CLOTRIMAZOLE ATHLETES FOOT CREAM

Active substance: CLOTRIMAZOLE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Clotrimazole Cream 1%
Clotrimazole Athlete’s Foot Cream (when sold under GSL regulations).

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tube contains 1%w/w Clotrimazole BP.

3

PHARMACEUTICAL FORM
Cream.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Legal category P:
Clotrimazole cream is indicated for the topical treatment of fungal skin
infections. It also exhibits activity against Trichomonas, streptococci,
staphylococci and Bacteroides.
Clotrimazole is recommended for the treatment of skin infections due to
dermatophytes (e.g. Trichophyton species), yeasts (e.g. Candida species),
moulds and other fungi. These include ringworm (tinea) infections (e.g.
athlete’s foot), paronychia, pityriasis versicolor, erythrasma and intertrigo.
The cream may also be used for the treatment of fungal nappy rash, candidal
vulvitis and candidal balanitis.
Legal category GSL:
For the treatment of tinea pedis (athlete’s foot) only.

4.2

Posology and method of administration
The cream should be applied thinly and evenly to the affected area 2 – 3 times
daily and rubbed in gently.
Treatment should be continued for at least one month for dermatophyte
infections, or for at least two weeks for candida infections.
If the feet are infected, they should be thoroughly washed and dried, especially
between the toes, before applying the cream.

4.3

Contraindications
Hypersensitivity to clotrimazole.
Legal category GSL only:
Do not use the cream to treat nail or scalp infections.

4.4

Special warnings and precautions for use
None known.

4.5

Interaction with other medicinal products and other forms of interaction
None known.

4.6

Pregnancy and lactation
In animal studies clotrimazole has not been associated with teratogenic effects
but following oral administration of high doses to rats there was evidence of
foetotoxicity. The relevance of this effect to topical application in humans is
not known. However, clotrimazole has been used in pregnant patients for over
a decade without attributable adverse effects. It is therefore recommended that
clotrimazole cream should be used in pregnancy only when considered
necessary by the clinician.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects

Local mild burning or irritation is experienced rarely by some patients after
topical application. If this is intolerable treatment should be stopped.
Hypersensitivity reactions may occur.

4.9

Overdose
Accidental oral ingestion: In the event, routine measures such as gastric lavage
should be performed as soon as possible after ingestion.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Clotrimazole is an imidazole antifungal agent which may act on the cell
membrane of the fungus. It is effective against a broad spectrum of fungi
including Epidermophyton, Microsporum and Trichophyton spp, coccidioides
immitis, histroplasma capsulatam, Aspergillus and candida spp. These may be
inhibited at concentrations of 1mcg per ml “in vitro” however up to 6mcg per
ml may be required “in vivo”. Other less susceptible fungi include
Cryptococcus neoformans, malassezia furfur (pityrosporum orbiculare),
paracoccidiorides brasiliensis, sprorothix schenckii, and allescheria,
madurella, and phialophora spp. Some strains of Staphylococcus aureus and
Streptococcus pyogenes have been reported to be sensitive. Trichomonas
vaginalis requires up to 100mcg per ml for inhibition.
Clotrimazole is usually fungistatic but in concentrations exceeding 10mcg per
ml it may be fungicidal. However, candida spp have been killed at
concentrations of 2mcg per ml.

5.2

Pharmacokinetic properties
When applied topically, clotrimazole penetrates the epidermis and there is
little if any systemic absorption.

5.3

Preclinical safety data
There are no preclinical safety data of relevance to the prescriber, which are
additional to those already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

The cream contains benzyl alcohol BP, polysorbate 60 BP, cetyl esters wax
USNF, cetostearyl alcohol BP, octyldodecanol, sorbitan monostearate BP and
purified water BP.

6.2

Incompatibilities
None known.

6.3

Shelf life
24 months.

6.4

Special precautions for storage
Store in a cool dry place.

6.5

Nature and contents of container
Low density polyethylene (LDPE) or aluminium tube with cap.
Pack sizes: 20g, 50g.
Packs sold as a GSL medicine must not contain more than 500mg of
clotrimazole (i.e. 50g cream).

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Generics [UK] Ltd t/a Mylan
Station Close
Potters Bar
Herts
EN6 1TL

8

MARKETING AUTHORISATION NUMBER(S)
PL: 04569/0194.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date MA granted:
Last renewal date:

10

10/09/87
26/03/99

DATE OF REVISION OF THE TEXT
October 2001.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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