Laticort^® (Ointment) Instructions for Use

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Pharmaceutical Works Jelfa, S.A. (Poland)

ATC Code

D07AB02 (Hydrocortisone butyrate)

Active Substance

Hydrocortisone butyrate

Dosage Form

Laticort®

Ointment for external use 0.1%: tubes 15 g

Dosage Form, Packaging, and Composition

Ointment for external use almost colorless, homogeneous, semi-transparent.

Excipients: white petrolatum – up to 1 g.

15 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Corticosteroids used in dermatology; corticosteroids; corticosteroids with moderate activity (group II)

Pharmacological Action

Topical glucocorticosteroid, a synthetic non-halogenated compound. Esterification of the hydrocortisone molecule with a butyric acid residue (butyrate) radically increased the activity of this substance compared to native hydrocortisone. It has a rapidly onset anti-inflammatory, anti-edema, and antipruritic effect.

Use in recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal system. Although use in high doses for a long time, especially with the use of occlusive dressings, can lead to an increase in plasma cortisol levels, this is usually not accompanied by a decrease in the reactivity of the pituitary-adrenal system, and discontinuation of use leads to rapid normalization of cortisol production.

Pharmacokinetics

After application, the active substance accumulates in the epidermis, mainly in the granular layer, systemic absorption is insignificant. A small amount of hydrocortisone 17-butyrate is absorbed into the systemic circulation unchanged. Most of hydrocortisone 17-butyrate is metabolized to hydrocortisone and other metabolites directly in the epidermis and subsequently in the liver. Metabolites and a small part of unchanged hydrocortisone 17-butyrate are excreted by the kidneys and through the intestines.

Indications

Superficial, non-infected skin diseases sensitive to topical corticosteroids: eczema; dermatitis (including atopic, contact, seborrheic); psoriasis; reactions to insect bites; skin itching of various etiologies.

ICD codes

Dosage Regimen

Apply a thin layer of ointment to the affected skin areas twice daily, in the morning and evening.

Gently rub in until completely absorbed. Limit the duration of application to the minimum period necessary to achieve therapeutic effect.

For adults and children over 6 months, the standard treatment course should not exceed two weeks without medical supervision.

Reduce application frequency to once daily or discontinue use upon symptom resolution. Do not use under occlusive dressings unless specifically directed by a physician.

When treating children, ensure the total application area does not exceed 20% of the body surface area.

Avoid application on the face, axillae, and groin unless prescribed. Do not apply to the eyelids or periorbital area due to risk of increased intraocular pressure or glaucoma.

Discontinue use and consult a physician if no clinical improvement is observed within 14 days of continuous treatment or if condition worsens.

Wash hands thoroughly after application, unless hands are the treated area. For chronic, hyperkeratotic, or lichenified lesions, the ointment base is preferred.

Adverse Reactions

Local reactions skin irritation; in rare cases – other local reactions characteristic of corticosteroid therapy.

Systemic reactions with prolonged use, application to large areas and/or use of occlusive dressings, side effects characteristic of systemic corticosteroids may be observed. The risk of local and systemic side effects is lower than with the use of fluorinated steroids.

Contraindications

Bacterial skin infections (strepto- and staphyloderma, gram-negative folliculitis); viral skin infections (herpes simplex, chickenpox, shingles); fungal skin infections; tuberculous and syphilitic skin lesions; parasitic skin infections; neoplastic skin changes (benign and malignant tumors); acne, rosacea, perioral dermatitis; post-vaccination period; violation of the integrity of the skin (wounds, ulcers); hypersensitivity to the drug; pregnancy, lactation period.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

Can be used in children from 6 months of age.

Special Precautions

Should not be applied to the periorbital area due to the risk of glaucoma. With systematic contact with the conjunctiva, there is a risk of increased intraocular pressure.

For pronounced lichenification, dryness, hyperkeratosis, it is better to use in the form of an ointment or lipocream.

Not recommended for use in the presence of atrophic skin changes.

The risk of local and systemic side effects increases when applied to extensive affected areas, with prolonged use, use of occlusive dressings, and in childhood.

If there is no effect within 2 weeks of continuous treatment, the diagnosis should be clarified.

As with the use of any corticosteroid, it is advisable to limit the duration of use and prescribe a course dose that is minimally sufficient to stop the skin process.

Use in pediatrics

Can be used in children from 6 months of age. In cases of using the drug in children, on the face area or under occlusive dressings, the duration of the treatment course must be reduced. When used in children, the area of the skin surface to which the drug is applied should not exceed 20% of the total.

In childhood, suppression of adrenal cortex function may develop faster. In addition, a decrease in the excretion of growth hormone may be observed. With long-term use, it is necessary to monitor body weight, height, and plasma cortisol levels. In a study in children receiving 30-60 g per week for 4 weeks compared with 1% hydrocortisone ointment, none of the children showed impaired adrenal cortex function, and no differences were observed between hydrocortisone 17-butyrate and regular hydrocortisone in this indicator.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.