Canisone Plus - instructions for use, dose, side effects, contraindications

Excipients: paraffin, cetostearyl alcohol, cetomacrogol 1000, paraffin liquid, butylhydroxytoluene, sodium hydrogen phosphate, sodium dihydrogen phosphate, chlorocresol, disodium edetate, propylene glycol, butylhydroxyanisole, purified water.

Description:

Homogeneous cream white or almost white color, free from foreign particles.

Pharmacotherapeutic group:Glucocorticosteroid for topical use + antibiotic-aminoglycoside + antifungal agent

ATX: & nbsp

S.01.C.A.05 Betamethasone in combination with antimicrobials

Pharmacodynamics:

Combined drug, has anti-inflammatory,

antiallergic, antibacterial and antifungal (fungicidal) action.

Gentamicin - a broad-spectrum antibiotic from the group of aminoglycosides, acts bactericidal.

Highly sensitive to 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. (Besides Streptococcus pneumoniae), Enterococcus faecalis; Providencia rettgeri.

Betamethasone - glucocorticosteroid, has a local anti-inflammatory, vasoconstrictive, anti-allergic effect.

Clotrimazole - antifungal agent from the group of imidazole derivatives for topical application. 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), limited neurodermatitis, eczema, dermatomycosis (dermatophytosis, candidiasis, multicolored lichen), especially in the groin and large folds of the skin; simple chronic lichen.

Contraindications:

Canisone® Plus is contraindicated in patients with a history of hypersensitivity reactions to any of its components. It is also contraindicated for skin tuberculosis, skin manifestations of syphilis, chickenpox, herpes simplex, skin postvaccial reactions, with open wounds.

Children under 2 years.

Carefully:

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 II and III trimesters of pregnancy should be resolved individually after consulting a doctor.

The possibility of excretion of clotrimazole with mother's milk has not been studied. Therefore, Kanison® Plus, a cream for external use, should be used with caution in nursing mothers.

Dosing and Administration:

Outwardly.

Канизон® Plus cream should be applied a thin layer on the entire affected surface of the skin and surrounding tissue twice a day - in the morning and at night. To ensure the effectiveness of the treatment, cannison® Plus cream should be used regularly. The duration of therapy depends on the size and location 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 effects:

Very rarely with the application of Kanison® Plus cream, there are: burning sensation, erythema, exudation, pigmentation disorder and itching.

Adverse reactions occurring with the use of local glucocorticosteroids (especially when using occlusive dressings): burning sensation, itching, dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, development of secondary infection, 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 gentamycin: transient skin irritation (erythema, itching), usually not requiring discontinuation of treatment.

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.

Interaction:

With the simultaneous use of Canison® Plus with antifungal preparations 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 gentamycin, superinfection occurs, the drug should be discontinued and a course of appropriate therapy prescribed.

Special instructions:

Canisone® Plus cream is not suitable for use in ophthalmology. It is necessary to avoid getting the cream in the eyes.

Prolonged local use of antibiotics can sometimes lead to an increase in resistant microflora. In this case, as well as with the development of irritation, sensitization or superinfection in the context of treatment with Cannisone Plus cream, 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 performed on large areas of the skin or when using occlusive dressings,especially with 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 Canizon® Plus cream, as with many other topical preparations based on glucocorticosteroids, on extensive surfaces and / or with occlusive dressing, suppression of the function of the hypothalamic-pituitary-adrenal system is possible, a decrease in the excretion of growth hormone, as well as an increase in intracranial pressure .

Form release / dosage:

Cream for external use.

Packaging:

For 15 g or 30 g of the drug in an aluminum tube.

1 tube with instructions for use in a cardboard pack.

Storage conditions:

Store in a dry, dark place at a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date stated on the label.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-003154/09

Date of registration:24.04.2009 / 20.07.2017

Expiration Date:Unlimited

The owner of the registration certificate:Agio Pharmaceuticals Ltd.Agio Pharmaceuticals Ltd. India

Representation: & nbspAgio Pharmaceuticals Ltd.Agio Pharmaceuticals Ltd.

Information update date: & nbsp30.11.2017

Illustrated instructions

Instructions

Canison® plus (Canison® plus)