Triderm 0.5 mg/g + 1 mg/g + 10 mg/g cream 15 g – uses, instructions and important information

Triderm 0.5 mg/g + 1 mg/g + 10 mg/g cream is a medicine for use on the skin containing three active substances: betamethasone, gentamicin and clotrimazole. Betamethasone is a potent corticosteroid, gentamicin is an aminoglycoside antibiotic and clotrimazole is an antifungal medicine.

Triderm is used for certain inflammatory skin conditions that respond to corticosteroids when they are complicated by a secondary bacterial or fungal infection caused by microorganisms sensitive to the active substances, or when the doctor suspects that such an infection is present. The pack contains one tube with 15 g of cream.

What is Triderm cream used for?

Triderm cream is used to relieve inflammatory symptoms of dermatoses that respond to topical corticosteroids when the affected skin is complicated by a secondary infection caused by bacteria or fungi sensitive to gentamicin and clotrimazole, or when there is a suspected risk of such an infection.

Clotrimazole acts against certain dermatophytes, Candida species and the microorganism associated with tinea versicolor. This does not mean that Triderm is suitable for every fungal infection, rash or itchy skin condition. Because it combines a potent corticosteroid, an antibiotic and an antifungal medicine, treatment should be selected by a doctor.

How is Triderm cream applied?

Always use this medicine exactly as your doctor or pharmacist has instructed. Triderm is intended for use on the skin only.

Adults: Apply a thin layer to the affected area and the surrounding skin and rub it in gently twice daily, in the morning and evening. Treatment should not normally continue for longer than 7 to 10 days unless the doctor gives different instructions.

Children over 2 years of age and adolescents: Apply a thin layer to a small affected area once daily. Treatment must be closely supervised by a doctor and should not continue for longer than 5 to 7 days.

Do not apply a larger amount, use the cream more frequently or continue treatment for longer than prescribed. Do not apply it under an airtight dressing or under a nappy.

When the potent corticosteroid or the combined antimicrobial treatment is no longer medically necessary, the doctor may recommend continuing treatment with a medicine containing only one appropriate active substance. Do not make this change without medical advice.

When must Triderm cream not be used?

Do not use Triderm cream:

• if you are allergic to betamethasone dipropionate, gentamicin sulfate, clotrimazole or any other ingredient;
• if you are allergic to other corticosteroids, imidazole derivatives or aminoglycoside antibiotics;
• during pregnancy;
• in children under 2 years of age;
• for viral skin infections, including chickenpox, herpes simplex or herpes zoster;
• for skin tuberculosis or skin changes caused by syphilis;
• for rosacea or rosacea-like dermatitis;
• during concurrent systemic treatment with aminoglycoside antibiotics;
• in patients with advanced kidney failure;
• under an airtight or occlusive dressing.

Triderm cream is not intended for use in the eyes, around the eyes, inside the ear canal or on mucous membranes.

Warnings and precautions

Stop using the cream and contact your doctor if an allergic reaction, marked irritation or worsening of the skin condition develops.

If the affected area does not improve within several days, becomes worse or develops new redness, lumps, skin thinning, injury or signs of another infection, consult your doctor again.

Do not apply the medicine to large areas of the body, especially areas covering more than approximately 10% of the body surface, or to open wounds, large burns or extensively damaged skin without consulting a doctor or pharmacist.

Special care is required when the cream is applied to the face, neck, scalp, genital, rectal, skin-fold or chafed areas. Application to these areas should not continue for longer than five days.

Long-term use of gentamicin on the skin may lead to excessive growth of microorganisms that are not sensitive to the antibiotic. If irritation, hypersensitivity or a new infection develops, the doctor may stop Triderm and prescribe different treatment.

Triderm is not recommended for nappy rash. A nappy, particularly a plastic nappy, may act like an occlusive dressing and increase absorption of the medicine.

Interactions with other medicines

Tell your doctor or pharmacist about all medicines you use, including creams, ointments, sprays and solutions applied to the skin.

Because of possible mutual inactivation, Triderm should not be used at the same time as other dermatological medicines on the same area unless the doctor has specifically recommended this.

It is particularly important to tell your doctor if you are being treated with medicines containing:

• amphotericin B;
• heparin;
• sulfadiazine;
• beta-lactam antibiotics, including certain cephalosporins;
• systemically administered aminoglycoside antibiotics.

Do not stop or change another prescribed treatment without consulting your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor before using any medicine.

Pregnancy: Triderm cream must not be used during pregnancy.

Breastfeeding: Triderm cream should not be used during breastfeeding because the active substances may pass into breast milk.

Driving and using machines

There is no evidence that proper application of Triderm cream to the skin affects the ability to drive or use machines.

Possible side effects

Like all medicines, Triderm cream may cause side effects, although not everybody gets them.

Very rare side effects, which may affect up to 1 in 10,000 people, include:

• changes in skin colour;
• burning, redness or itching;
• fluid accumulation in surrounding tissue;
• hypochromia, a change detected in a laboratory blood test.

Side effects of unknown frequency associated with gentamicin applied to the skin may include:

• temporary irritation, redness or itching;
• increased sensitivity to sunlight;
• harmful effects on hearing or balance;
• harmful effects on kidney function.

The risk of effects on hearing, balance or the kidneys is greater with prolonged application, use on a large surface or use on damaged skin and large wounds.

Side effects of unknown frequency associated with topical corticosteroids may include:

• burning, itching, irritation or dry skin;
• increased hair growth or an acne-like rash;
• lighter skin colour or changes in pigmentation;
• perioral dermatitis or allergic contact dermatitis;
• softening, thinning or maceration of the skin;
• stretch marks, heat rash or inflammation of hair follicles;
• secondary skin infections;
• blurred vision.

Side effects of unknown frequency associated with clotrimazole applied to the skin may include:

• stinging;
• blisters or peeling of the skin;
• hives or general skin irritation;
• swelling.

Children may be at greater risk of systemic corticosteroid effects, including hormonal disturbances, slowed growth, Cushing’s syndrome, adrenal suppression and increased pressure within the skull.

What if too much cream is used?

If you have applied more cream than prescribed or used it for longer than instructed, contact your doctor or pharmacist.

Prolonged or excessive use may suppress the hypothalamic-pituitary-adrenal axis, cause secondary adrenal insufficiency or corticosteroid effects such as Cushing’s syndrome. It may also encourage growth of organisms that are not sensitive to gentamicin and increase the risk of damage to hearing or kidney function.

What if an application is forgotten?

If you forget to apply Triderm as prescribed, apply it as soon as possible and then continue according to the usual schedule. Do not apply a double amount to make up for a missed application.

Stopping treatment

Do not independently extend, repeat or restart treatment for a later skin change that appears similar. Follow your doctor’s instructions regarding the duration and completion of treatment.

How should Triderm cream be stored?

• Keep out of the sight and reach of children.
• Store below 25 °C.
• After first opening, store below 25 °C and use within three months.
• Do not use after the expiry date stated on the package.

Do not dispose of unused medicines in wastewater or household waste. Return unused medicines to a pharmacy that collects pharmaceutical waste from members of the public.

Availability and price of Triderm cream

Pharmacist’s advice

Related information and skin care

Frequently asked questions about Triderm cream