Consumer medicine information

Trimacorte Cream

Clotrimazole; Hydrocortisone acetate

BRAND INFORMATION

Brand name

Trimacorte

Active ingredient

Clotrimazole; Hydrocortisone acetate

Schedule

S3 | S2

FULL CMI

TRIMACORTE CREAM

Active ingredient(s): Clotrimazole 1% w/w & Hydrocortisone Acetate 1% w/w

Consumer Medicine Information (CMI)

This leaflet provides important information about using TRIMACORTE Cream. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using TRIMACORTE Cream.

Where to find information in this leaflet:

1. Why am I using TRIMACORTE?
2. What should I know before I use TRIMACORTE?
3. What if I am taking other medicines?
4. How do I use TRIMACORTE?
5. What should I know while using TRIMACORTE?
6. Are there any side effects?
7. Product details

1. Why am I using TRIMACORTE?

TRIMACORTE Cream contains the active ingredients Clotrimazole (an antifungal) and Hydrocortisone Acetate (a corticosteroid).

TRIMACORTE Cream is used on the skin to relieve the redness, swelling, itching and discomfort of many inflamed fungal skin problems such as:

Candidal infections
Fungal infected dermatitis or eczema
Fungal skin rash
External symptoms of thrush
Tinea infections such as jock itch, ringworm and athlete's foot
Nappy rash.

Do not use in children under 2 years of age (e.g. nappy rash) unless a doctor has told you to.

For conditions without inflammation, use an antifungal agent without hydrocortisone.

Your doctor or pharmacist may have recommended TRIMACORTE Cream for another purpose. Ask your doctor or pharmacist if you have any questions about why TRIMACORTE Cream has been recommended for you.

TRIMACORTE Cream 30g is only available from your pharmacist.

2. What should I know before I use TRIMACORTE?

Warnings

Do not use TRIMACORTE Cream if:

you are allergic to any medicine containing clotrimazole or hydrocortisone, or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

you have skin itching without any inflammation or redness.
you have acne or rosacea.
you have a bacterial infection such as school sores.
you have a viral skin infection (such as cold sores, shingles or chicken pox).
you have skin which is cracked or broken.
you have a reaction of the skin resulting from a vaccination.
You have other serious infections of the skin.

Ask your doctor or pharmacist to be sure you do not have any of these conditions.

Do not use TRIMACORTE Cream if the expiry date (EXP) printed on the pack has passed. If you use this medicine after the expiry date has passed, it may not work as well.

Do not use TRIMACORTE Cream just before having a bath, shower or going swimming. If you do, you may reduce the effectiveness of TRIMACORTE Cream.

If you are not sure whether you should start using TRIMACORTE Cream, contact your doctor or pharmacist.

Check with your doctor or pharmacist if you:

have or have had any of the conditions listed above or any other medical conditions including receiving a transplanted organ or HIV/AIDS.
have been or are being treated with medicines, which affect your immune system.
have a condition associated with a defect in your immune system.
have a serious illness affecting your immune system.
are taking any medications containing corticosteroids for asthma or other conditions (e.g. arthritis, organ transplants).
have allergies to any other medicines or any other substances such as foods, preservatives or dyes.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of using TRIMACORTE Cream when pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed. Your doctor will discuss the risks and benefits of using TRIMACORTE Cream when breast-feeding. Do not apply TRIMACORTE Cream to the breasts before breast-feeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines such as creams, ointments and lotions, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with TRIMACORTE Cream and affect how it works.

Tell your doctor or pharmacist if you are using:

Asthma medication.
Medication for arthritis.
Medication for a recent organ transplant you have received.
Medication for the treatment of HIV/AIDS.

These medicines may affect how well TRIMACORTE Cream works. You may need to use different amounts of your medicine, or you may need to use different medicines. Your doctor or pharmacist will advise you.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect TRIMACORTE Cream.

4. How do I use TRIMACORTE?

How much to use

TRIMACORTE Cream is for external use only.
Gently rub a small amount of TRIMACORTE Cream into the affected area and surrounding skin twice daily. Apply enough cream to disappear into the skin without leaving any on the skin.
Do not use tight fitting nappies or plastic pants on a child being treated in the area of the nappy, as this may increase the chance of side effects. If the location of the skin condition is in an area normally covered with clothing, you should ensure that loose clothing is worn over the area being treated.
Follow all directions given to you by your doctor or pharmacist and the instructions provided with the medicine. If you do not understand the instructions on the box, tube or this leaflet, ask your doctor or pharmacist for help.
It is important to use TRIMACORTE Cream exactly as your doctor or pharmacist has told you. If you use it less often than you should, it may not work as well and your skin problem may not improve. Using is more often than you should may not improve your skin problems any faster and may cause or increase side effects.
Do not exceed the recommended dosage.

