Instructions for Elocom cream 0.1% tube 15 g
Composition
active ingredient: mometasone furoate;
1 g of cream contains mometasone furoate 1 mg;
Excipients: hexylene glycol, purified water, concentrated phosphoric acid, hydrogenated phosphotidylcholine, titanium dioxide (E 171), aluminum salt of starch octenylsuccinate, white wax, white soft paraffin.
Dosage form
Cream.
Main physicochemical properties: white or almost white, soft, homogeneous cream, without foreign inclusions.
Pharmacotherapeutic group
Corticosteroids for 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 excretions.
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 with Elocom® 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 of topically applied glucocorticosteroids (GCS) may cause reversible suppression of the hypothalamic-pituitary-adrenal axis with possible glucocorticosteroid insufficiency after discontinuation of treatment. Some patients may develop Cushing's syndrome, hyperglycemia, and glycosuria.
Patients using topical steroids on large areas of skin or using occlusive dressings should be periodically monitored 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 that occur with the use of systemic corticosteroids, including suppression of the function of the adrenal cortex, may also be observed with the local use of glucocorticosteroids, especially in infants and children.
Occlusion should not be used on children or on the face. Avoid contact of the cream with mucous membranes.
Topical steroids can be dangerous in psoriasis for many reasons, including relapse after tolerance develops, the risk of generalized pustular psoriasis, and the development of local or systemic toxicity due to impaired skin barrier function. Careful patient monitoring is essential when using the drug for psoriasis.
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® is not intended for ophthalmic use, including application to the eyelids. Do not allow the drug to get into the eyes.
Visual disturbances may occur with systemic and topical corticosteroids (including intranasal, inhaled, and intraocular administration). If symptoms such as blurred vision or other visual disturbances occur, the patient should be evaluated by an ophthalmologist to evaluate possible causes of visual disturbances, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy, which have been reported following the use of systemic and topical corticosteroids.
Ability to influence reaction speed when driving vehicles or other mechanisms
Not installed.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, treatment with the drug should be carried out only as prescribed by a doctor. However, in this case, it is necessary to avoid using the cream on large areas of skin or for a long period. There is no sufficient evidence of the safety of the drug for women during pregnancy. As with other topical glucocorticosteroids, Elocom® should be prescribed to pregnant women only if the potential benefit of use for the mother outweighs the potential risk to the fetus.
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.
Method of administration and doses
Elocom® cream 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
Children over 2 years of age should use the drug 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 increases with application 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 cream 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: very rarely - burning sensation; unknown - paresthesia.
Skin and subcutaneous tissue disorders: very rare - itching; not known - 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.
On the part of the organs of vision: unknown - blurred vision (see also the section "Special instructions for use").
Local adverse reactions that have been reported infrequently with the use of topical dermatological corticosteroids include: skin dryness and irritation, dermatitis, perioral dermatitis, skin maceration, striae, exacerbation of the disease, erythema, sweating and telangiectasia, papular, pustular rashes and tingling sensation.
Expiration date
2 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 ºС.
Packaging
Tubes of 15 g No. 1 in a cardboard box.
Vacation category
According to the recipe.
Producer
Schering-Plough Labo N.V., Belgium.
Location of the manufacturer and its business address
Industrial Park 30, Heist-op-den-Berg, 2220, Belgium.
