Lorinden^® S (Ointment) Instructions for Use

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Pharmaceutical Works Jelfa, S.A. (Poland)

ATC Code

D07BB01 (Flumetasone in combination with antiseptics)

Active Substances

Clioquinol (Rec.INN registered by WHO)

Flumetasone (Rec.INN registered by WHO)

Dosage Form

Lorinden® S

Ointment for external use 0.2 mg+30 mg/1 g: tube 15 g

Dosage Form, Packaging, and Composition

Ointment for external use in the form of a fatty mass of white color with a light yellow or gray tint; the presence of individual soft accumulations of crystals is allowed.

Excipients: white beeswax, petrolatum.

15 g – aluminum tubes with a lacquered inner surface (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial, antifungal, and anti-inflammatory action for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid + antimicrobial agent

Pharmacological Action

A combined agent, the action of which is due to the properties of the components included in its composition. As a result of the combined action of flumetasone and clioquinol (iodochlorhydroxyquin), it suppresses the development of inflammatory-allergic skin reactions complicated by bacterial and fungal infection.

Flumetasone is a synthetic difluorinated glucocorticosteroid for external use. It has anti-inflammatory, antiallergic, antipruritic, anti-edematous, and vasoconstrictive action. When acting on the skin, it prevents the marginal accumulation of neutrophils, which leads to a reduction in inflammatory exudate and the production of lymphokines, inhibition of macrophage migration, and a decrease in infiltration and granulation processes. It reduces the production of prostaglandins and leukotrienes by inhibiting the activity of phospholipase A₂ and reducing the release of arachidonic acid from cell membrane phospholipids. It causes a reduction of the ground substance of connective tissue, weakens proliferative and exudative reactions in the skin. It has a local vasoconstrictive action, which also reduces exudative reactions. It is an inhibitor of cellular kinins with proteolytic activity.

Clioquinol (iodochlorhydroxyquin) is a derivative of 8-hydroxyquinolines. Active against dermatophytes, yeast fungi (Microsporum spp., Trichophyton spp., Candida albicans) and gram-positive bacteria (Staphylococcus spp., Enterococcus spp.). It enhances the anti-exudative action of flumetasone.

Pharmacokinetics

Absorption and Distribution

When applied externally, the active components easily penetrate the stratum corneum.

Flumetasone is practically not absorbed into the bloodstream and does not have a systemic effect.

Clioquinol, when applied externally, may be slightly absorbed through the skin and bind to plasma proteins.

Metabolism and Excretion

Flumetasone is practically not metabolized in the skin. After absorption, the drug is mainly metabolized in the liver. It is excreted as metabolites and in small amounts unchanged in the urine and bile.

Clioquinol is partially biotransformed in the liver and excreted in the urine.

Indications

Skin diseases complicated by the addition of bacterial and/or fungal infection caused by microorganisms sensitive to clioquinol: dermatitis (including allergic, contact, occupational, seborrheic, solar, atopic); prurigo, eczema, multiforme exudative erythema, psoriasis, lichen planus, erythroderma, discoid lupus erythematosus, urticaria, secondary infections from insect bites, impetigo, infected intertrigo, dermatomycosis, actinomycosis, blastomycosis, sporotrichosis.

ICD codes

Dosage Regimen

Externally 2-3 times/day.

If it is necessary to use with a bandage, an air-permeable bandage should be used. In cases of excessive lichenification and hyperkeratosis, the agent is applied only under an occlusive dressing once every 24-48 hours.

In children and adolescents over 10 years of age, the use of the agent is possible only in exceptional cases, on limited areas of the skin; avoid application to the facial skin.

Adverse Reactions

Local reactions possibly – burning, skin itching, steroid acne, striae, dry skin, folliculitis; with prolonged use – skin atrophy, local hirsutism, telangiectasia, purpura, pigmentation disorders.

Systemic reactions with prolonged use and/or application to extensive areas of the skin, side effects characteristic of glucocorticosteroids are possible.

Contraindications

Hypersensitivity to the components of the agent; viral skin diseases (herpes, chickenpox); skin tuberculosis, skin manifestations of syphilis; skin neoplasms and precancerous skin conditions (skin cancer, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma); acne vulgaris and rosacea; perioral dermatitis, trophic leg ulcers associated with varicose veins, post-vaccination condition, skin infections (for use with an occlusive dressing); children under 10 years of age.

Use in Pregnancy and Lactation

Contraindicated for use in the first trimester of pregnancy.

Controlled studies of the possible teratogenic effect of topical application of flumetasone and iodochlorhydroxyquin during pregnancy have not been conducted, so the agent can be prescribed only if the intended benefit to the mother outweighs the potential risk to the fetus.

It is unknown to what extent flumetasone and Clioquinol are excreted in breast milk when applied externally. Special caution should be exercised when prescribing the agent during breastfeeding. Use is possible only in exceptional cases, for a short period and on limited areas of the skin (should not be applied to the skin of the mammary glands).

Pediatric Use

Contraindicated for use in children under 10 years of age.

In children and adolescents over 10 years of age, the use of the agent is possible only in exceptional cases, on limited areas of the skin; avoid application to the facial skin.

Special Precautions

The agent should not be applied to the facial skin, and contact with the eyes should be avoided.

It is not recommended to use the agent for a prolonged period or to apply it for a long time on extensive areas of the skin. With prolonged use of the agent on a large surface area of the skin, the risk of developing systemic side effects of glucocorticosteroids increases.

If a secondary infection appears at the site of application of the agent, medicinal products with more pronounced antibacterial or antifungal action should be used.

This agent should be used with caution in cases of atrophic skin changes, especially in elderly persons.

With prolonged use, the development of microbial resistance to clioquinol is possible.

In fungal diseases with secondary allergic reactions, the agent is used in exceptional cases, under medical supervision.

Drug Interactions

Vaccination and immunization should not be performed during therapy with this agent due to its immunosuppressive effect.

This agent should not be prescribed in combination with other medicinal products for external use.

When absorbed into the systemic bloodstream, flumetasone reduces the effectiveness of insulin, oral hypoglycemic agents, antihypertensive drugs, anticoagulants, and reduces the concentration of salicylates and praziquantel in the blood serum.

When used concomitantly, the risk of developing side effects of androgens, estrogens, oral contraceptives, anabolic steroids (hirsutism, acne); antipsychotic agents, bucarban, azathioprine (cataract); anticholinergics, antihistamines, tricyclic antidepressants, nitrates (glaucoma); diuretics (hypokalemia), cardiac glycosides (digitalis intoxication) increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.