DESCRIPTION

Desonide Ointment, 0.05% consists of desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-<(1-methylethylidene)bis(oxy)>-,(11ß,16α)) a artificial corticosteroid for topical dermatologic use. The corticosteroids constitute a course of primary fabricated steroids provided topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05% is C 24H 32O 6. It has the following structural formula:


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The molecular weight of desonide is 416.51. It is white to off-white powder. The solubility of desonide in distilled water saturated through the ether is 184 mg/L. Each gram of Desonide Ointment, 0.05% consists of 0.5 milligram of desonide microdistributed in a base of white petrolatum.


CLINICAL PHARMACOLOGY

Like other topical corticosteroids, desonide has anti-inflammatory, antipruritic, and also vasoconstrictive properties. The mechanism of the anti-inflammatory task of the topical steroids, in basic, is unclear. However before corticosteroids are thshould act by the induction of phospholipase A 2 inhibitory proteins, jointly referred to as, lipocortins. It is postulated that these proteins regulate the biosynthesis of potent mediators of inflammation such as prostaglandins and also leukotrienes by inhibiting the release of their widespread precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2.


Pharmacokinetics

The degree of percutaneous absorption of topical corticosteroids is determined by many kind of components, including the automobile and the integrity of the epidermal barrier. Occlusive dressings via hydrocortisone for approximately 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids deserve to be absorbed from normal intact skin. Inflammation and/or various other disease procedures in the skin may rise percutaneous absorption. Studies percreated via Desonide Ointment, 0.05% suggest that it is in the low range of potency as compared through various other topical corticosteroids.


INDICATIONS AND USAGE

Desonide Ointment, 0.05% is a low potency corticosteroid shown for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be supplied for much longer than 2 weeks unmuch less directed by a medical professional.


CONTRAINDICATIONS

Desonide Ointment, 0.05% is contraindicated in those patients through a background of hypersensitivity to any type of of the components of the preparation.

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General

Systemic absorption of topical corticosteroids deserve to create reversible hypothalamic-pituitary-adrenal (HPA) axis suppression through the potential for glucocorticosteroid insufficiency after withdrawal of therapy. Manifestations of Cushing"s syndrome, hyperglycemia, and also glucosuria have the right to additionally be produced in some patients by systemic absorption of topical corticosteroids while on therapy. Patients applying a topical steroid to a big surchallenge area or to locations under occlusion have to be evaluated periodically for proof of HPA axis suppression. This might be done by utilizing the ACTH stimulation, A.M. plasma cortisol, and also urinary cost-free cortisol tests. Patients receiving superpotent corticosteroids must not be treated for even more than two weeks at a time and just little areas should be treated at any one time because of the enhanced risk of HPA suppression. No particular studies appropriate to potential HPA suppression have actually been performed with Desonide Ointment, 0.05%. If HPA axis suppression is listed, an effort must be made to withattract the drug, to alleviate the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Ingenerally, signs and also symptoms of glucocorticosteroid insufficiency may happen requiring supplepsychological systemic corticosteroids. For information on systemic supplementation, watch prescribing indevelopment for those commodities. Pediatric patients may be even more susceptible to systemic toxicity from tantamount doses as a result of their larger skin surconfront to body mass ratios (check out PRECAUTIONS - Pediatric Use). If irritation creates, Desonide Ointment, 0.05% have to be discontinued and also correct treatment instituted. Allergic call dermatitis through corticosteroids is normally diagnosed by observing a faitempt to heal fairly than noting a clinical exacerbation as via the majority of topical products not containing corticosteroids. Such an observation should be corroborated via proper diagnostic patch trial and error. If concomitant skin infections are current or develop, an correct antifungal or antibacterial agent should be offered. If a favorable response does not occur promptly, usage of Desonide Ointment, 0.05% need to be discontinued till the infection has actually been adequately managed. Desonide Ointment, 0.05% must not be offered in the existence of infection at the therapy site, hypersensitivity to corticosteroids, or pre-existing skin atrophy. Desonide Ointment, 0.05% have to not be used in the eyes. FOR EXTERNAL USE ONLY.


Indevelopment for Patients

Patients utilizing topical corticosteroids should get the adhering to indevelopment and also instructions:

This medication is to be used as directed by the medical professional. It is for outside use only. Avoid call through the eyes.This medication should not be offered for any type of disorder other than that for which it was prescribed.The treated skin location have to not be bandaged, otherwise spanned or wrapped, so as to be occlusive unmuch less directed by the medical professional.Patients have to report to their doctor any signs of local adverse reactions.

