Instructions for Elocom ointment 0.1% tube 30 g
Composition
active ingredient: Mometasone furoate
1 g of ointment contains mometasone furoate 1 mg;
Excipients: hexylene glycol, purified water, diluted phosphoric acid, propylene glycol stearate, white wax, white soft paraffin.
Dosage form
Ointment.
Main physicochemical properties: white or almost white opaque ointment, without foreign inclusions.
Pharmacotherapeutic group
Corticosteroids for topical use in dermatology. ATX code D07A C13.
Pharmacological properties
Pharmacodynamics
Mometasone furoate is a synthetic glucocorticosteroid for topical use with anti-inflammatory, antipruritic, and antiexudative effects.
Pharmacokinetics
Pharmacokinetic studies have shown that systemic absorption after topical application of mometasone furoate 0.1% is minimal; approximately 0.4% of the applied dose is excreted from the body within 72 hours after application. It was practically impossible to determine the nature of the metabolites due to the small amounts present in blood plasma and excretion.
Indication
Inflammatory phenomena 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.
Contraindication
Elocom® is contraindicated in rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritus, diaper rash, bacterial (e.g. impetigo, pyoderma), viral (e.g. herpes simplex, herpes zoster and varicella, warts, genital warts, molluscum contagiosum), parasitic and fungal (e.g. candida or dermatophyte) infections, tuberculosis, syphilis or post-vaccination reactions. Elocom® should not be used on wounds or on ulcerated skin. The drug is contraindicated in patients with hypersensitivity to any of the components of the drug or to other glucocorticosteroids.
Interaction with other medicinal products and other types of interactions
Not installed.
Application features
If irritation or sensitization occurs, treatment should be discontinued and appropriate treatment initiated.
In case of concomitant skin infection, an appropriate antifungal or antibacterial drug should be used. If positive dynamics are not achieved within a short time, the use of Elocom® cream should be discontinued until the infection is completely eliminated.
Systemic absorption with topical application of various corticosteroids can cause reversible suppression of the hypothalamic-pituitary-adrenal axis with possible glucocorticosteroid insufficiency after discontinuation of treatment. Some patients may develop manifestations of Cushing's syndrome, hyperglycemia and glycosuria.
Patients using topical steroids on large areas of skin or using occlusive dressings should be periodically evaluated for hypothalamic-pituitary-adrenal axis suppression. This can be done by performing an ACTH stimulation test, measuring morning plasma cortisol levels, and measuring cortisol levels in media other than urine.
Any side effects seen with systemic corticosteroids, including adrenal suppression, may also occur with topical glucocorticosteroids, especially in infants and children.
Occlusion should not be used in children or on the face. Contact with mucous membranes should be avoided.
Abrupt discontinuation of long-term treatment may result in a rebound effect in the form of dermatitis with intense redness, irritation and burning. This can be prevented by gradual withdrawal of the drug, e.g. intermittent treatment, until complete discontinuation.
Glucocorticoids may alter the appearance of some lesions and make it difficult to make an appropriate diagnosis, which will also delay recovery.
Elocom® ointment contains propylene glycol, which may cause skin irritation.
Elocom® is not intended for ophthalmic use, including application to the eyelids. Do not allow the drug to get into the eyes.
Use during pregnancy and breastfeeding
It is not known whether topical corticosteroids can cause significant systemic absorption, resulting in amounts of the drug that can be detected in breast milk. Elocom® should be used during breastfeeding only after a careful analysis of the benefit-risk ratio. If treatment is prescribed in high doses or for a long period, breastfeeding should be discontinued.
The ability to influence the reaction speed when driving or working with other mechanisms
Not installed.
Method of administration and doses
Elocom® ointment should be applied in a thin layer to the affected areas of the skin once a day. The duration of treatment is determined by the severity and course of the disease and is determined individually.
The use of topical corticosteroids in children and on the face should be limited to the minimum amount compared to effective therapeutic regimens, and the duration of treatment should not exceed 5 days.
Children.
For children over 2 years of age, the drug is used only as prescribed by a doctor.
Because children have a greater surface area to body weight ratio than adults, they are at greater risk of hypothalamic-pituitary-adrenal (HPA) suppression and Cushing's syndrome with any topical corticosteroid, which is increased when applied to more than 20% of the body surface area.
It is recommended to use the smallest amount of glucocorticosteroids necessary to obtain a therapeutic effect, especially in children. The course of treatment should not exceed 5 days. Long-term treatment with glucocorticosteroids may delay the growth and development of the child.
The safety of Elocom® in children for more than 6 weeks has not been studied.
There are only limited data regarding the treatment of children under 2 years of age.
Mometasone should not be used to treat diaper dermatitis.
The ointment should not be used under occlusive dressings unless prescribed by a doctor, and should not be applied to areas under diapers or underwear that do not allow moisture to pass through.
Overdose
Excessive prolonged use of topical corticosteroids may suppress the function of the hypothalamic-pituitary-adrenal axis, which may manifest as secondary adrenal insufficiency, which is usually reversible.
In case of suppression of this system, the interval between applications should be increased, or a less active GCS should be used, or the drug should be discontinued.
The steroid content in each container is so small that in the unlikely event of accidental ingestion, the toxic effect will be almost imperceptible or absent.
Adverse reactions
The following are the adverse reactions reported in connection with the use of Elocom®, by organ system and frequency: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); unknown (cannot be estimated from the available data).
Infections and infestations: very rare – folliculitis; unknown – infections, furuncles.
Nervous system disorders: very rare – burning sensation; unknown – paresthesia.
Skin and subcutaneous tissue disorders: very rare - itching; unknown - contact dermatitis, skin hypopigmentation, hypertrichosis, atrophic skin streaks, acneiform dermatitis, skin atrophy.
General disorders and administration site conditions: not known – application site pain, application site reactions.
Propylene glycol, which is part of the drug, can cause skin irritation.
Local adverse reactions that have been reported infrequently in association with the use of topical dermatological corticosteroids include: skin dryness and irritation, dermatitis, perioral dermatitis, skin maceration, increased lesion area, increased allergic manifestations, erythema, striae, telangiectasias, papular, pustular eruptions, and tingling sensation.
Expiration date
3 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 ºС.
Packaging
Tubes of 15 g or 30 g No. 1 in a cardboard box.
Vacation category
According to the recipe.
Producer
Schering-Plough Labo NV, Belgium.
Location of the manufacturer and its business address
Industriepark 30, Heist-op-den-Berg, Antwerpen, B-2220, Belgium.
