Cortiderm

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KORTIDERM (CORTIDERM)

Composition:

Active substance: hydrocortisone butyrate;

1 g of the preparation contains hydrocortisone butyrate 1 mg;

Excipients: cetostearyl alcohol, cetostearyl polyethylene glycol ether, mineral oil, white soft paraffin, methylparaben (E 218), propylparaben (E 216), citric acid anhydrous, sodium citrate, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: white-colored cream.

Pharmacotherapeutic group. Corticosteroids for dermatological use.

ATC code D07AB02.

Pharmacological properties.

Pharmacodynamics.

Hydrocortisone butyrate is an active synthetic non-halogenated corticosteroid for topical use. It exerts anti-inflammatory, anti-edematous, and antipruritic effects. Its efficacy is comparable to that of halogenated steroids. Use at recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal system. Although prolonged use of large doses of the drug, especially when using occlusive dressings, may lead to increased cortisol levels in blood plasma, the responsiveness of the pituitary-adrenal system remains unaffected, and discontinuation of the drug results in rapid normalization of cortisol production.

Pharmacokinetics.

Absorption. After application, accumulation of the active substance occurs in the epidermis, predominantly in the stratum granulosum.

Metabolism. Hydrocortisone butyrate, absorbed through the skin, is metabolized to hydrocortisone and other metabolites directly in the epidermis, and subsequently in the liver.

Excretion. Metabolites and a minor portion of unchanged hydrocortisone butyrate are excreted in urine and feces.

Clinical characteristics.

Indications.

Conditions that respond to treatment with topical corticosteroids (e.g., eczema, dermatitis, psoriasis). Topical corticosteroids are generally not indicated for the treatment of psoriasis, but may be acceptable except for widespread plaque psoriasis, provided that precautions are observed (see section "Special precautions").

Contraindications.

Except in cases of combined treatment with appropriate chemotherapeutic agents:

• Skin lesions (wounds) caused by bacterial infections (e.g., pyoderma, syphilitic or tuberculous lesions), viral infections (e.g., varicella, herpes simplex, herpes zoster, common warts, flat warts, genital warts, molluscum contagiosum), fungal and yeast infections, parasitic infections (e.g., scabies);
• ulcerative skin lesions;
• corticosteroid-induced adverse reactions (e.g., perioral dermatitis, striae);
• ichthyosis, juvenile plantar dermatosis, acne vulgaris, rosacea, cutaneous vascular fragility, skin atrophy;
• hypersensitivity reactions to components of the drug or to corticosteroids (the latter are rare);
• skin neoplasms.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

Special precautions for use.

Systemic adverse reactions with topical corticosteroids in adults are very rare but can be serious, particularly adrenal cortical suppression with prolonged use of the drug.

Systemic effects risk is increased in the following cases:

• application over large skin areas, especially when using occlusive dressings or application to skin folds;
• long-term treatment;
• use in children (due to thinner skin and relatively larger body surface area);
• presence of components or excipients enhancing penetration through the stratum corneum and/or potentiating the effect of the active substance.

Risk of local adverse reactions increases with the potency of the drug and duration of treatment. Use with occlusive dressings or application to skin folds further increases this risk. Facial skin, scalp, and genital areas are particularly susceptible to adverse reactions. Inappropriate use, as well as the presence of bacterial, parasitic, fungal, or viral infections, may mask and/or exacerbate manifestations of these diseases.

The cream should not be applied to the eyelids due to the possibility of contact with the conjunctiva and an increased risk of developing open-angle glaucoma or subcapsular cataract.

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, ophthalmological consultation is recommended to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which has been reported after systemic or topical corticosteroid use.

Topical corticosteroids may be hazardous in patients with psoriasis for several reasons, including rebound syndrome due to development of tolerance, risk of generalized pustular psoriasis, or local and systemic toxic effects due to impaired skin barrier function. Steroids may be used in scalp psoriasis or chronic plaque psoriasis of hands and feet. Careful monitoring of patients is essential.

Children, including infants.

Adverse effects may occur in infants with excessive use. Particular caution is required in dermatoses of infants, especially diaper dermatitis. In such patients, treatment duration should generally not exceed 7 days.