When to use TRIMACORTE

TRIMACORTE Cream should be applied twice daily at about the same time.
You should use TRIMACORTE Cream only until the inflammation has subsided, and not for more than 7 days unless your doctor or pharmacist tells you to. If you use TRIMACORTE Cream for longer than your doctor or pharmacist tells you to the chance of side effects may increase. You should apply a cream containing only an anti-fungal agent for an extra two weeks after the inflammation has subsided. You must do this otherwise there might be a chance of the condition returning.

If you are not sure of how long you need to use TRIMACORTE Cream, talk to your doctor or pharmacist.

If you forgot to use it and it is almost time for your next application of TRIMACORTE Cream, skip the application you missed and apply the cream when you are next meant to. Otherwise, use it as soon as you remember, and then go back to using your cream as you would normally.

Do not use a double dose to make up for the dose that you missed.

If you use too much TRIMACORTE

If you think that you have used too much TRIMACORTE Cream or if you think that you or someone else may have swallowed TRIMACORTE Cream, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

5. What should I know while using TRIMACORTE?

Things you should do

If you feel that TRIMACORTE Cream is not helping your condition, tell your doctor or pharmacist
Tell your doctor or pharmacist if, for any reason, you have not used TRIMACORTE Cream exactly as prescribed. Otherwise, your doctor or pharmacist may think that it was not effective and change your treatment unnecessarily.
If you become pregnant while using TRIMACORTE Cream, tell your doctor or pharmacist.

Remind any doctor or pharmacist you visit that you are using TRIMACORTE Cream.

Things you should not do

Do not apply under dressings or on large areas of skin unless your doctor tells you.
Do not apply in or near the eyes.
Do not use to treat other complaints unless your doctor or pharmacist tells you to.
Do not use to treat acne.
Do not use on children under 2 years of age unless a doctor has told you to.
Do not use for more than 7 days unless a doctor has told you.
Do not use TRIMACORTE Cream on skin areas that rub together such as under the arm or in the groin area unless your doctor or pharmacist tells you to.
Do not wear tight fitting clothing over the area being treated with TRIMACORTE Cream.
Do not give TRIMACORTE Cream to anyone else, even if they have the same symptoms as yours.

Do not use large amounts of TRIMACORTE Cream for a long time. If you use large amounts for a long time, the chance of absorption through the skin and the chance of side effects may increase. Ask your doctor or pharmacist if you are concerned about the length of time you have been using TRIMACORTE Cream.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how TRIMACORTE affects you. It is not expected that TRIMACORTE Cream will affect these activities.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Alcohol is not expected to impact on the use of TRIMACORTE Cream.

Looking after your medicine

Keep TRIMACORTE Cream in a cool dry place where the temperature stays below 25°C.
Do not refrigerate or freeze.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious/common side effects

Less serious side effects	What to do
Drying, cracking, blistering, peeling, thinning, tightening or redness of the skin Burning or stinging feeling on the skin Bruising of the skin Acne-type lumps on the skin Itching or irritation of skin & loss of skin colour Skin condition getting worse Other obvious unexpected changes to the skin being treated Blurred vision	Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious/rare side effects

Serious side effects	What to do
Skin condition gets rapidly worse or skin becomes swollen Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What TRIMACORTE contains

Active ingredients (main ingredient)	Clotrimazole 1% w/w Hydrocortisone acetate 1% w/w
Other ingredients (inactive ingredients)	Cetostearyl alcohol Ceteareth-20 Light liquid paraffin Propylene glycol Water
Potential allergens	n/a

Do not take this medicine if you are allergic to any of these ingredients.

TRIMACORTE Cream does not contain lanolin, paraben preservatives or fragrances and washes off with water.

What TRIMACORTE looks like

TRIMACORTE Cream is a smooth, non-greasy white cream, which is available in a 30 gram tube in a carton (AUST R 291705).

