Data Sheet
CLOMAZOL
Clomazol vaginal cream, 3 Day Treatment (vaginal cream 2%)
Clomazol vaginal cream, 6 Day Treatment (vaginal cream 1%)
Clomazol Topical Cream 1%
Name of Medicine
Clotrimazole
1-(o-chloro- α, α - diphenylbenzyl) imidazole
C22H17ClN2
Molecular Weight 344.84
Clotrimazole is a colourless, crystalline, weakly alkaline substance, melting point 141°- 145°C, soluble in acetone, chloroform and ethanol and practically insoluble in water. It forms stable salts with both organic and inorganic acids. It is not photosensitive but is slightly hygroscopic, and may be hydrolysed in acid media.
Description
Clomazol vaginal cream 3 Day treatment
Clomazol 3 Day vaginal cream contains 20 mg/g (2% w/w) of clotrimazole in a cream base. The cream also contains glycerol monostearate, cetostearyl alcohol, benzyl alcohol (1% w/w), disodium edetate, cetomacrogol, propylene glycol, liquid paraffin, dimeticone, white soft paraffin and purified water.
Clomazol vaginal cream 6 Day treatment
Clomazol 6 Day vaginal cream contains 10 mg/g (1% w/w) of clotrimazole in a cream base. The cream also contains glycerol monostearate, cetostearyl alcohol, benzyl alcohol (1% w/w), disodium edetate, cetomacrogol, propylene glycol, liquid paraffin, dimeticone, white soft paraffin and purified water.
Clomazol Topical Cream
Clomazol Topical Cream contains 10 mg/g (1%) of clotrimazole in a cream base. The cream also contains glycerol monostearate, cetostearyl alcohol, benzyl alcohol (1% w/w), disodium edetate, cetomacrogol, propylene glycol, liquid paraffin, dimeticone, white soft paraffin and purified water.
Pharmacology
Clotrimazole cream containing 14C-labelled clotrimazole was administered intravaginally to five women (four without gynaecological disorder and one with Candida vaginitis). A maximum serum level of 0.01 µg/mL was found between 10 and 30 hours after administration.
Six hours after application of labelled topical clotrimazole cream the concentrations of clotrimazole ranged from 100 µg/cm3 in the stratum corneum to 0.05 - 1.0 µg/cm3 in the stratum reticulare and 0.1 µg/cm3 in the subcutis.
No measurable radioactivity was found in the serum within 48 hours after application of 0.8 g of the cream.
Studies of urinary excretion have shown that less than 0.5% of dermally applied clotrimazole cream appears in the urine over a five-day period of observation. Faecal excretion, the route by which most of the absorbed medicine is likely to be eliminated, has not been studied in man.
The primary mode of action of clotrimazole cream appears to be on the cell membrane of the fungi, damaging the permeability barrier.
A single course of intravaginal clotrimazole cream has produced mycological cure of vaginal candidiasis as follows:
5 g of 1% cream daily for six days approx. 75%
When a first course proved unsuccessful, a second course produced success in 8 of 12 women treated.
Indications
Clomazol 3 Day and 6 Day vaginal creams are indicated for the topical treatment of vulvovaginal candidiasis. Application of the cream to the glans penis of the partner may help prevent re-infection of the female.
Clomazol topical cream is indicated for the topical treatment of the following dermal infections:
- Tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm of the trunk and limbs) due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis.
- Candidiasis due to Candida albicans including cutaneous candidiasis, onychia (infection of the nail or nail bed), paronychia (infection of the nail fold), external genital candidiasis, candida balanitis (Candida in the male genital area), nappy rash.
- Pityriasis versicolor due to Malassezia furfur.
- Erythrasma (a chronic skin infection due to the bacterium Corynebacterium minutissimum).
Contraindications
Known hypersensitivity to clotrimazole and/or to any of the excipients.
Precautions
If evidence of local intolerance develops, consider withdrawal of the medicine and institution of appropriate therapy.
Clomazol creams are not intended for ophthalmic use.
Carcinogenicity/Mutagenicity
No carcinogenicity or mutagenicity has been observed in animal studies.
Use in Pregnancy (Category A)
While controlled clinical studies in pregnant women do not exist, epidemiological investigations give no indications that harmful effects on the mother and child should be anticipated when clotrimazole is used during pregnancy. However, as with all medicines in the first three months of pregnancy, clotrimazole should only be used after first consulting a doctor.
Sanitation of the birth canal should be ensured particularly during the last 4 - 6 weeks of pregnancy.
Use in Lactation
Because systemic absorption of clotrimazole following topical or vaginal application is marginal, there should be no risk for the infant during lactation.
Interactions with other Medicines
Not reported with topical forms of clotrimazole.
Effects on Laboratory Tests
Not known.
Interactions with Latex
Clomazol vaginal cream may reduce the effectiveness and safety of latex products, such as condoms and diaphragms. This effect is temporary and occurs only during treatment.
Adverse Reactions
Clotrimazole creams are generally well tolerated after local application. The following have been reported infrequently: erythema, stinging, blistering, peeling, oedema, pruritus, urticaria and general irritation.
Dosage And Administration
Clomazol vaginal cream 6 Day treatment (vaginal cream 1%)
Once daily, preferably in the evening for six successive days, one applicator should be filled with cream (approx. 5 g) and inserted as deeply as possible into the vagina with the patient lying on her back. The 35 g tube of cream for vaginal use provides for six such doses.
Clomazol vaginal cream 3 Day treatment (vaginal cream 2%)
Once daily, preferably in the evening for three successive days, one applicator should be filled with cream (approx. 5 g) and inserted as deeply as possible into the vagina with the patient lying on her back. The 20 g tube of cream for vaginal use provides for three such doses.
Clomazol Topical Cream
Apply sparingly to the affected areas and rub in gently, two or three times daily.
Duration of treatment
The following recommendations are made:
Cutaneous candidiasis 2 weeks
Dermatomycoses 2-4 weeks
Onychia and Paronychia due to C. albicans 4-8 weeks or more
Regular application of Clomazol topical 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.
Overdosage
Not applicable.
Presentations and Pack Sizes
Clomazol vaginal cream 3 Day treatment (vaginal cream 2%)
One tube containing 20 g of cream, 20 mg clotrimazole per gram (2% w/w) packed with three single-use disposable applicators and patient instruction sheet.
Clomazol vaginal cream 6 Day treament (vaginal cream 1%)
One tube containing 35 g of cream, 10 mg clotrimazole per gram (1% w/w) packed with six single-use disposable applicators and patient instruction sheet.
Clomazol Topical Cream
Packs of one tube containing 20 g of cream, 10 mg clotrimazole per gram (1% w/w).
Medicine Classification
Pharmacist Only Medicines
Clomazol vaginal cream
- 3 Day Cream
- 6 Day Cream
Pharmacy Medicines
Clomazol
- Topical Cream
Name and Address
Multichem NZ Ltd
Private Bag 93527
Takapuna
Auckland
Ph: (09) 488 0330
Fax: (09) 478 3841
Date of Preparation
23 July 2008