Adrenal cortex suppression (Cushing's syndrome) may develop rapidly in children. Growth hormone secretion may also be suppressed, and intracranial hypertension may occur. Signs of intracranial hypertension include bulging fontanelle, headache, and bilateral optic disc swelling. If long-term treatment is necessary, regular monitoring of the child's height, body weight, and plasma cortisol levels is advisable.

In comparative studies, no significant differences in adrenal cortical function were observed in children treated with 0.01% hydrocortisone butyrate cream or 1% hydrocortisone at doses of 30–60 grams per week over 4 weeks.

Excipients in the formulation.

Cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis).

Methylparaben (E 218) and propylparaben (E 216) may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

Pregnancy. Data on the use of hydrocortisone butyrate in pregnant women are lacking or limited. Animal studies indicate reproductive toxicity of the drug. Corticosteroids cross the placenta. Systemic use of high doses of corticosteroids has been associated with effects on the fetus or newborn (fetal growth retardation, adrenal cortical suppression).

Despite limited information on topical use of corticosteroids in pregnant women, due to their limited systemic absorption, short-term use of weak and moderate potency corticosteroids (classes 1 and 2), such as hydrocortisone, on limited skin areas may be considered. However, the aforementioned effects cannot be excluded with prolonged use or application over large skin areas. Such use should only be considered when specifically indicated.

Breastfeeding period. Hydrocortisone butyrate/metabolites are excreted in breast milk; however, when the drug is used at therapeutic doses, effects on breastfed newborns/infants are not expected. The drug may be used in breastfeeding women only for short-term treatment and on small skin areas. For long-term treatment or application over large areas of affected skin, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

There are no data on the effect of the drug on the ability to drive or operate machinery. Such an effect is not expected.

Method of Administration and Dosage

For topical use.

Apply a small amount of the preparation in a thin, even layer to the affected areas no more than twice daily.

Application under occlusive dressing may be used in cases of more resistant lesions, such as thickened psoriatic plaques on elbows and knees (except for weeping lesions).

Dosage

The total cumulative dose should not exceed 30–60 g of cream per week.

Adults and elderly patients

Adults and elderly patients should receive the same dosage, as there are no clinical data indicating that elderly patients require a special dosing regimen.

Children

Prolonged treatment should be avoided whenever possible.

For children aged 6 months to 1 year, the treatment period, if possible, should not exceed 7 days.

Overdose

Excessive use under occlusive dressing may lead to suppression of the adrenal glands. There are no specific antidotes or treatment procedures. If any adverse effects occur, discontinue use of the product and provide symptomatic treatment.

Adverse Reactions

Uncommon (>1/10,000, <1/100)

Skin and subcutaneous tissue disorders:

• Dermatitis, eczema, striae, contact dermatitis;
• Allergic contact dermatitis, pustular acne;
• Skin atrophy, often irreversible, associated with epidermal thinning, telangiectasia, purpura, and striae;
• Depigmentation, hypertrichosis;
• Rosacea-like and perioral dermatitis, with or without skin atrophy;
• Rebound effect, which may lead to steroid dependence;
• Delayed wound healing;
• Skin infection, redness, irritation, burning, rash, pruritus, dry skin, folliculitis, miliaria, acne, maceration.

Endocrine system disorders:

Adrenocortical suppression, Cushing's syndrome, hyperglycemia, glucosuria, growth retardation, and intracranial hypertension.

Very rare (<1/10,000, including isolated reports)

Eye disorders:

Increased intraocular pressure and risk of cataract development (with repeated exposure of the drug to the conjunctiva). Blurred vision (see also section "Special precautions").

Immune system disorders:

Hypersensitivity reactions.

Reporting suspected adverse reactions

It is important to report suspected adverse reactions after marketing authorization of the medicinal product. This enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system.

Shelf life. 3 years.

Storage conditions.

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

Do not refrigerate. Keep out of reach and sight of children.

Packaging.

10 g, 15 g, or 30 g in a tube, in a cardboard box.

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and location of operations.

Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenka Street, 22.

(all manufacturing stages, quality control, batch release)

Ukraine, 08301, Kyiv region, Boryspil city, Shevchenka Street, 100, building B-II (corpus 4).

(all manufacturing stages, batch release)