Laboratory Tests

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


Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal research studies have not been perdeveloped to evaluate the carcinogenic, mutagenic, or fertility special needs potential of Desonide Ointment, 0.05%.


Teratogenic effect

Pregnancy Category C -Corticosteroids have been presented to be teratogenic in laboratory animals once administered systemically at fairly low dosage levels. Some corticosteroids have actually been displayed to be teratogenic after dermal application in laboratory pets. Animal reproductive research studies have not been performed through Desonide Ointment, 0.05%. It is likewise not recognized whether Desonide Ointment, 0.05% can cause fetal damage once administered to a pregnant woguy or deserve to affect remanufacturing capacity. Tright here are no sufficient and well-controlled studies in pregnant womales. Desonide Ointment, 0.05% need to be provided during pregnancy just if the potential benefit justifies the potential hazard to the fetus.


Nursing Mothers

Systemically administered corticosteroids show up in huguy milk and also can suppress expansion, interfere via endogenous corticosteroid manufacturing, or cause various other untowards effects. It is not known whether topical administration of corticosteroids could lead to enough systemic absorption to create detectable amounts in humale milk. Due to the fact that many kind of drugs are excreted in huguy milk, caution should be worked out when Desonide Ointment, 0.05% is administered to a nursing woguy.

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Paediatric Use

Safety and performance in pediatric patients have not been establimelted. Since of a higher proportion of skin surconfront location to body mass, pediatric patients are at a higher threat than adults of HPA axis suppression and also Cushing’s syndrome as soon as they are treated with topical corticosteroids. They are therefore likewise at greater threat of adrenal insufficiency in the time of or after withdrawal of therapy. Adverse results consisting of striae have actually been reported through inproper usage of topical corticosteroids in infants and youngsters. HPA axis suppression, Cushing’s syndrome, direct expansion retardation, delayed weight get and also intracranial hyperanxiety have been reported in kids receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and also absence of response to ACTH stimulation. Manifestations of intracranial hyperstress and anxiety incorporate bulging fontanelles, headaches, and also bilateral papilledema.


ADVERSE REACTIONS

In managed clinical trials, the complete incidence of adverse reactions linked with the usage of Desonide Ointment, 0.05% was about 6%. These adverse reactions were erythema, induration, pruritus, irritation, oiliness, and peripheral edema. The complying with extra neighborhood adverse reactions have actually been reported infrequently through topical corticosteroids, and also they might happen more generally via the usage of occlusive dressings and higher potency corticosteroids. These reactions are noted in approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning and hypopigmentation. To report SUSPECTED ADVERSE REACTIONS, call Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


OVERDOSAGE

Topically applied Desonide Ointment, 0.05% deserve to be absorbed in enough amounts to produce systemic effects (watch PRECAUTIONS).


DOSAGE AND ADMINISTRATION

Desonide Ointment, 0.05% need to be applied to the impacted location as a thin film from two to 4 times daily depending on the severity of the condition. Similar to other corticosteroids, treatment should be discontinued as soon as regulate is accomplished. If no improvement is watched within two weeks, reassessment of diagnosis might be important. Desonide Ointment, 0.05% should not be supplied with occlusive dressings.


HOW SUPPLIED

Desonide Ointment, 0.05% is easily accessible as follows: 15 g tube (NDC 21922-004-04) 60 g tube (NDC 21922-004-07)


STORAGE

Store at 20-25°C (68-77°F) . Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C1, Madkaim Ind. Estate, Madkaim, Article Mardol, Ponda, Goa-403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev: 04 December 2019


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 15g Tube Carton Desonide Ointment, 0.05% 15 g tube (NDC 21922-004-04)

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PRINCIPAL DISPLAY PANEL - 15g Tube Label Desonide Ointment, 0.05% 15 g tube (NDC 21922-004-04)
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PRINCIPAL DISPLAY PANEL - 60g Tube Carton Desonide Ointment, 0.05% 60 g tube (NDC 21922-004-07)
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PRINCIPAL DISPLAY PANEL - 60g Tube Label Desonide Ointment, 0.05% 60 g tube (NDC 21922-004-07)
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