Miconazole oromucosal
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Sugar-free oromucosal gel containing miconazole
Drugs List
Therapeutic Indications
Uses
Denture stomatitis due to candida
Oropharyngeal candidiasis: treatment
Prophylaxis of candidiasis of the oropharynx
POM
Oral prophylaxis and treatment of fungal infections of the oropharynx.
P
Oral prophylaxis and treatment of fungal infections of the oropharynx.
Dosage
Adults
Oropharyngeal candidosis
Apply half a measuring spoon (2.5ml) of gel four times a day after meals. Treatment should be continued for at least a week after the symptoms have cleared.
The gel should not be swallowed immediately but kept in the mouth as long as possible.
For oral candidosis, dental prostheses should be removed at night and brushed with gel.
Children
Oropharyngeal candidosis
The lower age limit should be increased to 5 to 6 months of age for infants who are pre-term, or infants exhibiting slow neuromuscular development.
Children aged 2 to 18 years
(See Dosage; Adult).
Children aged 4 months to 2 years old
Apply a quarter of a measuring spoon (1.25ml, equivalent to approximately 25mg) of gel four times a day after meals. Each dose of the gel should be divided into smaller portions and the gel should be applied to the affected areas with a clean finger. The gel should not be swallowed immediately but kept in the mouth as long as possible.
Treatment should be continued for at least a week after the symptoms have cleared.
Children aged 1 month to 4 months (unlicensed)
Apply a quarter of a measuring spoon (1.25ml, equivalent to approximately 25mg) of gel four times a day after meals.
Treatment should be continued for at least a week after the symptoms have cleared.
Neonates
Oropharyngeal candidosis (unlicensed)
Apply 1ml of gel two to four times a day, smeared around the inside of the mouth after feeds.
Treatment should be continued for at least a week after the symptoms have cleared.
Administration
Caution should be taken when treating neonates and children that the gel does not obstruct the throat. The gel should not be applied to the back of the throat and each dose should be divided into smaller portions. Observe the patient for possible choking.
Contraindications
Hepatic impairment
Precautions and Warnings
Children under 4 months
Breastfeeding
Pregnancy
Some formulations may contain alcohol
Continue treatment for one week after symptoms have disappeared
If rash develops, consider possibility of Stevens-Johnson Syndrome
Advise patient to report skin reaction, pain, erythema, pruritus
Discontinue treatment if Stevens-Johnson Syndrome suspected
Discontinue if hypersensitivity reactions occur
Discontinue treatment if rash occurs
Advise patient on warfarin not to use this product except on medical advice
Choking risk in small children
Miconazole oral gel increases the plasma level of warfarin. Advise patient that if taking warfarin, they should not take this product without medical advice. If it is necessary to prescribe miconazole oral gel in a patient taking warfarin, monitor them for signs of over-anticoagulation, such as unexplained bruising, nosebleeds and haematuria. Advise patient to interrupt treatment and seek medical attention if these symptoms occur.
Pregnancy and Lactation
Pregnancy
Use miconazole oromucosal gel with caution in pregnancy.
The manufacturer suggests miconazole oromucosal gel should be avoided in pregnancy if possible. The potential hazards should be balanced against the possible benefits.
Animal studies with miconazole have shown no teratogenic effects however foetotoxic effects have been shown at high oral doses.
Lactation
Use miconazole oromucosal gel with caution in breastfeeding.
The manufacturers suggest caution should be exercised when prescribing miconazole oromucosal gel during breastfeeding. Hale (2010) suggests there are no paediatric concerns via the mother's milk. Schaefer suggests miconazole is acceptable for use during breastfeeding.
Counselling
Advise patients that for local application, the gel should be kept in the mouth for as long as possible.
Advise patients to take care when treating neonates and children that the gel does not obstruct the throat: the gel should not be applied to the back of the throat, if necessary the dose should be divided into smaller portions. Observe the patient for possible choking.
Advise patients taking warfarin, they should not take this product without medical advice, and to report unexplained bruising, nosebleeds and haematuria.
Advise patients to discontinue the gel if hypersensitivity or irritation occurs. Inform patients about the signs of serious skin reactions and to discontinue the gel at first appearance of skin rash.
Side Effects
Acid regurgitation
Anaphylactic reaction
Angioedema
Choking
Diarrhoea
Dry mouth
Dysgeusia
Hepatitis
Hypersensitivity reactions
Nausea
Oral discomfort
Product taste abnormal
Rash
Stevens-Johnson syndrome
Stomatitis
Tongue discolouration
Toxic epidermal necrolysis
Urticaria
Vomiting
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: November 2013
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
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.
Summary of Product Characteristics: Daktarin oral gel. Janssen-Cilag Ltd. Revised December 2015.
Summary of Product Characteristics: Daktarin sugar free 2% oral gel. McNeil Products Ltd. Revised August 2010.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 December 2022
MHRA Drug Safety Update September 2017
Available at: https://www.mhra.gov.uk
Last accessed: 29 December 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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