Lorinden^® A (Ointment) Instructions for Use

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Pharmaceutical Works Jelfa, S.A. (Poland)

ATC Code

D07XB01 (Flumetasone in combination with other drugs)

Active Substances

Salicylic acid (USP)

Flumetasone (Rec.INN)

Dosage Form

Lorinden® A

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

Dosage Form, Packaging, and Composition

Ointment for external use white with a light yellowish tint, homogeneous.

Excipients: propylene glycol, lanolin, petrolatum.

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

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Corticosteroids used in dermatology; corticosteroids in combination with other agents; moderate-potency corticosteroids in combination with other agents

Pharmacological Action

Combined medicinal product with anti-inflammatory and keratolytic action for external use.

Flumetasone is a synthetic glucocorticosteroid that has anti-inflammatory, anti-edematous, anti-allergic, and antipruritic effects.

It inhibits the activity of phospholipase A₂, which leads to suppression of prostaglandin and leukotriene synthesis, and inhibits the release of inflammatory mediators.

It inhibits the migration of leukocytes and lymphocytes to the site of inflammation.

It prevents the marginal accumulation of neutrophils, leading to a reduction in inflammatory exudate, cytokine production, and inhibition of macrophage migration, thereby reducing infiltration and granulation processes.

It suppresses the proteolytic activity of tissue kinins, delays fibroblast growth, and prevents the development of connective tissue at the site of inflammation.

It reduces hyperemia, manifestations of hypersensitivity reactions, and proliferative and exudative processes occurring in the connective tissue at the site of inflammation.

Salicylic acid is an NSAID that promotes the penetration of glucocorticosteroids and imparts additional anti-parakeratotic, moderate keratolytic, and local hypothermic properties to the drug, facilitating the penetration of flumetasone into the skin.

Furthermore, it has antibacterial and fungicidal action and also restores the protective function of the skin.

It suppresses the secretion of sebaceous and sweat glands.

Pharmacokinetics

The absorption of flumetasone is higher in children than in adults and increases when applied to skin folds, the face, skin with damaged epidermis, skin affected by an inflammatory process, under occlusive dressings, and when applied to extensive skin areas (in which case it may exert systemic effects).

Due to the external route of administration and the keratolytic action of salicylic acid, flumetasone easily penetrates the stratum corneum of the skin, through the keratinized layers of the skin, where it accumulates.

Flumetasone is practically not metabolized in the skin.

After minimal absorption into the systemic circulation, flumetasone is biotransformed in the liver.

It is excreted in the urine and, to a lesser extent, in the bile as glucuronic acid conjugates, as well as in small amounts unchanged.

Indications

Acute and chronic allergic dermatoses, especially those accompanied by excessive skin keratinization: atopic dermatitis; diffuse neurodermatitis; chronic lichen Vidal; various forms of subacute and chronic eczema (especially horny eczema); hyperkeratosis (e.g., ichthyosis); chronic dyshidrosis; psoriasis; seborrhea; lichen planus; lichen ruber verrucosus; as part of combination therapy for bullous skin diseases (including bullous eruptions on the skin of the palms and soles); prurigo with severe lichenification; photodermatitis; multiforme exudative erythema; external otitis; discoid lupus erythematosus; insect bites.

ICD codes

Dosage Regimen

Apply a thin layer of ointment to the affected skin areas two to three times daily.

After acute inflammation subsides, reduce application frequency to once or twice daily.

Continue treatment for an additional 3 to 4 days after clinical symptoms have completely resolved.

For chronic skin conditions, the total treatment duration must not exceed 3 weeks.

Avoid application to large body surface areas, especially in children and patients with renal impairment.

Do not use occlusive dressings unless specifically directed by a physician, as this increases systemic absorption.

Discontinue use and consult a physician if no improvement is observed within a reasonable period or if condition worsens.

Do not apply to the face, eyelids, or mucous membranes.

Wash hands thoroughly after application, unless the hands are the treated area.

Adverse Reactions

Local reactions are possible – burning, skin itching, dry skin; with prolonged use – skin atrophy, local hirsutism, telangiectasias, purpura, steroid acne, perioral dermatitis, pigmentation disorders.

Systemic reactions with prolonged use, application to extensive skin areas and/or use of occlusive dressings, side effects characteristic of glucocorticosteroids are possible. With external application of the drug on the skin of the eyelids, the development of cataracts or glaucoma is sometimes possible later.

Contraindications

Bacterial skin diseases; viral skin diseases (including chickenpox, herpes zoster); fungal skin diseases; acute weeping and subacute exudative stages of skin diseases; skin tuberculosis; skin manifestations of syphilis; skin neoplasms; precancerous skin conditions; acne vulgaris and rosacea; trophic leg ulcers associated with varicose veins; first trimester of pregnancy; infants and young children; hypersensitivity to the components of the combination.

Use in Pregnancy and Lactation

Use is contraindicated in the first trimester of pregnancy. Use during pregnancy is possible as an exception, on limited skin areas and only if the intended benefit to the mother outweighs the potential risk to the fetus.

Use during lactation (breastfeeding) is possible in exceptional cases, for a short duration, on limited skin areas. Application of the drug to the skin of the breasts is contraindicated.

Use in Renal Impairment

Repeated application to extensive skin areas should be avoided in patients with severe renal failure (systemic effects of salicylic acid are possible).

Special Precautions

Application to the skin of the face is contraindicated. Care must be taken to ensure that the drug does not come into contact with mucous membranes and the conjunctiva.

It is not recommended to exceed the course of treatment. With prolonged use on large skin areas, the frequency of side effects increases.

If an infection appears at the application site, agents with more pronounced antibacterial or antifungal action should be used.

Caution should be exercised when using in individuals with atrophic skin changes, especially in elderly patients.

Repeated application to extensive skin areas should be avoided in patients with severe renal failure (systemic effects of salicylic acid are possible).

Use in pediatrics

In children, it is used only in cases of absolute necessity, for a short course, on small body surfaces.

Effect on ability to drive vehicles and operate machinery

The drug does not limit psychophysical activity, the ability to drive vehicles, or operate moving machinery.

Drug Interactions

During treatment, vaccination and immunization are contraindicated due to the immunosuppressive effect of the drug.

It should not be used in combination with other topical preparations.

With systemic absorption of the drug, glucocorticosteroids reduce the effect of insulin, oral hypoglycemic agents, antihypertensive drugs, anticoagulants, and decrease the serum concentration of praziquantel.

The risk of side effects increases when combined with the following drugs: androgens, estrogens, oral contraceptives, anabolic steroids (hirsutism, acne), antipsychotics, bucarban, azathioprine (cataract), anticholinergics, antihistamines, tricyclic antidepressants, nitrates (glaucoma), diuretics (hypokalemia), cardiac glycosides (digitalis intoxication).

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.