Pharmaderm^® (Ointment) Instructions for Use

Marketing Authorization Holder

Pharmasintez, JSC (Russia)

Manufactured By

Lok-Beta Pharmaceuticals (India), Private Limited (India)

Packaging and Quality Control Release

Pharmasintez, JSC (Russia)

ATC Code

D07AC01 (Betamethasone)

Active Substance

Betamethasone (Rec.INN registered by WHO)

Dosage Form

Pharmaderm®

Ointment for external use 0.05%: tubes 15 g or 30 g

Dosage Form, Packaging, and Composition

Ointment for external use white with a yellowish tint, semi-transparent, homogeneous.

Excipients : liquid paraffin – 40 mg, isopropyl myristate – 10 mg, propylene glycol – 30 mg, white soft paraffin – up to 1 g.

15 g – aluminum tubes (1) – cardboard boxes.
30 g – aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

Betamethasone dipropionate is a synthetic glucocorticosteroid. It has anti-inflammatory, antipruritic, antiallergic, vasoconstrictive, anti-exudative, and antiproliferative effects.

When applied to the skin surface, it constricts blood vessels, relieves itching, reduces the release of inflammatory mediators (from eosinophils and mast cells), interleukins 1 and 2, gamma-interferon (from lymphocytes and macrophages), inhibits activity and reduces the permeability of the vascular wall.

It interacts with specific receptors in the cell cytoplasm, stimulates the synthesis of messenger ribonucleic acid, inducing the formation of proteins, including lipocortin, which mediate cellular effects.

Lipocortin inhibits phospholipase A₂, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, prostaglandins, leukoproteins (which contribute to the development of inflammation, allergies and other pathological processes).

Pharmacokinetics

With external use in therapeutic doses, transdermal absorption of the active substance into the blood is very insignificant.

The use of occlusive dressings, inflammation and skin diseases increase transdermal absorption, which may lead to an increased risk of systemic side effects.

Indications

Skin diseases amenable to glucocorticosteroid therapy: atopic dermatitis/neurodermatitis, allergic contact dermatitis, eczema (various forms), contact dermatitis (including occupational) and other non-allergic dermatitis (including solar and radiation dermatitis), reactions to insect bites, psoriasis, bullous dermatoses, discoid lupus erythematosus, lichen planus, exudative multiforme erythema, pruritus of various etiologies, erythroderma.

ICD codes

Dosage Regimen

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

Gently rub the ointment into the skin until fully absorbed.

The frequency of application and duration of treatment depend on the severity of the condition and patient response.

For adults and children over 12 years, use the minimum effective dose for the shortest period necessary to control symptoms.

For children aged 1 to 12 years, limit treatment to five days and avoid application under occlusive dressings.

Do not use on children under 1 year of age.

For chronic conditions like psoriasis, apply once or twice daily until plaques thin and scale reduces.

In acute inflammatory dermatoses, apply until acute phase subsides, then discontinue or reduce frequency.

If no clinical improvement is observed within one week, re-evaluate the diagnosis.

Avoid application on the face, groin, or axillae unless directed by a physician.

Do not apply to large surface areas or under occlusive dressings for prolonged periods due to risk of systemic absorption.

If applying to intertriginous areas, use sparingly and monitor for signs of skin atrophy or striae.

Wash hands before and after application, unless hands are the treated area.

Discontinue use if irritation or signs of infection develop.

Adverse Reactions

Skin and subcutaneous tissue disorders skin itching, burning, irritation, dry skin, folliculitis, hypertrichosis, striae, acneiform eruptions (“steroid” acne), hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, local hirsutism, telangiectasia, miliaria, purpura.

Laboratory and instrumental data hyperglycemia, glucosuria.

Eye disorders blurred vision.

Other reversible suppression of adrenal cortex function, manifestation of Cushing’s syndrome.

Contraindications

Hypersensitivity, bacterial (skin tuberculosis, skin manifestations of syphilis), fungal, viral (chickenpox, herpes simplex) skin diseases, post-vaccination skin reactions, open wounds, trophic leg ulcers, rosacea, acne vulgaris, skin cancer, nevus, atheroma, melanoma, hemangioma, xanthoma, sarcoma, children under 1 year of age (cream and ointment) and under 2 years (spray), breastfeeding period.

With caution

Cataract, diabetes mellitus, glaucoma, tuberculosis (with long-term use or application to large areas of the body), children aged 2 to 12 years (spray).

Use in Pregnancy and Lactation

Contraindicated during pregnancy and during lactation (breastfeeding).

Pediatric Use

The drug is contraindicated for use in children under 1 year of age (ointment and cream) and under 2 years (spray).

With caution when using the spray form in children from 2 to 12 years old.

Special Precautions

Long-term use of the drug on the skin of the face is not recommended, as the development of rosacea, perioral dermatitis and acne is possible. The course of treatment should not exceed 5 days.

The medicinal product is not intended for use in ophthalmology. Avoid getting the drug into the eyes. If the drug gets on the mucous membranes of the eye, the development of cataracts, glaucoma, fungal eye infections and exacerbation of herpetic infection is possible.

With prolonged treatment, when applied to large skin surfaces, as well as in the armpits and groin folds, when using occlusive dressings, diapers, systemic absorption of glucocorticosteroids is possible.

When applied to large areas and/or under an occlusive dressing, suppression of the hypothalamic-pituitary-adrenal system function and the development of symptoms of hypercortisolism are possible, a decrease in the excretion of growth hormone and an increase in intracranial pressure may be observed.

The spray form is preferable for use in the acute form of dermatosis, including those accompanied by exudation (formation of weeping surfaces).

Use in pediatrics

Use in children aged 1-2 years is possible only under medical supervision. Children are more susceptible to the risk of suppression of the hypothalamic-pituitary-adrenal system function due to the use of topical glucocorticosteroids than adults, due to their larger ratio of body surface area to body weight and, accordingly, increased absorption of this agent.

In children, this is accompanied by low plasma cortisol levels and lack of response to ACTH stimulation. The occurrence of Cushing’s syndrome, growth and development disorders, slowing of weight gain, increased intracranial pressure, manifested by bulging fontanelle, headaches, bilateral optic disc edema is possible.

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

Over-the-Counter

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.