Canison/Canison-B/Canison Plus

Canison: Clotrimazole.
Canison-B: Clotrimazole, beclomethasone dipropionate.
Canison Plus: Clotrimazole, betamethasone dipropionate, gentamicin sulfate.

Canison: Each gram contains clotrimazole 10 mg (1% w/w).
Canison-B: Each gram contains: Clotrimazole 10 mg (1 % w/w), Beclomethasone Dipropionate 0.25 mg (0.025% w/w).
Canison Plus: Each gram contains: Betamethasone (as dipropionate) 640 mcg, Gentamicin (as sulphate) 1 mg, Clotrimazole 10 mg.

Pharmacology: Canison: Clotrimazole is a broad-spectrum, antifungal agent that is used for the treatment of dermal infection caused by various species of pathogenic dermatophytes, yeasts and Malassezia furfur.
It also exhibits activity against Trichomonas, staphylococci and Bacteroides. The primary mode of action of clotrimazole appears to be on the cell membrane of the fungi, damaging the permeability barrier.
Canison-B: Clotrimazole is a broad spectrum antifungal agent available for topical use. It is active against yeasts and dermatophytes and also has some action against certain gram positive bacteria. Beclomethasone Dipropionate a corticosteroid, is effective in the treatment of corticosteroid responsive dermatoses primarily because of its anti-inflammatory, antipruritic and vasoconstrictive actions.
Canison Plus: Betamethasone dipropionate, a corticosteroid, is effective in the treatment of corticosteroid responsive dermatoses primarily because of its anti-inflammatory, antipruritic and vasoconstrictive actions.
Gentamicin is active against a wide range of Bacilli. Gentamicin binds irreversibly to the 30S sub-unit of the bacterial ribosome, blocking protein synthesis by inhibiting the movement of peptidyl-tRNA associated with translocation as well as increasing the frequency of misreading of the genetic code due to incorrect codon-anticodon interaction. The effect is bactericidal.
Clotrimazole is a broad spectrum antifungal agent available for topical use. It is active against yeasts and dermatophytes and also has some action against certain gram positive bacteria.
Pharmacokinetics: Canison: Clotrimazole cream containing ¹⁴C-labelled clotrimazole was administered intravaginally to 5 women: 4 without gynecological disorders and 1 with candida vaginitis. A maximum serum level of 0.01 mg/mL was found between 10 and 30 hrs after administration.
Studies of urinary excretion have shown that <0.5% of dermally applied clotrimazole appears in the urine over a 5-day period of observation. Fecal excretion, the route by which most of the absorbed drug is likely to be eliminated, has not been studied in humans.

Canison: Used topically in superficial candidiasis and in the skin infections Pityriasis versicolor and dermatophytosis. Clotrimazole is also indicated in the treatment of vulvovaginal candidiasis.
Canison-B: For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for non-inflammatory tinea infections. The efficacy of Clotrimazole and Beclomethasone Dipropionate cream for the treatment of infections caused by zoophilic dermatophytes (eg. Microsporum canis) has not been established.
Canison Plus: For the topical treatment of common fungal infections and other skin disorders caused by susceptible organisms with or without allergic inflammations.

Canison: Apply sparingly to the affected area and rub-in gently, 2-3 times daily.
Cutaneous Candidiasis: 2 weeks.
Dermatomycoses: 3-4 weeks.
Onychia and Paronychia due to C. albicans: ≥4-8 weeks.
Regular application of clotrimazole cream is essential for successful treatment, and whether or not a cure is confirmed mycologically, treatment should be continued for 2 weeks after all clinical signs have disappeared.
Special Remarks: Attention to hygiene is important in the management of fungal diseases of the feet. Dry accordingly after washing the feet, especially between toes.
Clotrimazole cream may be useful in mycotic paronychia or onychia following removal of the nail.
Clotrimazole cream may also be used in conjunction with clotrimazole vaginal tablets in the management of Candida vulvovaginitis or infection of the perianal area, while application of the cream to the glans penis of the partner may help prevent reinfection of the female. It is suggested that treatment be timed so as to avoid the menstrual period and to be complete before the onset of menstruation.
Canison-B: Gently massage sufficient amount of cream into the affected skin areas twice a day, in the morning and evening.
Or as prescribed by the physician.
Cream should not be used with occlusive dressings.
Canison Plus: Gently massage sufficient amount of cream into the infected area and its surrounding skin areas twice a day, in the morning and evening, for 2 weeks in tinea cruris and tinea corporis and for 4 weeks in tinea pedis.
Cream should not be used with occlusive dressing.

Canison/Canison-B: Hypersensitivity to other corticosteroids or imidazoles or any components of the formulation.
Canison Plus: Hypersensitivity to any of the components of the formulation.

General: If irritation or hypersensitivity develops with the use of clotrimazole, treatment should be discontinued and appropriate therapy instituted.
Canison: For Patients: The patient should be advised to use Canison for the full treatment line even though the symptoms may have improved. The physician should be notified if there is no improvement after 4 weeks of treatment. The physician should be informed if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization. Avoid sources of infection or reinfection.
Canison-B: Canison-B cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris and amounts greater than 45 g per week of cream should not be used. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential glucocorticosteroid insufficiency after withdrawal of treatment. Patients applying Canison-B cream to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. If irritation develops, treatment should be discontinued and appropriate therapy should be instituted.
Canison Plus: If irritation or hypersensitivity develops with the use of the drug, treatment should be discontinued and appropriate therapy instituted. The use of gentamicin may result in overgrowth of non susceptible organisms including fungi. If super infection occurs during gentamicin therapy, the drug should be discontinued and appropriate therapy instituted. General systemic absorption of topical corticosteroids has produced reversible hypothalamic-hyperglycaemia and glycosuria in some patients. The use of cream for longer than 4 weeks is not recommended.

Canison: There are no adverse effects with the use of Canison.
Canison-B: There are no adverse effects with the combination of Clotrimazole and Beclomethasone Dipropionate.
Canison Plus: There are no adverse effects with the combination gentamicin sulphate, clotrimazole and betamethasone dipropionate.

Canison: Clotrimazole is generally well tolerated after local application. The following have been reported infrequently: Erythema, stinging, blistering, peeling, edema, pruritus, urticaria and general irritation.
Canison-B: Itching, irritation, dryness, infection of the hair follicles, increased hair, acne, change in skin color, allergic skin reaction, skin thinning and stretch marks have been reported with topical corticosteroid.
Canison Plus: Rarely patients may experience local mild burning or irritation immediately after applying the cream. Very rarely the patients may find this irritation intolerable and stop treatment.

FOR EXTERNAL USE ONLY.

Canison/Canison-B: Store at a temperature not exceeding 30°C. Do not freeze.
Canison: Keep in a dry place.
Canison Plus: Store at temperatures not exceeding 30°C.
Shelf-Life: Canison: 3 years.

Topical Anti-Infectives with Corticosteroids / Topical Antifungals & Antiparasites

D01AC01 - clotrimazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
D06AX07 - gentamicin ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.
D07XC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids in other combinations. Used in the treatment of dermatological diseases.
D07AC15 - beclometasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.

Canison:Non-Rx;Canison-B/Canison Plus:Rx