Momederm

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MOMEDERM® (MomEDERM®)

Composition:

Active substance: mometasone;

1 g of ointment contains 1 mg of mometasone furoate;

Excipients: citric acid monohydrate; propylene glycol; mineral oil; lanolin alcohol; cetostearyl alcohol; glycerol monostearate; white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: semi-transparent, greasy, white or almost white mass.

Pharmacotherapeutic group.

Corticosteroids for dermatological use. ATC code D07AC13.

Pharmacological properties.

Pharmacodynamics.

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

Pharmacokinetics.

Systemic absorption following 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. Characterization of metabolites was practically impossible due to the low amounts present in blood plasma and excreta.

Clinical characteristics.

Indications.

Inflammatory manifestations and pruritus in dermatoses amenable to corticosteroid therapy, including psoriasis (except generalized plaque psoriasis) and atopic dermatitis, in adults and children aged 2 years and older.

Contraindications.

Hypersensitivity to mometasone furoate or to other corticosteroids, or to any excipients of the product; bacterial infections (e.g., impetigo, pyoderma), viral infections (e.g., herpes simplex, herpes zoster, varicella, common warts, genital warts, condylomata acuminata), parasitic and fungal skin infections (e.g., Candida or dermatophytes), as well as cutaneous tuberculosis, cutaneous manifestations of syphilis, acne vulgaris, acne rosacea, perioral dermatitis, skin reactions following vaccination, perianal and genital pruritus, skin atrophy, and disruption of skin integrity (should not be applied to wounds or ulcerated skin), diaper dermatitis. The product is contraindicated in rosacea of the face, acne, and perioral inflammatory dermatoses. The ointment should not be used under occlusive dressing due to increased percutaneous absorption of corticosteroids.

Interaction with other medicinal products and other forms of interaction.

No interactions have been observed with topical application of glucocorticosteroids. However, it should be noted that vaccination against smallpox and other types of immunization (especially during prolonged treatment over large skin areas) are not recommended during treatment with this product due to the possible lack of an adequate immunological response, such as production of specific antibodies.

Special precautions for use.

In case of irritation or sensitization, application of the drug should be discontinued and appropriate treatment initiated.

If secondary skin infection develops, appropriate antifungal or antibacterial therapy should be administered. If positive response is not achieved within a short period of time, treatment with Momederm® ointment should be discontinued until the infection is completely resolved.

Systemic absorption following topical application of various glucocorticosteroids (GCS) may cause reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, with potential glucocorticosteroid insufficiency after discontinuation of treatment. In some patients, signs of Cushing's syndrome, hyperglycemia, and glucosuria may occur.

Visual disturbances may occur with systemic and topical (including intranasal, inhaled, and intraocular) use of corticosteroids. If a patient develops symptoms such as blurred vision or other visual disturbances, an ophthalmologist should be consulted to determine possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which has been reported following both systemic and topical corticosteroid use.

Patients receiving topical corticosteroids over large skin areas or under occlusive dressings should be periodically evaluated for HPA axis suppression. This evaluation may include ACTH stimulation testing, measurement of morning plasma cortisol levels, or other biological fluids, but not urine. Any adverse effects associated with systemic corticosteroid use, including adrenal cortex suppression, may also occur with topical application of glucocorticosteroids, particularly in infants and children.

Contact of the ointment with mucous membranes should be avoided.

Momederm® ointment is not recommended for use in children under 2 years of age, as safety and efficacy of the drug in this age group have not been established.

Topical corticosteroids may be hazardous in psoriasis for several reasons, including rebound relapses after development of tolerance, risk of generalized pustular psoriasis, and increased local and systemic toxicity due to impaired skin barrier function. Careful monitoring is essential when corticosteroids are used in psoriasis.

Special precautions are required when using this drug in patients with psoriasis, as topical corticosteroid therapy may be hazardous, particularly due to the possibility of disease relapse following development of intolerance, as well as the risk of pustular psoriasis and generalized toxic effects resulting from compromised skin integrity.

As with all potent glucocorticoids, abrupt discontinuation of treatment should be avoided. Abrupt cessation after prolonged therapy may lead to rebound symptoms such as intense erythema, irritation, and burning sensation (rebound dermatitis). This can be prevented by gradual withdrawal, for example, intermittent treatment, until complete discontinuation.

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

The drug must not enter the eyes.

Local and systemic toxicity, particularly with prolonged use over large areas of damaged skin, in skin folds, or under occlusive polyethylene film dressings, has been frequently observed. Do not apply under closed dressings to the facial skin of adults or children. When applied to the face, duration of treatment should not exceed 5 days. Prolonged therapy should be avoided in all patients, regardless of age.

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

Momederm® topical ointment is not intended for ophthalmic use, including application to the eyelids, due to the risk of glaucoma or subcapsular cataract.

