Desowen

Desonide (Desowen) 0.05% (500 mcg/g) Cream: Each gram contains: Desonide Ph. Eur. 500 mcg.
Desonide (Desowen) 0.05% (500 mcg/g) Lotion: Each gram contains: Desonide Ph. Eur. 500 mcg.
Excipients with known effect: Cream: Sorbic acid (E200), propylene glycol (E1520).
Lotion: Stearyl alcohol, propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate, sodium lauryl sulphate.
Excipients/Inactive Ingredients: Cream: Potassium sorbate, Polysorbate 60, Sorbic acid, Propyl gallate, Wax SE, Beeswax synthetic, Stearic acid, Isopropyl palmitate, Propylene glycol, Sodium hydroxide solution, Citric acid anhydrous solution and Purified water.
Lotion: Vehicle: Tetrasodium EDTA tetrahydrate, Methyl parahydroxybenzoate, Sodium lauryl sulfate, Liquid paraffin 15-25 mPa.s, Glyceryl monostearate SE, Sorbitan monostearate, Cetyl alcohol, Stearyl alcohol, Propyl parahydroxybenzoate, Propylene glycol, Sodium hydroxide solution, Citric acid anhydrous solution and Purified water.

Pharmacology: Pharmacodynamics: Dermatological Corticosteroids: Dermatological corticosteroids are divided into 4 potency levels on the basis of cutaneous vasoconstriction tests: very high, high, medium and low potency.
Desonide (Desowen) has medium potency.
Desonide acts on some inflammatory processes (e.g. contact hypersensitivity) and the pruriginous effect related to them.
Vasoconstrictor. Inhibitor of cell proliferation.
Pharmacokinetics: The degree of dermal barrier crossing, and systemic effects depend on the magnitude of the area treated, the degree of epidermal impairment and the duration of treatment. The effects are more likely, the longer the duration of treatment.

Preferred indications in which local corticosteroid therapy is considered as the best treatment: Contact eczema; Atopic dermatitis.
Indications in which local corticosteroid therapy constitutes one of the usual treatments: Stasis dermatitis; Psoriasis as follow-on treatment, for skin folds or in children; Seborrheic dermatitis except facial seborrheic dermatitis.
Short-duration circumstantial indications: Insect bites and parasitic prurigo as a follow on to etiologic treatment.
The cream form is particularly intended for weeping, acute lesions.

Cutaneous route.
Administration frequency up to 3 times daily for short-term use.
An increase in the number of daily applications may exacerbate the adverse effects without enhancing the therapeutic effects.
Treatment of large skin areas requires monitoring of the number of tubes used.
The product should be applied in separate spots, then spread using gentle massage to ensure that the product is entirely absorbed.
Some types of dermatosis (psoriasis, atopic dermatitis, etc.) require gradual discontinuation of treatment. This may be obtained by decreasing the frequency of applications and/or using less potent corticosteroids or a weaker pharmaceutical form.

Not applicable.

Hypersensitivity to one of the products contained in the preparation.

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, which is particularly difficult, is then required.
The product is not recommended in patients with acne, rosacea and perioral dermatitis.
The product should not be applied on skin areas affected by bacterial and mycobacterial, viral, fungal, parasitic infections or ulcerous wounds.
Due to the systemic penetration of corticosteroids, treatment of large skin areas or application under occlusive dressings may induce the systemic effects of systemic corticosteroid therapy, particularly in infants and young children. Those effects consist in a cushingoid syndrome and growth retardation. The effects resolve following treatment discontinuation, but abrupt discontinuation may be followed by acute adrenal failure.
In the event of application to the eyelid, the duration of treatment must be limited. Prolonged application exposes the patient to the risk of glaucoma.
Visual disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Special precautions for use: In infants, corticosteroids of medium potency should preferably be avoided.
Particular attention must be paid to avoid spontaneous occlusive phenomena, which occur in skin folds or under diapers.
In the event of bacterial or fungal superinfection of a corticosteroid-responsive dermatosis, use specific treatment before the corticosteroid treatment.
If signs of local intolerance develop, discontinue the treatment and conduct an etiologic investigation.
Effects on the ability to drive and use machines: Not applicable.

Pregnancy: No teratogenicity study has been conducted with local corticosteroids.
However, the studies conducted on oral corticosteroids have not shown any evidence of a higher risk of malformation than that observed in the overall population. In consequence, topical corticosteroids may be prescribed during pregnancy, if required.
Lactation: Breast-feeding is possible during treatment with this medicinal product.
Do not apply the product to the breasts during lactation, due to the risk of product ingestion by the neonate.

Prolonged use of corticosteroids of medium potency may induce cutaneous atrophy, telangiectasia (particularly on the face), striae atrophicae (at the roots of the limbs in particular and occurring more readily in adolescents), ecchymotic purpura secondary to atrophy, and cutaneous fragility.
On the face, corticosteroids may give rise to peri-oral dermatitis or exacerbate rosacea.
Delayed cicatrization of atonic wounds, decubitus ulcers and leg ulcers may be observed.
Risk of systemic effects.
Acneiform or pustular rash, hypertrichosis and depigmentation have been reported. Secondary infections, particularly under occlusive dressings or in skin folds, in contact allergic dermatitis, have also been reported during the use of local corticosteroids.
The following adverse reactions have been reported in post-marketing (frequency = unknown): Skin infection; Allergic contact dermatitis; Pruritus; Skin burning sensation; Erythema; Rash; Vision, blurred (see Precautions).

The concomitant use of other corticosteroids in the form of tablets, drops or injections may intensify the side effects.

Store at a temperature not exceeding 25°C.

Topical Corticosteroids

D07AB08 - desonide ; Belongs to the class of moderately potent (group II) corticosteroids. Used in the treatment of dermatological diseases.

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