Moleskin® lotion

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Moleskin® Lotion (Moleskin Lotion)

Composition:

Active substance: mometasone furoate;

1 g of lotion contains mometasone furoate 1 mg;

Excipients: isopropyl alcohol; propylene glycol; hydroxypropyl cellulose; sodium dihydrogen phosphate, dihydrate; phosphoric acid, concentrated; purified water.

Pharmaceutical form. Lotion.

Main physicochemical properties: colorless liquid with slight opalescence.

Pharmacotherapeutic group. Corticosteroids for dermatological use.

ATC code D07AC13.

Pharmacological Properties

Pharmacodynamics

Mometasone furoate is a synthetic glucocorticosteroid for topical use with anti-inflammatory, antipruritic, and anti-exudative effects.

Pharmacokinetics

Pharmacokinetic studies have shown that systemic absorption after topical application of 0.1% mometasone furoate is minimal; approximately 0.4% of the applied dose is excreted from the body within 72 hours after application. Determining the nature of metabolites was practically impossible due to the small amounts present in blood plasma and excretions.

Clinical Characteristics

Indications

Treatment of inflammation and itching caused by dermatoses of the scalp skin (scalp), as well as dermatoses responsive to corticosteroid therapy, such as psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis in adults and children aged 2 years and older.

Contraindications

Moleskin® lotion is contraindicated in rosacea, vulgaris acne, skin atrophy, perioral dermatitis, perianal and genital pruritus, diaper rash, bacterial (e.g. impetigo, pyoderma), viral (e.g. herpes simplex, herpes zoster, varicella, common warts, genital warts, molluscum contagiosum), parasitic and fungal (e.g. Candida or dermatophytes) infections, tuberculosis, syphilis, or post-vaccination reactions. Moleskin® lotion should not be applied to wounds or ulcerated skin. The drug is contraindicated in patients with hypersensitivity to any component of the product or to other corticosteroids.

Interaction with other medicinal products and other forms of interaction

Not established.

Special precautions for use

If irritation or sensitization occurs, application should be discontinued and appropriate treatment initiated.

In case of development of secondary skin infection, appropriate antifungal or antibacterial agents should be used. If positive response is not achieved within a short period of time, treatment with Molexquin® lotion should be stopped until the infection is completely resolved.

Systemic absorption following topical application of various glucocorticosteroids may result in reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis function, potentially leading to glucocorticosteroid insufficiency after discontinuation of treatment. In some patients, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria may occur.

Patients receiving large doses of topical steroids or using occlusive dressings should be monitored periodically for evidence of HPA axis suppression. Such evaluation may include ACTH stimulation testing, measurement of plasma morning cortisol levels, or other methods, but not urine testing.

Any adverse effects associated with systemic corticosteroids, including adrenal suppression, may also occur with topical application of glucocorticosteroids, particularly in infants and children.

Occlusive dressings should not be used in children or on the face. Contact of the product with mucous membranes should be avoided.

Topical steroids may be hazardous in psoriasis for several reasons, including relapse after development of tolerance, risk of generalized pustular psoriasis, and development of local or systemic toxicity due to impaired skin barrier function. Careful patient monitoring is essential when using this product in psoriasis.

Abrupt discontinuation after prolonged treatment may lead to rebound phenomenon, presenting as dermatitis with intense redness, irritation, and burning. This can be prevented by gradual withdrawal of the drug, for example, intermittent treatment, until complete discontinuation.

Glucocorticoids may alter the signs of certain skin lesions and complicate the establishment of an accurate diagnosis, thereby delaying recovery.

Molexquin® lotion contains propylene glycol, which may cause skin irritation.

Molexquin® lotion is not intended for ophthalmic use, including application to the eyelids. Contact with the eyes must be avoided.

Visual disturbances, including blurred vision or other visual changes, may occur during systemic or topical use of corticosteroids (including intranasal, inhaled, and intraocular administration). If such symptoms occur, the patient should undergo ophthalmologic examination to evaluate possible causes of visual disturbance, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported after systemic and topical corticosteroid use.

