NDC 68180-954 Hydrocortisone Valerate

Hydrocortisone Valerate

NDC Product Code 68180-954

NDC 68180-954-01

Package Description: 1 TUBE in 1 CARTON > 15 g in 1 TUBE

NDC 68180-954-02

Package Description: 1 TUBE in 1 CARTON > 45 g in 1 TUBE

NDC 68180-954-03

Package Description: 1 TUBE in 1 CARTON > 60 g in 1 TUBE

NDC Product Information

Hydrocortisone Valerate with NDC 68180-954 is a a human prescription drug product labeled by Lupin Pharmaceuticals, Inc.. The generic name of Hydrocortisone Valerate is hydrocortisone valerate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Lupin Pharmaceuticals, Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Hydrocortisone Valerate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYDROCORTISONE VALERATE 2 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • STEARETH-2 (UNII: V56DFE46J5)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STEARETH-100 (UNII: 4OH5W9UM87)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • PETROLATUM (UNII: 4T6H12BN9U)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Lupin Pharmaceuticals, Inc.
Labeler Code: 68180
FDA Application Number: ANDA210307 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 10-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Hydrocortisone Valerate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx onlyFor Dermatologic Use Only. Not for Ophthalmic Use.

Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States.Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, India.June 2018                                                                                                                    ID: 255069

Description

Hydrocortisone valerate cream USP contain hydrocortisone valerate, 11β,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 is C26H38O6. It has the following structural formula:Hydrocortisone valerate has a molecular weight of 446.58. It is a white to off-white crystalline powder, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP contains 2 mg hydrocortisone valerate USP in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum.

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 A2 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 A2.

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 indicate that it is in the medium range of potency as compared with other topical corticosteroids.

Indications And Usage

Hydrocortisone valerate cream USP is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.

Contraindications

Hydrocortisone valerate cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.Hydrocortisone valerate cream has produced mild, reversible adrenal suppression in adult patients when used under occlusion for 5 days, 15 grams twice a day over 25 to 60% body surface area or when used three times a day over 20 to 30% body surface area to treat psoriasis for 3 to 4 weeks. 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 corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for these products.Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS - Pediatric Use).If irritation develops, hydrocortisone valerate cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of hydrocortisone valerate cream should be discontinued until the infection has been adequately controlled.

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 to their physician any signs of local adverse reactions.Hydrocortisone valerate cream should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressings (see DOSAGE AND ADMINISTRATION).This medication should not be used on the face, underarms, or groin areas unless directed by the physician.As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression:            ACTH stimulation test            A.M. plasma cortisol test            Urinary free cortisol test

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 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.

Pregnancy

Teratogenic EffectsPregnancy 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/m2/day) were administered to rats and 5 mg/kg/day (60 mg/m2/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 surface 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 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when hydrocortisone valerate cream USP, 0.2% is administered to a nursing woman.

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 Cushing's 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, Cushing's 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 include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Clinical studies of hydrocortisone valerate cream 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.

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, 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 to the use of hydrocortisone valerate cream, 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%.

Overdosage

Topically applied hydrocortisone valerate cream can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Dosage And Administration

Hydrocortisone valerate cream 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 should not be used with occlusive dressings unless directed by a physician. Hydrocortisone valerate cream should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

How Supplied

Hydrocortisone valerate cream USP, 0.2%, is supplied in 15 g (NDC 68180-954-01), 45 g (NDC 68180-954-02) and 60 g (NDC 68180-954-03) tube sizes.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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