Who distributes TRIMACORTE Cream

Nova Pharmaceuticals Australasia Pty Ltd
Suite 305, 10 Norbrik Drive
Bella Vista NSW 2153

Sponsor
Nova Pharmaceuticals Australasia Pty Ltd
Suite 305, 10 Norbrik Drive
Bella Vista NSW 2153

This leaflet was prepared in July 2022.

Published by MIMS May 2023

BRAND INFORMATION

Brand name

Trimacorte

Active ingredient

Clotrimazole; Hydrocortisone acetate

Schedule

S3 | S2

Name of the medicine

Trimacorte cream contains the active ingredients clotrimazole and hydrocortisone acetate.

Excipients.

Cetaeth-20, cetostearyl alcohol, liquid paraffin, propylene glycol (preservative) and water.

Description

Clotrimazole.

Chemical name: 1-[(2-chlorophenyl) diphenylmethyl]-1H-imidazole. Molecular formula: C₂₂H₁₇ClN₂. MW: 344.84. CAS: 23593-75-1. Melting point: 141 to 145°C. It is a colourless, crystalline, weakly alkaline substance, soluble in acetone, chloroform and ethanol and practically insoluble in water. It forms stable salts with both organic and inorganic acids. It is not photosensitive but is slightly hygroscopic, and may be hydrolysed in acid media.

Hydrocortisone acetate.

Chemical name: 11β, 17-dihydroxy-3, 20-dioxopregn-4-en-21-yl acetate. Molecular formula: C₂₃H₃₂O₆. MW: 404.5, CAS: 50-03-3. Hydrocortisone acetate is an odourless, white or almost white crystalline powder. It is practically insoluble in water, slightly soluble in anhydrous ethanol and in methylene chloride.
Trimacorte Cream contains the active ingredients clotrimazole 1% w/w and hydrocortisone acetate 1% w/w.
Trimacorte Cream also contains cetaeth-20, cetostearyl alcohol, liquid paraffin, propylene glycol (preservative) and water.
Topical corticosteroid/ antifungal. On topical application, corticosteroids (hydrocortisone acetate) produce anti-inflammatory, antipruritic and vasoconstrictor actions. The activity of the drugs is thought to result at least in part from binding with a steroid receptor. Clotrimazole is a broad spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeast and Pityrosporum orbiculare. The antifungal action appears to be on the cell membrane of the fungi, damaging the permeability barrier.

Pharmacology

Clotrimazole.

Synthetic imidazole derivative with broad spectrum antifungal activity and some antibacterial activity. It exerts its antifungal activity by altering cell membrane permeability by interfering with ergosterol synthesis. The cell membrane is unable to function as a selective barrier, and potassium and other cellular constituents are lost.
Clotrimazole is effective against a wide variety of fungi, including yeasts and dermatophytes. In vitro, clotrimazole concentrations of 1 microgram/mL or less inhibit most strains of Trichophyton rubrum, T. mentagrophytes, Epidermophyton floccosum and Microsporum canis. At a concentration of 3 microgram/mL or less, clotrimazole inhibits most other susceptible organisms including Pityrosporum orbiculare, Aspergillus fumigatus, Candida albicans, some strains of Staphylococcus aureus and Streptococcus pyogenes and a few strains of Proteus vulgaris and Salmonella.

Hydrocortisone acetate.

Corticosteroid, which in general, decreases inflammation by stabilising leucocyte lysosomal membranes; preventing the release of the destructive contents from leucocytes; inhibiting macrophage accumulation in inflamed areas; reducing leucocyte adhesion to the capillary endothelium; reducing capillary wall permeability and oedema formation; decreasing complement components; antagonising histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown.

Pharmacokinetics.

Clotrimazole.

Following topical application to the skin, only very small amounts of clotrimazole appear to be absorbed systemically. Six hours after the topical application of labelled clotrimazole, the concentration of clotrimazole ranged from 100 microgram/cm³ in the stratum corneum to 0.05 to 1 microgram/cm³ in the stratum reticulare and 0.1 microgram/cm³ in the subcutis. No measurable radioactivity was found in the serum within 48 hours after application of 0.8 g of a 1% cream.
Studies of urinary excretion have shown that less than 0.5% of dermally applied clotrimazole appears in the urine over a five day period of observation. Faecal excretion, the route by which most of the absorbed drug is likely to be eliminated, has not been studied in humans.

Hydrocortisone acetate.

