Universal reference book for medicines
Product name: BELOGENT ® (BELOGENT ® )

Active substance: betamethasone, gentamicin

Type: The drug with antibacterial and anti-inflammatory action for external use

Manufacturer: BELUPO, Pharmaceuticals & Cosmetics (Croatia)
Composition, form of production and packaging
?
Cream for external application of white color, homogeneous, without mechanical inclusions.
1 g

betamethasone dipropionate 640 μg,

which corresponds to the content of betamethasone 500 μg

gentamicin (in the form of sulfate) 1 mg

Auxiliary substances: chlorocresol, sodium dihydrogen phosphate monohydrate, phosphoric acid, paraffin soft white, paraffin liquid, macrogol cetostearate, cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%), sodium hydroxide, water.

15 g - aluminum tubes (1) - cardboard packs.

20 g - aluminum tubes (1) - packs of cardboard.

30 g - aluminum tubes (1) - cardboard packs.

40 g - aluminum tubes (1) - packs of cardboard.

?
Ointment for external use in white, translucent, homogeneous.
1 g

betamethasone dipropionate 640 μg,

which corresponds to the content of betamethasone 500 μg

gentamicin (in the form of sulfate) 1 mg

Auxiliary substances: paraffin liquid, paraffin soft white.

15 g - aluminum tubes (1) - cardboard packs.

20 g - aluminum tubes (1) - packs of cardboard.

30 g - aluminum tubes (1) - cardboard packs.

40 g - aluminum tubes (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

The drug with antibacterial, anti-inflammatory and anti-allergic action for external use.

Betamethasone has anti-inflammatory, anti-allergic, antiproliferative and antipruritic effect.
When applied to the surface of the skin, betamethasone has a rapid and powerful effect in the inflammatory focus, reducing the severity of objective symptoms (erythema, edema, lichenification) and subjective sensations (itching, irritation, pain).
Gentamicin has a bactericidal effect of a wide spectrum in relation to the majority of gram-positive and gram-negative microorganisms , incl.
strains of Streptococcus spp. (beta-hemolytic, alpha-hemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative and some strains producing penicillinase), Proteus spp., Escherichia coli.
PHARMACOKINETICS

Data on the pharmacokinetics of the Belogen drug are not available.

INDICATIONS

Dermatoses, allergic and inflammatory skin diseases, in which effective therapy with topical SCS, and the course of which is complicated by a bacterial infection or there is a risk of its attachment, including:

- eczema;

- atopic dermatitis;

- diffuse neurodermatitis;

- contact (including professional) dermatitis;

- allergic dermatitis;

- seborrheic dermatitis;

- impetigo;

- psoriasis;

- Red flat lichen;

- phlebotoderma;

anogenital itching;

- infected dermatitis (for example, developed as a result of an insect bite).

The drug can be used in children from 1 year.

DOSING MODE

The drug is intended for external use only.

Cream or ointment for external use is applied to the affected area with a thin layer in the amount necessary to cover the affected surface, 2 times / day, slightly rubbing.
On areas with denser skin (for example, elbows, palms and feet), as well as places from which the drug is easily washed, the Belogent can be applied more often. The duration of a continuous course of treatment is usually not more than 4 weeks.
To prevent relapse in the treatment of chronic diseases, therapy should continue for some time after the disappearance of all symptoms.

During the year, repeated courses of therapy are possible.

The cream for external use is used for acute therapy, including.
wetting skin lesions.
Ointment for external use is intended for the therapy of subacute and chronic dermatoses, incl.
dry, lichenized and flaky lesions.
SIDE EFFECT

Side effects, as a rule, are mildly expressed.

Dermatological reactions: rarely - hypersensitivity reactions (itching, burning, hyperemia), acne-like changes, hypopigmentation, striae, skin atrophy, hypertrichosis, telangiectasia.

When developing a hypersensitivity reaction or adverse reactions, the drug should be discarded.

CONTRAINDICATIONS

- viral skin infections;

- skin postvaccinal reactions;

- open wounds;

- trophic ulcers;

- Acne vulgaris;

- rosacea;

- chickenpox;

- cutaneous manifestations of syphilis;

- Tuberculosis of the skin;

- hypersensitivity to betamethasone, gentamicin, or to any of the auxiliary components of the drug.

PREGNANCY AND LACTATION

The use of the drug Belogent in pregnant women is possible only in those cases when the intended use for the mother exceeds the risk for the fetus.
In such cases, the use of the drug should be short and, if possible, be limited to small areas of skin.
During the period of breastfeeding, the use of the drug Belogent is possible on strict indications, but the drug should not be applied to the skin of the breast before feeding.

APPLICATION FOR CHILDREN

Belogent can be given to children with caution and for the shortest possible time.
Do not use the drug in children under the bandages and, especially under plasticized diapers, this increases the absorption of the drug and increases the risk of side effects.
SPECIAL INSTRUCTIONS

It is not recommended to use the product on the face for a long time, since
possible the development of rosacea, perioral dermatitis and acne.
The drug should not be used in the eye area, due to the likelihood of the drug getting on the mucous membrane, which can contribute to the development of cataracts, glaucoma, fungal infections of the eye and exacerbation of herpetic infection.

Some areas of the body, such as axillary cavities, inguinal folds where there is natural occlusion, are more susceptible to the risk of streaking, so the use of the drug in these areas of the skin should be short-lived.

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

Use in Pediatrics

Belogent can be given to children with caution and for the shortest possible time.
Do not use the drug in children under the bandages and, especially under plasticized diapers, this increases the absorption of the drug and increases the risk of side effects.
Impact on the ability to drive vehicles and manage mechanisms

Data on the adverse effects of the drug on the ability to drive vehicles and mechanisms are not available.

OVERDOSE

With prolonged continuous use of the drug, especially in children, on extensive skin surfaces, application to the skin with impaired integrity or when used under the occlusive dressing, it is possible to develop side effects associated with increased absorption of betamethasone or gentamicin.
It should be emphasized that the probability of developing such phenomena is extremely small.
Treatment: it is recommended to cancel the drug and, if necessary, to prescribe symptomatic therapy.

DRUG INTERACTION

The interaction of the drug Belogent with other drugs is unknown.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 4 years.
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