DesOwen: Indications, Dosage, Precautions, Adverse Effects
Россия
  • Россия
  • Украина

DesOwen - Product Information

Manufacture: Galderma Laboratories
Country: Australia
Condition: Atopic Dermatitis, Dermatitis, Skin Conditions (Dermatological Disorders)
Class: Topical steroids
Ingredients: desonide, sodium lauryl sulphate, light liquid paraffin, cetyl alcohol, stearyl alcohol, propylene glycol, methyl hydroxybenzoate, propyl hydroxybenzoate, sorbitan monostearate, self-emulsifying glyceryl monostearate, edetate sodium, sodium hydroxide and/or citric acid, purified water.

Type of Application

DESOWEN Cream, Ointment, Lotion contains the topical corticosteroid desonide, a nonfluorinated.

Chemical Structure: 11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione-cyclic-16, 17-acetonide.
Molecular Formula: C24H32O6, molecular weight : 416.52
Chemical Abstracts Number: 638-94-8
Structural Formula:

Description

Cream contains 0.5 mg of desonide dispersed in 1g of vehicle buffered to the pH range of normal skin. It contains propylene glycol, polysorbate 60, emulsifying wax, isopropyl palmitate, stearic acid, synthetic beeswax, propyl gallate, citric acid, sodium hydroxide and purified water. It is preserved with sorbic acid and potassium sorbate.

Ointment contains 0.5 mg of desonide in a 1g of base consisting of liquid paraffin and polyethylene.

Lotion contains 0.5 mg of desonide in 1 g of lotion vehicle consisting of sodium lauryl sulfate, light liquid paraffin, cetyl alcohol, stearyl alcohol, propylene glycol, methyl hydroxybenzoate, propyl hydroxybenzoate, sorbitan monostearate, self emulsifying glyceryl monostearate, edetate sodium and purified water. The lotion may contain citric acid and/or sodium hydroxide for pH adjustment.

Pharmacology

Pharmacodynamic Properties

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity is unclear. There is evidence to suggest a correlation between vasoconstriction and therapeutic efficacy in man. The McKenzie-Stoughton vasoconstrictor assay yields a ranking on a seven-point scale in which the first rank is the most potent. This assay method has been used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. Desonide 0.05% is a group VI corticosteroid when assessed in this way. The DESOWEN preparations are classified as mild topical corticosteroids in the USA where this method of assessment of potency is used. In Europe a four-point measure of potency is used, with one designated the most potent. Desonide 0.05% is ranked 3, a mid-potent topical corticosteroid under this system.

Pharmacokinetic Properties

Sufficient corticosteroid may be absorbed to give a systemic effect following topical application. The extent of percutaneous absorption is determined by many factors including the vehicle, the presence of broken skin and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation or other disease processes can increase percutaneous absorption. Occlusive dressings substantially increase percutaneous absorption of topical corticosteroids. Thus occlusive dressings may be a valuable therapeutic adjunct for the treatment of resistant dermatoses. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolised primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Therapeutic Indications

Desowen Cream 0.05%, Lotion 0.05% and Ointment 0.05% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses for adults and children aged 2 years and older.

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. Desowen preparations are also contraindicated in most viral infections of the skin (vaccinia, herpes simplex), tuberculosis, acne and rosacea. Application to ulcerated lesions and to the eyelids is also contraindicated (risk of glaucoma).

Precautions

Prolonged use of corticosteroids of medium potency on the face is associated with a risk of occurrence of corticosteroid-related dermatitis that is, paradoxically, corticosteroid-responsive, with a rebound after each treatment discontinuation. Gradual withdrawal by tapering is then required.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal axis suppression, manifestations of Cushings syndrome, hyperglycemia and glucosuria in some patients.

Conditions which augment systemic absorption include the application of more potent steroids, use over a large surface area, prolonged use and the addition of occlusive dressings. Therefore patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted an attempt should be made to reduce the frequency of application or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical steroids. Infrequently signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

The duration of continuous treatment should not exceed 8 weeks in either adults or children.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see “Use in children”). If signs of skin or subcutaneous atrophy occur discontinue treatment.

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections the use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly the corticosteroid should be discontinued until the infection has been adequately controlled.

FOR EXTERNAL USE ONLY.

Use in Pregnancy

Pregnancy category B3. Corticosteroids may be teratogenic in laboratory animals when administered systemically or topically at relatively low dosage levels and a generic 0.05% desonide cream was reported as teratogenic when applied daily at topical maternal doses of 0.6 and 2g/kg in rats and 2 g/kg in rabbits over appropriate gestational periods. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore drugs of this class should be used during pregnancy only if potential benefit justifies the potential risk to the foetus and should not be used extensively, in large amounts, or for prolonged periods.

