Expiration date: 04/2026

The composition and form of issue:

Cream for external use 1g contains:

betamethasone dipropionate 0.64 mg

(equivalent to 0.5 mg betamethasone) 

gentamicin sulfate (calculated as base) 1 mg

excipients: chlorocresol sodium dihydrogen phosphate monohydrate phosphoric acid, white petrolatum, mineral oil, macrogol cetostearyl ether 22 cetostearyl alcohol sodium hydroxide purified water 

in tubes of 15 or 30 grams in a cardboard bundle 1 tuba.

Ointment for topical application 1g contains:

betamethasone dipropionate 0.64 mg

(equivalent to 0.5 mg betamethasone) 

gentamicin sulfate (calculated as base) 1 mg

excipients: mineral oil, white petrolatum 

in tubes of 15 or 30 grams in a cardboard bundle 1 tuba.

Description pharmaceutical form:

Ointment for external use: white, translucent, homogeneous ointment.

The topical cream: white, homogenous cream without mechanical inclusions.

Pharmacological action:

Betamethasone has anti-inflammatory, antiallergic, antiproliferative and antipruritic effects. When applied to the surface of the skin, has quick and strong action in inflammation, reducing the severity of objective symptoms (erythema, edema, lichenification) and the subjective sensations (itching, irritation, pain).

Gentamicin exerts antibacterial (bactericidal) action broad-spectrum against most gram-positive and gram-negative microorganisms, including strains of streptococci (beta hemolytic, alpha hemolytic), Staphylococcus aureus (coagulasepositive, coagulasepositive and some strains producing penicillinase), Proteus, Escherichia coli.

Indications:

Dermatoses, allergic and inflammatory skin disease that responds to therapy with topical corticosteroids, for which bacterial infection or there is a danger of its becoming in children from 1 year and adults:

• eczema, atopic dermatitis
  
• dermatitis — atopic, contact (including professional), allergic, seborrheic
  
• infected dermatitis, developed as a result of insect bites
  
• impetigo
  
• psoriasis
  
• lichen planus
  
• phlebotomine
  
• anogenital itching.
  

Contraindications:

• hypersensitivity to betamethasone, gentamicin and other components of the drug
  
• viral infection of the skin, skin post-vaccination reactions
  
• open wounds, trophic ulcers
  
• acne vulgaris, rosacea
  
• varicella
  
• cutaneous manifestations of syphilis
  
• tuberculosis of the skin.
  

Application of pregnancy and breast-feeding:

Perhaps if the expected effect therapy outweighs the potential risk to the fetus. During pregnancy, the use should not be prolonged and, if possible, be confined to small areas of skin. In the period of breastfeeding only on strict indications, but never apply the drug on the mammary gland before feeding.

Side effects:

Are of a slight character. Rarely (as with the use of other corticosteroids) may develop hypersensitivity reactions (burning, itching, redness), acne-like changes, hypopigmentation, striae, skin atrophy, hypertrichosis, telangiectasia.

In the case of hypersensitivity reactions should cancel the therapy and consult a doctor.

Drug interactions:

Unknown.

Method of application and dose:

Topically, the cream or ointment applied to the affected area of the skin in a thin layer, slightly vtiraya, 2 times a day. In areas with tighter skin (elbows, hands, feet), as well as places from which the drug is easy to wash, it can be applied more often. The duration of continuous treatment is usually not more than 4 weeks. For relapse prevention in the treatment of chronic diseases, treatment must continue for some time after disappearance of all symptoms. During the year, it is possible to repeat therapy.

The drug is in the form of cream used for the treatment of acute, including weeping skin lesions.

The drug is in the form of an ointment intended for the treatment of subacute and chronic dermatoses, including dry, lichenizirovannah and scaly lesions.

Overdose:

During long-term continuous use of the drug, especially in children, on large surfaces of skin, applied to the skin with impaired integrity or when used under occlusive dressing, may develop systemic side effects, but the probability of this is extremely small.

Special instructions:

The preparation is intended for external use only.

We do not recommend prolonged use of the drug on the skin because the rosacea, perioral dermatitis and acne.

It should not be used in the eye area, in regard to the probability of getting the drug on mucous membranes that may contribute to the development of cataract, glaucoma, fungal eye infections and exacerbation of herpes infection.

Some areas of the body (axilla, inguinal folds), where there is natural occlusion are more vulnerable to the risk of striae, therefore, the use of the drug in these sections should be short.

In the case of a fungal infection on the skin, it is necessary the additional use of antifungal agents.

During long-term continuous use of the drug, especially in children, on large surfaces of skin, applied to the skin with impaired integrity or when used under occlusive dressing, may develop systemic side effects, but the probability of this is extremely small.

Application in Pediatrics. Can be applied to children with caution and for a short period. The duration of treatment should be as short as possible. You should not use the drug to children under the bandages and especially plasticized diapers, because it enhances the absorption of the drug and increases the risk of side effects.

Effects on ability to drive vehicles and mechanisms. Does not affect the ability to drive vehicles and mechanisms.