DERYLIFE
(Clobetasol)




COMPOSITION

1 g of cream contains

Active ingredient: clobetasol propionate 0.5 mg.

Excipients: paraffin, propylene glycol, chlorocresol, cetomacrogol, polyoxyl 40 hydrogenized castor oil, polyoxyl 15 hydroxy stearate, cetostearyl alcohol, purified water.

THERAPEUTIC INDICATIONS

- psoriasis;

- eczema (various forms);

- lichen ruber planus;

- discoid lupus erythematosus;

- dermal diseases resistant to therapy with less potent topical glucocorticosteroids.

The drug is recommended for use in patients with skin lesions accompanied by madescence and pronounced inflammation.

CONTRAINDICATIONS

- hypersensitivity to the drug components;

- acne erythematosa and acne vulgaris;

- skin cancer;

- prurigo nodularis;

- perioral dermatitis;

- perianal and genital itch;

- bacterial, viral and fungal skin diseases (herpes simplex, varicella, cutaneous tuberculosis, actinomycosis, etc.);

- widespread plaque and pustular psoriasis;

- age under 1 year;

- lactation period.

ADVERSE EFFECTS

A long-term administration of topical glucocorticosteroids in high doses or their application on large areas of skin may be accompanied by systemic absorption with subsequent development of hypercorticism symptoms. The risk of this complication is increased in children, especially when using occlusive dressings, while a diaper may serve as a dressing.

A prolonged treatment with highly active topical corticosteroids in high doses can cause atrophic skin changes, particularly its thinning, appearance of linear atrophies (striae), dilation of superficial blood vessels, especially when using occlusive dressings and applying the drug on the skin with folds. Skin pigmentation and hypertrichosis may develop. In rare cases, the treatment of psoriasis with topical glucocorticosteroids (or their cancellation) provokes the development of pustular psoriasis.

Sometimes Derylife can cause aggravation of disease symptoms.

DOSAGE AND ADMINISTRATION

Derylife cream is for external use.

Apply a thin layer of Derylife cream to the affected skin 1-2 times a day until the effect is achieved. The treatment cannot be performed for more than 4 weeks without assessing the need for its continuation. Repeated short courses of treatment with Derylife may be performed to treat exacerbations of skin diseases. If continued therapy with corticosteroids is needed, less active drugs should be used.

In particularly resistant cases, especially in the presence of hyperkeratosis, an anti-inflammatory effect of Derylife cream can be enhanced by imposing for the night a bandage made of polyethylene film to the site of the drug application, which is usually followed by a positive effect. In the future, the achieved effect can be maintained by application of an occlusive dressing.

SPECIAL INDICATIONS

It should be avoided to use topical glucocorticoids for long periods, particularly in the treatment of young children, as this may lead to suppression of adrenal function. The drug administration in children requires medical supervision at least once a week. Atrophic skin changes as a result of prolonged use of topical glucocorticoids may appear more often on the face than on other body areas.

When applying cream on eyelids care must be exercised to avoid eye contact because it can cause glaucoma.

The treatment of psoriasis with topical glucocorticoids may be accompanied with the development of the disease recurrences, tolerance to the drug, generalized pustular form of the disease, local or systemic toxicity due to impaired barrier function of the skin, therefore close follow-up of the patient is particularly important.

An appropriate antimicrobial therapy should be performed when a secondary infection develops. Any signs of generalized infection requires withdrawal of topical glucocorticoid therapy and administration of appropriate antimicrobial therapy.

Bacterial infection is encouraged by the warm, moist conditions caused by occlusive dressings, therefore the skin should be necessarily cleansed before a fresh dressing is applied.

Cream is not recommended to dilute.

PREGNANCY AND LACTATION

Derylife cream should be used with caution during pregnancy.

The safety of clobetasol propionate administration during lactation has not been established.

MANUFACTURED FORM AND PACKAGE

Derylife cream 50 g for external use in an aluminum tube.

1 tube together with a patient information leaflet in a carton box.

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