Powercourt, 0.05% cream 15 g

Mechanism of action

The glucocorticosteroid for external use.

Prevents marginal accumulation of neutrophils reduces inflammatory exudation and production of lymphokines inhibits macrophage migration reduces the intensity of infiltration and granulation processes has local anti-inflammatory antipruritic anti-allergic and anti-exudative effects.

Pharmacokinetics:

Indications

Clobetasol is a very strong glucocorticosteroid indicated for the short-term treatment of symptoms of inflammation and itching in dermatoses sensitive to glucocorticosteroid therapy and when immune to less strong glucocorticosteroids (for older adults and children over 1 year old):

Active ingredient

Composition

Active ingredient:

Clobetasol propionate 0.05 g.

Auxiliary substances:

Paraffin (soft, white);

Liquid paraffin;

Cetomacrogol;

Sodium phosphate monohydrate;

Sodium phosphate dihydrate;

butyl hydroxytoluene;

methyl parahydroxybenzoate;

propylparahydroxybenzoate;

propylene glycol;

purified water.

How to take, the dosage

Externally.

The cream is recommended for use in skin lesions accompanied by mucous membranes.

The cream is applied in a thin layer as little as is needed to cover the entire affected area once or twice a day and rubbed in gently. It can be used for a long time or as long as needed up to 4 weeks. Do not use for a period longer than 4 weeks. If prolonged treatment is necessary, gradually reduce the frequency of application or use a less active product. After each application of Powercort, allow sufficient time for absorption before applying the emollient.

Short (intermittent) courses of Powercort are used to prevent exacerbations of skin conditions.

In particularly resistant cases, particularly in the presence of hyperkeratosis, the effect of the Powercort external application cream may be augmented if necessary by an overnight application of an occlusive dressing (polyethylene film) over the application area which is usually followed by a positive symptom response. Thereafter, the achieved effect can usually be maintained without the use of an occlusive dressing.

If the condition worsens or does not improve within 2-4 weeks, the diagnosis and ongoing treatment should be reconsidered. The maximum dose should not exceed 50 g of cream per week.

The treatment with Powercort should be phased out as soon as disease control has been achieved and the emollient treatment should be continued as maintenance therapy.

The abrupt withdrawal of Powercort may lead to a recurrence of pre-existing dermatoses.

The use in the facial area

The course of treatment should be limited to 5 days if possible; occlusive dressings should not be used.

Hard-to-treat dermatoses: patients with frequent recurrences

In cases of acute disease, once a continuous course of topical glucocorticosteroid treatment has been achieved, intermittent use (once daily or twice weekly without an occlusive dressing) may be considered. This treatment has been shown to be effective in reducing the rate of recurrence. Application of the drug should be continued to all previously affected skin areas or known areas of potential exacerbation. This regimen should be combined with routine daily application of emollients. The condition and the benefits and risks of continued treatment should be evaluated regularly.

Pecial patient groups

Children

Children are more likely to have local and systemic side effects with topical glucocorticosteroid therapy and generally require shorter courses of treatment with less active agents than adults.

Powercort should be used with caution in children to ensure that it is applied in the minimum amount needed for therapeutic benefit.

The course of treatment in children should be limited to 5 days if possible; follow-up with a physician at least once a week is required. Occlusive dressings should not be used.

Patients in the elderly

Clinical studies have not shown any difference in efficacy between elderly and younger patients. The greater prevalence of reduced hepatic or renal function in elderly patients may result in slower excretion of the drug if it is systemically absorbed. Therefore, it should be used in elderly patients in minimal amounts and for as short a period as possible while ensuring that the desired clinical effect is achieved.

Patients with impaired renal and/or hepatic function

In case of systemic absorption of the drug (when applied to extensive skin surfaces over a prolonged period) its metabolism and excretion may be delayed leading to an increased risk of systemic toxicity. Therefore, it should be used in such patients in the minimum amount and for the shortest possible period, while ensuring the achievement of the desired clinical effect.

Interaction

Special Instructions

Powercort should be used with caution in patients with a history of local hypersensitivity to glucocorticosteroids or to any excipient of the drug.

The local hypersensitivity reactions may be similar to the symptoms of the underlying disease. In some individuals, increased systemic absorption of external glucocorticosteroids may result in manifestations of hypercorticism (Icenko-Cushing’s syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal system leading to development of glucocorticosteroid insufficiency.

If any of the above is observed, the drug should be withdrawn gradually reducing the frequency of application or replaced with a less active glucocorticosteroid. Sudden discontinuation of treatment may result in glucocorticosteroid failure.

Risk factors for increased systemic effects include: activity of the glucocorticosteroid and formulation of the drug for external use duration of use application to large areas of skin use in closed areas of skin (i.e. in intertriginous areas or under occlusive dressings (diapers and diapers on infants may act as occlusive dressings)) increased stratum corneum hydration Use in areas of thin skin, such as the face; application to damaged skin or other conditions that may compromise the integrity of the skin barrier

In comparison to adults, children and infants may have a higher rate of absorption of topical glucocorticosteroids, which may increase the risk of systemic side effects. This is because children have an immature skin barrier and a higher body surface area to body weight ratio than adults.

Per pediatric use

If possible, long-term external glucocorticosteroid treatment should be avoided in children younger than 12 years of age, because long-term external glucocorticosteroid use can cause inhibition of adrenal function.

Children are more likely than adults to have atrophic skin changes when glucocorticosteroids are used topically. If clobetasol is prescribed in children, the course of treatment should be limited to 5 days and monitoring by a physician at least once a week is required. Do not use occlusive dressings.

