Drugs List

Therapeutic Indications

Uses

Prevention of reinfection: treatment of penis of partner (external cream)
Vaginitis - due to candida (adjunctive therapy)
Vulvitis - due to candida

Contraindications

None known

Precautions and Warnings

Children under 16 years
Patients over 60 years
Pregnancy
Undiagnosed gynaecological haemorrhage
Vaginal ulceration
Vulval ulceration

Male & female: Damages latex condoms and diaphragms
Male & female: Ensure adequate contraception during treatment
Advise patient to see doctor if symptoms persist for 7 days with treatment
Advise patient to seek medical advice if more than 2 episodes in 6 months
Seek medical advice if previous history of sexually transmitted infection

Pregnancy and Lactation

Pregnancy

Use clotrimazole with caution in pregnancy.

Clotrimazole may be used during pregnancy, but only under the supervision of a doctor 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.

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 to 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.

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

Blisters (application site)
Burning sensation (local)
Contact dermatitis
Dyspnoea
Erythema
Hypersensitivity reactions
Hypotension
Irritation (localised)
Oedema at application site
Pain
Pruritus
Rash
Skin peeling
Syncope
Urticaria

Presentation

Cream containing 2% clotrimazole

Drugs List

Therapeutic Indications

Uses

Prevention of reinfection: treatment of penis of partner (external cream)
Vaginitis - due to candida (adjunctive therapy)
Vulvitis - due to candida

Dosage

Adults

Contraindications

None known

Precautions and Warnings

Children under 16 years
Patients over 60 years
Pregnancy
Undiagnosed gynaecological haemorrhage
Vaginal ulceration
Vulval ulceration

Male & female: Damages latex condoms and diaphragms
Male & female: Ensure adequate contraception during treatment
Advise patient to see doctor if symptoms persist for 7 days with treatment
Advise patient to seek medical advice if more than 2 episodes in 6 months
Seek medical advice if previous history of sexually transmitted infection

Pregnancy and Lactation

Pregnancy

Use clotrimazole with caution in pregnancy.

Clotrimazole may be used during pregnancy, but only under the supervision of a doctor 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.

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 to 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.

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

Counselling

Advise patient to see doctor if symptoms persist for 7 days with treatment.

Advise patient to seek medical advice if more than 2 episodes in 6 months.

Advise patients to seek medical advice if previous history of sexually transmitted infection.

Latex contraceptives such as condoms and diaphragms may be damaged by clotrimazole vaginal cream and consequently their efficacy may be reduced. Alternative precautions should therefore be adopted during use and for at least 5 days after using this product.

Side Effects

Blisters (application site)
Burning sensation (local)
Contact dermatitis
Dyspnoea
Erythema
Hypersensitivity reactions
Hypotension
Irritation (localised)
Oedema at application site
Pain
Pruritus
Rash
Skin peeling
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: May 2014

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com [Accessed on April 4, 2014].

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com [Accessed on April 4, 2014].

Summary of Product Characteristics: Canesten Thrush Cream. Bayer Plc. Revised November 2013.

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 7, 2013
Last accessed: April 3, 2014