1. Name Of The Medicinal Product
Canesten Dermatological Powder
(also available as Canesten AF Dual Action Powder)
2. Qualitative And Quantitative Composition
Clotrimazole 1% w/w.
For excipients, see 6.1.
3. Pharmaceutical Form
Powder for topical application.
4. Clinical Particulars
4.1 Therapeutic Indications
Legal Category P
Canesten Dermatological Powder should be used externally as an adjunct to treatment with Canesten Cream, Solution or Dermatological Spray and as a prophylactic against reinfection, particularly in infections involving skin folds, and where perspiration is a problem.
Legal Category GSL
Should be used as an adjunct to treatment with Canesten AF Dual Action Cream or Canesten AF Dual Action Spray and as a prophylactic against reinfection of tinea pedis (athlete's foot) only.
4.2 Posology And Method Of Administration
Canesten Dermatological Powder should be sprinkled onto the affected areas two to three times daily after using Canesten Cream, Solution or Dermatological Spray. The powder may also be dusted inside articles of clothing and footwear which are in contact with the infected area.
4.3 Contraindications
Hypersensitivity to clotrimazole or the excipient rice starch.
Legal Category GSL Only
Do not use the powder to treat nail or scalp infections.
4.4 Special Warnings And Precautions For Use
None.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None.
4.6 Pregnancy And Lactation
Data on a large number of exposed pregnancies indicate no adverse effects of Clotrimazole on pregnancy or on the health of the foetus/newborn child. To date, no relevant epidemiological data are available.
Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
Rarely patients may experience local mild burning or irritation immediately after applying the powder. Very rarely the patient may find this irritation intolerable and stop treatment.
Other undesirable effects:
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4.9 Overdose
In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). It should be carried out only if the airway can be protected adequately.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC Code: D01A C01
Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity. It also exhibits activity against Trichomonas, staphylococci, streptococci and Bacteroides. It has no effect on lactobacilli.
Mechanism of Action
Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.
Pharmacodynamic Effects
Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.
The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In-vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive.
Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.
5.2 Pharmacokinetic Properties
Pharmacokinetic investigations after dermal application have shown that clotrimazole is practically not absorbed from the intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of clotrimazole were below the detection limit of 0.001 μg/ml, reflecting that clotrimazole applied topically does not lead to measurable systemic effects or side effects.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Rice starch
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
60 months.
6.4 Special Precautions For Storage
No special storage requirements.
6.5 Nature And Contents Of Container
Polyethylene powder canister with a perforated conical plug for dusting and a screw cap. The canister contains 30g of powder.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Bayer plc
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA.
Trading as Bayer plc, Consumer Care Division
8. Marketing Authorisation Number(S)
PL 0010/0067
9. Date Of First Authorisation/Renewal Of The Authorisation
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10. Date Of Revision Of The Text
April 2006
LEGAL CATEGORY
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