Clobeskine cream 0.05% tube 25 g

Dosage form. Cream.

Pharmacotherapeutic group.
Corticosteroids for use in dermatology. Highly active corticosteroids (group IV). Clobetasol. ATS code D07A D01.

Clinical characteristics.
Indications.
Psoriasis (except widespread plaque psoriasis), persistent eczema, lichen planus, discoid lupus erythematosus and other skin diseases that are not amenable to treatment with less active corticosteroids.

Contraindications.
Rosacea, acne and perioral dermatitis.
Perianal and genital itching.
Skin lesions caused by viruses (herpes simplex virus, chickenpox).
Hypersensitivity to the components of the drug.
Skin lesions primarily infected with fungi or bacteria; dermatoses in children under one year of age, including dermatitis and diaper rash.

Method of application and dosage.
The cream should be applied in a thin layer to the affected areas of the skin 1-2 times a day until the condition improves. As with the use of other highly active corticosteroids, after achieving control of the disease, treatment should be discontinued. Improvement from treatment occurs individually, in patients who tolerate treatment well, the result may appear after a few days. It is recommended to continue treatment for no more than 4 weeks; if the condition does not improve, it is necessary to clarify or revise the diagnosis.
To prevent exacerbation of the disease, repeated short courses of treatment with the drug can be carried out. If long-term continuous treatment with steroids is necessary, other, less potent, drugs should be used.
In very persistent lesions, especially in areas of hyperkeratosis, the anti-inflammatory effect of the drug Clobeskine can be enhanced by covering the affected area being treated with polyethylene film. To achieve a positive result, apply an airtight bandage overnight. The effect already achieved is maintained by simply applying the drug to the skin without covering with a film.

Adverse reactions.
Adverse reactions are classified by organs and systems and by frequency of occurrence. By frequency of occurrence, adverse reactions are divided into the following categories: very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥ 1/10000, <1/1000), very rarely (<1/10000), including isolated cases.
From the immune system:very rarely – hypersensitivity. Local hypersensitivity reactions such as erythema, rash, itching, urticaria, local burning of the skin and allergic contact dermatitis may occur at the application sites and be similar to the symptoms for which the drug was prescribed.
If signs of hypersensitivity occur, the use of the drug must be discontinued immediately.
On the part of the endocrine system: very rarely – signs of hypercorticism. As with other topical corticosteroids, prolonged use in large quantities or application to large areas may lead to signs of hypercorticism due to significant systemic absorption. Such cases are most likely if the drug is used in infants and children, as well as when using an airtight dressing. In infants, diapers act as an airtight dressing.
Provided that the weekly dose of the drug in adults does not exceed 50 g, any suppression of the pituitary or adrenal glands is likely to be temporary, with a rapid return to normal as soon as the short course of steroid therapy is discontinued.
Vascular system: infrequently – dilation of superficial blood vessels.
Prolonged and intensive treatment with highly active corticosteroid drugs can cause dilation of superficial blood vessels, especially when using hermetic bandages or rubbing the drug into skin folds.
Skin and subcutaneous tissue: infrequently – local atrophy, atrophic skin stripes; very rarely – thinning of the skin, changes in pigmentation, hypertrichosis, exacerbation of the main symptoms, pustular psoriasis.
Prolonged and intensive treatment with highly active corticosteroid drugs can cause atrophic changes, such as atrophic skin stripes and thinning of the skin, especially when using hermetic bandages or rubbing the drug into skin folds.

Overdose.
The probability of acute overdose is very small. In case of chronic overdose or misuse, signs of hypercorticism may occur, requiring a reduction or gradual discontinuation of the use of topical corticosteroids, which must be carried out under medical supervision, given the risk of adrenal insufficiency.

Use during pregnancy or breastfeeding.
Topical steroids should not be widely used to treat pregnant women in large doses or for a long time.
Lactation
The safety of clobetasol propionate during lactation has not been established.

Children.
The drug is contraindicated for the treatment of dermatoses in children under one year of age, including dermatitis and diaper rash.

Features of use.
Prolonged use of Clobeskin should be avoided, especially in infants and children, due to the possibility of adrenal suppression even without the application of an occlusive dressing. If it is necessary to use Clobeskin in children, it is recommended to review the course of treatment every week. It should be noted that diapers in infants can act as an airtight dressing.
Prolonged use of potent topical steroids can lead to atrophic changes in the skin, especially on the face. This should be borne in mind when treating lesions such as psoriasis, discoid lupus erythematosus and severe eczema.
If the drug is applied to the eyelids, care should be taken to ensure that it does not get into the eye, as this may cause glaucoma.
The use of topical steroids for the treatment of psoriasis may in some cases lead to relapse of the disease, the development of tolerance, increase the risk of generalized pustular psoriasis and the development of local or systemic (reversible suppression of the hypothalamic-pituitary-adrenal system) toxicity due to impaired skin barrier function. Therefore, careful patient care is important when treating psoriasis with Clobetasol Propionate.
In the case of treatment of infected skin inflammations, appropriate antimicrobial therapy should be carried out. Any spread of infections requires discontinuation of topical corticosteroid therapy and the use of appropriate systemic antimicrobial therapy. The skin should be cleansed before applying occlusive dressings, because the heat and moisture that form under the dressing contribute to the development of bacterial infection.
Patients should wash their hands after applying Clobetasol Propionate, unless the drug is intended for the treatment of the hands.
Clobetasol Propionate cream should not be diluted.

Ability to influence the reaction rate when driving or operating other mechanisms.
Clobetasol propionate does not affect the ability to drive or operate machinery.

Interaction with other medicinal products and other types of interactions.
Drug interactions of the drug are not described.

Pharmacological properties.
Pharmacodynamics. The main effect of clobetasol propionate on the skin is a nonspecific anti-inflammatory effect due to vasoconstriction and a decrease in collagen synthesis.
Pharmacokinetics.The penetration of clobetasol propionate through the skin varies between individuals and may be increased by the use of occlusive dressings or by inflammation or skin damage. In subjects with healthy skin, mean peak plasma concentrations of clobetasol propionate of 0.63 ng/mL were observed in one study 8 hours after the second application (13 hours after the first application) of 30 g of 0.05% clobetasol propionate ointment. Following a second dose of 30 g of 0.05% clobetasol propionate cream, mean peak plasma concentrations were slightly higher than those observed with the ointment and were observed 10 hours later. In another study, mean peak concentrations (approximately 2.3 ng/mL and 4.6 ng/mL) were observed, respectively, in patients with psoriasis and eczema 3 hours after a single application of 25 g of 0.05% clobetasol propionate ointment. After absorption through the skin, the drug most likely undergoes the same metabolic pathway as corticosteroids after systemic administration. However, the systemic metabolism of clobetasol has not been fully established.

Pharmaceutical characteristics.
Main physicochemical properties: opaque white or almost white cream, homogeneous consistency.

Shelf life. 2 years.

Storage conditions.
Store in original packaging at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Packaging.
Cream 0.05%, 25 g in tubes in a box.