betamethasone, gentamicin (betamethasone, gentamicin)

Pharmacological action

Belogent is a combined preparation with antibacterial and anti-inflammatory effects for external use.

Betamethasone is a synthetic fluorinated glucocorticoid, has a pronounced anti-inflammatory, immunosuppressive and antiproliferative effect with a slight mineralocorticoid effect.

Reduces the formation, release and activity of chemical inflammatory mediators (kinin, histamine, liposomal enzymes, prostaglandins), inhibits the migration of macrophages and leukocytes to the lesion site, reduces vasodilation and increased permeability of blood vessels, which reduces the extraction of blood serum and the formation of edema.

Inhibit type III and IV hypersensitivity reactions, blocking the toxic effect of the antigen-antibody complexes, which concentrate at the walls of blood vessels, causing allergic vasculitis.

Inhibits the action of lymphokines, target cells, and macrophages.

Prevents the access of sensitized T-lymphocytes and macrophages to target cells.

Gentamicin is an antibiotic from the group of aminoglycosides with pronounced bactericidal action, the mechanism of which is based on the inhibition of protein synthesis in the bacterial cell by binding to a specific receptor protein in the 30S region of the ribosome and interference with the initial complex between the RNA and 30S region, inhibiting protein synthesis. The result is an erroneous reading of DNA and the formation of non-functional proteins.

Gentamicin is active against gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae gram-positive bacteria: Streptococcus spp. (sensitive strains of alpha and beta hemolytic streptococcus group A), Staphylococcus aureus (coagulase-positive, coagulase-negative and some penicillinase-producing strains).

Indications

- infected allergic and non-allergic skin diseases (including acute, subacute and chronic contact allergic dermatitis, seborrheic dermatitis, diaper dermatitis, atopic dermatitis, pruritus pruritus, coin-shaped eczema, dyshidrothermal dermatosis, dermatitis peptic dermatitis, dermatitis dermatitis and dermatitis dermatitis , radiation dermatitis, infected dermatitis resulting from an insect bite)

- infected dermatoses (including psoriasis, exfoliative dermatitis, red flat lichen ).

Ointment Belogent is recommended for the treatment of chronic dermatoses (dry, lichenized and flaky) or in cases where the occlusive effect of the ointment as a medium is necessary.

Contraindications

viral skin infections

skin tuberculosis

perioral dermatitis

rosacea

skin reactions at the site of vaccination

hypersensitivity to Belogent components.

Pregnancy and lactation

Adequate and well-controlled studies of the safety of external use of corticosteroids and gentamicin during pregnancy have not been conducted. Therefore, the use of Belogent is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus. In such cases, the use of Belogent should be short-lived and limited to a small area of ​​the skin.

During lactation, the use of Belogent is possible only according to strict indications, but at the same time, the drug should not be applied to the skin of the mammary gland before feeding. When using the drug, betamethasone can enter the systemic circulation in an amount sufficient to be excreted in breast milk at detectable concentrations, however, it has been established that if the dosing regimen is observed, this amount is safe for the baby.

In experimental studies, it was found that with topical application of potent GCS in laboratory animals, a teratogenic effect is noted, but the teratogenicity of betamethasone has not been studied under such conditions. Experiments in rats and rabbits did not reveal the teratogenic effect of gentamicin. Nevertheless, it is known that gentamicin crosses the placental barrier and reaches a concentration in the blood plasma of the fetus that is comparable to the concentration in the blood plasma of the mother.

Composition

1 g ointment contains betamethasone (in the form of dipropionate) 500 mcg,

gentamicin (in the form of sulfate) 1 mg

other ingredients:

mineral oil,

white petrolatum

Dosage and administration

For adults, Belogent ointment is applied to the affected area with a thin layer, lightly rubbing in a circular motion, in the amount necessary to cover the affected surface, 2 times / day. On areas of the skin with a denser epidermis and in places from which the drug is easily eliminated with a normal lifestyle (palms and feet), it should be applied more often.

Duration of treatment should not exceed 3 weeks.

In chronic diseases, for the prevention of relapse, treatment should be continued under medical supervision for some time after the disappearance of all symptoms.

For children, the drug Belogent is prescribed with great care, for the shortest possible time due to that with a larger area of ​​skin in relation to body weight compared with adults and an insufficiently developed epidermis in children, absorption of a proportionally greater amount of betamethasone, and, accordingly, gentamicin, and, consequently, manifestations of systemic toxicity, is possible.

Use under diapers (especially plasticized ones) enhances absorption because diapers act as an occlusive dressing.

If the application time is missed, Belogent should be applied to the affected skin as soon as possible. If the time for the next use of the drug is approaching, the missed dose should be skipped, while there is no need to increase the amount of the drug during the next use.

Drug Interactions

Clinically significant drug interactions of Belogent with other drugs have not been described.

Overdose

Symptoms: Systemic adverse reactions characteristic of betamethasone or gentamicin may develop.

Extremely rare, in the case of significant amounts of gentamicin entering the systemic bloodstream as a result of prolonged use of the drug over a large area of ​​the affected skin, especially in patients who simultaneously take ototoxic and nephrotoxic drugs and in patients with impaired renal function, gentamicin may cause damage to the auditory nerve and vestibular rupture. tinnitus, as well as impaired renal function.

Treatment: The drug should be discontinued immediately. If necessary, conduct symptomatic therapy.

Storage Conditions

The product should be stored at a temperature not exceeding 25 ° C.

Shelf life

4 years.

Deystvuyushtee substance

Betamethasone, Gentamicin

Terms and conditions

without prescription

dosage form

ointment

Prescribing

Prescribing

Pregnant as prescribed by the doctor, Nursing mothers as prescribed by the doctor , For children over 1 year, For children prescribed by a doctor, For adults

Belupo, medicines and kos metika d.d, Croatia



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