- Approval Id
- 00c6af0d6f23f058
- Drug Approval Emc Name
- Canesten Athlete's Foot 1% w/w Cream
- Drug Name
- Canesten Athlete's Foot 1% w/w Cream
- Company Name
- Bayer plc
- Company Address
- 400 South Oak Way, Reading, Berkshire, RG2 6AD
- Company Website
- http://www.bayer.co.uk
- Company Telephone
- +44 (0)118 206 3000
- Company Medical Info Email
- medical.information@bayer.co.uk
- Atc Code
- D01AC01
- Legal Category
- General Sales List
- Authorisation Holder
- Bayer plc
400 South Oak Way
Reading
RG2 6AD
- Authorisation Number
- PL 00010/0645
- Authorisation Date
- | | |
| --- | --- |
| 04/10/2012 | |
- Instruction Authorisation Holder
- Bayer plc
400 South Oak Way
Reading
RG2 6AD
- Instruction Authorisation Number
- PL 00010/0645
- Instruction Authorisation Date
- | | |
| --- | --- |
| 04/10/2012 | |
- Instruction Composition
- Clotrimazole 1% w/w.
\*\*Excipients with known effect:\*\* cetostearyl alcohol 100mg in each gram of cream, benzyl alcohol 20mg in each gram of cream.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- A white cream for topical use.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the treatment of tinea pedis and tinea cruris.4.2 Posology and method of administration
There is no separate dosage schedule for the young or elderly.
The cream should be applied thinly 2-3 times daily and rubbed in gently. A strip of cream (½ cm long) is enough to treat an area of about the size of the hand. If the feet are infected they should be washed and dried, especially between the toes, before applying the cream. The treatment should be continued for at least one month to prevent re-infection; however a physician should be consulted if symptoms do not improve within 7 days.4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Do not use the cream to treat nail or scalp infections.4.4 Special warnings and precautions for use
This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). The cream also contains benzyl alcohol which may cause allergic reactions and mild local irritation.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy:\*\*
There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.
\*\*Lactation:\*\*
There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects. Clotrimazole may be used during lactation.
\*\*Fertility:\*\*
No human studies of the effects of clotrimazole on fertility have been performed; however, animal studies have not demonstrated any effects of the drug on fertility.4.7 Effects on ability to drive and use machines
Clotrimazole cream has no or negligible influence on the ability to drive or use machines.4.8 Undesirable effects
As the listed undesirable effects are based on spontaneous reports, assigning an accurate frequency of occurrence for each is not possible.
Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.
Vascular disorders: syncope, hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnoea.
Skin and subcutaneous tissue disorders: blister, dermatitis contact, erythema, paraesthesia, skin exfoliation, pruritus, rash, urticaria, stinging skin/burning sensation skin.
General disorders and administration site conditions: application site irritation, application site reaction, oedema, pain.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.
However, in the event of accidental oral ingestion, gastric lavage is rarely required and should be considered only if a life-threatening amount of Clotrimazole has been ingested within the preceding hour or if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group:\*\* Antifungals for topical use – imidazole and triazole derivatives
\*\*ATC Code:\*\* D01A C01
\*\*Mechanism of Action\*\*
Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane.
Clotrimazole has a broad antimycotic spectrum of action \*in vitro\* and \*in vivo\*, which includes dermatophytes, yeasts, moulds, etc.
Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062-8.0 µg/ml substrate. The mode of action of clotrimazole is primarily 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.
In addition to its antimycotic action, clotrimazole also acts on gram-positive microorganisms (Streptococci / Staphylococci / Gardnerella vaginalis), and gram-negative microorganisms (Bacteroides).
\*In vitro\* clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci - with the exception of Enterococci - in concentrations of 0.5-10 µg/ml substrate.
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 minimally 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 mcg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects.5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity and carcinogenicity.
Clotrimazole was not teratogenic in reproductive toxicity studies in mice, rats and rabbits. In rats high oral doses were associated with maternal toxicity, embryotoxicity, reduced fetal weights and decreased pup survival.
