Composition, form of production and packaging
? Cream for external use 1 g
betamethasone dipropionate 640 Ојg
clotrimazole 10 mg
gentamicin sulfate 1 mg
15 g - aluminum tubes (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
The combined preparation has anti-inflammatory, anti-allergic, antibacterial and antifungal (fungicidal) action.
Gentamicin is a broad-spectrum antibiotic from the group of aminoglycosides, it acts bactericidal. Highly sensitive gram-negative microorganisms - Proteus spp.(indol-positive and indolotric), Escherichia coli, Klebsiella spp. Salmonella spp., Shigella spp., Campylobacter spp. Staphylococcus spp. (methicillin-resistant).
Sensitive: Enterococcus faecalis, Serratia spp., Pseudomonas spp., Acinetobacter spp., Citrobacter spp.
Resistant: Neisseria meningitidis, Treponema pallidum, anaerobic microbes: Streptococcus spp. (except Streptococcus pneumoniae), Enterococcus faecalis;Providencia rettgeri.
Betamethasone - glucocorticosteroid, has a local anti-inflammatory, vasoconstrictive, antiallergic effect.
Clotrimazole is an antifungal agent from the group of imidazole derivatives for topical use. It acts due to a disruption in the synthesis of ergosterol, which is an integral part of the cell membrane of fungi. Has a wide range of action. Effective against dermatophytes, mold fungi, fungi of the genus Candida, Malassezia furfur, Corynebacterium minutissimum, Streptococcus spp., Staphylococcus spp., Trichomonas vaginalis.
INDICATIONS
- simple and allergic dermatitis (complicated by secondary infection);
- Atopic dermatitis (including diffuse neurodermatitis);
- eczema;
- dermatomycosis (dermatophytosis, candidiasis, multicolored lichen), especially when localized in the groin and large folds of the skin;
- simple chronic lichen (limited neurodermatitis).
DOSING MODE
Outwardly.
Canisone Plus cream should be applied a thin layer on the entire affected surface of the skin and surrounding tissue 2 times a day - in the morning and at night. To ensure the effectiveness of treatment, cannison Plus cream should be used regularly. The duration of therapy depends on the size and localization of the lesion, as well as, the patient's response.
If clinical improvement does not occur after 3-4 weeks of treatment, this may serve as a reason for specifying the diagnosis.
SIDE EFFECT
Very rarely, when you apply Canison Plus, the cream is noted: burning sensation, erythema, exudation, pigmentation and itching.
Adverse reactions occurring with the use of local glucocorticosteroids (especially with the use of occlusive dressings): burning sensation, itching, dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection development, skin atrophy, striae , sweating.
Adverse reactions due to clotrimazole: erythema, tingling sensation, the appearance of blisters, peeling, local edema, itching, hives, skin irritation.
Adverse reactions due to gentamicin: transient skin irritation (erythema, pruritus), usually not requiring discontinuation of treatment.
CONTRAINDICATIONS
- Tuberculosis of the skin;
- cutaneous manifestations of syphilis;
- chickenpox;
- Herpes simplex;
- skin postvocyanalnye reactions;
- open wounds;
- Children under 2 years;
- indication of reactions of hypersensitivity to any of its components in the anamnesis.
With caution: pregnancy (I trimester), long-term treatment, use in large areas of the skin or in violation of the integrity of the skin, the use of occlusive dressings (especially in children).
PREGNANCY AND LACTATION
It is not recommended to use the drug in the first trimester of pregnancy. In clinical and experimental studies, it has not been established that the use of clotrimazole during pregnancy has a negative effect on the health of women and the fetus. However, the question of the appropriateness of prescribing in the II and III trimesters of pregnancy should be addressed individually after a doctor's consultation. The possibility of excretion of clotrimazole with mother's milk has not been studied.Therefore, Canizon Plus, a cream for external use should be used in nursing mothers with caution.
APPLICATION FOR CHILDREN
For children, the drug is prescribed only on strict indications and under medical supervision. possible development of systemic side effects associated with betamethasone. With the application of Canisone Plus cream, as with many other topical preparations based on glucocorticosteroids, on vast surfaces and / or with occlusive dressing, the hypothalamic-pituitary-adrenal system may be suppressed, a decrease in the excretion of growth hormone, and an increase in intracranial pressure may be observed.
SPECIAL INSTRUCTIONS
Canisone Plus cream is not intended for use in ophthalmology. It is necessary to avoid getting the cream in the eyes.
Prolonged local use of antibiotics can sometimes lead to the growth of resistant microflora. In this case, as well as with the development of irritation, sensitization or superinfection, against the background of treatment with Cannisone Plus, treatment should be discontinued and appropriate therapy prescribed. There were cross-allergic reactions with aminoglycoside antibiotics.
Any side effects that occur with the use of systemic glucocorticosteroids, including suppression of the function of the adrenal cortex, can also be observed with topical application of glucocorticosteroids, especially in children.
Systemic absorption of glucocorticosteroids or gentamicin for topical application will be higher if treatment is carried out on large areas of the skin or with the use of occlusive dressings, especially during long-term treatment or in violation of the integrity of the skin. It is necessary to avoid applying gentamicin to open wounds and damaged skin. Otherwise, there may be side effects, characteristic of gentamicin in its systemic application. Appropriate precautions should be taken in such cases, especially when treating children. With prolonged use of the drug, it is recommended to cancel it gradually.
Use in Pediatrics
For children, the drug is prescribed only on strict indications and under medical supervision. possible development of systemic side effects associated with betamethasone. With the application of Canisone Plus cream, as with many other topical preparations based on glucocorticosteroids, on vast surfaces and / or with occlusive dressing, the hypothalamic-pituitary-adrenal system may be suppressed, a decrease in the excretion of growth hormone, and an increase in intracranial pressure may be observed.
OVERDOSE
Symptoms: with prolonged use of local glucocorticosteroids in high doses, it is possible to suppress adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercorticism, including Cushing's syndrome.
Overdose of clotrimazole in its local application does not lead to the appearance of any symptoms.
With a single overdose of gentamicin, the appearance of any symptoms is also not expected.
Long-term treatment with gentamicin in elevated doses can lead to an increase in insensitive flora.
Treatment: symptomatic. Acute symptoms of hypercorticoidism are usually reversible. If necessary, correct the electrolyte imbalance. In the case of chronic glucocorticosteroid toxicity, gradual elimination of glucocorticosteroids is recommended.
DRUG INTERACTION
With the simultaneous use of cannison plus with antifungal drugs of other groups, the effectiveness of these drugs, applied externally, decreases. The use of gentamicin can lead to an excessively rapid growth of refractory (with a high degree of resistance) microorganisms, including fungi. If, within the therapeutic course of treatment with gentamicin, superinfection occurs, the drug should be discontinued and a course of appropriate therapy prescribed.
TERMS OF RELEASE FROM PHARMACY
Without recipe.
TERMS AND CONDITIONS OF STORAGE
Store in a dry, dark place at a temperature of no higher than 25 В° C. Do not freeze. Keep out of the reach of children. Shelf life - 2 years.
