Belogent, cream 40 g

Belogent® is an anti-inflammatory, anti-allergic, antipruritic, antibacterial agent.

Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS) with anti-inflammatory, anti-allergic, antipruritic and vasoconstrictive effects.

When applied to the skin surface it narrows vessels, relieves itching, reduces release of inflammatory mediators (from eosinophils and mast cells), interleukins 1 and 2, gamma-interferon (from lymphocytes and macrophages), inhibits activity of hyaluronidase and reduces vascular wall permeability.

It interacts with specific receptors in the cell cytoplasm, stimulating the synthesis of mRNA, inducing the formation of proteins, including lipocortin, which mediate cellular effects. Lipocortin inhibits phospholipase A2, blocks release of arachidonic acid and biosynthesis of endoperoxides, prostaglandins, leukotrienes (contributing to inflammation, allergy and other pathological processes).

Gentamicin is a broad-spectrum antibiotic of aminoglycoside group. It has a bactericidal effect and provides highly effective local treatment of primary and secondary bacterial skin infections.

Active against Gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumonia; and against Gram-positive bacteria: Streptococcus spp. (sensitive strains of ß- and α-hemolytic Streptococcus group A), Staphylococcus aureus (coagulase-positive, coagulase-negative strains and some strains producing penicillinase).

It is inactive against anaerobes, fungi and viruses.

Pharmacokinetics

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

Indications

Active ingredient

Composition

1 g of the cream contains

The active ingredient:

betamethasone dipropionate – 0.640 mg (0.064%) converted to betamethasone – 0.500 mg

gentamicin sulfate converted to gentamicin base – 1.000 mg (0.1%);

Auxiliary substances: chlorocresol, sodium dihydrophosphate monohydrate, phosphoric acid, soft white paraffin, liquid paraffin, macrogoal cetostearate, cetostearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%], sodium hydroxide, water.

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How to take, the dosage

For external use only.

Belogent® Topical Cream is applied to the affected area in a thin layer in the amount needed to cover the affected surface twice a day, rubbing lightly. On areas of thicker skin (e.g., elbows, palms and feet) or where the product rubs off easily, Belogent® can be applied more frequently, but no more than 4 times a day.

The duration of a continuous course of treatment is usually no more than 4 weeks. In the case of chronic diseases, therapy should be continued for a period of time after all symptoms have disappeared in order to prevent relapse. During the year it is possible to repeat the therapy more than once.

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Interaction

Its interaction of the drug Belogent with other medicines is unknown.

Special Instructions

Long-term (more than 4 weeks) external use of Belogent® on the face is not recommended because rosacea, perioral dermatitis, and acne may develop.

Belogent® should not be used in the eye area because of the possibility of contact of the drug with the mucosa which may lead to cataracts, glaucoma, fungal infections of the eye and exacerbation of herpetic infection.

Some areas of the body such as the armpits and groin folds where there is a sort of natural occlusion are at greater risk of stretch marks, so continued use of topical cream on these areas of skin should be short-lasting (no more than 4 weeks).

In cases where fungal microflora develops on the skin, additional use of an antifungal agent is necessary.

Influence on driving and operating ability

There are no data on the adverse effects of Belogent® Topical Cream on driving and operating ability.

Contraindications

Side effects

When using the drug in therapeutic doses, side effects are usually mild.

Rarely, as with other glucocorticosteroids, hypersensitivity reactions (itching, burning, redness), irritation, dry skin, acne-like changes, hypopigmentation, stretch marks, skin atrophy, folliculitis, hypertrichosis, telangiectasia may develop.

In case of prolonged uncontrolled treatment and application over a large surface area, systemic side effects typical of GCS may develop.

In case of hypersensitivity or side effects, the therapy should be stopped and a physician should be consulted.

Overdose

In prolonged continuous use, especially in children, on extensive skin surfaces, application to skin with compromised integrity or when used under an occlusive dressing, side effects associated with increased absorption of betamethasone or gentamicin may develop.

It should be emphasized that the likelihood of these occurring is extremely low.

Treatment: It is recommended that the drug be discontinued and symptomatic therapy administered if necessary.

Pregnancy use

Topical application of Belogent® cream for topical use in pregnant women and nursing mothers is allowed under the supervision of a physician. In such cases, the use of the drug should be of short duration and, if possible, limited to small areas of the skin.

The drug should not be applied to the skin of the mammary gland before breastfeeding.

Similarities