (68462-575-17)	15 Oct, 2018	N/A	No
68462-575-47	45 g in 1 TUBE (68462-575-47)	15 Oct, 2018	N/A	No
68462-575-65	60 g in 1 TUBE (68462-575-65)	15 Oct, 2018	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

Product Elements:

Hydrocortisone valerate hydrocortisone valerate hydrocortisone valerate hydrocortisone propylene glycol sodium lauryl sulfate steareth-100 methylparaben petrolatum steareth-2 stearyl alcohol citric acid monohydrate water sodium acryloyldimethyltaurate isohexadecane polysorbate 80 acrylamide

Indications and Usage:

Indications and usage hydrocortisone valerate cream, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.

Dosage and Administration:

Dosage and administration hydrocortisone valerate cream, 0.2% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. as with other corticosteroids, therapy should be discontinued when control is achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. hydrocortisone valerate cream, 0.2% should not be used with occlusive dressings unless directed by a physician. hydrocortisone valerate cream, 0.2% should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

Contraindications:

Contraindications hydrocortisone valerate cream, 0.2% is 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 have been reported with topical corticosteroids, and they 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, and miliaria. in controlled clinical studies involving pediatric patients one month to 2 years of age (n=29), the incidence of adverse experiences, regardless of relationship to the use of hydrocortisone valerate cream, 0.2%, was approximately 21%. reported reactions included stinging (10%), eczema (7%), fungal infection (3%), and gastrointestinal disorder (3%). in controlled clinical studies involving pediatric patients 2 to 12 years of age (n=153), the incidence of adverse experiences, regardless of relationship t Read more...

o the use of hydrocortisone valerate cream, 0.2%, was approximately 10%. reported reactions included stinging (3%), burning skin (2%), infection (body as a whole) (2%). skin irritation, eczema, pruritus, application site reaction, rash, rash maculopapular, and dry skin were all reported at incidences of approximately 1%.

Use in Pregnancy:

Pregnancy: teratogenic effects, pregnancy category c corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. dermal embryofetal developmental studies were conducted in rabbits and rats with hydrocortisone valerate cream, 0.2%. hydrocortisone valerate cream, 0.2%, was administered topically for 4 hours/day, rather than the preferred 24 hours/day, during the period of organogenesis in rats (gestational days 5 to 16) and rabbits (gestational days 6 to 19). topical doses of hydrocortisone valerate up to 9 mg/kg/day (54 mg/m 2 /day) were administered to rats and 5 mg/kg/day (60 mg/m 2 /day) were administered to rabbits. in the absence of maternal toxicity, a significant increase in delayed skeletal ossification in fetuses was noted at 9 mg/kg/day [2.5x the maximum recommended human dose (mrhd) based on body sur Read more...

face area (bsa) comparisons] in the rat study. no malformations in the fetuses were noted at 9 mg/kg/day (2.5x mrhd based on bsa comparisons) in the rat study. indicators of embryofetal toxicity, significant decrease in fetal weight at 2 mg/kg/day (1x mrhd based on bsa) and a significant increase in post-implantation loss and embryo resorption at 5 mg/kg (3x mrhd based on bsa), were noted in the rabbit study. a significant increase in delayed skeletal ossification in fetuses was noted at 5 mg/kg/day (3x the mrhd based on bsa comparisons) in the rabbit study. increased numbers of fetal malformations (e.g., cleft palate, omphalocele and clubbed feet) were noted at 5 mg/kg/day (3x mrhd based on bsa comparisons) in the rabbit study. there are no adequate and well-controlled studies in pregnant women. hydrocortisone valerate cream, 0.2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use:

Pediatric use safety of this product in pediatric patients has not been established. there is no data on adrenal suppression and/or growth suppression. 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 cushingâs syndrome when they are treated with topical corticosteroids. they are therefore also at a greater risk of adrenal insufficiency during and/or after withdrawal of treatment. adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (see precautions ) hpa axis suppression, cushingâs 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 inc Read more...

lude bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use:

Geriatric use clinical studies of hydrocortisone valerate cream, 0.2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Overdosage:

Overdosage topically applied hydrocortisone valerate cream, 0.2% can be absorbed in sufficient amounts to produce systemic effects (see precautions ).

Description:

Description hydrocortisone valerate cream usp, 0.2% contains hydrocortisone valerate, usp, pregn-4-ene-3,20-dione, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-, (11Î²)-;cortisol 17-valerate or 11Î²,17,21-trihydroxypregn-4-ene-3,20-dione 17-valerate, a synthetic corticosteroid for topical dermatologic use. the corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. chemically, hydrocortisone valerate, usp is c 26 h 38 o 6 . it has the following structural formula: hydrocortisone valerate, usp has a molecular weight of 446.58. it is a white or almost white crystalline powder, freely soluble in acetone and dichloromethane; soluble in alcohol; insoluble in water. each gram of hydrocortisone valerate cream usp, 0.2% contains 2 mg hydrocortisone valerate, usp in a hydrophilic base composed of citric acid monohydrate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sepineo p 600, steareth-100, stearyl alcohol, sodium lauryl sulfate and white petrolatum. chemical structure

Clinical Pharmacology:

Clinical pharmacology like other topical corticosteroids, hydrocortisone valerate 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 2 . 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 dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone fo Read more...

r 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 hydrocortisone valerate cream, 0.2% indicate that it is in the medium 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 dressings with hydrocortisone for up to 24 hours have 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 hydrocortisone valerate cream, 0.2% indicate that it is in the medium range of potency as compared with other topical corticosteroids.

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 of hydrocortisone valerate. hydrocortisone valerate cream, 0.2% was shown to be non-mutagenic in the ames-salmonella/microsome plate test. there are no studies which assess the effects of hydrocortisone valerate on fertility and general reproductive performance.

How Supplied:

How supplied hydrocortisone valerate cream usp, 0.2%, is supplied in the following tube sizes: 15 g â ndc 68462-575-17 45 g â ndc 68462-575-47 60 g â ndc 68462-575-65

Information for Patients:

Information for patients patients using topical corticosteroids should receive the following information and instructions: 1. this medication is to be used as directed by the physician. it is for external use only. avoid contact with the eyes. 2. this medication should not be used for any disorder other than that for which it was prescribed. 3. the treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician. 4. patients should report to their physician any signs of local adverse reactions. 5. hydrocortisone valerate cream, 0.2% should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressings. (see dosage and administration ) 6. this medication should not be used on the face, underarms, or groin areas unless directed by the physician. 7. as with other corticosteroids, therapy should be discontinued when control is achieved. if no improvement is seen within 2 weeks, contact the phys Read more...

ician.

Package Label Principal Display Panel:

Package/label display panel ndc 68462-575-17 hydrocortisone valerate cream 0.2% - 15 g- tube hydro-vale-cream-15g-tube

Package/label display panel ndc 68462-575-17 hydrocortisone valerate cream 0.2% - 15 g- carton hydro-vale-cream-15g-carton

Package/label display panel ndc 68462-575-47 hydrocortisone valerate cream 0.2% - 45 g- tube hydro-vale-cream-45g-tube

Package/label display panel ndc 68462-575-47 hydrocortisone valerate cream 0.2% - 45 g- carton hydro-vale-cream-45g-carton

Package/label display panel ndc 68462-575-65 hydrocortisone valerate cream 0.2% - 60 g- tube hydro-vale-cream-60g-tube

Package/label display panel ndc 68462-575-65 hydrocortisone valerate cream 0.2% - 60 g- carton hydro-vale-cream-60g-carton

Comments/ Reviews:

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