The rate and extent of hydrocortisone acetate absorption through the skin varies among individual patients. Following topical application of a corticosteroid to most areas of normal skin, only minimal amounts of the lipophilic drug partitions into the predominantly aqueous dermoepidermal layer (visible epidermis and dermis) and subsequently into the systemic circulation.
Absorption is, however, markedly increased when the skin has lost its keratin layer or the rate limiting properties of the stratum corneum. Physical disruption of the stratum corneum, inflammation and/or disease to the epidermal barrier (e.g. psoriasis, eczema) may result in increased absorption. Hydrocortisone is absorbed to a greater degree from the skin of the ear region (around and behind), scrotum, axilla, eyelid, face and scalp than from the skin of the forearm, knee, elbow, palm and sole. Prolonged absorption persists even after the area of application has been washed, possibly because the drug is retained in the stratum corneum and/or the dermoepidermal layer.
Hydrocortisone is metabolised by the liver and most other tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in urine mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.
Children are at a greater risk of systemic absorption of topical steroids due to higher permeation properties of the skin and increased surface area to body mass ratio.

Clinical Trials

Not applicable.

Indications

For dermatophyte and yeast infections of the skin when inflammation is prominent. This includes conditions such as fungal infected dermatitis, intertrigo and Candida nappy rash.

Contraindications

Trimacorte cream is contraindicated for use:
in patients with known history of hypersensitivity to hydrocortisone, clotrimazole or any components of the formulation;
in tuberculous conditions of the skin, acute Herpes simplex, vaccinia, varicella and all viral infections;
in primary infected skin lesions caused by infection with fungi or yeasts when inflammation is not prominent;
in primary or secondary infections due to bacteria;
in rosacea;
in acne vulgaris;
in pruritus without inflammation;
in the eyes;
in patients with markedly impaired circulation since skin ulceration has occurred in these patients following the use of corticosteroids;
on occluded areas of skin.

Precautions

For external use only.
Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids. There may be a need for periodic evaluation for hypothalamo-pituitary-adrenal (HPA) axis suppression by using the urinary free cortisol test or the corticotrophin stimulation test. If either of the above are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see Adverse Effects).
Risk factors for increased corticosteroidal systemic effects are:
Potency and formulation of topical steroid.
Duration of exposure.
Application to a large surface area.
Use on occluded areas of skin e.g. on intertriginous areas or under occlusive dressings (in infants the nappy may act as an occlusive dressing).
Increasing hydration of the stratum corneum.
Use on thin skin areas such as the face.
Use on broken skin or other conditions where the skin barrier may be impaired.

Infection.

Extension of the infection may occur due to the masking effect of the steroid. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.
The immunosuppressive effects of topical corticosteroids may impair the normal function of T cells and macrophages. The result of such impairment may be the activation of latent infection or exacerbation of intercurrent infections, including those caused by Mycobacterium, Toxoplasma, Strongyloides, Pneumocystis, Cryptococcus, Nocardia and amoeba. Therefore topical corticosteroids should be used with caution in patients with impaired T cell function or in those patients receiving other immunosuppressive therapy.

Application to the face.

Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.

Application to the eyelids.

If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataracts and glaucoma might result from repeated exposure.

Chronic leg ulcers.

Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.

Local hypersensitivity.

Local hypersensitivity reactions may resemble symptoms of the condition under treatment (see Adverse Effects). If signs of hypersensitivity appear, application should be stopped and alternative therapy instituted.

Dilution.

Products which contain antimicrobial agents should not be diluted.

Contraceptives.

This product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions during treatment and for at least five days after cessation of treatment.

Psoriasis.

Topical corticosteroids should be used with caution in the management of psoriasis, as exacerbation of the disease or pustular psoriasis may occur during or on withdrawal of topical corticosteroid therapy.

Renal/ hepatic impairment.

The minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Use in pregnancy.

(Category A)
Well-conducted epidemiological studies have not identified adverse events of clotrimazole on pregnancy or on the health of the foetus.
Administration of hydrocortisone with clotrimazole during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus. Trimacorte cream should not be used on extensive areas in pregnant women. The minimum quantity should be used for the minimum duration.

Use in lactation.

It is not known whether topical administration of hydrocortisone with clotrimazole could result in sufficient systemic absorption to produce detectable amounts in breast milk. However, systemic corticosteroids are distributed into breast milk.
Administration of Trimacorte cream during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation, Trimacorte cream should not be applied to the breasts to avoid accidental ingestion by the infant.

Paediatric use.

Clotrimazole.

