Elokom, ointment 0.1% 15 g

Elocom is a synthetic non-fluorinated glucocorticoid for external use.

The mechanism of action appears to be related to inducing the release of proteins that inhibit phospholipase A2 and are collectively known as lipocortins. These proteins are thought to control the biosynthesis of potent inflammatory mediators such as PG and LT by inhibiting the release of their common precursor, arachidonic acid.

Carcinogenesis, mutagenesis. In genetic toxicity studies of mometazone furoate, including the Ames assay, mouse lymphoma test, and micronucleus test, there was no evidence of mutagenic effects of the drug.

There have been no long-term animal experiments to evaluate the carcinogenic effects of the drug.

Pharmacokinetics

The extent to which topical glucocorticosteroids penetrate the skin depends on many factors, including the composition of the drug and the integrity of the epidermal barrier. Inflammation and other skin processes can increase skin penetration.

In a single topical application to intact skin (without an occlusive dressing) approximately 0.7% of the ointment dose and approximately 0.4% of the cream are detectable in the blood after 8 hours. There is reason to believe that the level of glucocorticosteroid absorption in the dosage form of lotion is also insignificant.

Indications

Amelioration and elimination of inflammatory reactions and itching in dermatoses sensitive to GCS therapy in adults and children from 2 years of age.

Active ingredient

Composition

1 g ointment contains:

the active ingredient:

mometasone furoate 1 mg;

auxiliary substances:

hexylene glycol,

phosphoric acid,

propylene glycol stearate,

How to take, the dosage

The ointment is applied in a thin layer to the affected areas of the skin once a day.

Special Instructions

Elocom is not intended for use in ophthalmology.

When using GCS for external use as a result of systemic absorption, reversible suppression of hypothalamic-pituitary-adrenal system function and symptoms of adrenal insufficiency after drug withdrawal are possible. Patients may develop Cushing’s syndrome, hyperglycemia, glucosuria.

In patients using GCS on large areas of skin surface the functions of hypothalamic-pituitary-adrenal system should be regularly checked (ACTH stimulation test, morning plasma cortisol levels). If signs of inhibition of hypothalamic-pituitary-adrenal system function appear, the interval between applications should be increased, the drug should be discontinued, the drug should be switched to a less active GCS; in some cases, if necessary, corticosteroids for systemic use should be prescribed.

Elocom is not recommended for use with occlusive dressings. Close medical supervision is required if this use is necessary.

The drug should not be applied to the face or to the axillary and inguinal folds.

If signs of skin irritation or hypersensitivity occur during use, treatment should be stopped and appropriate therapy should be given.

If secondary infection has occurred, antimicrobial therapy should be prescribed. If the drug has no effect, it should be withdrawn.

If there is no improvement after 2 weeks of therapy, the clinical picture should be reassessed and the diagnosis clarified.

Contraindications

Hypersensitivity to components of the drug Elokom and other GCS.

Side effects

In controlled clinical trials in 812 patients, the incidence of adverse events associated with the use of Elokom ointment was 4.8%. Burning, tingling, itching, skin atrophy, and furunculosis have been reported; pink acne has been reported. In controlled clinical trials in children aged 2-12 years (n=74) the frequency of adverse events (burning, itching, furunculosis) associated with the use of the ointment was about 7%.

Pregnancy use

Adequate, well-controlled studies of the teratogenic potential of mometasone furoate when used during pregnancy have not been performed. The use of Elokom cream, ointment, or lotion in pregnancy is possible only if the expected benefits of treatment to the mother outweigh the potential risk to the fetus.

When used systemically, glucocorticosteroids appear in breast milk, which can lead to growth retardation of the baby, interference with endogenous glucocorticosteroid synthesis, and other adverse effects.

There is no evidence that systemic absorption of glucocorticosteroids by topical administration can result in detectable amounts in breast milk. However, due to the fact that many drugs are excreted with breast milk, nursing women should use Elokom cream, ointment, lotion with caution.

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