Children

Pediatric patients may be more sensitive to the systemic toxicity of equivalent doses due to their higher surface area to body weight ratio.

Momederm® ointment may be used cautiously in adolescents and children aged 2 years and older; however, safety and efficacy of use beyond 3 weeks have not been established. As safety and efficacy in children under 2 years of age have not been established, use in this age group is not recommended.

Momederm® ointment contains cetyl stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

The medicinal product contains 100 mg of propylene glycol per 1 g of ointment. Propylene glycol may cause skin irritation.

Use during pregnancy or breastfeeding.

Pregnancy.

Treatment with this drug during pregnancy or breastfeeding should be carried out only under medical supervision.

The safety of topical glucocorticosteroids in pregnant women has not been established; therefore, use of this class of drugs during pregnancy is justified only when the expected benefit to the mother outweighs the potential risk to the fetus.

This class of drugs should not be used in high doses, over large skin areas, or for prolonged periods during pregnancy.

Breastfeeding period.

It is not known whether topical corticosteroids, due to systemic absorption, can pass into breast milk. The decision to discontinue breastfeeding or to discontinue drug therapy should be made after careful consideration of the benefit-risk ratio, taking into account the necessity of the drug for the mother. If treatment with high doses or long-term use is required, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

Not established.

Method of Administration and Dosage.

Adults.

Apply the ointment as a thin layer to affected skin areas once daily. Do not use the ointment on the facial skin for longer than 5 days. Do not apply the ointment under occlusive dressing. The duration of treatment should be determined individually by a physician, taking into account the course of the disease.

Children.

The drug should be used in children aged 2 years and older only as prescribed by a physician, when other treatment methods have proven ineffective for conditions causing discomfort.

It is recommended to use the lowest possible amount of glucocorticosteroids necessary to achieve a therapeutic effect, especially in children. The treatment course should not exceed 5 days. Prolonged glucocorticosteroid therapy may impair growth and development in children.

Because the ratio of body surface area to body weight is greater in children than in adults, children are at higher risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome when using any topical glucocorticosteroid. For the same reason, children are also at increased risk of adrenal insufficiency upon discontinuation of topical glucocorticosteroid therapy. Skin atrophy, including the development of striae, may occur more rapidly in children treated with topical glucocorticosteroids. The risk of HPA axis suppression increases in children when glucocorticosteroids are applied over areas exceeding 20% of the body surface. Cases of HPA axis suppression, Cushing's syndrome, growth retardation, failure to gain weight, and intracranial hypertension have been reported in children receiving various topical glucocorticosteroids. Signs of adrenal insufficiency include low plasma cortisol levels and lack of response to ACTH stimulation. Intracranial hypertension may lead to bulging fontanelle, headache, and bilateral papilledema.

The drug should not be used for the treatment of diaper dermatitis.

Do not apply the ointment to skin areas covered by diapers or non-breathable underwear in children (due to the occlusive effect).

The safety and efficacy of mometasone in children after more than 3 weeks of treatment have not been established.

Overdose.

Symptoms.

Excessive or prolonged use of topical corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis, potentially resulting in secondary adrenal insufficiency. In isolated cases, prolonged uncontrolled use of topical glucocorticoids may cause edema, arterial hypertension, hyperglycemia, symptoms of hypercorticism, cataract, glaucoma, allergic reactions, and skin damage including urticaria.

Treatment.

Appropriate symptomatic treatment as directed by a physician is indicated. Acute symptoms of hypercorticism are usually reversible. If necessary, correction of electrolyte imbalance, oxygen therapy, administration of barbiturates, and ephedrine in cases of depression may be required. Gradual withdrawal of corticosteroids is recommended after prolonged use.

Adverse reactions.

Adverse effects reported in connection with the use of medicinal products containing mometasone are listed below by organ system and frequency of occurrence: 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); unknown (frequency cannot be determined from available data).

Local adverse effects may occur with topical use, which have been infrequently reported in connection with the use of dermatological corticosteroids for topical application, namely: dryness and irritation of the skin, dermatitis, perioral dermatitis, maceration of the skin, miliaria, telangiectasia, striae, exacerbation of the disease, erythema, papular and pustular eruptions, and sensation of pricking.

Children

Since children have a larger surface area to body weight ratio, they are more prone to suppression of the hypothalamic-pituitary-adrenal axis and manifestations of Cushing's syndrome when using any topical corticosteroids, compared to adults.

Prolonged treatment with corticosteroids may impair growth and development in children.

Shelf life.

2 years.

Storage conditions.

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

Do not freeze.

Packaging. 15 g ointment in a tube.

Prescription status. Prescription only.

Manufacturer.

Elfa Pharmaceutical Works A.T.

Manufacturer's address and place of business.

58-500 Jelenia Góra, ul. Wincentego Pola 21, Poland.