NDC 0115-1517 Desonide

Desonide

NDC Product Code 0115-1517

NDC 0115-1517-64

Package Description: 1 BOTTLE in 1 CARTON > 59 mL in 1 BOTTLE

NDC 0115-1517-65

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Desonide with NDC 0115-1517 is a a human prescription drug product labeled by Amneal Pharmaceuticals Of New York Llc. The generic name of Desonide is desonide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Amneal Pharmaceuticals Of New York Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Desonide 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.

  • DESONIDE .5 mg/mL

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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

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.
  • 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: Amneal Pharmaceuticals Of New York Llc
Labeler Code: 0115
FDA Application Number: ANDA207855 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: 12-18-2017 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’.

* Please review the disclaimer below.

Desonide 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

Description

Desonide Lotion, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21- dihydroxy-16,17 [(1methylethylidene) bis(oxy)]-, (11β, 16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.Chemically, desonide is C24H32O6. It has the following structural formula:Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water.Each gram of Desonide Lotion contains 0.5 mg of desonide in a base of cetyl alcohol, edetate sodium, glyceryl stearate SE, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, sorbitan monostearate, and stearyl alcohol. May contain citric acid and/or sodium hydroxide for pH adjustment.

Clinical Pharmacology

Like other topical corticosteroids, desonide 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 Desonide Lotion indicate that it is in the low to medium range of potency as compared with other topical corticosteroids.

Indications And Usage

Desonide Lotion is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Contraindications

Desonide Lotion 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. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA axis suppression.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 and complete 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 those products.Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface area to body mass ratios. (See PRECAUTIONS- Pediatric use).If irritation develops, Desonide Lotion should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing 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 Desonide Lotion 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 or 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.

Laboratory Tests

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

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on reproduction with the use of Desonide Lotion.

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. Animal reproduction studies have not been conducted with Desonide Lotion. It is also not know whether Desonide Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Desonide Lotion should be given to a pregnant woman only if clearly needed.

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 Desonide Lotion is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. 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 when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. 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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Adverse Reactions

In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide was approximately 8%. These were: stinging and burning approximately 3%, irritation, contact dermatitis, condition worsened, peeling of skin, itching, intense transient erythema, and dryness/scaliness, each less than 2%.The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.To report SUSPECTED ADVERSE REACTIONS, contact Impax Laboratories, Inc. at 1-800-934-6729, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

Topically applied Desonide Lotion can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Dosage And Administration

Desonide Lotion should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition. SHAKE LOTION WELL BEFORE USING.As with  other  corticosteroids, therapy  should  be discontinued  when  control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Desonide Lotion should not be used with occlusive dressings.

How Supplied

Desonide Lotion, 0.05% is supplied in bottles containing: 2 fl oz NDC 0115-1517-644 fl oz NDC 0115-1517-65Storage Conditions: Store between 2° and 30°C (36° and 86°F).

* Please review the disclaimer below.