Use in Lactation

It is not known whether topical corticosteroids are absorbed sufficiently to be excreted in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless caution should be exercised when topical steroids are administered to a nursing woman.

Use in Children

Desowen cream, lotion and ointment should not be administered to children under the age of two years. HPA axis suppression has been assessed in a clinical study in which Desowen ointment was administered for 4 weeks. HPA axis suppression has not been assessed during longer periods of administration. Because of a larger skin surface area to body weight ratio, paediatric patients may show a greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing’s syndrome than mature patients. HPA suppression, Cushing’s syndrome and intracranial hypertension have been reported in children using topical corticosteroids. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Carcinogenicity, Mutagenicity and Impairment of Fertility

Desonide has not been investigated in long term carcinogenicity studies in animals. However, budesonide, which has a close structural resemblance to desonide, caused an increased incidence of primary hepatocellular tumours in male rats dosed orally at 25 and 50 μg/kg/day. In a repeat study, budesonide, prednisolone and triamcinolone acetonide all had this effect, indicating a class effect of corticosteroids. A related corticosteroid, flunisolide, caused an increased incidence of pulmonary adenomas in mice in a 22 month study, and an increased incidence of mammary adenocarcinomas in rats in a 24 month study.
There is no information on the genotoxicity of desonide. No mutagenic or clastogenic effects were found following genotoxicity testing of related drugs budesonide and prednisolone. The effect of desonide on fertility has not been investigated in animals or humans.

Adverse Reactions

The following local adverse reactions are reported infrequently with DESOWEN but 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 millaria.

Desowen Cream, Lotion, Ointment

Table:             Adverse events ( > 1%) by type reported in clinical studies.
These are not necessarily drug related.
Desowen
desonide
(n = 643)
Hytone
hydrocortis
one 1%
(n = 125)
Aclovate
alclomethasone
dipropionate
0.05% (n = 60)
Tridesilon
desonide
(n = 207)
Ointment
(n=118)
Cream
(n=447)
Lotion
(n=78)
Body as a whole
Condition aggravated - - 2.4%
Flu syndrome 3.4% -
Pain 1.6% -
Central Nervous
System
Headache 6.7%
Insomnia 1.6 %
Skin & appendage
Dry skin - 1.6%
Exfoliative dermatitis - 1.6% -
Pruritis - - 1.6% -
Rash 1.9% # 2.9%
Skin disorder: 1.6% * 2.4% ** 1.6%***
Other events (type not stated) - 6.6%

* 1 impetigo &1 skin infection; ** 1 pediculosis, 1 mite infection, 1 impetigo; *** smooth skin.
# It was not possible to identify the arm of the study in which ‘rash’ occurred so cream/lotion figures have been pooled.

Post-Marketing Surveillance

The incidence of adverse drug reactions recorded in global post-marketing surveillance data is less than 1%.

Post Marketing Data

very common     ≥ 1/10
common         ≥ 1/100 and < 1/10
uncommon       ≥ 1/1000 and < 1/100
rare             ≥ 1/10,000 and < 1/1000
very rare         < 1/10,000

Body as a Wwhole Disorders

Uncommon:      Allergic reaction (including facial oedema and application site reaction)
Rare:            Reaction aggravated (flare up of original condition)

Skin and Appendages Disorders

Uncommon:      Rash (irritation including stinging and burning at site of application)
                Pruritus
Rare:           Skin disorder (not otherwise specified)

Dosage and Administration

Desowen (desonide) Cream 0.05%, Lotion 0.05% or Ointment 0.05% should be applied as a thin film to the affected areas two to three times daily depending on the severity of the condition. Shake lotion well before using. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Periods of continuous treatment should not exceed 8 weeks in adults or children.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions).

Presentation

DESOWEN Cream 0.05% and Ointment 0.05% is supplied in tubes containing 25g, 30g, 50g and 60g. DESOWEN lotion 0.05% is supplied in bottles containing 10mL, 30mL, 60mL and 100mL.

Storage Conditions

Store below 25°C. Avoid freezing.

Approved by the Therapeutic Goods Administration: 21st December 1998

Desowen cream AUST R 67167
Desowen ointment AUST R 67174
Desowen lotion AUST R 67182

Distributor

Galderma Australia Pty Ltd.
13B Narabang Way
Belrose NSW 2085.