Composition, form of production and packaging
? Cream for external application of white color, homogeneous.
1 g
beclomethasone dipropionate 250 Ојg
clotrimazole 10 mg
gentamicin (in the form of sulfate) 1 mg
Excipients: propylene glycol, cetomacrogol, petrolatum, paraffin liquid, benzyl alcohol, methyl parahydroxybenzoate (methylparaben), propyl parahydroxybenzoate (propylparaben), butylhydroxytoluene, sodium dihydrogen phosphate monohydrate, sodium hydrophosphate, purified water.
15 g - aluminum tubes (1) - cardboard packs.
30 g - aluminum tubes (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Combination drug for external use with anti-inflammatory, anti-allergic, antifungal and antibacterial action.
Beclomethasone has anti-inflammatory, antiallergic, antiexudative and antipruritic effect. It inhibits the accumulation of leukocytes, the release of lysosomal enzymes and mediators of inflammation, inhibits phagocytosis, reduces vascular-tissue permeability, prevents the formation of inflammatory edema.
Clotrimazole has an antifungal effect due to a disruption in the synthesis of ergosterol, which is an integral part of the fungal cell membrane. It is active against:Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida albicans, Malassezia furfur (Pityrosporum orbiculare).
Gentamicin is a broad-spectrum antibiotic from the group of aminoglycosides, which has a bactericidal effect. It is active against gram-negative bacteria:Pseudomonas aeruginosa, Enterobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; Gram-positive bacteria: Streptococcus spp., Staphylococcus aureus.
PHARMACOKINETICS
Pharmacokinetics studies were not conducted.
INDICATIONS
- dermatoses complicated by a secondary infection;
- epidermophytia of the feet;
- dermatomycosis (including with localization in the inguinal region), caused by susceptible to the drug pathogens.
DOSING MODE
The cream is applied a thin layer on the affected skin 2 times / day (morning and evening). The duration of treatment depends on the effectiveness and tolerability of therapy and is, as a rule, no more than 2-4 weeks.
In children aged 7-16 years, the drug is used strictly according to the indications and under the supervision of a doctor.
SIDE EFFECT
Dermatological reactions: burning sensation, hyperemia, erythema, peeling, dryness, maceration, skin atrophy, striae, hypertrichosis, folliculitis, sweating, steroid acne, perioral dermatitis, telangiectasia, hypopigmentation, pyoderma, furunculosis.
Allergic reactions: edema, hives, allergic contact dermatitis.
Systemic reactions (including suppression of adrenal cortex function) are possible with prolonged use.
CONTRAINDICATIONS
- Tuberculosis of the skin;
- cutaneous manifestations of syphilis;
- chickenpox;
- Herpes simplex;
- skin postvaccinal reactions;
- children's age till 7 years;
- Pregnancy;
- the period of lactation (breastfeeding);
- application to the open wound surface;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The use of the drug during pregnancy is contraindicated.
If you need to use the drug during lactation, you should decide whether to stop breastfeeding.
APPLICATION FOR CHILDREN
Contraindication: children under 7 years.
SPECIAL INSTRUCTIONS
The drug is not used in ophthalmology.
Contraindicated apply to the skin in the eye area.
With the aim of increasing the effectiveness of therapy, it is possible to use occlusive dressings. It should be taken into account that transdermal absorption of beclomethasone and gentamicin increases, which leads to an increased risk of systemic side effects.
When developing a stable bacterial or fungal microflora, discontinue the use of the drug and prescribe appropriate therapy.
It is possible to develop cross-resistance with aminoglycoside antibiotics.
Use in Pediatrics
For children, the drug is prescribed only on strict indications and under medical supervision. systemic side effects associated with beclomethasone may develop. When applying the drug on large surfaces and / or under an occlusive dressing, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system and develop symptoms of hypercorticism, and also decrease the excretion of growth hormone and increase intracranial pressure.
OVERDOSE
Symptoms: weight gain, swelling, hypertension, glucosuria, hypokalemia (symptoms of hypercorticism).
Treatment: symptomatic therapy, if necessary - correction of electrolyte balance. It is recommended to gradually stop the drug.
DRUG INTERACTION
Interactions of the drug with other drugs have not been identified.
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, protected from light at a temperature of no higher than 25 В° C; Do not freeze. Shelf life - 3 years.