Safety and effectiveness in children have been established for clotrimazole when used as recommended for approved indications.

Hydrocortisone acetate.

In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults. Care should be taken when using hydrocortisone with clotrimazole to ensure the amount applied is the minimum that provides therapeutic benefit.
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.

HPA-axis suppression.

Cushing's syndrome and intracranial hypertension have occurred in children receiving topical corticosteroid. Manifestations of adrenal suppression in children include retardation of linear growth, delayed weight gain, low plasma cortisol concentrations and lack of response to corticotrophin stimulation (see Actions, Pharmacokinetics). Manifestations of intracranial hypertension include bulging fontanelles, headache, and bilateral papilloedema. Parents should be advised not to use tight fitting nappies or plastic pants on a child being treated in the area of the nappy, since such garments may constitute occlusive dressings.

Use in the elderly.

The minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Adverse Effects

Although adverse reactions are not ordinarily encountered with the topical application of hydrocortisone or clotrimazole, as with all drugs patients may react adversely to either one or both of these agents when applied topically as a combination.
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1,000 and < 1/100), rare (≥ 1/10,000 and < 1/1,000) and very rare (< 1/10,000), including isolated reports.

Post-marketing data.

Immune system disorders.

Very rare: Hypersensitivity.

Endocrine disorders.

Very rare: Hypothalamic-pituitary adrenal (HPA) axis suppression: Cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels, steroid withdrawal syndrome.

Skin and subcutaneous tissue disorders.

Not known: Allergic contact dermatitis/dermatitis, urticaria, skin atrophy, pigmentation changes, exacerbation of underlying symptoms, skin burning/skin pain, hypertrichosis, rash, pruritus, erythema, dry skin, skin striae, blisters, skin exfoliation, irritation, skin oedema, hyperaesthesia, skin cracking, thinning and tightening, rosacea, telangiectasia, increased fragility of cutaneous blood vessels, folliculitis, acne eruption, perioral dermatitis, maceration, miliaria, purpura.
Adverse dermatological effects usually improve when treatment is discontinued but may persist for long periods, atrophic striae may be permanent. Adverse dermatological effects are most likely to occur in intertriginous and facial areas.

Dosage and Administration

For topical use only.
The cream should be applied on clean dry areas of affected skin. Apply thinly and gently rub in using only enough to cover the entire affected area twice a day for up to seven days. Regular application is essential for successful treatment, whether or not a cure is confirmed mycologically.
If an emollient is being used, allow adequate time for absorption after each application before applying the emollient.
Patients should be advised to wash their hands after applying Trimacorte cream, unless it is the hands that are being treated.
Treatment should not be continued for more than seven days without medical supervision. If the condition worsens or does not improve within seven days, treatment and diagnosis should be re-evaluated.
To prevent relapse of fungal infection, all possibly infected areas should be treated at the same time and treatment with an appropriate topical antifungal should be continued for at least two weeks after disappearance of all signs of infection.
Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical corticosteroids. If an affected dermatitis requires further treatment to achieve control of the pre-existing dermatoses, once the fungal infection is treated, it may be necessary to continue therapy with another corticosteroid preparation not containing clotrimazole.

Note.

Non-occlusive loose clothing should be worn during treatment of any affected area normally covered by clothing.

Children.

Children are more likely to develop local and systemic side effects of topical corticosteroids and in general, require shorter courses of treatment than adults (see Precautions).
Care should be taken when using hydrocortisone acetate with clotrimazole to ensure the amount applied is the minimum that provides therapeutic benefit.

Elderly.

The minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Renal/ hepatic impairment.

The minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Overdosage

Symptoms and signs.

Topically applied hydrocortisone acetate with clotrimazole may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may occur (see Precautions, Adverse Effects). Dizziness, nausea and vomiting may be seen.

Treatment.

In the event of chronic overdosage or misuse, topical corticosteroids should be withdrawn gradually by reducing the frequency of application because of the risk of adrenal insufficiency.
Further management should be as clinically indicated or as recommended by the Poisons Information Centre (telephone 13 11 26).

Presentation

Trimacorte cream is presented in tubes of 30 g.

Storage

Store below 25°C. Do not refrigerate or freeze.

Poison Schedule

Schedule 3 - Pharmacist Only Medicine.

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Consumer medicine information

Trimacorte Cream

Clotrimazole; Hydrocortisone acetate

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BRAND INFORMATION