Use during pregnancy or breastfeeding

During pregnancy or breastfeeding, treatment with this product should be used only as directed by a physician. Even then, application over large areas of skin or for prolonged periods should be avoided. There are insufficient data to confirm the safety of this product in pregnant women. As with other topically applied glucocorticosteroids, Molexquin® lotion should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus.

It is unknown whether topical application of corticosteroids may result in sufficient systemic absorption to produce detectable amounts of the drug in breast milk. Molexquin® lotion should be used during breastfeeding only after careful assessment of benefit versus risk. If treatment involves high doses or prolonged use, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery

Not established.

Dosage and Administration

Spray the required amount of Moleskin® lotion to cover the affected area once daily. Gently and thoroughly rub in until the product is completely absorbed.

The use of topical corticosteroids in children and on the face should be limited to the minimum amount necessary to achieve therapeutic efficacy, and treatment duration should not exceed 5 days.

Method of Application

• Unscrew the cap while holding the bottle in an upright position.
• Screw on the pump dispenser.
• Remove the cap from the pump dispenser and attach the spray nozzle.
• Bring the tip of the spray nozzle close to the affected area.
• Press firmly with the index finger to deliver the required number of sprays.

Children

Moleskin® lotion may be used in children aged 2 years and older only under medical supervision.

Because children have a larger skin surface area to body weight ratio compared to adults, they are at higher risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome when using any topical corticosteroids, especially when applied over more than 20% of the body surface.

The smallest effective amount of glucocorticosteroid necessary to achieve therapeutic benefit should be used, particularly in children. Treatment duration should not exceed 5 days. Prolonged glucocorticosteroid therapy may impair growth and development in children.

The safety of Moleskin® lotion use in children for more than 6 weeks has not been established.

There is limited data on the use of this product in children under 2 years of age.

Mometasone should not be used for the treatment of diaper dermatitis.

The lotion should not be used under occlusive dressings unless directed by a physician, and should not be applied to areas under diapers or non-breathable underwear.

Overdose

Excessive or prolonged use of topical corticosteroids may suppress the hypothalamic-pituitary-adrenal (HPA) axis, potentially leading to secondary adrenal insufficiency, which is usually reversible.

In case of HPA axis suppression, the dosing interval should be increased, a corticosteroid with lower potency should be used, or the treatment should be discontinued.

The amount of steroid in each bottle of Moleskin® lotion is so small that in the unlikely event of accidental ingestion, toxic effects would be negligible or absent.

Adverse reactions

The adverse reactions reported in connection with the use of MoleSkin® lotion are listed below by system organ class and frequency: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Infections and infestations: very rare – folliculitis; not known – infections, furuncles.

Nervous system disorders: very rare – burning sensation; not known – paraesthesia.

Skin and subcutaneous tissue disorders: very rare – pruritus; not known – contact dermatitis, skin hypopigmentation, hypertrichosis, skin atrophic striae, acneiform dermatitis, skin atrophy.

General disorders and administration site conditions: not known – pain at application site, application site reactions.

Eye disorders: not known – blurred vision (see also section "Dosage and administration").

Propylene glycol contained in the product may cause skin irritation.

Local adverse reactions rarely reported with topical dermatological corticosteroids include: dryness and irritation of the skin, dermatitis, perioral dermatitis, maceration of the skin, striae, miliaria, telangiectasias, papular and pustular eruptions, and sensation of pricking.

Reporting of suspected adverse reactions

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

Shelf life. 2 years.

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

Packaging. 50 ml in a glass bottle made of light-protective glass;

1 bottle with a pump dispenser and spray in a carton.

Prescription status. Prescription only.

Manufacturer. JSC "Farmak".

Manufacturer's address and place of business

74, Kyrylivska Street, Kyiv, 04080, Ukraine