Belogent Cream 40 g

Indications

Local treatment of skin diseases responsive to GCS therapy, in the presence of secondary bacterial infection or the likelihood of its development: eczema, atopic dermatitis, neurodermatitis, contact dermatitis (including occupational), allergic dermatitis, psoriasis, lichen planus, seborrheic dermatitis, exfoliative dermatitis, radiation dermatitis. Infected dermatitis resulting from insect bites, scabies, and chafing. Belogent® is primarily used for the treatment of acute and subacute stages of inflammatory skin diseases, including those accompanied by exudation.

Application method and doses

For external use.
Belogent® is applied to the affected area in a thin layer, gently rubbing it in, 1-2 times a day. The area of skin to which the drug is applied should not exceed 10% of the total skin surface. On areas with thicker skin (for example, elbows, palms, and soles), as well as places where the drug can be easily wiped off, the drug can be applied more frequently, but no more than 4 times a day. The necessary frequency of application should be determined by a doctor, based on the severity of the disease. In mild cases, application once a day is usually sufficient; in more severe lesions, more frequent application may be required. The duration of treatment depends on the severity, localization of the lesion, and the patient's response to treatment. When treating chronic diseases, therapy should be continued for 3-7 days after all symptoms have disappeared. The duration of treatment should not exceed 3 weeks.
When applying the drug to the face, on areas with thin skin, and in children, the application should be in minimal amounts that provide a therapeutic effect. The course of treatment should be limited to 5 days. For children from 1 year old, Belogent® is prescribed with caution and for the shortest possible duration. The drug is applied once a day.
If there is no improvement after treatment, or if symptoms worsen, or new symptoms appear, it is necessary to consult a doctor. Use the drug only according to the indications, method of application, and in the doses specified in the instructions for use.

Composition

1 g of cream for external use contains:
active ingredients: betamethasone dipropionate 0.640 mg (equivalent to 0.500 mg of betamethasone) and gentamicin sulfate 1.660 mg (equivalent to 1.000 mg of gentamicin);
excipients: chlorocresol - 1.000 mg, sodium dihydrogen phosphate monohydrate - 3.000 mg, phosphoric acid - 0.020 mg, soft white paraffin - 150.000 mg, liquid paraffin - 60.000 mg, macrogol cetostearyl ether - 22.500 mg, cetostearyl alcohol - 72.000 mg, sodium hydroxide - q.s., purified water - q.s. to 1.000 g.

Homogeneous cream of white color without mechanical inclusions.

Section: Contraindications

Increased sensitivity to betamethasone, gentamicin, or any of the excipients of the drug, as well as to other aminoglycosides or corticosteroids; pregnancy (prolonged treatment of extensive skin areas); skin tuberculosis, skin manifestations of syphilis, chickenpox; viral skin infections (herpes simplex, shingles); vaccination period and post-vaccination skin reactions; fungal skin diseases; rosacea and rosacea-like dermatitis; open wounds; age under 1 year; perioral dermatitis, acne, skin atrophy, perianal and genital itching.

Use during pregnancy and breastfeeding
Pregnancy
Before using Belogent®, if you are pregnant, suspect that you might be pregnant, or are planning a pregnancy, you should consult a doctor. The use of Belogent® during pregnancy is allowed only in cases where the expected benefit to the mother outweighs the risk to the fetus. In such cases, the use of the drug should be short-term, limited to small areas of skin, and under the supervision of a treating physician.
Breastfeeding
Since it is currently unknown whether topical corticosteroids penetrate into breast milk, a decision should be made to either discontinue breastfeeding or to stop the drug, considering the necessity of its use for the mother. Avoid contact between the child and the skin surface to which the drug is applied.

Special Instructions

Any side effects of systemic corticosteroids, including suppression of adrenal cortex function, may also be observed with the use of topical corticosteroids, especially in children. Systemic absorption of topical corticosteroids may increase with prolonged use, treatment of extensive body surfaces, or use of occlusive dressings. In such cases, especially in children, precautions should be taken when using the medication, including determining the frequency of use, duration of treatment, and the possibility of discontinuing the medication as prescribed by a doctor.
Vision disturbances may occur with systemic and local use of corticosteroids; in such cases, an ophthalmologist should be consulted.
Atrophic changes may manifest on the facial skin more frequently than on other body surfaces after prolonged treatment with topical corticosteroids; in this case, the treatment course should not exceed 5 days. Caution should be exercised in individuals with existing atrophic skin changes, especially in the elderly. Care should be taken when applying the medication to the face, folds, areas of natural flexion, and areas with thin skin.
Prolonged use of the medication in children should be conducted under medical supervision. In children, the treatment course should not exceed 5 days. Occlusive dressings should not be used.
When applying to the eyelids, caution should be exercised to prevent the medication from getting into the eyes, as repeated exposure may lead to cataracts and glaucoma. In case of accidental contact with the eyes, they should be rinsed thoroughly with water.
With prolonged corticosteroid therapy, sudden discontinuation of therapy may lead to rebound syndrome, manifesting as dermatitis with intense skin redness and a burning sensation. Therefore, after a prolonged treatment course, the medication should be discontinued gradually, for example, by transitioning to an intermittent treatment regimen before completely stopping it.
The medication contains cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis), and chlorocresol, which may cause allergic reactions. If signs of increased sensitivity or skin irritation related to the use of the medication are observed, treatment should be discontinued, and a doctor should be consulted.
Systemic absorption of gentamicin with local use may increase when applied to extensive areas of skin, especially with prolonged treatment or in the presence of skin damage. In such cases, especially in children, caution should be exercised due to the possible development of adverse effects characteristic of gentamicin with systemic use (see the "Side Effects" section).
Cross-allergic reactions to antibiotics from the aminoglycoside group are possible.
With prolonged local use of gentamicin, there may sometimes be an increase in resistant microflora, including fungal. In this case, treatment should be discontinued, and appropriate therapy should be prescribed.
If there is no effect from treatment within two weeks, it is recommended to consult a doctor for diagnosis clarification and treatment.
If irritation or increased sensitivity is noted during the use of the medication, treatment should be discontinued, and an alternative therapy should be selected.
The medication is not intended for use in ophthalmology, for treating wounds, and varicose ulcers on the legs.

