Cloveit

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KLOVATE® (CLOVATE®)

Composition:

Active substance: clobetasol;

1 g of ointment contains clobetasol propionate 0.5 mg;

Excipients: sorbitan sesquioleate, propylene glycol, white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: white, greasy, soft translucent mass.

Pharmacotherapeutic group. Topical corticosteroids.

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.

Skin penetration of clobetasol propionate varies among individuals and may increase with the use of occlusive dressings or in the presence of inflamed or damaged skin. In individuals with healthy skin, mean peak plasma concentrations of clobetasol propionate of 0.63 ng/mL may be observed 8 hours after the second application (13 hours after the first application) of 30 g of 0.05% clobetasol propionate ointment. After application of the second dose of 30 g of 0.05% clobetasol propionate cream, mean peak plasma concentrations may be slightly higher than with the ointment and may occur at 10 hours. Other peak concentrations (approximately 2.3 ng/mL and 4.6 ng/mL) may be observed at 3 hours after a single application of 25 g of 0.05% clobetasol propionate ointment in patients with psoriasis and eczema, respectively. After absorption through the skin, the drug is likely to undergo the same metabolic pathway as corticosteroids following systemic administration. However, the systemic metabolism of clobetasol has not been fully established.

Clinical characteristics.

Indications.

Psoriasis (except generalized plaque psoriasis), recalcitrant eczemas, lichen planus, discoid lupus erythematosus, and other skin disorders unresponsive to less potent corticosteroids.

Contraindications.

Untreated skin infections.

Rosacea.

Common acne.

Pruritus without inflammation.

Perianal and genital pruritus.

Perioral dermatitis.

Hypersensitivity to any component of the drug.

Clobetasol is not intended for the treatment of primarily infected skin lesions caused by fungi (e.g., candidiasis, tinea) or bacterial microorganisms (e.g., impetigo), dermatitis, diaper rash.

Interaction with other medicinal products and other forms of interactions.

Concomitant use with agents that may inhibit CYP3A4 (e.g., ritonavir, itraconazole) inhibits corticosteroid metabolism, potentially leading to systemic effects. The clinical significance of such 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.

Use the medication with caution in patients with a history of local hypersensitivity reactions to corticosteroids or any of the excipients. Local hypersensitivity reactions (see section "Adverse Reactions") may resemble 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 corticosteroids. If any of the aforementioned 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 "Adverse Reactions").

Risk factors for systemic effects include:

• Potency and formulation of the topical corticosteroid;
• Duration of treatment;
• Application over a large skin surface area;
• Use on skin surfaces in close contact (e.g., intertriginous areas) 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 under other conditions involving impaired skin barrier function;
• Children may absorb a proportionally greater amount of topical corticosteroid compared to adults and are therefore more susceptible to systemic adverse effects. This is due to their underdeveloped skin barrier and larger skin surface area relative to body mass.

Children.

Prolonged use of topical corticosteroids in children aged 1 to 12 years should be avoided whenever possible due to their higher risk of adrenal suppression.

Children are more susceptible to developing atrophic changes with topical corticosteroid use. If Klovait® is required for treatment in children, therapy should be limited to a few days and reviewed weekly.

Infection risk with occlusive dressings.

The risk of bacterial infections increases in warm and moist environments, such as those under occlusive dressings. Therefore, the skin should be thoroughly cleansed before each new dressing application.

Psoriasis treatment.

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

Concomitant infections.

When treating inflamed, infected lesions, appropriate antibacterial therapy should be administered. If infection spreads, topical corticosteroids should be discontinued and appropriate antibacterial treatment initiated.

Chronic leg ulcers.

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

Application to the face.

Applying ointment to facial skin is not recommended, as atrophic changes occur more frequently in this area. If necessary, use should be limited to a few days.

Application to the eyelids.

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

Visual disorders.

Visual disturbances may occur with systemic and topical corticosteroid use. If a patient experiences symptoms such as blurred vision or other visual disturbances, an ophthalmological examination should be performed to identify possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSC), which has been reported following systemic and topical corticosteroid use.

