Akriderm^® GENTA (Ointment, Cream) Instructions for Use

ATC Code

D07CC01 (Betamethasone in combination with antibiotics)

Active Substances

Gentamicin (Rec.INN registered by WHO)

Betamethasone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical corticosteroids + aminoglycoside antibiotic

Pharmacotherapeutic Group

Topical glucocorticosteroid + aminoglycoside antibiotic

Pharmacological Action

Anti-inflammatory, anti-allergic, antipruritic, antibacterial agent.

Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS) that has anti-inflammatory, anti-allergic, antipruritic, and vasoconstrictive effects. When applied topically, it constricts blood vessels, relieves itching, reduces the release of inflammatory mediators (from eosinophils and mast cells), interleukins-1 and -2, γ-interferon (from lymphocytes and macrophages), inhibits the activity of hyaluronidase, and reduces vascular wall permeability. It interacts with specific receptors in the cell cytoplasm, stimulates the synthesis of mRNA, 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, leukotrienes (which contribute to the development of inflammation, allergies, and other pathological processes).

Gentamicin is a broad-spectrum antibiotic of the aminoglycoside group. It has a bactericidal effect and provides highly effective local treatment of primary and secondary bacterial skin infections. It is active against gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; gram-positive bacteria: Streptococcus spp. (susceptible strains of group A hemolytic streptococcus), Staphylococcus aureus (coagulase-positive, coagulase-negative strains and some penicillinase-producing strains).

Pharmacokinetics

When the drug is applied topically in therapeutic doses, the transdermal absorption of the active substances into the blood is very insignificant. The use of occlusive dressings increases the absorption of betamethasone and gentamicin, which may lead to an increased risk of systemic side effects.

Indications

• Dermatitis (simple and allergic), especially secondarily infected;
• Eczema (atopic, infantile, nummular);
• Atopic dermatitis (diffuse neurodermatitis);
• Lichen simplex chronicus (circumscribed neurodermatitis);
• Solar dermatitis;
• Exfoliative dermatitis;
• Radiation dermatitis;
• Intertrigo;
• Psoriasis;
• Pruritus.

ICD codes

Dosage Regimen

Ointment

Adults

The ointment is applied in a thin layer to the affected area of the skin and surrounding tissues 2 times/day (in the morning and in the evening), gently rubbing in with circular motions. On areas of the skin with a thicker epidermis and in places from which the drug is easily removed (palms and soles), the ointment should be applied more frequently. The duration of treatment depends on the effectiveness and tolerability of therapy and is usually no more than 2-4 weeks.

Children

The drug is allowed for children from 2 years of age only for strict indications and under medical supervision.

Due to the fact that in children the skin surface area relative to body weight is larger, and the epidermis is not sufficiently developed, with topical application of the drug, absorption of a proportionally larger amount of active substances is possible and, therefore, there is a greater risk of systemic side effects. The drug should be used in children for the shortest possible time and with all precautions.

Cream

The drug is for external use.

The cream is applied in a thin layer to the affected area of the skin 2 times/day (in the morning and in the evening).

The frequency of application of the drug is determined based on the severity of the disease. In mild cases, it is sufficient to apply the cream 1 time/day; for more severe lesions, more frequent application is possible.

The duration of treatment depends on the effectiveness and tolerability of therapy and is 2-4 weeks.

In the absence of clinical improvement, it is necessary to clarify the diagnosis.

Adverse Reactions

Very rarely, when using Akriderm^® GENTA ointment, a burning sensation, erythema, exudation, pigmentation disorder, and itching are noted.

Adverse reactions encountered with the use of topical GCS (especially when using occlusive dressings): burning sensation, itching, dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, development of secondary infection, skin atrophy, striae, miliaria. Very rarely (in cases of significant systemic absorption of gentamicin) there is a risk of damage to the auditory nerve and vestibular apparatus, accompanied by tinnitus and hearing impairment. Such side effects develop in cases where patients are simultaneously taking ototoxic or nephrotoxic drugs and in case of impaired renal function.

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

In children – suppression of the pituitary-hypothalamus-adrenal system, Cushing’s syndrome, growth retardation, lag in weight gain, increased intracranial pressure (betamethasone).

Contraindications

• Skin tuberculosis;
• Vaccinia;
• Viral skin infections;
• Perioral dermatitis;
• Rosacea;
• Skin manifestations of syphilis;
• Skin post-vaccination reactions;
• Children under 2 years of age;
• Hypersensitivity to betamethasone, gentamicin or to any of the excipients that make up the drug.

Use in Pregnancy and Lactation

The safety of topical use of GCS in pregnant women has not been established; the prescription of drugs of this group during pregnancy is justified only if the potential benefit to the mother outweighs the possible risk to the fetus. During pregnancy, drugs of this group should not be used in high doses or for a long time.

It has not been established whether the drug penetrates into breast milk, so breastfeeding should be discontinued.

Pediatric Use

The drug is allowed for children from 2 years of age only for strict indications and under medical supervision.

Due to the fact that in children the skin surface area relative to body weight is larger, and the epidermis is not sufficiently developed, with topical application of the drug, absorption of a proportionally larger amount of active substances is possible and, therefore, there is a greater risk of systemic side effects. The drug should be used in children for the shortest possible time and with all precautions.

Special Precautions

Akriderm^® GENTA ointment is not recommended for use on the skin of the face and scalp.

The use of the ointment under occlusive dressings is not recommended, except in cases where it is necessary.

Avoid getting Akriderm^® GENTA ointment into the eyes and the periorbital area.

The ointment should not be used to treat varicose trophic ulcers of the leg and open wounds.

With prolonged use of the ointment on large areas of the skin with impaired integrity, there is a potential possibility of gentamicin absorption and, accordingly, the development of symptoms of ototoxicity.

Some areas of the body (groin folds, armpits and perianal area) are more susceptible to the risk of striae. Therefore, the duration of application of the drug on these areas of the body should be limited.

In cases of fungal superinfection, additional use of an antifungal agent is necessary.

Effect on the ability to drive vehicles and mechanisms

There are no data on the adverse effect of the drug on the ability to drive vehicles and mechanisms.

Overdose

Symptoms with prolonged use of topical GCS in high doses, suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing’s syndrome, is possible.

With a single overdose of gentamicin, the appearance of any symptoms is not expected.

Long-term treatment with gentamicin in increased doses can lead to the growth of non-susceptible flora.

Treatment is symptomatic. Acute symptoms of hypercortisolism are usually reversible. If necessary, electrolyte balance correction is performed.

Drug Interactions

No interactions of the drug with other medicinal products have been identified.

Storage Conditions

Store out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.