Akriderm Genta, ointment, 30g

Composition

In 100 g of ointment:

active ingredients:  

betamethasone dipropionate – 0.064 g,

gentamicin sulfate in terms of active anhydrous substance-0.1 g

excipients:  

propyl parahydroxybenzoate (nipazole),

liquid paraffin (vaseline oil),

isopropyl palmitate,

petrolatum.

Pharmacological action

Akriderm GENTA is a combined drug for external use that has anti-inflammatory, anti-allergic and antibacterial effects. Betamethasone dipropionate is a glucocorticosteroid that has anti-inflammatory, anti-allergic, anti-exudative, anti-edematous and antipruritic effects. It inhibits the accumulation of white blood cells, the release of lysosomal enzymes and pro-inflammatory mediators in the inflammatory focus, inhibits phagocytosis, reduces vascular-tissue permeability, and prevents the formation of inflammatory edema. Gentamicin is a broad-spectrum antibiotic from the group of aminoglycosides. It has a bactericidal effect against pathogens of primary and secondary bacterial skin infections. Active against gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; gram-positive bacteria: Streptococcus spp. (sensitive strains of beta-and alpha-hemolytic streptococcus group A), Staphytococcus spp. (coagulase-positive, coagulase-negative, and some penicillinase-producing strains). Inactive against anaerobes, fungi and viruses.

Indications

Treatment of steroid-sensitive dermatoses complicated by primary and / or secondary bacterial infection, eczema (atopic, pediatric, monetoid), limited and diffuse allergodermatoses, including those complicated by gentamicin-sensitive infection, dermatitis (simple and allergic), atopic dermatitis, solar dermatitis, exfoliative and radiation dermatitis, diaper rash, psoriasis, pruritus.

Use during pregnancy and lactation

The safety of topical use of glucocorticosteroids in pregnant women has not been established; the use of drugs of this group during pregnancy is justified only if the potential benefit to the mother exceeds 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 it is necessary to stop breastfeeding.

Contraindications

Hypersensitivity to the components of the drug.

Skin tuberculosis, viral skin infections, vaccinations, perioral dermatitis, rosacea.

Side effects

Very rarely, when using Akriderm® GENTA ointment, there are: burning sensation, erythema, exudation, pigmentation disorder and itching. Adverse reactions that occur with the use of topical corticosteroids:  (especially when applying occlusive dressings): burning sensation, itching, dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, development of secondary infection, skin atrophy, striae, sweating. Extremely 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 when patients simultaneously take ototoxic or nephrotoxic drugs and when renal function is impaired. With prolonged treatment or application on a large surface – the development of systemic side effects of glucocorticosteroids: increased body weight, osteoporosis, increased blood pressure, edema, ulceration of the gastrointestinal mucosa, exacerbation of hidden foci of infection, hyperglycemia, agitation, insomnia, menstrual disorders. In children-depression of the pituitary-hypothalamus-adrenal system, Cushing’s syndrome, growth retardation, lag in weight gain, increased intracranial pressure (betamethasone).

Interaction

Interactions of the drug with other drugs were not detected.

How to take, course of use and dosage

Adult ointment is applied in a thin layer to the affected area of the skin and surrounding tissues 2 times a day (morning and evening), lightly rubbing in circular motions. On areas of skin with a thicker epidermis and in places from which the drug is easily eliminated (palms and feet), the ointment should be applied more often. The duration of treatment depends on the effectiveness and tolerability of the therapy and is usually no more than 2-4 weeks. Children are allowed to prescribe the drug from the age of two only under strict indications and under the supervision of a doctor. Due to the fact that in children the area of the skin in relation to body weight is larger, and the epidermis is not sufficiently developed, with external use of the drug, it is possible to absorb proportionally more active substances and, therefore, there is a greater risk of developing systemic side effects. Use the drug in children should be as short as possible and in compliance with all precautions.

Overdose

Symptoms:  Long-term use of topical corticosteroids in high doses may lead to suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercorticism, including Cushing’s syndrome. With a single gentamicin overdose, no symptoms are expected. Long-term treatment with gentamicin in high doses can lead to the growth of insensitive flora. Treatment:  Symptomatic. Acute symptoms of hypercorticism are usually reversible. If necessary, correct the electrolyte balance.

Special instructions

The drug is not used in ophthalmology. Avoid contact with eyes, damaged skin, and open wound areas.

In order to increase the effectiveness of therapy, it is possible to use occlusive dressings. It should be taken into account that this increases the transdermal absorption of betamethasone and gentamicin, which leads to an increased risk of systemic side effects.

If a stable bacterial or fungal microflora appears, the drug should be discontinued and appropriate therapy should be prescribed. it is possible to develop cross-resistance with aminoglycoside antibiotics.

Form of production

Ointment.

Storage conditions

At a temperature of 15-25 °C.

Shelf

life is 2 years.

Active ingredient

Betamethasone, Gentamicin

Dosage form

ointment

Description

For adults, Children prescribed by a doctor, Children over 1 year old, Pregnant women prescribed by a doctor

Indications

Eczema, Psoriasis, Dermatitis, Dermatosis, Allergies, Diaper Rash