Drugs List

Therapeutic Indications

Uses

Athletes foot
Fungal infection - nails
Fungal infection of skin

Dosage

Apply twice daily until lesions have healed.
Apply the cream for nail infections and the powder for at least 10 days after lesions have healed.
If using the cream with the powder, apply both formulations once daily. Continue this application for at least one week after lesions have healed.

Contraindications

None known

Precautions and Warnings

Breastfeeding
Pregnancy

Not all presentations are licensed for all indications
Some formulations contain benzoic acid
Avoid contact with eyes
Avoid contact with mucous membranes
Discontinue if hypersensitivity reactions occur
Avoid inhalation of the powder

Pregnancy and Lactation

Pregnancy

Use miconazole nitrate with caution in pregnancy.

Topical use of miconazole nitrate is absorbed in small amounts, animal studies have shown no teratogenic effects on the use of miconazole nitrate during pregnancy (Briggs et al, 2015). Schaefer (2015) states miconazole is the antifungal drug of choice to use during pregnancy. The manufacturer states high oral doses have been found to cause foetal toxicity and therefore suggests caution should be used when administrating miconazole nitrate during 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 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 miconazole nitrate with caution in breastfeeding.

Briggs (2015) states that there limited published information on the use of miconazole in breastfeeding, however there is limited risk on the infant when using topically applied miconazole nitrate. Schaefer (2015) states that miconazole nitrate is the antifungal drug of choice to use in breastfeeding. Hale (2015) states there is little or no absorption from the topical use of miconazole nitrate, however it is not known if miconazole nitrate is excreted in human breast milk. The manufacturer suggests to use miconazole with caution in 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

Anaphylactic reaction
Angioneurotic oedema
Burning sensation (local)
Contact dermatitis
Erythema
Hypersensitivity reactions
Pruritus
Rash
Skin irritation
Urticaria

Presentation

Topical formulations of miconazole nitrate

Drugs List

Therapeutic Indications

Uses

Athletes foot
Fungal infection - nails
Fungal infection of skin

Dosage

Apply twice daily until lesions have healed.
Apply the cream for nail infections and the powder for at least 10 days after lesions have healed.
If using the cream with the powder, apply both formulations once daily. Continue this application for at least one week after lesions have healed.

Contraindications

None known

Precautions and Warnings

Breastfeeding
Pregnancy

Not all presentations are licensed for all indications
Some formulations contain benzoic acid
Avoid contact with eyes
Avoid contact with mucous membranes
Discontinue if hypersensitivity reactions occur
Avoid inhalation of the powder

Pregnancy and Lactation

Pregnancy

Use miconazole nitrate with caution in pregnancy.

Topical use of miconazole nitrate is absorbed in small amounts, animal studies have shown no teratogenic effects on the use of miconazole nitrate during pregnancy (Briggs et al, 2015). Schaefer (2015) states miconazole is the antifungal drug of choice to use during pregnancy. The manufacturer states high oral doses have been found to cause foetal toxicity and therefore suggests caution should be used when administrating miconazole nitrate during 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 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 miconazole nitrate with caution in breastfeeding.

Briggs (2015) states that there limited published information on the use of miconazole in breastfeeding, however there is limited risk on the infant when using topically applied miconazole nitrate. Schaefer (2015) states that miconazole nitrate is the antifungal drug of choice to use in breastfeeding. Hale (2015) states there is little or no absorption from the topical use of miconazole nitrate, however it is not known if miconazole nitrate is excreted in human breast milk. The manufacturer suggests to use miconazole with caution in 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

Anaphylactic reaction
Angioneurotic oedema
Burning sensation (local)
Contact dermatitis
Erythema
Hypersensitivity reactions
Pruritus
Rash
Skin irritation
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: January 2017

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.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 12 January 2017.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publication. Accessed on 12 January 2017.

Summary of Product Characteristics: Daktarin 2% Cream. McNeil Products Limited. Revised August 2016.

Summary of Product Characteristics: Daktarin Powder. McNeil Products Limited. Revised August 2016.

Summary of Product Characteristics: Daktarin Aktiv Spray Powder. McNeil Products Limited. Revised August 2016.

Summary of Product Characteristics: Daktarin Aktiv cream. McNeil Products Limited. Revised August 2016.

Summary of Product Characteristics: Daktarin 2% w/w cream. Janssen-Cilag Limited. Revised August 2016.