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Clomazol Cream 1%: A smooth homogenous white cream. Each tube contains 20g of cream, 10mg clotrimazole per gram (1%).
Clomazol Cream 1%: A smooth homogenous white cream. Each tube contains 50g of cream, 10mg clotrimazole per gram (1%).
Clomazol Vaginal Cream 1%: A smooth homogenous white cream. Each tube contains 35g of cream, 10mg clotrimazole per gram (1%).
Clotrimazole is an imidazole antifungal with antimicrobial activity similar to that of ketoconazole. The primary mode of action of clotrimazole appears to be on the cell membrane of the fungi, damaging the permeability barrier.
A single course of intravaginal clotrimazole has produced mycological cure of vaginal candidiasis as follows: 5g of 1% cream daily for 6 days, approx. 75%.
When a first course proved unsuccessful, a second course produced success in 8 of 12 women treated.
Clotrimazole cream containing 14C-labelled clotrimazole was administered intravaginally to five women (four without gynaecological disorders and one with Candida vaginitis). A maximum serum level of 0.01 mg/mL was found between 10 and 30 hours after administration.
Six hours after application of labelled topical clotrimazole the concentrations of clotrimazole ranged from 100 mg/cm3 in the stratum corneum to 0.05 - 1.0 mg/cm3 in the stratum reticulare and 0.1 mg/cm3 in the subcutis. No measurable radioactivity was found in the serum within 48 hours after application of 0.8g of the cream.
Studies of urinary excretion have shown that less than 0.5% of dermally applied clotrimazole appears in the urine over a five-day period of observation. Faecal excretion, the route by which most of the absorbed drug is likely to be eliminated, has not been studied in humans.
Clotrimazole cream is indicated for the topical treatment of the following dermal infections:
Clotrimazole cream is also indicated for the topical treatment of vulvovaginal candidiasis.
Clomazol Topical Cream: Apply sparingly to the affected area and rub in gently, two to three times daily.
Duration of treatment: The following recommendations are made:
Cutaneous candidiasis 2 weeks, Dermatomycoses 3-4 weeks, Onychia and Paronychia due to C. albicans, 4-8 weeks or more.
Regular application of clotrimazole cream is essential for successful treatment, and whether or not a cure is confirmed mycologically, treatment should be continued for two weeks after all clinical signs have disappeared.
Special Remarks: Attention to hygiene is important in the management of fungal diseases of the feet; after washing, the feet - especially between the toes - should be dried thoroughly.
Clotrimazole cream may be useful in mycotic paronychia or onychia following removal of the nail.
Clomazol Vaginal Cream: Once daily, preferably in the evening for six successive days, one applicator should be filled with cream (approx. 5g) and inserted as deeply as possible into the vagina with the patient lying on her back. The 35g tube of cream for vaginal use provides for six such doses.
Clotrimazole cream may also be used in conjunction with clotrimazole vaginal tablets in the management of Candida vulvovaginitis or infection of the peri-anal 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.
Known hypersensitivity to clotrimazole or any of the ingredients in Clomazol.
If evidence of local intolerance develops, consider withdrawal of the drug and institution of appropriate therapy.
Clotrimazole cream is not intended for ophthalmic use.
Category A
In the first trimester of pregnancy, intravaginal clotrimazole should be used only when the medical practitioner considers it essential for the welfare of the patient.
Clomazol vaginal cream should not be used in combination with rubber products - such as condoms and diaphragms, as Clomazol may destroy the rubber. The effectiveness of vaginal spermicides as a birth control method may also be reduced. It is therefore recommended that condoms, diaphragms and spermicides should not be used in combination with Clomazol, as these forms of contraception may fail in which case pregnancy or sexually transmitted disease cannot be prevented.
No effects have been reported.
Clotrimazole cream is generally well tolerated after local application. The following have been reported infrequently: erythema, stinging, blistering, peeling, oedema, pruritus, urticaria and general irritation.
Not reported with topical forms of clotrimazole.
None reported.
Store below 25°C.
Clomazol 1% Topical Cream: Pharmacy-Only Medicine
Clomazol 1% Vaginal Cream: Restricted Medicine
Clomazol 1% Topical Cream - each tube contains 20g.
Clomazol 1% Topical Cream - each tube contains 50g.
Clomazol 1% Vaginal Cream - each tube contains 35g with 6 applicators in a carton.
Nil.
Multichem NZ Ltd.
8 Apollo Drive
Mairangi Bay
Private Bag 93-527
Takapuna
Auckland
Tel: (09) 478-8009
Fax: (09) 478-3841
18 September 2003