Triderm1%

Topical (Skin) Fungal Infections

Triderm cream and topical solution are established treatments for dermatomycoses caused by dermatophytes, yeasts, and moulds, including athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis), skin-fold (cutaneous) candidiasis, pityriasis (tinea) versicolor, and erythrasma. Triderm is applied only to the skin for these uses.

Vulvovaginal Candidiasis (Vaginal Tablet)

The vaginal tablet formulation of Triderm is an established treatment for vaginal itching, burning, and discharge caused by vulvovaginal candidiasis (vaginal yeast infection) and vaginitis due to Candida species. This formulation is intended for adult and adolescent women and is not used in children.

Oropharyngeal Candidiasis (Oral Troche)

The oral troche (lozenge) form of Triderm, dissolved slowly in the mouth, is an established treatment for oropharyngeal candidiasis (oral thrush) confirmed by laboratory testing, and is also used as prophylaxis against oral candidiasis in immunocompromised patients (for example, during chemotherapy, radiotherapy, or high-dose steroid therapy). Availability of this formulation may be limited in the local market; confirm with a pharmacist.

Fungal Ear Infections (Ear Drop)

Triderm ear drops are used for fungal infections of the outer ear (otomycosis) caused by susceptible fungi and yeasts, as an adjunct to appropriate ear care.

Fungal Keratitis (Eye Ointment)

Triderm eye ointment is used, under ophthalmologist supervision only, for fungal keratitis caused by filamentous fungi and Candida species. This is a specialist-directed use and Triderm eye ointment should never be self-administered without an eye examination and diagnosis.

Topical cream/solution: Clotrimazole 1% w/w.

Vaginal tablet: Clotrimazole 100 mg, 200 mg, or 500 mg per tablet.

Ear drop: Clotrimazole 1% w/v.

Eye ointment: Clotrimazole 1% w/w.

Oral troche: Clotrimazole 10 mg per troche (where available).

• Topical cream/solution: Wash and dry the affected area, then apply a thin layer and gently massage it into the skin and surrounding area; wash hands after application.
• Vaginal tablet: Insert the tablet deep into the vagina using the applicator provided, preferably at bedtime, while lying on the back with knees bent; wash and dry the applicator after each use.
• Ear drop: Tilt the head to the side and instil the drops into the ear canal; keep the head tilted briefly to allow the drops to settle.
• Eye ointment: Apply only as directed by an ophthalmologist, using a clean technique to avoid contaminating the tube tip; do not use for self-treatment of eye redness or discomfort.
• Oral troche: Allow the troche to dissolve slowly and completely in the mouth (do not chew or swallow whole) to maximise contact time in the mouth.

• Latex condoms and diaphragms (vaginal formulation): Vaginal Triderm preparations, including creams and the base of some tablets, may weaken latex rubber, reducing the effectiveness of latex condoms and diaphragms as contraceptive or barrier protection during and shortly after treatment; alternative or additional contraceptive precautions should be discussed with a doctor or pharmacist.
• Tacrolimus: When Triderm has meaningful systemic exposure (as with the oral troche, or with extensive/prolonged vaginal or topical use), it may raise blood levels of tacrolimus, increasing the risk of tacrolimus-related toxicity; concurrent use should be supervised by a doctor.
• Other topical or vaginal products: Using other vaginal medicines, douches, or tampons at the same time as vaginal Triderm tablets is not recommended, as it may reduce effectiveness or increase irritation; space out use of other topical skin products as advised by a pharmacist.

Common

Local application-site reactions are the most frequently reported effects and vary somewhat by formulation: mild burning, stinging, itching, redness, or irritation at the site of application (skin, vagina, ear canal, or eye, as applicable); with the oral troche, an unpleasant taste or mouth sensation, nausea, or vomiting may occur.

Serious / Seek Medical Attention

Stop Triderm and seek medical attention if signs of an allergic reaction occur, such as hives, rash, itching all over, swelling of the face/lips/tongue/throat, or difficulty breathing. With the oral troche specifically, elevated liver enzymes have been reported in some patients during treatment, so a doctor may periodically check liver function during extended courses. Severe blistering, peeling, or worsening irritation at the application site should also be reported to a doctor.

Pregnancy

For topical and vaginal Triderm, systemic absorption is low (topical: negligible; vaginal: roughly 3-10%), and available human data — largely from second- and third-trimester vaginal use — have not shown an increased risk of birth defects at recommended doses. Data specific to first-trimester use are more limited, so topical or vaginal Triderm should be used in pregnancy only when a doctor considers it necessary, and a pregnant woman should always inform her doctor before starting treatment. For the oral troche, which has higher systemic exposure, animal studies have shown adverse effects at doses far exceeding the human dose and adequate controlled human studies are lacking; the oral troche should be used in pregnancy only if a doctor determines the benefit justifies the potential risk.

