Celestoderm-V^® with Garamycin (Cream) Instructions for Use

Marketing Authorization Holder

BAYER, JSC (Russia)

Manufactured By

Famar, A.V.E. (Greece)

Or

Schering-Plough Labo N.V. (Belgium)

ATC Code

D07CC01 (Betamethasone in combination with antibiotics)

Active Substances

Gentamicin (Rec.INN registered by WHO)

Betamethasone (Rec.INN registered by WHO)

Dosage Forms

	Celestoderm-V® with Garamycin®	Cream for external use 1 mg+1 mg/1 g: tubes of 15 g or 30 g
		Ointment for external use 1 mg+1 mg/1 g: tubes of 15 g or 30 g

Dosage Form, Packaging, and Composition

Cream for external use is white in color, of soft consistency, homogeneous, and does not contain foreign inclusions.

Excipients: white soft paraffin – 150 mg, cetearyl alcohol – 72 mg, liquid paraffin – 60 mg, macrogol cetostearyl ether – 22.5 mg, phosphoric acid – 0.02 mg, sodium dihydrogen phosphate dihydrate – 3.39 mg (equivalent to 3 mg of sodium dihydrogen phosphate monohydrate), chlorocresol – 1 mg, sodium hydroxide and phosphoric acid (to adjust pH), purified water – q.s. to 1 g.

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

Ointment for external use is from almost white to light yellow in color, homogeneous, without foreign particles.

Excipients: liquid paraffin – 100 mg, white soft paraffin – q.s.

15 g – lacquered aluminum tubes (1) – cardboard packs.
30 g – lacquered aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Topical glucocorticosteroid + aminoglycoside antibiotic

Pharmacological Action

Combined medicinal product.

Betamethasone is a glucocorticosteroid that exerts local anti-inflammatory, vasoconstrictive, and anti-allergic effects.

It inhibits the release of cytokines and inflammatory mediators, reduces the metabolism of arachidonic acid, and induces the formation of lipocortin.

Gentamicin is a broad-spectrum antibiotic from the aminoglycoside group, acting bactericidally.

It is effective against microorganisms: Streptococcus (beta-hemolytic and alpha-hemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative, and also some strains producing penicillinase), Proteus vulgaris, Escherichia coli, Pseudomonas aeruginosa, Enterobacter aerogenes.

It is not active against anaerobes, fungi, and viruses.

Indications

Simple and allergic dermatitis (especially complicated by secondary infection); eczema; atopic dermatitis; diffuse neurodermatitis; simple chronic lichen (circumscribed neurodermatitis); anogenital pruritus; senile pruritus; seborrheic dermatitis; intertrigo; solar dermatitis; exfoliative dermatitis; psoriasis; erythroderma; lichen planus; dyshidrosis.

ICD codes

Dosage Regimen

Apply a thin layer of the cream or ointment to the affected skin areastwice daily.

Gently rub in the preparation until fully absorbed.

For mild cases, a single daily application may be sufficient.

Select the dosage form based on the nature of the dermatosis.

Use the ointment for dry, scaly, or lichenified lesions, such as those associated with chronic eczema or psoriasis.

Use the cream for moist, weeping, or intertriginous areas and for conditions affecting oily skin.

Limit the treatment duration to the minimum period necessary to achieve therapeutic control.

Avoid applying the product under occlusive dressings unless specifically directed by a physician, as this increases systemic absorption.

Do not use on large body surface areas, on broken skin, or for prolonged periods due to the risk of systemic effects.

Discontinue use and consult a physician if no improvement is observed within a reasonable period, or if irritation or signs of sensitization occur.

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

Prevent contact with the eyes and mucous membranes.

Adverse Reactions

Skin and subcutaneous tissue disorders at the application site – burning, itching, irritation, dry skin, folliculitis, hypertrichosis, steroid acne, hypopigmentation.

Transient skin irritation is possible: itching, erythematous rash (Gentamicin).

When using occlusive dressings – skin maceration, infection, skin atrophy, striae, miliaria.

With prolonged treatment or application to a large surface – development of systemic side effects of glucocorticosteroids: weight gain, osteoporosis, increased blood pressure, edema, ulceration of the gastrointestinal mucosa, exacerbation of latent foci of infection, hyperglycemia, agitation, insomnia, menstrual cycle disorders.

Systemic reactions: in children, suppression of the pituitary-hypothalamus-adrenal system, Cushing’s syndrome, growth retardation, delayed weight gain, increased intracranial pressure (betamethasone) are possible.

Contraindications

Skin tuberculosis; skin manifestations of syphilis; chickenpox; herpes simplex; vaccinia (dermatosis occurring as a complication of smallpox vaccination); post-vaccination skin reactions; lactation period (breastfeeding); hypersensitivity.

With caution

First trimester of pregnancy.

Use in Pregnancy and Lactation

Use with caution during pregnancy, especially in the first trimester.

Contraindicated for use during the lactation period (breastfeeding).

Special Precautions

Avoid contact with eyes.

If signs of sensitization or irritation appear, treatment should be discontinued.

In case of superinfection development, the drug should be discontinued and adequate antibacterial therapy prescribed.

It should be borne in mind that systemic absorption increases when applied to large areas of the skin, using large doses and for a long time, as well as when applied under occlusive dressings.

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.