Drugs List

Therapeutic Indications

Uses

Candidal balanitis
Fungal infection of skin
Nappy rash due to candida
Vulvitis - due to candida

Contraindications

None known

Precautions and Warnings

Pregnancy

Not all available brands are licensed for all indications
Contains cetostearyl alcohol: may cause irritation
Male & female: Damages latex condoms and diaphragms

Cream may cause damage to latex condoms and diaphragms, advise patient to use alternative methods of contraception during and for at least 5 days after treatment.

GSL products are only licensed for sale for use in the treatment of tinea pedis (athlete's foot) and tinea cruris (jock itch). In tinea pedis and tinea cruris, patients should consult physician if no improvement with 7 days.

Pregnancy and Lactation

Pregnancy

Use clotrimazole with caution in pregnancy under the supervision of a physician or midwife.

Some studies on exposed pregnancies found no association with adverse effects on the health of the foetus or neonate. However, one study did find significant increase in the risk of spontaneous abortions with first trimester vaginitis treatment.

Schaefer (2015) considers clotrimazole and miconazole as the topical antimycotics of choice in pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use clotrimazole with caution in breastfeeding.

It is not known if clotrimazole, applied topically is distributed into breast milk. It has been used without adverse effects for some considerable time. Clotrimazole has poor oral bioavailability, it is unlikely to adversely affect the breastfed infant.

Any excess cream should be removed from the nipples before nursing.

Schaefer (2015) considers clotrimazole and nystatin as the local antimycotics of choice during breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Blisters (application site)
Burning sensation
Dyspnoea
Erythema
Hypotension
Irritation at application site
Oedema
Pain
Pruritus
Rash
Skin peeling
Stinging
Syncope
Urticaria

Presentation

Cream containing clotrimazole.

Drugs List

Therapeutic Indications

Uses

Candidal balanitis
Fungal infection of skin
Nappy rash due to candida
Vulvitis - due to candida

Dosage

Adults

Contraindications

None known

Precautions and Warnings

Pregnancy

Not all available brands are licensed for all indications
Contains cetostearyl alcohol: may cause irritation
Male & female: Damages latex condoms and diaphragms

Cream may cause damage to latex condoms and diaphragms, advise patient to use alternative methods of contraception during and for at least 5 days after treatment.

GSL products are only licensed for sale for use in the treatment of tinea pedis (athlete's foot) and tinea cruris (jock itch). In tinea pedis and tinea cruris, patients should consult physician if no improvement with 7 days.

Pregnancy and Lactation

Pregnancy

Use clotrimazole with caution in pregnancy under the supervision of a physician or midwife.

Some studies on exposed pregnancies found no association with adverse effects on the health of the foetus or neonate. However, one study did find significant increase in the risk of spontaneous abortions with first trimester vaginitis treatment.

Schaefer (2015) considers clotrimazole and miconazole as the topical antimycotics of choice in pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use clotrimazole with caution in breastfeeding.

It is not known if clotrimazole, applied topically is distributed into breast milk. It has been used without adverse effects for some considerable time. Clotrimazole has poor oral bioavailability, it is unlikely to adversely affect the breastfed infant.

Any excess cream should be removed from the nipples before nursing.

Schaefer (2015) considers clotrimazole and nystatin as the local antimycotics of choice during breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Blisters (application site)
Burning sensation
Dyspnoea
Erythema
Hypotension
Irritation at application site
Oedema
Pain
Pruritus
Rash
Skin peeling
Stinging
Syncope
Urticaria

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: February 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of product characteristics: Canesten Antifungal Cream And Canesten Fungal Infection 1%w/w cream. Bayer Plc. Revised March 2015.

Summary of Product Characteristics: Canesten Cream. Bayer Plc. Revised July 2015.

Summary of Product Characteristics: Canesten Dual Action 1% w/w Cream. Bayer Plc. Revised March 2015.

Summary of Product Characteristics: Clotrimazole 1% Cream. Mylan. Revised June 2016.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Clotrimazole. Last revised: September 07, 2013
Last accessed: February 09, 2018