Poverkort

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PОWЕRCORT (POWERCORT)

Composition:

Active substance: clobetasol;

1 g of cream contains 0.5 mg of clobetasol propionate;

Excipients: mineral oil, white soft paraffin, non-ionic emulsifying wax, methylparaben (E 218), propylparaben (E 216), butylhydroxytoluene (E 321), propylene glycol, sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate anhydrous, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: soft white cream.

Pharmacotherapeutic group.

Corticosteroids for topical use. Simple corticosteroids. Very potent corticosteroids (group IV). Clobetasol.

ATC code D07AD01.

Pharmacological properties.

Pharmacodynamics.

The primary effect of clobetasol propionate on the skin is a non-specific anti-inflammatory action due to vasoconstriction and reduced collagen synthesis.

Pharmacokinetics.

The penetration of clobetasol propionate through the skin varies among individuals and may be increased when using occlusive dressings or in the presence of skin inflammation or damage. In individuals 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. After administration of a second dose of 30 g of 0.05% clobetasol propionate cream, mean peak plasma concentrations were slightly higher than with the ointment and were observed at 10 hours. In another study, mean peak concentrations (approximately 2.3 ng/mL and 4.6 ng/mL) were observed in patients with psoriasis and eczema, respectively, 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 administered systemically. However, the systemic metabolism of clobetasol has not been fully established.

Clinical Characteristics.

Indications.

Clobetasol is a highly potent topical corticosteroid indicated for short-term use in adults, elderly patients, and children aged 1 year and older, for the treatment of relatively more resistant inflammatory and pruritic manifestations of steroid-responsive dermatoses that are unresponsive to less potent corticosteroids.

Such conditions include:

• psoriasis (excluding generalized plaque psoriasis);
• dermatoses that are difficult to treat;
• lichen planus;
• discoid lupus erythematosus;
• other skin disorders unresponsive to less potent corticosteroids.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Untreated skin infections.

Rosacea.

Common acne.

Pruritus without inflammation.

Perianal and genital pruritus.

Perioral dermatitis.

Poverkort is not intended for the treatment of dermatoses in children under 1 year of age, including diaper dermatitis and diaper rash.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with agents capable of inhibiting CYP3A4 (e.g., ritonavir, itraconazole, cobicistat) inhibits corticosteroid metabolism, potentially leading to increased systemic effects. The clinical significance of such an interaction depends on the dose of the drug, the route of administration of the corticosteroid, and the potency of the CYP3A4 inhibitor.

Special precautions for use.

Serious osteonecrotic infections (including necrotizing fasciitis) and systemic immunosuppression (sometimes leading to reversible Kaposi's sarcoma-related lesions) have been reported with prolonged use of clobetasol propionate beyond recommended doses (see section "Dosage and administration"). In some cases, patients were concurrently using other potent oral/topical corticosteroids or immunosuppressants (e.g., methotrexate, mycophenolate mofetil). If treatment with topical corticosteroids is clinically justified for longer than 4 weeks, consideration should be given to switching to a less potent corticosteroid agent.

The medicinal product should be used with caution in patients with a history of local hypersensitivity reactions to corticosteroids or any excipients. Local hypersensitivity reactions (see section "Side effects") may mimic symptoms of the condition being treated.

Manifestations of hypercorticism (Cushing's syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis with adrenal insufficiency in some individuals may result from increased systemic absorption of topical steroids. If any of the above symptoms occur, treatment should be gradually discontinued by reducing the frequency of application or switching to a less potent corticosteroid. Abrupt discontinuation may lead to glucocorticoid insufficiency (see section "Side effects").

Risk factors for systemic effects include:

• Potency and formulation of the topical steroid;
• Duration of use;
• Application over a large surface area;
• Use on occlusive skin areas, such as skin folds or under occlusive dressings (in infants, diapers may act as occlusive dressings);
• Increased hydration of the stratum corneum;
• Application to areas with thin skin, such as the face;
• Application to damaged skin or conditions with impaired skin barrier function.

Compared to adults, children may absorb a proportionally greater amount of topical corticosteroid and are therefore more susceptible to systemic adverse effects. This is due to children having an underdeveloped skin barrier and a larger skin surface area relative to body mass compared to adults.

Children

Prolonged use of topical corticosteroids in infants and children under 12 years of age should be avoided whenever possible, as they are at higher risk of adrenal suppression.

Children are more prone to developing atrophic changes with topical corticosteroids. Treatment of children with Poverkort should not last longer than 5 days, if possible. The need for continued treatment should be reviewed weekly.

Risk of infection with occlusive dressings

Poverkort must not be used in children under occlusive dressings.

The risk of bacterial infections increases in warm and moist conditions, particularly under occlusive dressings. Therefore, the skin should be thoroughly cleaned before each dressing application.

Psoriasis treatment

Topical corticosteroids should be used with caution in the treatment of psoriasis, as in some cases, relapses, development of tolerance, risk of generalized pustular psoriasis, and local or systemic toxicity due to impaired skin barrier function have been reported. When used for psoriasis, patients should be under close medical supervision.

Concomitant infections

Appropriate antibacterial therapy should always be prescribed when treating infected inflammatory lesions. If infection spreads, topical corticosteroids should be discontinued and appropriate antibacterial treatment initiated.

Chronic leg ulcers

Topical corticosteroids are sometimes used to treat dermatitis around chronic leg ulcers. However, such use is associated with an increased incidence of local hypersensitivity reactions and a higher risk of local infections.

Application to the face

Application of the cream to facial skin is not recommended, as this area is more susceptible to atrophic changes. If necessary, use should be limited to 5 days.

Application to eyelids

When applying the cream to the eyelids, care should be taken to avoid contact with the eyes, as repeated exposure may lead to cataract and glaucoma.