In rats clotrimazole and/or its metabolites were secreted into milk at levels higher than in plasma by a factor of 10 to 20 at 4 hrs after administration, followed by a decline to a factor of 0.4 by 24 hrs.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Sorbitan stearate
Polysorbate 60
Cetyl palmitate
Cetostearyl alcohol
Octyldodecanol
Benzyl Alcohol
Purified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months.6.4 Special precautions for storage
Do not store above 25oC.6.5 Nature and contents of container
The cream is filled into aluminium tubes with internal lacquer coating and HDPE screw-on caps and enclosed in an outer carton. Pack sizes available are 15g, 25g and 30g.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
- Instruction Content
- ## Composition
Clotrimazole 1% w/w.
\*\*Excipients with known effect:\*\* cetostearyl alcohol 100mg in each gram of cream, benzyl alcohol 20mg in each gram of cream.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
A white cream for topical use.
## Clinical Particulars
4.1 Therapeutic indications
For the treatment of tinea pedis and tinea cruris.4.2 Posology and method of administration
There is no separate dosage schedule for the young or elderly.
The cream should be applied thinly 2-3 times daily and rubbed in gently. A strip of cream (½ cm long) is enough to treat an area of about the size of the hand. If the feet are infected they should be washed and dried, especially between the toes, before applying the cream. The treatment should be continued for at least one month to prevent re-infection; however a physician should be consulted if symptoms do not improve within 7 days.4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Do not use the cream to treat nail or scalp infections.4.4 Special warnings and precautions for use
This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). The cream also contains benzyl alcohol which may cause allergic reactions and mild local irritation.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy:\*\*
There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.
\*\*Lactation:\*\*
There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects. Clotrimazole may be used during lactation.
\*\*Fertility:\*\*
No human studies of the effects of clotrimazole on fertility have been performed; however, animal studies have not demonstrated any effects of the drug on fertility.4.7 Effects on ability to drive and use machines
Clotrimazole cream has no or negligible influence on the ability to drive or use machines.4.8 Undesirable effects
As the listed undesirable effects are based on spontaneous reports, assigning an accurate frequency of occurrence for each is not possible.
Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.
Vascular disorders: syncope, hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnoea.
Skin and subcutaneous tissue disorders: blister, dermatitis contact, erythema, paraesthesia, skin exfoliation, pruritus, rash, urticaria, stinging skin/burning sensation skin.
General disorders and administration site conditions: application site irritation, application site reaction, oedema, pain.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.
However, in the event of accidental oral ingestion, gastric lavage is rarely required and should be considered only if a life-threatening amount of Clotrimazole has been ingested within the preceding hour or if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group:\*\* Antifungals for topical use – imidazole and triazole derivatives
\*\*ATC Code:\*\* D01A C01
\*\*Mechanism of Action\*\*
Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane.
Clotrimazole has a broad antimycotic spectrum of action \*in vitro\* and \*in vivo\*, which includes dermatophytes, yeasts, moulds, etc.
Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062-8.0 µg/ml substrate. The mode of action of clotrimazole is primarily 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.
In addition to its antimycotic action, clotrimazole also acts on gram-positive microorganisms (Streptococci / Staphylococci / Gardnerella vaginalis), and gram-negative microorganisms (Bacteroides).
\*In vitro\* clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci - with the exception of Enterococci - in concentrations of 0.5-10 µg/ml substrate.
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 minimally 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 mcg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects.5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity and carcinogenicity.
Clotrimazole was not teratogenic in reproductive toxicity studies in mice, rats and rabbits. In rats high oral doses were associated with maternal toxicity, embryotoxicity, reduced fetal weights and decreased pup survival.
In rats clotrimazole and/or its metabolites were secreted into milk at levels higher than in plasma by a factor of 10 to 20 at 4 hrs after administration, followed by a decline to a factor of 0.4 by 24 hrs.
## Pharmaceutical Particulars
6.1 List of excipients
Sorbitan stearate
Polysorbate 60
Cetyl palmitate
Cetostearyl alcohol
Octyldodecanol
Benzyl Alcohol
Purified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months.6.4 Special precautions for storage
Do not store above 25oC.6.5 Nature and contents of container
The cream is filled into aluminium tubes with internal lacquer coating and HDPE screw-on caps and enclosed in an outer carton. Pack sizes available are 15g, 25g and 30g.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
