1 Name of Medicine
Clotrimazole.
2 Qualitative and Quantitative Composition
Clotrimazole is a white to pale yellow, crystalline powder, practically insoluble in water, soluble in chloroform and ethanol.
Clotrimazole 3 Day Cream contains 20 mg/g (2% w/w) clotrimazole.
Clotrimazole 6 Day Cream contains 10 mg/g (1% w/w) clotrimazole.
In addition the creams also contain propylene glycol, disodium edetate, cetomacrogol 1000, cetostearyl alcohol, liquid paraffin, dimeticone 100, white soft paraffin, self emulsifying glyceryl monostearate, benzyl alcohol and purified water.
3 Pharmaceutical Form
APOHEALTH Thrush 3 Day Cream (20 g).
Soft, shiny, white cream.
APOHEALTH Thrush 6 Day Cream (35 g).
Soft, shiny, white cream.4.1 Therapeutic Indications
Effective treatment of vaginal candidiasis and relief of associated symptoms such as itching, burning and vaginal discharge.
4.2 Dose and Method of Administration
The cream (5 g) should be inserted as deeply as possible into the vagina once daily, at bedtime - for three successive days if using clotrimazole 3 day cream, or six consecutive days if using clotrimazole 6 day cream. This is best achieved using the plastic applicator provided and following the directions in the Consumer Medicine Information.
It is suggested that treatment be timed so as to avoid the menstrual period and to be complete before the onset of menstruation.
The clotrimazole cream may also be used 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 re-infection of the female.
4.3 Contraindications
Known hypersensitivity to clotrimazole or any of the excipients.
Not for ophthalmic use.
4.4 Special Warnings and Precautions for Use
Clotrimazole vaginal cream is for intravaginal use only and is not to be taken orally.
Local irritation and contact dermatitis may occur.
Use in the elderly.
No data available.
Paediatric use.
No data available.
Effects on laboratory tests.
No data available.4.5 Interactions with Other Medicines and Other Forms of Interactions
Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.
Interaction with barrier contraceptives.
The mineral oil in this cream may weaken condoms or vaginal contraceptive diaphragms and reduce their effectiveness. It is recommended that these contraceptives are not used whilst using this cream, and for 72 hours after the end of treatment.4.6 Fertility, Pregnancy and Lactation
Effects on fertility.
Although systemic absorption following vaginal administration is low, caution should be exercised when clotrimazole is administered to nursing mothers as there is no information on whether or not clotrimazole is excreted in breast milk.
(Category A)
Category A definition: drugs which have been taken by a large number of pregnant women and women of child-bearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
In the first trimester of pregnancy, clotrimazole should only be used when the medical practitioner considers it essential for the welfare of the patient.
Administration in the second and third trimester of pregnancy has not produced any untoward effects on the course of the pregnancy or on the foetus.
In the third trimester of pregnancy, extreme caution should be observed when using applicators due to the risk of rupturing the membranes and inducing miscarriage or premature birth, or introducing infection. Using pessaries without an applicator is recommended during the third trimester.
No data available.4.7 Effects on Ability to Drive and Use Machines
The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.
4.8 Adverse Effects (Undesirable Effects)
Clotrimazole cream is generally well tolerated after local application.
Erythema, stinging, blistering, peeling, oedema, pruritus, urticaria and general irritation have been reported infrequently. There have been rare reports of mild burning, skin rash and lower abdominal cramps and burning or slight irritation in the sexual partner.
Reporting suspected adverse effects.
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.4.9 Overdose
Acute overdosage with either vaginal or topical application of clotrimazole is unlikely and not expected to be life threatening.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
5 Pharmacological Properties
5.1 Pharmacodynamic Properties
Mechanism of action.
Clotrimazole is an imidazole antifungal agent and interacts with the cell membrane of sensitive fungi altering its permeability and eventually causing the activation of autolytic enzymes.
A single course of intravaginal clotrimazole is usually required to produce mycological cure of vaginal candidiasis. A second course may be required if the first course is unsuccessful. However, other pathogens should be considered and investigated before a second course is commenced.
Topical clotrimazole penetrates the epidermis but there is little systemic absorption and slight absorption from the vagina.
Clotrimazole inhibits Candida albicans and, in in vitro studies, Blastomyces dermatitidis, Candida spp, Coccidioides immitis, Cryptococcus neoformans (Torula histolytica), dermatophytes (Trichophyton, Microsporum, Epidermophyton), Histoplasma capsulatum, Nocardias spp (less sensitive than true fungi), Paracoccidioides brasiliensis, Sporothrix schenckii.
Clotrimazole has little or no activity against Haemophilus vaginalis or Trichomonas vaginalis.
Clinical trials.
No data available.
5.2 Pharmacokinetic Properties
No data available.
5.3 Preclinical Safety Data
Genotoxicity.
Clotrimazole has no mutagenic effect.
Carcinogenicity.
An 18-month study has not revealed any carcinogenic effect.6 Pharmaceutical Particulars
6.1 List of Excipients
See Section 2 Qualitative and Quantitative Composition.
6.2 Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.
6.3 Shelf Life
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
6.4 Special Precautions for Storage
Store below 25°C.
6.5 Nature and Contents of Container
APOHEALTH Thrush 3 Day Cream (20 g).
Tube with 3 single use disposable applicators.
AUST R 150662.
APOHEALTH Thrush 6 Day Cream (35 g).
Tube with 6 single use disposable applicators.
AUST R 150663.
6.6 Special Precautions for Disposal
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
6.7 Physicochemical Properties
Chemical structure.
Chemical Name: 1-(o-chloro- α,α-diphenylbenzyl) imidazole.
Molecular Formula: C22H17ClN2.
Molecular Weight: 344.84.
CAS number.
23593-75-1.7 Medicine Schedule (Poisons Standard)
S3 - Pharmacist Only Medicine.
Summary Table of Changes
