Belogent, ointment 40 g

Pharmacodynamics

Belogent® is an anti-inflammatory, anti-allergic, antipruritic, antibacterial agent.
Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS) with anti-inflammatory, anti-allergic, antipruritic and vasoconstrictor action.

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 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 pneumonia; and 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).

Pharmacokinetics

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

Indications

Active ingredient

Composition

1 g of the ointment contains:

The active ingredient:

betamethasone dipropionate – 0.640 mg in terms of betamethasone – 0.500 mg

gentamicin sulfate converted to gentamicin base – 1,000 mg;

Excipients:

Liquid paraffin,

Soft white paraffin.

How to take, the dosage

For external use only.

The Belogent® Topical Ointment is applied to the affected area in a thin layer in the amount needed to cover the affected surface twice a day, rubbing lightly. Areas of thicker skin (such as elbows, palms and feet) or those that rub off easily can be treated more frequently.

The duration of a continuous course of treatment is usually no more than 4 weeks. To prevent relapses in the treatment of chronic diseases, therapy should be continued for some time after all symptoms have disappeared. It is possible to repeat therapy several times during the year.

Interaction

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 kind of natural occlusion are at greater risk for stretch marks, so continuous use of topical ointment in these areas of skin should be short-lived (max. 4 weeks).

In cases of the development of fungal microflora 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 the drug Belogent® Ointment for Topical Use on the ability to drive and operate vehicles.

Contraindications

Hypersensitivity in patients to betamethasone, gentamicin or any of the drug’s excipients; viral skin infections, postvaccinal skin reactions, open wounds, trophic ulcers, acne vulgaris, rosacea, varicella, cutaneous manifestations of syphilis, skin tuberculosis.

Side effects

The side effects are usually mild. Rarely, as with other glucocorticosteroids, hypersensitivity reactions (itching, burning or redness), acne-like changes, hypopigmentation, stretch marks, skin atrophy, hypertrichosis, telangiectasia may develop.

If hypersensitivity or side effects occur, discontinue treatment and see a physician.

Overdose

Pregnancy use

Topical application of Belogent® ointment for external use in pregnant women 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.

When breastfeeding, the use of the drug Belogent® is possible under strict indications, but at the same time the drug must not be applied to the skin of the mammary gland before breastfeeding.

Similarities