Effect on the ability to drive vehicles and operate machinery
There is no data on the adverse effects of the Belogent® medication on the ability to drive vehicles and operate machinery.

Section: Side Effects

When the drug is applied externally in therapeutic doses, side reactions are generally mild.
Skin and subcutaneous tissue disorders: burning, itching, irritation, dry skin, folliculitis, hypertrichosis, steroid acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, telangiectasia, skin maceration, skin atrophy, striae, heat rash, secondary skin infections, pigmentation changes, hair depigmentation. Rash, itching, swelling, erythema, and other signs of skin irritation caused by the use of gentamicin.
With prolonged treatment or application over large skin areas, systemic side effects characteristic of corticosteroids may develop: weight gain, osteoporosis, increased blood pressure, edema, ulceration of the gastrointestinal mucosa, exacerbation of hidden infection foci, hyperglycemia, agitation, insomnia, menstrual cycle disturbances.
In children, systemic side effects of corticosteroids may occur: suppression of hypothalamic-pituitary-adrenal system function, Cushing's syndrome, growth retardation, lag in weight gain, and increased intracranial pressure.
Local application of corticosteroids has been associated with systemic side reactions, such as blurred vision.
Prolonged external use of gentamicin in large doses or application to extensive areas of skin may be accompanied by systemic absorption leading to adverse effects characteristic of gentamicin when used systemically. Cross-allergic reactions to antibiotics from the aminoglycoside group have been observed. Very rarely, there may be an increase in resistant microflora, including fungal. Application of the drug in the periorbital area may lead to the development of cataracts, glaucoma, and blurred vision.
If you experience side effects listed in the instructions, or if they worsen, or if you notice any other side effects not listed in the instructions, inform your doctor.

Section: Overdose

Symptoms. Prolonged use of corticosteroids for external application in large doses may cause suppression of the pituitary-adrenal system, which can lead to the development of secondary adrenal insufficiency and the appearance of symptoms of hypercortisolism, including Cushing's syndrome. A single overdose of gentamicin is not accompanied by any symptoms. Prolonged use or use in doses exceeding the recommended amounts may lead to a significant increase in insensitive microflora, including fungal, at the site of infection.
Treatment. Appropriate symptomatic treatment is indicated. Acute symptoms of overdose are usually reversible. If necessary, correction of electrolyte balance is recommended. In cases of chronic toxic effects, gradual withdrawal of corticosteroids is recommended. If there is uncontrolled growth of insensitive microorganisms or the development of a fungal infection, treatment should be discontinued and appropriate therapy should be selected.

Interactions with other medicinal products have not been registered.

Section: Pharmacodynamics

Betamethasone dipropionate is a synthetic fluorinated glucocorticosteroid (GCS) that exerts anti-inflammatory, anti-allergic, anti-itch, vasoconstrictive, immunosuppressive, and antiproliferative effects. When applied to the skin surface, it constricts blood vessels, alleviates itching, reduces the release of inflammatory mediators (from eosinophils and mast cells), interleukins 1 and 2, gamma-interferon (from lymphocytes and macrophages), inhibits the activity of hyaluronidase, and decreases the permeability of the vascular wall. It interacts with specific receptors in the cell cytoplasm, stimulating the synthesis of messenger ribonucleic acid that induces the formation of proteins, including lipocortin, which mediates cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid, and the biosynthesis of endoperoxides, prostaglandins, and leukotrienes (which contribute to the development of inflammation, allergies, and other pathological processes).
Gentamicin is a broad-spectrum antibiotic from 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; and gram-positive bacteria: Streptococcus spp. (sensitive strains of β- and α-hemolytic group A streptococcus), Staphylococcus aureus (coagulase-positive, coagulase-negative strains, and some strains producing penicillinase).
It is inactive against anaerobes, fungi, and viruses.

Pharmacokinetics

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

Description

Belogent cream is a medicinal product with antibacterial, anti-inflammatory, and anti-allergic effects for external use. Betamethasone has anti-inflammatory, anti-allergic, antiproliferative, and antipruritic effects.
Gentamicin has a broad-spectrum bactericidal action against most gram-positive and gram-negative microorganisms. Local treatment of skin diseases susceptible to GCS therapy, in the presence of secondary bacterial infection or the likelihood of its development: eczema, atopic dermatitis, neurodermatitis, contact dermatitis (including occupational), allergic dermatitis, psoriasis, lichen planus, seborrheic dermatitis, exfoliative dermatitis, radiation dermatitis. Infected dermatitis that developed as a result of insect bites, scabies, and diaper rash.
Belogent is primarily used for the treatment of acute and subacute stages of inflammatory skin diseases, including those accompanied by exudation. The drug can be used in children from 1 year of age. The duration of treatment depends on the severity, localization of the lesion, and the patient's response to treatment. In the treatment of chronic diseases, therapy should be continued for 3-7 days after all symptoms have disappeared. The duration of treatment should not exceed 3 weeks. It is recommended to consult a doctor before use.