Clotrimazole pessaries, vaginal cream, pessary & cream packs, vaginal &
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Pessaries, cream and combination packs containing clotrimazole.
Drugs List
Therapeutic Indications
Uses
Prevention of reinfection: treatment of penis of partner (external cream)
Vaginitis - due to candida
Vaginitis - due to candida (adjunctive therapy)
Vulvitis - due to candida
Unlicensed Uses
Recurrent vulvovaginal candidiasis
Dosage
Adults
Pessary 100mg
Two pessaries nightly for three nights, or one pessary nightly for six nights.
If necessary, a second treatment may be carried out.
Pessary 200mg
One pessary nightly for three nights.
If necessary, a second treatment may be carried out.
Pessary 500mg
One pessary to be inserted at night.
If necessary, a second treatment may be carried out.
For treatment of unlicensed indication, recurrent vulvovaginal candidiasis, topical application of imidazole should be applied for a period of 10 to 14 days then one pessary may be inserted at night once a week for 6 months.
Vaginal cream 10%
Insert contents of pre-filled applicator intra-vaginally preferably at night.
If necessary, a second treatment may be carried out.
Pessary and external cream combination pack
One pessary to be inserted at night.
Apply external cream thinly to the vulva and surrounding area 2 to 3 times daily and rub in gently.
Treatment with the cream should continue until symptoms of the infection disappear.
Vaginal cream and external cream combination pack
Insert contents of pre-filled applicator intra-vaginally preferably at night.
Apply external cream thinly to the vulva and surrounding area 2 to 3 times daily and rub in gently.
Treatment with the cream should continue until symptoms of the infection disappear.
Children
Children aged 16 to 18 years
(See Dosage; Adult)
Children under 16 years
Not recommended.
Additional Dosage Information
As a matter of practicality, pessary and vaginal cream treatment should not be undertaken during menstruation as menstrual flow may wash out these products. Treatment should be finished before the onset of menstruation.
Contraindications
None known
Precautions and Warnings
Abdominal pain of unknown cause
Children under 16 years
Pain on micturition
Patients over 60 years
Systemic infection
Undiagnosed irregular menstrual bleeding
Pregnancy
Vaginal ulceration
Vulval ulceration
Not all available brands are licensed for all indications
Some formulations contain cetostearyl alcohol
Pregnancy: Care should be taken to avoid trauma by applicator
Male & female: Damages latex condoms and diaphragms
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
Latex contraceptives such as condoms and diaphragms may be damaged by clotrimazole pessaries, vaginal cream, and external 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.
Tampons, intravaginal douches, spermicides or other vaginal products are not to be used while using clotrimazole pessaries and/or vaginal creams.
Pieces of undissolved pessary may be noticed by women with vaginal dryness. To help prevent this, it is important that the pessary is inserted as high into the vagina as possible at bedtime.
Some formulations contain cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Pregnancy and Lactation
Pregnancy
Clotrimazole is considered safe during pregnancy.
There are limited amount of data from the use of clotrimazole in pregnant women. At low systemic exposures of clotrimazole following vaginal treatment, harmful effects with respect to reproductive toxicity are not predicted.
During pregnancy the pessary should be inserted without using an applicator.
Clotrimazole 10% vaginal creams should not be used in pregnancy as the cream cannot be inserted without the use of an applicator.
Manufacturer advices use only under the supervision of a doctor or midwife.
Lactation
Clotrimazole is considered safe during 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.
Manufacturer advises a decision must be made whether to discontinue breastfeeding to discontinue/abstain from clotrimazole treatment taking in to account the benefit of breastfeeding for the child and the benefit of treatment for the woman.
Counselling
Advise patients to consult their physician if symptoms have not resolved within 7 days of starting treatment.
Advise patients that latex contraceptives such as condoms and diaphragms may be damaged by clotrimazole pessaries, vaginal cream, and topical 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.
Advise patients that tampons, intravaginal douches, spermicides or other vaginal products are not to be used while using clotrimazole pessaries and/or vaginal creams.
Side Effects
Abdominal pain
Allergic reaction
Blisters (application site)
Burning sensation (local)
Contact dermatitis
Dyspnoea
Erythema
Hypotension
Irritation (localised)
Oedema
Pelvic pain
Pruritus
Rash
Skin peeling
Syncope
Urticaria
Vaginal discomfort
Vaginal haemorrhage
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 2019
Reference Sources
Summary of Product Characteristics: Canesten 100mg Pessary. Bayer Plc. Revised August 2017.
Summary of Product Characteristics: Canesten 200mg Pessary. Bayer Plc. Revised August 2017.
Summary of Product Characteristics: Canesten 500mg Pessary. Bayer Plc. Revised August 2017.
Summary of Product Characteristics: Canesten Thrush Pessary 500mg Pessary. Bayer Plc. Revised August 2017.
Summary of Product Characteristics: Canesten Thrush Soft Gel Pessary 500mg vaginal capsules. Bayer Plc. Revised August 2017.
Summary of Product Characteristics: Canesten Thrush Combi Internal & External Creams 10% w/w / 2%w/w vaginal cream and cream. Bayer Plc. Revised August 2017.
Summary of Product Characteristics: Canesten Thrush Internal Cream 10% w/w vaginal cream. Bayer Plc. Revised January 2018.
Summary of Product Characteristics: Canesten 10% w/w vaginal cream. Bayer Plc. Revised August 2017.
Summary of Product Characteristics: Canesten Combi Pessary & External Cream 500mg / 2%w/w pessary and cream. Bayer Plc. Revised August 2017.
Summary of Product Characteristics: Canesten Thrush Soft Gel Pessary & External cream 500mg/ 2%w/w vaginal capsule and cream. Revised August 2017.
Summary of Product Characteristics: Canesten Combi Soft Gel Pessary & External cream 500mg / 2%w/w vaginal capsule and cream. Revised August 2017.
Summary of Product Characteristics: Canesten Thrush Combi Pessary & External Cream 500mg / 2w/w pessary and cream. Bayer Plc. Revised August 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 May 2019
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: 31 October 2018
Last accessed: 08 May 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.