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

Dermatoses, allergic and inflammatory skin diseases that respond to therapy with topical corticosteroids, the course of which is complicated by a bacterial infection or there is a risk of its occurrence in children over 1 year of age and in adults:
eczema, diffuse neurodermatitis;
dermatitis – atopic, contact (including occupational), allergic, seborrheic;
infected dermatitis that develops as a result of insect bites;
impetigo;
psoriasis;
lichen planus;
phlebotoderma;
anogenital itching.
Infected dermatitis that develops as a result of insect bites, scabies, scratching, abrasions, thermal skin lesions and diaper rash.

Pyoderma of various localizations (strepto-staphyloderma, impetigo, sycosis, ecthyma). Belogent® cream is used primarily for the treatment of acute and subacute stages of inflammatory skin diseases, including those accompanied by exudation.

Pharmacological effect

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

Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS) that has anti-inflammatory, antiallergic, antipruritic and vasoconstrictor effects.

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

Interacts with specific receptors in the cytoplasm of the cell, stimulates the synthesis of mRNA, inducing the formation of proteins, including lipocortin, mediating cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, prostaglandins, leukotrienes (promoting the development of inflammation, allergies and other pathological processes).

Gentamicin is a broad-spectrum antibiotic of the 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 gram-positive bacteria: Streptococcus spp. (susceptible strains of ß- and α-hemolytic streptococcus group A), Staphylococcus aureus (coagulase-positive, coagulase-negative strains and some penicillinase-producing strains).

Inactive against anaerobes, fungi and viruses.

Pharmacokinetics

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

Special instructions

Long-term (more than 4 weeks) external use of Belogent® on the facial skin is not recommended, as the development of rosacea, perioral dermatitis and acne is possible.

Belogent® should not be used in the eye area due to the likelihood of the drug getting into the mucous membrane, which can contribute to the development of cataracts, glaucoma, fungal infections of the eye and exacerbation of herpetic infections.

Some areas of the body, such as the armpits, groin folds, where there is a kind of natural occlusion, are more at risk of developing stretch marks, so continuous use of the cream for external use on these areas of the skin should be short-term (no more than 4 weeks).

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

Impact on the ability to drive vehicles and machinery

There are no data on the adverse effects of Belogent® cream for external use on the ability to drive vehicles and operate machinery.

Active ingredient

Betamethasone, Gentamicin

Composition

1 g of cream contains

Active substance:

betamethasone dipropionate – 0.640 mg (0.064%) in terms of betamethasone – 0.500 mg

gentamicin sulfate in terms of gentamicin base – 1,000 mg (0.1%);

Excipients: chlorocresol, sodium dihydrogen phosphate monohydrate, phosphoric acid, soft white paraffin, liquid paraffin, macrogol cetostearate, cetostearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%], sodium hydroxide, water.

Pregnancy

Local use of Belogent® cream for external 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 short-term and, if possible, limited to small areas of the skin.

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

Contraindications

Hypersensitivity in patients to betamethasone, gentamicin or any of the auxiliary components of the drug; viral skin infections, skin post-vaccination reactions, open wounds, trophic ulcers, acne vulgaris, rosacea, chicken pox, skin manifestations of syphilis, skin tuberculosis.

Side Effects

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

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

With prolonged uncontrolled treatment and application to a large surface, systemic side effects characteristic of GCS may develop.

If a hypersensitivity reaction or side effects occur, therapy should be discontinued and consult a doctor.

Interaction

The interaction of Belogent with other drugs is unknown.

Overdose

With long-term continuous use of the drug, especially in children, on large surfaces of the skin, application to skin with compromised integrity, or when used under an occlusive dressing, the development of side effects associated with increased absorption of betamethasone or gentamicin is possible.

It should be emphasized that the likelihood of such phenomena developing is extremely low.

Treatment: it is recommended to discontinue the drug and, if necessary, prescribe symptomatic therapy.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

4 years

Manufacturer

Belupo, medicines and cosmetics d.d., Croatia