Serious osteonecrotic infections (including necrotizing fasciitis) and systemic immunosuppression (sometimes leading to reversible Kaposi's sarcoma lesions) have been reported with prolonged use of clobetasol propionate exceeding 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.

Healthcare providers should be aware that fabrics such as dressings, clothing, and bedding that come into contact with the medication may become highly flammable. Patients should be warned of this risk and advised to avoid open flames during treatment.

Klovait, ointment, contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding.

Pregnancy.

Data on the use of Klovait® in pregnant women are limited.

Topical application of corticosteroids in pregnant animals has caused fetal developmental abnormalities. The relevance of these findings to humans has not been established. Klovait® should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus. Use the minimum amount of medication for the shortest duration necessary.

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 amounts appear in breast milk. Klovait® should be used during breastfeeding only if the potential benefit to the mother outweighs the potential risk to the infant. If prescribed during breastfeeding, the ointment 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. Based on the adverse reaction profile, no effect on reaction speed when driving or operating machinery is expected.

Method of Administration and Dosage.

Clobetasol propionate belongs to the class of the most potent topical corticosteroids (Group IV), and prolonged use may lead to serious adverse effects (see section "Special Warnings and Precautions for Use"). If treatment with a topical corticosteroid remains clinically justified beyond 4 weeks, consideration should be given to switching to a less potent corticosteroid. Repeated, but short-term, courses of clobetasol propionate may be used to control exacerbations (see details below).

The ointment is particularly suitable for the treatment of dry skin surfaces, as well as skin with lichenified or scaly lesions.

The ointment should be applied in a thin layer to affected areas of the skin once or twice daily until improvement occurs. As with other highly potent corticosteroids, treatment should be discontinued once control of the disease is achieved. Improvement may occur within a few days in patients who respond well, although the time to response varies individually. Treatment is recommended not to exceed 4 weeks; if no improvement is observed, the diagnosis should be reconsidered or reviewed.

To prevent disease relapse, repeated short courses of treatment with Clovate® may be administered. If long-term continuous steroid therapy is required, alternative, less potent steroid preparations should be used.

For particularly resistant lesions, especially in areas of hyperkeratosis, the anti-inflammatory effect of Clovate® may be enhanced, if necessary, by covering the affected area with polyethylene film. For optimal results, apply the occlusive dressing overnight. Once improvement is achieved, maintain the therapeutic effect by simple application of the product to the skin without film coverage.

Children.

The medicinal product is contraindicated for the treatment of dermatoses, including dermatitis, in children under 1 year of age.

Overdose.

Symptoms.

With regular use, Clovate® may be absorbed in amounts 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, Clovate® should be gradually withdrawn by reducing the frequency of application or by replacing it with a less potent corticosteroid, due to the risk of glucocorticoid insufficiency.

Further management should be based on the patient's clinical condition or according to national guidelines for the treatment of poisoning, if applicable.

Side effects

Infections and infestations: opportunistic infections.

Immune system disorders: local hypersensitivity.

Endocrine system disorders: suppression of the hypothalamic-pituitary-adrenal (HPA) axis: Cushingoid features (e.g., moon face, central obesity), delayed growth and weight gain in children, osteoporosis, glaucoma, hyperglycemia/glucosuria, cataract, arterial hypertension, weight gain/obesity, decreased levels of endogenous cortisol, alopecia, brittle hair.

Skin and subcutaneous tissue disorders: pruritus, local sensation of burning/pain in the skin, local skin atrophy*, atrophic striae*, telangiectasia*, skin thinning*, skin wrinkling*, skin dryness*, pigmentary changes*, hypertrichosis, exacerbation of underlying symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria.

Visual disorders: blurred vision (see section "Special precautions"). If topical application involves use on eyelid skin, glaucoma or cataract may occur.

General disorders and administration site conditions: irritation/pain at application site.

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

Shelf life. 2 years.

Shelf life after first opening of the tube – 3 months.

Storage conditions. Store out of reach of children at a temperature not exceeding 25°C.

Packaging. 25 g ointment in a tube.

Prescription status. Prescription only.

Manufacturer:

Pharmaceutical Plant Elfarma A.T.

Manufacturer's name and address:
58-500 Jelenia Góra, ul. Wincentego Pola 21, Poland.