PROBET [Clobetasol propionate] 25 mg Cream for external use

instructions for the medical use of the medicinal product

PROBET

Tradename: Probet, Пробет

International non-proprietary name or generic name: clobetasol, клобетазол

Dosage form: cream for external use.

Composition for 1 tube:

active substance: clobetasol propionate 25 mg.

excipients: cetyl stearyl alcohol, glyceryl mono- and distearate, white petrolatum, light liquid paraffin, stearic acid, ethylparaben, glycerin, peregal O, purified water.

Pharmacotherapeutic group: Glucocorticosteroid (GCS) for local use

ATX code: D07AD01

Pharmacological properties

Pharmacodynamics

GCS for external use. Prevents the marginal accumulation of neutrophils, reduces inflammatory exudation and the production of lymphokines, inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, has local anti-inflammatory, antipruritic, antiallergic, antiexudative effects.

Pharmacokinetics

After application of clobetasol to the skin in the form of topical dosage forms for healthy skin, the average Cmax of the active substance is about 0.63 ng/ml and is achieved in plasma after approximately 8-13 hours. In patients with psoriasis and eczema, the average Cmax is achieved after approximately 3 hours after and is 2.3-4.6 ng/ml.

When applied to large areas of the skin, absorption is possible (damage to the integrity or inflammation of the skin increases absorption) and a systemic effect.

Metabolized mainly in the liver, a small part in the kidneys. Excreted in urine.

Indications for use

For short-term treatment of symptoms of inflammation and skin itching in dermatoses sensitive to corticosteroid therapy and unresponsive to less potent corticosteroids for adults, the elderly and children over one year of age:

• psoriasis (except for widespread plaque psoriasis);

• dermatoses that are difficult to treat;

• lichen planus;

• discoid lupus erythematosus;

• other skin diseases resistant to therapy with less potent glucocorticosteroids.

Contraindications

• hypersensitivity to clobetasol (or any other glucocorticosteroids) or any other component of the drug;

• untreated skin infections;

• rosacea (rosacea);

• acne;

• perioral dermatitis;

• skin itching in the absence of inflammation;

• perianal and genital itching;

• pregnancy;

• breastfeeding period;

• children under 1 year of age.

Method of administration and dosage

Externally.

The cream is recommended to be used to treat damp and weeping areas of the skin.

The drug should be applied in a thin layer and rubbed in gently, using in minimal quantities sufficient to cover the entire affected area 1 or 2 times a day until the condition improves, then the frequency of application should be reduced or the drug replaced with a less strong one. After each use, the product must be left for sufficient time to absorb before applying the emollient. To prevent exacerbations of skin diseases, short (intermittent) courses of treatment are carried out. For more persistent lesions, especially in the presence of hyperkeratosis, the effect of Probet cream, if necessary, can be enhanced by applying an occlusive dressing made of polyethylene film to the treatment site. Usually, applying an occlusive dressing overnight is sufficient to obtain a satisfactory response. Further improvement can usually be maintained by applying the drug without a bandage. If the condition worsens or does not improve within 2-4 weeks, the diagnosis and treatment should be re-evaluated.

Treatment should not last more than 4 weeks. If continued treatment is necessary, a less potent drug should be used.

The maximum dose should not exceed 50 g of cream per week. Treatment with the drug should be gradually withdrawn once disease control is achieved, and treatment with the emollient should be continued as maintenance therapy.

Abrupt withdrawal of the drug can lead to a relapse of previously existing dermatoses.

Dermatoses that are difficult to treat: patients with frequent relapses of the disease

In case of acute illness, once the effect of a continuous course of treatment with Probet is achieved, the possibility of intermittent use of the drug (once a day, twice a week, without an occlusive dressing) may be considered. This treatment has been shown to effectively reduce the incidence of relapses. Application of the drug should be continued to all previously affected areas of the skin or to know areas of potential exacerbation. This regimen should be combined with routine daily use of emollients. The patient's condition and the benefits and risks of continuing treatment should be regularly assessed.

Application on the face

Use in the facial area is undesirable, since this area is more susceptible to atrophic changes.

Treatment courses should be limited to five days, and the use of occlusive dressings is not recommended.
Special patient groups

Children. Children are more likely to develop local and systemic side effects from topical corticosteroid therapy and generally require shorter courses of treatment using less active agents than adults. Caution should be exercised when using Cloveit® in children to ensure that the drug is applied in the minimum amount necessary to achieve a therapeutic effect. The course of treatment in children should be limited, if possible, to five days; Observation by a doctor is required at least once a week. Occlusive dressings should not be used.

Elderly patients and patients with impaired renal/liver function. The drug should be used in minimal quantities and for the shortest possible period to achieve the required clinical effect.

Patients should be advised to wash their hands after using Probet cream, unless the drug is prescribed for the treatment of hands.

Side effect

The adverse events presented below are listed depending on the anatomical and physiological classification and frequency and occurrence. The frequency of occurrence is defined as follows: very common (≥ 1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10000 and <1 /1000), very rare (<1/10000, including isolated cases). Frequency categories were formed based on clinical trials of the drug and post-marketing surveillance.

Frequency of occurrence of adverse events
Infectious and parasitic diseases

Very rare: infection caused by opportunistic organisms.

Immune system disorders

Very rare: hypersensitivity.
Endocrine system disorders

Very rare: suppression of the hypothalamic-pituitary-adrenal system. Cushingoid signs (moon face, central obesity), delayed weight gain and/or growth retardation in children, osteoporosis, glaucoma, hyperglycemia and/or glycosuria, cataracts, hypertension, weight gain or obesity, decreased endogenous cortisol levels, alopecia, hair fragility.
Skin and subcutaneous tissue disorders

Common: itching, burning sensation or soreness.

