Elocom, 0.1% 30 ml

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 absorption rate of glucocorticosteroid in the dosage form of lotion is also negligible.

Indications

Active ingredient

Composition

1 ml of lotion contains:

the active ingredient:

mometasone furoate 1 mg;

excipients:

Isopropyl alcohol 40%,

propylene glycol,

hydroxypropyl cellulose,

sodium phosphate,

distilled water.

Phosphoric acid and sodium hydroxide may be used to establish a pH value of approximately 4.5.

How to take, the dosage

The lotion is applied in a few drops to the affected areas of the skin once a day; after application, gently rub the lotion in until it disappears from the skin surface. For maximum effectiveness and economy of use, bring the bottle nose close to the affected area of skin and gently squeeze the bottle.

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

Side effects

In clinical studies in 209 patients, the following adverse events were noted: burning (4 cases), acne (2 cases), itching (1 case). In a hypersensitivity/painful sensitivity study on 156 healthy volunteers, the occurrence of folliculitis (4 cases) was noted.

The following adverse events may rarely occur with topical administration of glucocorticosteroid drugs, in descending order of frequency: skin irritation and dryness, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, stretch marks and sweat. The likelihood of these adverse events increases with the use of occlusive dressings.

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 administered systemically, glucocorticosteroids appear in breast milk, which may lead to growth retardation of the baby, effects on endogenous glucocorticosteroid synthesis, and other adverse effects. There is no evidence that systemic absorption of glucocorticosteroids when topically applied can result in detectable amounts in breast milk.

We should use Elokom cream, ointment and lotion with caution in breast milk.

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