Breastfeeding

Only small amounts of Triderm are expected to pass into breastmilk after topical or vaginal use, and it is not expected to cause harm to a nursing infant; if Triderm is applied near the breast/nipple area, any residue should be wiped away before breastfeeding. Data on the oral troche during breastfeeding are limited; a doctor should be consulted before use while breastfeeding.

• For external/local use only (topical, vaginal, ear forms): These formulations of Triderm are not intended for oral ingestion or, except for the specific ophthalmic ointment used under specialist care, for the eyes; accidental contact with the eyes should be followed by thorough rinsing with water.
• Confirm diagnosis before self-treatment: Non-prescription topical or vaginal Triderm should only be used for infections previously diagnosed by a doctor, or for classic, uncomplicated symptoms; a doctor should be consulted if this is a first-time vaginal infection, if symptoms recur more than a few times in six months, or if there is no improvement within the expected treatment period.
• Barrier contraception caution: Vaginal Triderm may reduce the reliability of latex condoms and diaphragms — see Drug Interactions for details.
• Complete the full course: Stopping Triderm too early, even if symptoms improve, may allow the infection to return; the prescribed duration should be completed unless a doctor advises otherwise.
• Avoid during menstruation (vaginal tablet): Vaginal tablet treatment is generally best completed outside the menstrual period, as menstrual flow may reduce contact time and effectiveness; tampons should not be used during treatment as they may absorb the medicine.
• Eye ointment requires specialist supervision: Because fungal keratitis is a serious eye condition, Triderm eye ointment should be used only under the direct supervision of an ophthalmologist, with regular follow-up.

For topical, vaginal, ear, and eye formulations of Triderm, systemic toxicity from accidental overdose or ingestion of a small amount is considered unlikely because systemic absorption from these routes is low; local irritation may occur if excessive amounts are applied. If Triderm cream, tablets, drops, or ointment are swallowed in a larger-than-expected amount, especially by a child, a doctor or the national poison information service should be contacted for advice. For the oral troche, specific overdose data are not established in prescribing information, but supportive medical care and observation are recommended, and excessive or prolonged use has been associated with elevated liver enzymes and gastrointestinal symptoms such as nausea and vomiting; a doctor should be contacted if a much larger number of troches than prescribed has been taken.

Children: Topical skin Triderm (cream/solution) may be used in children as directed by a doctor for confirmed fungal skin infections. The vaginal tablet is not intended for use in children. Ear drops and eye ointment should only be used in children under medical/specialist supervision. The oral troche is not recommended in children under 3 years of age, and pediatric prophylactic use has not been established; see Pediatric Use for details.

Elderly: No specific dose adjustment is established for elderly patients using topical, vaginal, ear, or troche Triderm; general precautions regarding skin fragility and correct application technique apply.

Renal impairment: Because systemic absorption of topical, vaginal, ear, and eye formulations is low, specific dose adjustment for renal impairment has not been established as necessary; the oral troche has not been specifically studied in renal impairment, so a doctor should be consulted.

Hepatic impairment: Specific dose adjustment for hepatic impairment has not been established for topical, vaginal, ear, or eye Triderm. Because the oral troche has been associated with elevated liver enzymes in some patients, it should be used with caution and periodic liver function monitoring in patients with existing liver disease, under a doctor's guidance.

Pregnant/breastfeeding women: See Pregnancy and Lactation for details.

Duration depends on the formulation and the infection being treated. Topical skin infections generally require 1-4 weeks of continuous application depending on the type of infection (see Dosage table); if there is no improvement within about 4 weeks, a doctor should reassess the diagnosis. Vaginal tablet regimens range from a single dose to a 6-day course depending on the product and whether the infection is a first episode or recurrent. Ear drop treatment typically continues for at least 2 weeks after signs of infection resolve. The oral troche treatment course is typically 14 days for active infection, while prophylactic use continues for the duration of the period of increased risk (for example, through a course of chemotherapy), as directed by a doctor. In all cases, the full course prescribed should be completed even if symptoms improve earlier.

Use of Triderm in children depends on the formulation. Topical skin cream/solution has established safety and effectiveness in children when used for confirmed fungal skin infections at the recommended dose and applied by or under the supervision of a caregiver, following the same regimens as in adults (see Dosage table); a doctor should confirm the diagnosis and appropriate duration. The vaginal tablet formulation is not used in children. Ear drops and eye ointment should be used in children only under a doctor's or specialist's direction, as pediatric dosing data for these forms are limited. The oral troche is contraindicated in children under 3 years old (who cannot reliably dissolve a troche without chewing or choking risk), and its safety and effectiveness for prophylactic use in children have not been established; treatment use in older children should be directed by a doctor.