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PDP-DESONIDE is a brand name for Desonide, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
05% Cream or Ointment should be applied to the affected skin thoroughly covering the area. The usual dosage is two to three times daily; however, this may be increased in the treatment of refractory cases. pdp-DESONIDE Cream contains the following non-medicinal ingredients: aluminum sulfate, calcium acetate, dextrin, glycerin, kolliphor, light mineral oil, methylparaben, purified water, sodium lauryl sulfate, wax, white petrolatum.
pdp-DESONIDE Ointment contains the following non-medicinal ingredient: white petrolatum.
AVAILABILITY OF DOSAGE FORMS pdp-DESONIDE Cream:
Supplied in tubes of 15 grams and 60 grams. pdp-DESONIDE Ointment: Supplied in tubes of 60 grams. Store below 30°C. Avoid freezing. PHARMACOLOGY Since the introduction of hydrocortisone for the topical treatment of various dermatological disorders, a great many analogs have been synthesized in attempts to increase potency and reduce side effects.
Some of the chemical modifications of hydrocortisone which singly or in combination have proven effective in this respect include methylation, halogenation (fluorine), hydroxylation, oxidation (dehydrogenation), esterification and (where the glycol moiety is present) acetonide formation.
One or more such structural modifications to the basic hydrocortisone molecule are to be found in each of the several potent topical steroids presently available. Desonide is a new addition to this important class of therapeutic agents.
Being a chemically modified hydrocortisone, its structure is similar in certain respects to other members of the class. Desonide is unique, however, in that it is non-halogenated. Historically, fluorination was one of the first chemical modifications found to dramatically enhance the systemic anti-inflammatory properties of hydrocortisone and until now this structural feature has persisted in steroids intended 8 for the treatment of dermatological disorders by the topical route of administration.
The anti-inflammatory activity of desonide cream has been assessed using a number of model systems: a summary of the relative potencies obtained in the various assays is found in Table 1. While no single assay system is adequate for predicting relative efficacy, the results indicate that desonide cream is a potent anti-inflammatory steroid, comparable to the fluorinated steroids.
0 100b --- Ear Edema Modelc Assay No. 1 Assay No. 8) --- a Based on the ability of the steroid to reverse (or prevent the full development of) ocular inflammation produced by irradiation with ultraviolet light. b Not determined in parallel with hydrocortisone.
: Endocrinology, 77: 625, 1965. d An approximation, due to lack of parallelism. e Based on the method of Winter and Porter; J. Am. Pharm. Assoc. Sci. , 46: 515, 1957. ; Endocrinology, 41: 55, 1947. TOXICOLOGY Acute Toxicity The LD50 in rats was 93 mg/kg subcutaneously (with 95% confidence limits to 65 to 134 mg/kg).
As with all topical corticosteroids, pdp-DESONIDE (desonide) should not be used in untreated bacterial, tubercular and fungal infections of the skin or in viral infections with skin lesions, including herpes simplex, vaccinia and varicella.
It is also contraindicated in individuals with history of hypersensitivity to its components. WARNINGS The safety of topical corticosteroids during pregnancy or lactation has not been established. The potential benefit of topical corticosteroids, if used during pregnancy or lactation, should be weighed against possible hazard to the fetus or the nursing infant.
If used under an occlusive dressing, particularly over extensive areas, sufficient absorption may take place to give rise to adrenal suppression and other systematic effects. Topical corticosteroids are not for ophthalmic use. PRECAUTIONS Although side effects are not ordinarily encountered with topically-applied corticosteroids, as with all drugs, a few patients may react unfavorably under certain conditions.
Should sensitivity or idiosyncratic reactions occur, the agent should be discontinued and appropriate steps taken. Topical steroids should not be used extensively on pregnant patients, in large amounts or for prolonged periods of time.
Patients should be advised to inform subsequent physicians of the prior use of corticosteroids. Causal factors should be eliminated whenever possible. It is recommended that rotation of the sites of application and intermittent therapy be considered.