Visual disturbances

Visual disturbances may occur with both systemic and topical use of corticosteroids. If a patient experiences symptoms such as blurred vision or other visual disturbances, they should be referred to an ophthalmologist to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported after systemic and topical corticosteroid use.

Poverkort cream contains:

• Propylene glycol, which may cause skin irritation;
• Methylparaben (E 218) and propylparaben (E 216), which may cause allergic reactions (possibly delayed);
• Butylated hydroxytoluene (E 321), which may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes;
• Paraffin. Patients should be warned not to smoke or be near open flames due to the risk of severe burns. If the medicinal product comes into contact with fabric (clothing, bed linen, dressings, etc.), the material may ignite easily and cause a serious fire. Washing clothing and bed linen reduces paraffin accumulation in fabric but does not completely eliminate it.

Use during pregnancy or breastfeeding.

Pregnancy

Data on the use of Poverkort in pregnant women are limited.

Topical application of corticosteroids in pregnant animals has been shown to cause developmental toxicity. The relevance of these findings to humans is unknown. Clobetasol may be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus. The smallest effective amount for the shortest duration should be used.

Breastfeeding

The safety of clobetasol propionate during breastfeeding has not been established. It is unknown whether topical corticosteroids can be systemically absorbed to an extent that measurable levels of the drug appear in breast milk. Poverkort should be used during breastfeeding only if the expected benefit to the mother outweighs the potential risk to the infant. If prescribed during breastfeeding, the cream should not be applied to the breasts to avoid accidental oral exposure of the infant.

Ability to affect reaction speed when driving or operating machinery.

No studies have been conducted to assess this effect. Given the side effect profile, no influence on reaction speed during driving or operating machinery is expected.

Method of administration and dosage.

The cream is particularly suitable for the treatment of moist and weeping skin areas.

Apply the cream gently in a thin layer, covering all affected areas of the skin, once or twice daily until improvement of clinical symptoms occurs (with adequate response to treatment, improvement is usually achieved within a few days). Thereafter, reduce the frequency of application or switch to a less potent preparation. After each application of the cream, wait for a certain period to allow complete absorption before applying a moisturizer. If clinical symptoms worsen or do not improve within 2–4 weeks, the diagnosis and treatment should be reevaluated.

For control of flare-ups, repeated short courses of treatment with Poverkort may be used. Treatment should not last longer than 4 weeks. If long-term continuous therapy is required, less potent agents should be used.

The maximum weekly dose should not exceed 50 g.

In cases of more resistant lesions, especially those with hyperkeratosis, the effect of Poverkort may be enhanced, if necessary, by covering the affected skin area with an occlusive polyethylene dressing. Usually, applying the occlusive film only overnight is sufficient to achieve a satisfactory result. The improvement achieved is typically maintained by applying the cream without the occlusive dressing.

Once disease control is achieved, treatment with clobetasol should be gradually discontinued, and a moisturizer should continue to be used as maintenance therapy.

Recurrence of previous dermatoses may occur with abrupt discontinuation of clobetasol.

For topical use only.

Dermatoses that are difficult to treat. Patients with frequent disease flare-ups.

As soon as the effect of continuous topical corticosteroid therapy has been achieved during the acute phase of the disease, intermittent application (once daily, twice weekly, without occlusive dressing) should be considered. This regimen has been shown to effectively reduce the frequency of flare-ups.

Continue applying the product to all previously affected skin areas or to known sites of potential flare-up. This treatment regimen should be combined with daily continuous use of emollients. The patient's clinical condition, as well as the benefits and risks of continued treatment, should be regularly assessed.

Children.

Poverkort is contraindicated for the treatment of dermatoses in children under 1 year of age, including dermatitis and diaper rash.

Overdose.

Symptoms and signs.

With regular use, Poverkort may be absorbed in quantities sufficient to produce systemic effects. The likelihood of acute overdose is very low; however, with chronic overdose or improper use, signs of hypercortisolism may occur.

Treatment.

In case of overdose, Poverkort should be gradually withdrawn by reducing the frequency of cream application or replaced with a less potent corticosteroid due to the risk of developing glucocorticoid insufficiency.

Further treatment should be based on the patient's clinical condition or current guidelines for the management of poisoning.

Adverse Reactions

The adverse reactions listed below are classified by system organ class and frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), including isolated cases.

Infections and infestations

Very rare: Opportunistic infections.

Immune system disorders

Very rare: Local hypersensitivity.

Endocrine system disorders

Very rare: Suppression of the hypothalamic-pituitary-adrenal (HPA) axis: Cushingoid signs (e.g., moon face, central obesity), suppression of weight gain/growth in children, osteoporosis, hyperglycemia/glucosuria, arterial hypertension, weight gain/obesity, decreased levels of endogenous cortisol, alopecia, hair fragility.

Skin and subcutaneous tissue disorders

Common: Itching, sensation of local burning/pain in the skin.

Uncommon: Local skin atrophy*, atrophic striae*, telangiectasia*.

Very rare: Skin thinning*, skin wrinkling*, skin dryness*, pigmentary changes*, hypertrichosis, exacerbation of underlying symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne.

* Skin lesions secondary to local and/or systemic hypothalamic-pituitary-adrenal axis suppression.

General disorders and administration site conditions

Very rare: Irritation/pain at the application site.

Eye disorders

Very rare: Glaucoma, cataract.

Frequency not known: Visual blurring.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life

2 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging

15 g of cream in an aluminum tube, in a cardboard box.

Prescription status

Prescription only.

Manufacturer

Glenmark Pharmaceuticals Ltd. / Glenmark Pharmaceuticals Ltd.

Manufacturer's address and place of business

Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422 007, India /
Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422 007, India.