Application in psoriasis

In some cases, external treatment of psoriasis with glucocorticosteroids may be accompanied by a recurrence of symptoms, resistance to the drug, development of generalized pustular psoriasis and local or systemic toxicity due to skin barrier failure, so close monitoring of the patient is especially important.

Companying infection

If secondary infection occurs, appropriate antibiotic therapy should be given. External glucocorticosteroid use should be discontinued and appropriate antibacterial treatment should be given if there is any sign of spreading infection.

The risk of infection during occlusion

The warm, moist conditions created when the occlusive dressing is applied are conducive to bacterial infection, so be sure to clean the skin thoroughly before applying a new dressing.

Cronic shin ulcers

Over-the-counter glucocorticosteroids are sometimes used to treat dermatitis around chronic shin ulcers. However, such use may be accompanied by an increased incidence of local hypersensitivity reactions and an increased risk of local infections.

Application to the face

Application to the face is undesirable because this area is more prone to atrophic changes.

The treatment should be limited to 5 days when applied to the face.

Per application to the eyelids

When applying the cream to the eyelids, close attention must be paid to avoid getting it in the eyes because repeated use may cause cataracts and glaucoma. If you accidentally get the product in your eyes, flush them thoroughly with water.

Contraindications

Hypersensitivity, pink and juvenile acne, perioral dermatitis, bacterial, viral and fungal skin infections, genital and perianal itching, pregnancy and lactation, children (under 1 year).

Side effects

Externally.

The cream is recommended for use in skin lesions accompanied by mucous membranes.

The cream is applied in a thin layer as little as is needed to cover the entire affected area once or twice a day and rubbed in gently. It can be used for a long time or as long as needed up to 4 weeks. Do not use for a period longer than 4 weeks. If prolonged treatment is necessary, gradually reduce the frequency of application or use a less active product. After each application of Powercort, allow sufficient time for absorption before applying the emollient.

Short (intermittent) courses of Powercort are used to prevent exacerbations of skin conditions.

In particularly resistant cases, particularly in the presence of hyperkeratosis, the effect of the Powercort external application cream may be augmented if necessary by an overnight application of an occlusive dressing (polyethylene film) over the application area accompanied by a positive symptom response. Thereafter, the achieved effect can usually be maintained without the use of an occlusive dressing.

If the condition worsens or does not improve within 2-4 weeks, the diagnosis and ongoing treatment should be reconsidered. The maximum dose should not exceed 50 g of cream per week.

The treatment with Powercort should be phased out as soon as disease control has been achieved and the emollient treatment should be continued as maintenance therapy.

The abrupt withdrawal of Powercort may lead to a recurrence of pre-existing dermatoses.

The use in the facial area

The course of treatment should be limited to 5 days if possible; occlusive dressings should not be used.

Hard-to-treat dermatoses: patients with frequent recurrences

In cases of acute disease, once a continuous course of topical glucocorticosteroid treatment has been achieved, intermittent use (once daily or twice weekly without an occlusive dressing) may be considered. This treatment has been shown to be effective in reducing the rate of recurrence. Application of the drug should be continued to all previously affected skin areas or known areas of potential exacerbation. This regimen should be combined with routine daily application of emollients. The condition and the benefits and risks of continued treatment should be evaluated regularly.

Pecial patient groups

Children

Children are more likely to have local and systemic side effects with topical glucocorticosteroid therapy and generally require shorter courses of treatment with less active agents than adults.

Powercort should be used with caution in children to ensure that it is applied in the minimum amount needed for therapeutic benefit.

The course of treatment in children should be limited to 5 days if possible; follow-up with a physician at least once a week is required. Occlusive dressings should not be used.

Patients in the elderly

Clinical studies have not shown any difference in efficacy between elderly and younger patients. The greater prevalence of reduced hepatic or renal function in elderly patients may result in slower excretion of the drug if it is systemically absorbed. Therefore, it should be used in elderly patients in minimal amounts and for as short a period as possible while ensuring that the desired clinical effect is achieved.

Patients with impaired renal and/or hepatic function

In case of systemic absorption of the drug (when applied to extensive skin surfaces over a prolonged period) its metabolism and excretion may be delayed leading to an increased risk of systemic toxicity. Therefore, it should be used in such patients in the minimum amount and for the shortest possible period, while ensuring the achievement of the desired clinical effect.

Overdose

Symptoms and Signs

Powercort when used topically may be absorbed in amounts sufficient to cause systemic effects. The development of an acute overdose is unlikely. However, in case of chronic overdose or improper use of Powercort, symptoms of hypercorticism may develop.

Treatment

In case of an overdose of Powercort, the drug should be gradually withdrawn by reducing the frequency of application or replaced with a less active glucocorticosteroid under medical supervision because of the risk of adrenal insufficiency.

Particular further treatment should be based on the clinical situation or as recommended by the poison center, if available.

Pregnancy use

Fertility

There are no data to evaluate the effect of external glucocorticosteroids on fertility in humans. When administered subcutaneously to rats, clobetasol had no effect on mating ability; however, when administered in high doses, a decrease in fertility was noted.

Pregnancy

There are insufficient data on the use of clobetasol in pregnant women.

According to preclinical studies, clobetasol may adversely affect fetal development.

The significance of this data in humans has not been studied.

The drug should be used during pregnancy only if the potential benefit to the mother outweighs the possible risk to the fetus.

If the drug is prescribed during pregnancy, the minimum amount of cream should be used for the shortest possible time.

The period of breastfeeding

The use of the drug during breastfeeding is contraindicated.

Similarities