Uncommon: local skin atrophy, striae, telangiectasia.

Very rare: thinning, wrinkling of the skin, dry skin, changes in pigmentation, hypertrichosis, worsening of disease symptoms, allergic contact dermatitis, pustular psoriasis, erythema, rash, urticaria.
General and administration site disorders

Very rare: irritation and/or soreness at the application site.

Skin manifestations are secondary to local and/or systemic effects of hypothalamic-pituitary-adrenal axis suppression.

When applied to large surfaces over a long period of time (for example, more than 2 weeks), patients may develop systemic side effects: gastritis, ulceration of the gastrointestinal mucosa, increased intraocular pressure; symptoms of hypercortisolism.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction with other medicinal products

Coadministration of drugs that can inhibit CYP3A4 (e.g., ritonavir and itraconazole) is known to inhibit the metabolism of corticosteroids, resulting in increased systemic exposure. The extent to which this interaction is clinically significant depends on the dose and route of administration of the corticosteroid and the activity of the CYP3A4 inhibitor.

Special instructions and precautions

Before using the drug, consult your doctor.

Local hypersensitivity reactions may be similar to the symptoms of an ongoing disease.

In some patients, as a result of increased systemic absorption of glucocorticosteroids for external use, manifestations of hypercortisolism (Cushing's syndrome) and reversible inhibition of the hypothalamic-pituitary-adrenal system may occur, leading to the development of glucocorticosteroid insufficiency. If any of the above violations are observed, the drug should be discontinued, gradually reducing the frequency of its application, or replaced with a less active glucocorticosteroid. Abrupt cessation of treatment may lead to the development of glucocorticosteroid deficiency.

During drug therapy, periodic monitoring of the function of the adrenal cortex is necessary by determining the level of cortisol in the blood and urine after stimulation of the adrenal glands with adrenocorticotropic hormone (ACTH). Risk factors for increased systemic effects include: the activity of the glucocorticosteroid and the composition of the drug for external use, duration of use, application of the drug to large areas of skin, use in closed areas of the skin (for example, in areas with diaper rash or under an occlusive dressing (diapers and nappies in infants) can play the role of an occlusive dressing)), increased hydration of the stratum corneum, use on areas with thin skin, such as the face; application to damaged skin or other conditions that may involve compromised skin barrier integrity. Use in children

Probet cream should be used with caution, especially as long-term therapy, in children over one year of age, since in this group of patients, due to a higher ratio of body surface area to body weight than in adults, a proportionately larger amount of glucorticosteroids can be absorbed and develop faster. dysfunction of the hypothalamic-pituitary-adrenal system and systemic undesirable effects characteristic of glucorticosteroids, including growth and development delay. If possible, long-term treatment with topical glucocorticosteroids should be avoided in children under 12 years of age, since long-term topical use of glucocorticosteroids may cause suppression of adrenal function. In children, more often than in adults, atrophic changes in the skin occur with external use of glucocorticosteroids. When prescribing Probeta therapy to children, the course of treatment should be limited to five days, and observation by a doctor is also required at least once a week. Do not use occlusive dressings.

Use for psoriasis

The drug should be used with extreme caution in patients with psoriasis, due to possible relapse of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis and the development of local or systemic toxic reactions due to impaired skin barrier function. Patients with psoriasis should be under medical supervision during treatment.

Concomitant infection

In case of development of a secondary bacterial or fungal infection, it is necessary to prescribe external use of an antibacterial or antifungal drug. If symptoms of infection spread, you should stop using the drug until the infection has resolved.

Risk of infection due to occlusion

Warm, moist conditions in skin folds, as well as the conditions created when applying an occlusive dressing, promote the development of bacterial infection. When using an occlusive dressing, the skin should be cleaned before applying a new dressing.

Chronic leg ulcers

Glucocorticosteroids for external use are in some cases used to treat dermatitis around chronic leg ulcers. However, such use may be accompanied by an increased incidence of local hypersensitivity reactions and an increased risk of local infections.

Application on the face and eyelids

Since facial skin is more susceptible to the development of atrophic changes, the use of the drug is undesirable. When prescribed - therapy for no more than 5 days.

The drug should be used with caution on the skin around the eyes or eyelids due to the risk of developing glaucoma or cataracts, as well as in patients with a history of these diseases, who may experience an exacerbation of these diseases. Avoid contact of the cream with the eyes and mucous membranes. If the drug accidentally gets into your eyes, rinse them thoroughly with water.

Risk of developing central serous chorioretinopathy

If a patient experiences symptom such as blurred vision or other visual disturbances, consider referring the patient to an ophthalmologist to investigate possible causes of the disturbance, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy.

Use in elderly patients

The drug should be used with caution in case of existing atrophic changes in the subcutaneous tissue, especially in the elderly.

Overdose

Symptoms: the development of acute overdose is unlikely. In case of chronic overdose or improper use of the drug, symptoms of hypercortisolism may develop.

Treatment: in case of overdose, the drug should be gradually discontinued, reducing the frequency of its application or replacing it with a less active glucocorticosteroid, under medical supervision due to the risk of adrenal insufficiency. Further treatment should be carried out taking into account the clinical situation.

Release form

50 g of cream in an aluminum tube with a polypropylene lid. One tube along with instructions for use in a cardboard box.

Storage conditions

Store at temperatures below 30°C.

Keep out of the reach of children!

Shelf life

3 years. Do not use after the expiration date stated on the packaging.

Vacation conditions

By prescription.