Mechanism of action - combined drug with antibacterial and anti-inflammatory action for external use. Betamethasone is a synthetic fluorinated glucocorticoid, has a pronounced anti-inflammatory, immunosuppressive and anti-proliferative effect with a slight mineralocorticoid effect. Reduces the formation, release and activity of chemical mediators of inflammation (kinin, histamine, liposomal enzymes, prostaglandins), inhibits the migration of macrophages and leukocytes to the site of damage, reduces vasodilation and increased permeability of blood vessels, which reduces the extravasation of serum and the formation of edema. Inhibit III and IV type of hypersensitivity reactions, while blocking the toxic effect of complexes of "antigen-antibody", which are concentrated near the walls of blood vessels, causing allergic vasculitis. Inhibits the action of lymphokines, target cells and macrophages. Prevents access of sensitized T-lymphocytes and macrophages to target cells.
Gentamicin is an antibiotic from the group of aminoglycosides with a pronounced bactericidal effect, the mechanism of which is based on inhibiting protein synthesis in a bacterial cell by binding to the receptor specific protein in the 30S ribosome region and interfering with the initial complex between the RNA and 30S site, 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 strains that produce penicillinase). Indications and usageinfected allergic and non-allergic skin diseases (including acute, subacute and chronic contact allergic dermatitis, seborrheic dermatitis, diaper dermatitis, atopic dermatitis, pruritus, monovid eczema, dyshidrotic dermatitis, pyodermic non-allergic dermatitis, asymptomatros; dermatitis, developed as a result of insect bite); infected dermatoses (including psoriasis, exfoliative dermatitis, lichen planus).
The cream is used for the treatment of acute, moist skin lesions.
The ointment is recommended for the treatment of chronic dermatoses (dry, lichenized and scaly) or in cases where the occlusive effect of the ointment as a medium is necessary. Adults cream or ointment is applied to the affected skin with a thin layer, gently rubbing in a circular motion, in an amount necessary to cover the affected surface, 2 times / day. On areas of skin with tighter epidermis and in places where the drug is easily removed during normal life (palms and feet), it should be applied more often. The duration of treatment should not exceed 3 weeks.
In chronic diseases, for the prevention of recurrence, treatment should continue under the supervision of a physician for some time after the disappearance of all symptoms.
For children, the drug is prescribed with great care, for perhaps a shorter period due to the fact that with a larger area of the skin in relation to body weight as compared to adults and insufficiently developed epidermis in children, absorption of proportionally more betamethasone and, accordingly, gentamicin and, therefore, manifestations of systemic toxicity. Application under diapers (especially plasticized) enhances absorption, because diapers act as an occlusive dressing.
In case the application time is missed, Belogent cream or ointment should be applied to the affected skin as soon as possible. If the time of the next use of the drug is approaching, you should skip the missed dose, and there is no need to increase the amount of the drug in the next application. Adverse reactionsLocal reactions: hypopigmentation, burning sensation, irritation, erythema.
Systemic reactions caused by the action of betamethasone: in some cases - systemic side effects caused by suppression of the hypothalamic-pituitary-adrenal system, decreased tolerance to carbohydrates and Cushing's syndrome, in children - growth retardation and increased intracranial pressure.
Systemic reactions due to gentamicin: in isolated cases, with significant systemic absorption, there is a risk of damage to the auditory nerve and vestibular apparatus, accompanied by tinnitus, hearing loss (more often with the simultaneous use of other ototoxic or nephrotoxic drugs and with concomitant renal dysfunction).
When using the drug in therapeutic doses, side effects are usually mild. Contraindicationsviral infections of the skin; lupus; perioral dermatitis; rosacea; skin reactions at the vaccination site; hypersensitivity to the drug.
Pregnancy and breastfeedingAdequate and well-controlled studies of the safety of external use of GCS 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 and limited to a small area of skin.
During lactation, the use of Belogent is possible only under strict indications, but 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 into breast milk at detectable concentrations, but it has been established that, if the dosage regimen is observed, this amount is safe for the baby.
In experimental studies it was found that when externally applied potent corticosteroids in laboratory animals, a teratogenic effect is noted, however, the teratogenicity of betamethasone in such conditions has not been studied. Experiments on rats and rabbits did not detect the teratogenic effect of gentamicin. Nevertheless, it is known that gentamicin penetrates the placental barrier and in the blood plasma of the fetus reaches concentrations comparable to those in the mother's blood plasma. Special notesDo not recommend the use of Belogent under occlusive dressings.
Do not recommend long-term use of the drug on the skin of the face due to the possible development of dermatitis type rosacea, perioral dermatitis, atrophy of the skin of the face and acne.
Belogent should not be allowed to enter the eyes due to the possible development of cataracts, glaucoma, fungal infections of the eye and exacerbation of herpes infection.
White Agent is not used for the treatment of varicose trophic ulcers of the leg.
If the first use of Belogenta develop skin hypersensitivity reactions (itching, burning and redness), the drug should be immediately canceled.
Patients with impaired liver function and patients who need long-term treatment with Belogent cream or ointment, especially when using an occlusive dressing, need careful medical observation, since they may have enhanced absorption of betamethasone and the development of systemic adverse reactions.In this category of patients, the function of the hypothalamic-pituitary-adrenal system should be periodically monitored (test for free cortisol in urine and plasma, test ACTH-stimulation). If there are signs of suppression, it is necessary either to cancel the drug, or to increase the interval between its use or replace it with a weaker GCS. At the same time, in some cases, symptoms of withdrawal syndrome (fever, myalgia, arthralgia, weakness) may occur, which requires systemic replacement therapy for GCS.
Some areas of the body, such as the inguinal region, the armpits, and the perianal region, where there is a kind of natural occlusion, are more susceptible to the appearance of stretch marks when Belogent is used externally, therefore the use of the drug in these areas of the skin should be limited to the maximum.
With the development of fungal superinfection lesions of the skin, additional use of antimicrobial agents is necessary.
Do not recommend the use of the drug on the scalp.
It should be borne in mind that long-term external use of gentamicin may cause the selection of strains of pathogens resistant to aminoglycosides, therefore its external use is not recommended in patients with weakened immunity and in other high-risk groups. The results of experimental studies
Animal studies have shown that the combination of betamethasone and gentamicin for topical use is well tolerated. Data on the carcinogenic effects of betamethasone and gentamicin are not available. Use in pediatrics
During the period of Belogent therapy, children need careful medical observation, since they may have enhanced absorption of betamethasone and the development of systemic side effects. Clinical manifestations include growth retardation, delayed weight gain, a decrease in plasma cortisol levels, and a lack of response to ACTH stimulation. Increased intracranial pressure is manifested in the swelling of the fontanel, headaches and bilateral edema of the optic papillae. Such phenomena develop extremely rarely, are, as a rule, reversible and disappear immediately after the cessation of treatment. Symptoms: possible development of systemic adverse reactions characteristic of betamethasone or gentamicin.
Exceptionally rarely, if significant amounts of gentamicin enter the systemic circulation as a result of prolonged use of the drug over a large area of affected skin, especially in patients who take ototoxic and nephrotoxic drugs at the same time, and in patients with impaired renal function, gentamicin can cause damage to the auditory nerve and vestibular apparatus, accompanied by tinnitus, and renal dysfunction.
Treatment: the drug should be immediately lifted. If necessary, conduct symptomatic therapy. Clinically significant drug interactions with other drugs are not described. The drug should be stored at a temperature not higher than 25 ° C. Shelf life - 4 years. Pharmacy sales terms
The drug is available on prescription. |
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