Elocom^®-S (Ointment) Instructions for Use

Marketing Authorization Holder

MSD Pharmaceuticals, LLC (Russia)

Manufactured By

Zentiva Saglik Urunleri Sanayi Ve Ticaret, A.S. (Turkey)

ATC Code

D07XC03 (Mometasone in combination with other drugs)

Active Substances

Salicylic acid (USP)

Mometasone (Rec.INN)

Dosage Form

Elocom®-S

Ointment 1 mg+50 mg/1 g: tubes 15 g or 45 g

Dosage Form, Packaging, and Composition

Ointment homogeneous, white or almost white in color.

Excipients: hexylene glycol 120 mg, propylene glycol stearate 20 mg, purified water 30 mg, petrolatum 729 mg, white beeswax 50 mg.

15 g – aluminum tubes (1) – cardboard packs.
15 g – plastic tubes (1) – cardboard packs.
45 g – aluminum tubes (1) – cardboard packs.
45 g – plastic tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory and keratolytic action for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid + keratolytic agent

Pharmacological Action

Combined medicinal product with anti-inflammatory and keratolytic action.

Mometasone furoate is a glucocorticoid. It has anti-inflammatory, antipruritic, and vasoconstrictive properties. In vitro experiments have shown that mometasone furoate is a potent inhibitor of the synthesis of three cytokines involved in the development and maintenance of the inflammatory process: interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α).

Salicylic acid causes desquamation of the stratum corneum of the skin.

Pharmacokinetics

After a single topical application, approximately 1.5% of the applied dose is systemically absorbed. The drug that enters the systemic circulation is excreted in urine and feces.

Indications

For the relief of inflammatory manifestations and hyperkeratosis: in psoriasis; in atopic dermatitis; in seborrheic dermatitis.

ICD codes

Dosage Regimen

Apply a thin layer of ointment to the affected skin areas once daily.

Gently rub in until fully absorbed. The maximum daily dose is 15 g.

Limit the duration of application to the shortest period necessary to achieve therapeutic effect.

Avoid application to the face, groin, or axillae.

Do not use with occlusive dressings, including diapers or plastic pants.

Discontinue treatment if skin irritation or excessive dryness occurs.

If a secondary skin infection develops, initiate appropriate antimicrobial therapy and interrupt corticosteroid use until the infection is controlled.

Use with caution in patients with diabetes mellitus or peripheral vascular disease.

Monitor pediatric patients for potential HPA axis suppression during prolonged therapy.

Wash hands thoroughly after application unless the hands are the treatment area.

Adverse Reactions

Local reactions mild or moderate burning at the application site, itching, skin atrophy, peeling, irritation, skin maceration, dry skin, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, appearance of skin striae atrophicae, miliaria, secondary infections, hypertrichosis.

Systemic reactions in children, suppression of the hypothalamic-pituitary-adrenal system function is possible, including the development of Cushing’s syndrome.

Contraindications

Children’s age (under 12 years); hypersensitivity to mometasone furoate or salicylic acid; bacterial, viral (herpes simplex, chickenpox, shingles) or fungal skin infections, rosacea or perioral dermatitis, post-vaccination reactions, tuberculosis, syphilis.

With caution

Diabetes mellitus, peripheral vascular inflammation, skin irritation or infection, as well as during pregnancy and lactation.

Use in Pregnancy and Lactation

Used during pregnancy and breastfeeding only when the expected benefit to the mother outweighs the potential risk to the fetus.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

Use strictly as prescribed by a doctor to avoid complications. Appropriate precautions must be taken in case of application to large areas of skin or anticipated long-term use of the drug. This is especially important in pediatrics. Because the ratio of skin surface area to body weight is higher in children than in adults, children are more predisposed than adults to suppression of the hypothalamic-pituitary-adrenal system and the development of Cushing’s syndrome in response to glucocorticosteroid therapy.

Children should receive the minimum amount of glucocorticosteroids necessary to achieve the effect. Long-term therapy with glucocorticosteroids may have an undesirable effect on the growth and development of children.

Glucocorticosteroids may cause a change in the appearance of the affected skin areas, which makes it difficult to make a correct diagnosis.

Not intended for use in ophthalmology.

In case of irritation, including excessive skin dryness, application should be discontinued and appropriate treatment prescribed.

If a concomitant skin infection develops, the necessary antifungal or antibacterial agent should be used. If a positive response to treatment is not achieved quickly, application should be interrupted until the infection is properly eliminated.

Not recommended for use with occlusive dressings, including diapers and plastic pants.

Do not apply to the face or in the groin and armpit areas.

Drug Interactions

With topical application, small amounts of salicylates have been noted in the blood plasma.

According to data on the interaction of salicylates with other substances after oral administration or skin application, the action of the following medicinal compounds may be altered: tolbutamide, methotrexate, heparin, pyrazinamide, uricosuric agents, and coumarin-type drugs.

Other glucocorticosteroids and ammonium sulfate may affect the content of salicylic acid.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.