Drugs List

Therapeutic Indications

Uses

Fungal infection - nails

Dosage

The solution should be applied to the affected nails and immediately surrounding skin every twelve hours using the applicator brush supplied.

The duration of treatment is up to six months but may be extended to twelve months.

Contraindications

Pregnancy

Precautions and Warnings

Breastfeeding

Avoid contact with eyes
Avoid contact with mucous membranes
Discontinue if hypersensitivity reactions occur

Pregnancy and Lactation

Pregnancy

Tioconazole is contraindicated in pregnancy.

At the time of writing there is limited published information regarding the use of tioconazole during human pregnancy. Animal studies have not shown teratogenic effects, however at high doses tioconazole showed renal abnormalities in rat embryos. It is not known whether tioconazole crosses the human placenta, although Briggs (2015) states the molecular weight of tioconazole is low enough, but systemic absorption is unlikely. Briggs (2015) also suggests other antifungal agents would be better to use during pregnancy. The manufacturer suggests due to the extensive duration of treatment, tioconazole is contraindicated 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 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 tioconazole with caution in breastfeeding.

At the time of writing there is limited published information regarding the use of tioconazole during breastfeeding. Briggs (2015) states that the molecular weight (approximately 388) is low enough to be excreted into breast milk, however systemic absorption is unlikely. Hale (2014) and Schaefer (2015) both state that oral bioavailability following topical application of tioconazole is minimal therefore unlikely to cause harm to the infant. The manufacturer suggests breastfeeding should be temporarily discontinued while using tioconazole.

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
Application site reaction
Bullous eruption
Burning sensation
Contact sensitisation
Dermatitis
Dry skin
Hypersensitivity reactions
Irritation (localised)
Nail disorders
Oedema
Pain
Paraesthesia
Periorbital oedema
Pruritus
Rash
Tingling sensation
Urticaria

Presentation

Topical formulation of tioconazole

Drugs List

Therapeutic Indications

Uses

Fungal infection - nails

Dosage

The solution should be applied to the affected nails and immediately surrounding skin every twelve hours using the applicator brush supplied.

The duration of treatment is up to six months but may be extended to twelve months.

Contraindications

Pregnancy

Precautions and Warnings

Breastfeeding

Avoid contact with eyes
Avoid contact with mucous membranes
Discontinue if hypersensitivity reactions occur

Pregnancy and Lactation

Pregnancy

Tioconazole is contraindicated in pregnancy.

At the time of writing there is limited published information regarding the use of tioconazole during human pregnancy. Animal studies have not shown teratogenic effects, however at high doses tioconazole showed renal abnormalities in rat embryos. It is not known whether tioconazole crosses the human placenta, although Briggs (2015) states the molecular weight of tioconazole is low enough, but systemic absorption is unlikely. Briggs (2015) also suggests other antifungal agents would be better to use during pregnancy. The manufacturer suggests due to the extensive duration of treatment, tioconazole is contraindicated 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 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 tioconazole with caution in breastfeeding.

At the time of writing there is limited published information regarding the use of tioconazole during breastfeeding. Briggs (2015) states that the molecular weight (approximately 388) is low enough to be excreted into breast milk, however systemic absorption is unlikely. Hale (2014) and Schaefer (2015) both state that oral bioavailability following topical application of tioconazole is minimal therefore unlikely to cause harm to the infant. The manufacturer suggests breastfeeding should be temporarily discontinued while using tioconazole.

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
Application site reaction
Bullous eruption
Burning sensation
Contact sensitisation
Dermatitis
Dry skin
Hypersensitivity reactions
Irritation (localised)
Nail disorders
Oedema
Pain
Paraesthesia
Periorbital oedema
Pruritus
Rash
Tingling sensation
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: December 2016

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 05 December 2016.

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 Publications.Accessed on 05 December 2016.

Summary of Product Characteristics: Trosyl Nail Solution. Pfitzer Ltd. Revised July 2013.