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Topical imidazole antifungal Pregnancy: §4.6: in animal studies tioconazole was not teratogenic; at high doses it increased the incidence of renal abnormalities in rat embryos, but this effect was minor and transient. There is insufficient evidence as to the drug's safety in human pregnancy although absorption after topical administration is negligible. Because of the extensive duration of treatment required for nail infections, use of Trosyl Nail Solution is contra-indicated throughout pregnancy. Breast-feeding: it is unknown whether the drug is excreted in human milk; because many drugs are, nursing should be temporarily discontinued while Trosyl is administered.

Tioconazole

Brand names: Trosyl

Tioconazole is a topical imidazole antifungal used to treat vulvovaginal candidiasis and, in other formulations, fungal nail infection.

Adult dose

Dose: Nail infections due to susceptible fungi (dermatophytes and yeasts) and bacteria: apply the solution to the affected nails and immediately surrounding skin, every twelve hours, using the applicator brush supplied. Duration of treatment is up to six months but may be extended to twelve months.
Route: Topical (nail solution, 283 mg/mL, applied with the applicator brush)
Frequency: Every twelve hours (twice daily)
Indication and product match: the pinned product is Trosyl 283 mg/mL Nail Solution (eMC product 1071); its §4.1 is 'topical treatment of nail infections due to susceptible fungi (dermatophytes and yeasts) and bacteria', the page's lead indication (onychomycosis) and route (topical). Not covered by this card: the page's second indication, vaginal candidiasis (a vaginal presentation of tioconazole) - the pinned UK SPC is the nail solution only and carries no vaginal dose. No maximum dose is printed. Not for ophthalmic use (§4.4). Use in the elderly: no special precautions required; use the adult dose. Contraindicated in pregnancy because of the extensive duration of treatment needed for nail infections.

Paediatric dose

Dose: Use the adult dose: apply to the affected nails and immediately surrounding skin every twelve hours for up to six months, which may be extended to twelve months.
Route: Topical
Frequency: Every twelve hours
§4.2 'Use in children': no special precautions are required; use the adult dose. The SPC does not state a minimum age.

Dose adjustments

Renal

No renal dose adjustment is stated in the SPC.

Hepatic

No hepatic dose adjustment is stated in the SPC.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients
  • Individuals shown to be hypersensitive to imidazole antifungal agents
  • Pregnancy (contraindicated throughout pregnancy)

Side effects

  • Local irritation, usually seen during the first week of treatment, transient and mild
  • Oedema peripheral (common)
  • Dermatitis and rash (uncommon)
  • Frequency not known: allergic reaction, paraesthesia, bullous eruption, contact dermatitis, dry skin, periorbital oedema, nail disorder (discoloration, periungual inflammation, nail pain), pruritus, skin irritation, skin exfoliation, urticaria, pain, burning sensation
  • Systemic allergic reactions are uncommon; anaphylactoid reactions have been reported with other (non-dermatological) formulations

Interactions

  • None known (§4.5)

Monitoring

  • If a sensitivity reaction develops, discontinue treatment and institute appropriate therapy
  • Not for ophthalmic use - avoid contact with the eyes

Clinical monograph

How it works

It inhibits fungal cytochrome P450-dependent synthesis of ergosterol, disrupting the fungal cell membrane and producing a fungistatic to fungicidal effect against Candida species.

Prescribing in practice

  • Confirm the diagnosis of candidiasis and arrange review if symptoms persist or recur, as recurrent or treatment-resistant symptoms may indicate another cause.
  • Oil-based vaginal products can damage latex condoms and diaphragms, reducing their reliability.
  • Local irritation, burning, or itching at the application site can occur.

Monitoring

No laboratory monitoring is required; review if symptoms do not settle or frequently recur.

Counselling the patient

  • Use the vaginal preparation as directed, usually at bedtime.
  • Avoid relying on latex condoms or diaphragms while using oil-based vaginal products.
  • Seek review if symptoms persist, worsen, or keep coming back.

Evidence & guidelines

An established topical azole for vulvovaginal candidiasis consistent with current prescribing references.

Reference: NICE CKS; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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