Suitable precautions should be taken in using topical corticosteroids in patients with statis dermatitis and other skin diseases with impaired circulation. Prolonged use of corticosteroid- containing products, particularly when applied under occlusive dressings, may produce striae or atrophy of the skin or subcutaneous tissue, in which event treatment with such products should be 5 discontinued.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This compound is approximately six times more toxic than hydrocortisone and at least 60 times more powerful as an anti-inflammatory agent than hydrocortisone. This separation between toxic and anti-inflammatory properties could substantially reduce the risk of acute toxicity with 9 desonide.
20% of desonide were well tolerated in rats and dogs respectively. In view of the fact that a high anti-inflammatory potency was anticipated in this steroid and that probably small quantities may be clinically required, the preceding results indicate that there is minimum risk of clinical toxicity.
20% of desonide produced minimum changes. The cutaneous reaction observed with this dose was scarcely apparent and although two deaths were observed, the acute dermal LD50 is considerably greater than 16 g/kg. 20% daily of the final formulation of desonide cream, the following was observed: one death, minimum dermal response, and evidence of systemic absorption.
The dermal responses during the use of these concentrations were not related to the doses and were maximum during the first week of the study. In view of these observations, it seems that the reactions observed were the results of the abrading procedure used, and that the application of the preparations, rather than producing irritation, slowed the formation of scar tissue, thus delaying the normal reduction of the erythema and edema which occurs after abrading.
The observation of one death and of changes in different organs indicate that the dermal application of the final formulation produces systemic effects; the responses observed were characteristic of the changes produced by the repeated administration of steroids.
Considering the anti-inflammatory potency of this compound, the high doses used in the sub-acute toxicity study and the clear relationship between the action on the system and the size of dosage, it is possible to predict a minimum risk of systemic toxicity with the use of compounds containing desonide.
05% cream formulation of the steroid for three months. Body weight gains were normal in females but were reduced in males at the mid and high dose levels. Food 10 […]
In case of bacterial infection of the skin, appropriate anti-bacterial agents should be used as primary therapy. If it is considered necessary, the topical corticosteroid may be used as an adjunct to control inflammation, erythema and itching.
If a symptomatic response is not noted within a few days to a week, the local applications of corticosteroid should be discontinued until the infection is brought under control. Occlusive dressing should not be applied if there is an elevation of body temperature.
Topical corticosteroids should be used with caution on lesions close to the eye. ADVERSE REACTIONS Side effects have been rare and consist mainly of local burning irritation and itching. When this occurs, the possibility of sensitization must be kept in mind.
Because skin atrophy, striae, hypertrichosis and adrenal suppression have been shown to occur with prolonged and indiscriminate use of topical corticosteroids, particularly under occlusion, due to percutaneous absorption, similar phenomena could conceivably occur with prolonged and excessive use of desonide.
Folliculitis, acneform eruptions, dryness of skin, maceration of skin and hypopigmentation have been shown to occur with the use of topical corticosteroids, and could presumably appear with the use of desonide. Allergic contact dermatitis has been reported following the use of products containing methylparaben, which is present in pdp-DESONIDE cream as a preservative.
Posterior subcapsular cataracts have been reported following the systematic use of corticosteroids.
Treatment of Accidental Ingestion:
There is no specific antidote, but gastric lavage should be performed. 6 PHARMACEUTICAL INFORMATION Drug Substance: Common Name: Desonide Chemical Name: 11B, 21-Dihydroxy-16a, 17a-isopropylidinedioxy-1, 4-pregnadiene-3, 20-dione. 52 Description: Desonide is a white to off-white fine powder, it is practically odourless and stable in air.
The vehicle for pdp-DESONIDE Cream is Acid Mantle Creme (Dome), utilizing methylparaben as preservative. The vehicle for pdp-DESONIDE Ointment is White Petrolatum USP, without parabens or other preservatives.