Akriderm Genta, ointment 30 g

Acriderm GENTA is a combined preparation for external use with anti-inflammatory, anti-allergic and antibacterial effect.

Betamethasone dipropionate is a glucocorticosteroid with anti-inflammatory, anti-allergic, anti-exudative, anti-edema and antipruritic effect. It inhibits leukocyte accumulation, release of lysosomal enzymes and proinflammatory mediators in inflammation focus, inhibits phagocytosis, decreases vascular and tissue permeability and prevents inflammatory edema formation.

Gentamicin is a broad-spectrum antibiotic of aminoglycoside group. It has bactericidal action against pathogens of primary and secondary bacterial skin infections.

Active against Gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; against Gram-positive bacteria: Streptococcus spp. (sensitive strains of beta- and alpha-hemolytic Streptococcus group A), Staphytococcus spp. (coagulase-positive, coagulase-negative and some strains producing penicillinase). Inactive against anaerobes, fungi and viruses.

Indications

Treatment of steroid-sensitive dermatoses complicated by primary and/or secondary bacterial infection, eczema (atopic, childhood, coin-shaped), limited and diffuse allergic dermatoses, including complicated by infection sensitive to gentamicin, dermatitis (simple and allergic), atopic dermatitis, solar dermatitis, exfoliative and radiation dermatitis, diaper rash, psoriasis, itching.

Pharmacological effect

Akriderm GENTA is a combined preparation for external use that has anti-inflammatory, antiallergic and antibacterial effects.

Betamethasone dipropionate is a glucocorticosteroid that has anti-inflammatory, antiallergic, antiexudative, decongestant and antipruritic effects. Inhibits the accumulation of leukocytes, the release of lysosomal enzymes and pro-inflammatory mediators at the site of inflammation, inhibits phagocytosis, reduces vascular tissue permeability, and prevents the formation of inflammatory edema.

Gentamicin is a broad-spectrum antibiotic from the aminoglycoside group. 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. (susceptible strains of group A beta- and alpha-hemolytic streptococcus), Staphytococcus spp. (coagulase-positive, coagulase-negative and some penicillinase-producing strains). Inactive against anaerobes, fungi and viruses.

Special instructions

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

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

If resistant bacterial or fungal microflora appears, use of the drug should be discontinued and appropriate therapy should be prescribed. the development of cross-resistance with aminoglycoside antibiotics is possible.

Active ingredient

Betamethasone, Gentamicin

Composition

In 100 g ointment:

active substances:

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,

Vaseline.

Pregnancy

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

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

Contraindications

Hypersensitivity to the components of the drug.

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

Side Effects

Very rarely, when using Akriderm® GENTA ointment, the following are observed: burning sensation, erythema, exudation, pigmentation disorders and itching.

Adverse reactions encountered when using local corticosteroids: (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, stretch marks, prickly heat.

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 in cases where patients are simultaneously taking ototoxic or nephrotoxic drugs and in cases of impaired renal function.

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

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

Interaction

No interactions of the drug with other drugs have been identified.

Overdose

Symptoms: With long-term use of local corticosteroids 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, no symptoms are expected to appear.

Long-term treatment with gentamicin in high doses may lead to the growth of insensitive flora.
Treatment: Symptomatic. Acute symptoms of hypercortisolism are usually reversible. If necessary, electrolyte balance is corrected.

Storage conditions

At a temperature of 15–25 °C.

Shelf life

2 years.

Manufacturer

Akrikhin JSC, Russia