Consumer medicine information

Myxazole Cream

Clotrimazole; Hydrocortisone

BRAND INFORMATION

Brand name

Myxazole Cream

Active ingredient

Clotrimazole; Hydrocortisone

Schedule

What is in this leaflet

This leaflet answers some common questions about Myxazole Cream. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Myxazole Cream against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Myxazole Cream is used for

Myxazole Cream contains hydrocortisone (it belongs to a group of medicines called corticosteroids) and clotrimazole (it belongs to a group of medicines called antifungals).

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

Tinea pedis (athlete's foot)
External symptoms of thrush
Jock itch
Ringworm
Fungal skin rash
Fungally infected eczema or dermatitis.
Fungally infected nappy rash

Myxazole Cream should only be used in children under 2 years of age (e.g. fungal nappy rash) if a doctor has told you to.

Ask your doctor or pharmacist if you have any questions about why this medicine has been prescribed for you.

Your doctor or pharmacist may have prescribed it for another reason.

Before you use Myxazole Cream

When you must not use it

Do not use Myxazole Cream if you have an allergy to:

any medicine containing hydrocortisone or clotrimazole
any of the ingredients listed at the end of this leaflet.

Do not use Myxazole Cream if

you have a viral skin infection (such as cold sores, shingles or chicken pox)
the skin on the area to be treated is cracked or broken
you have other infections of the skin (such as acne, rosacea, perioral dermatitis, school sores, lues, tuberculosis)
you have a reaction of the skin resulting from a vaccination.
You have skin itching without any inflammation or redness.

Do not use Myxazole Cream after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

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

Before you start to use it

Tell your doctor or pharmacist if:

you have allergies to any other medicines, foods, preservatives or dyes
you are taking any medication containing corticosteroids for other conditions (e.g. asthma, arthritis, organ transplants)
you have a serious illness affecting your immune system.
You have problems with your circulation.

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

Do not apply Myxazole Cream to the breasts before breast feeding.

If you have not told your doctor or pharmacist about any of the above, tell him/her before you start using Myxazole Cream.

Using other medicines

Tell your doctor or pharmacist if you are using any other creams, ointments or lotions or taking any other medicine. This includes any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Myxazole Cream may interfere with each other. These include:

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

These medicines may be affected by Myxazole Cream or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to use Myxazole Cream

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

Gently rub a small quantity of Myxazole Cream in a thin film into the affected area two times daily for up to 7 days.

Apply enough cream to disappear into the skin without leaving any on the skin.

Wash your hands after use, unless you are treating the hands.

If the location of the skin condition is an area normally covered with clothing, you should ensure that loose clothing is worn over the affected area to be treated.

It is important to use Myxazole 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 it more often than you should may not improve your skin problem any faster and may cause or increase side effects.

How long to use it

Continue using Myxazole Cream for as long as your doctor or pharmacist tells you.

The usual treatment is up to 7 days.

If you use Myxazole Cream for longer than your doctor tells you, the chance of side effects may increase.

Your doctor or pharmacist may ask you to apply a cream containing a single anti-fungal agent for an extra two weeks after the skin condition appears to be cured.

You must do this otherwise there might be a chance of the condition returning.

Ask your doctor if you are concerned about the length of time you have been using Myxazole cream.

If you forget to use it

If it is almost time for your next application of Myxazole 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 are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you swallow it

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have swallowed Myxazole Cream. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are using Myxazole Cream

Things you must do

Tell any other doctors, dentists, and pharmacists who treat you that you are using Myxazole Cream.

If you feel that Myxazole Cream is not helping your condition, tell your doctor or pharmacist.

If you become pregnant while using this medicine, tell your doctor.

Things to be careful of

The ingredients in Myxazole Cream may affect the latex used in barrier contraceptives such as condoms and diaphragms.

You may need to use other methods of contraception whilst using this medicine and for at least 5 days after last using the cream.

Take care when applying Myxazole Cream to the eyelids to make sure it does not get into your eyes.

If you accidently get Myxazole cream in your eyes, wash them well with water.

Do not give Myxazole Cream to anyone else, even if they have the same symptoms as yours.

Do not use Myxazole to treat other complaints unless your doctor tells you to.

Do not use Myxazole under dressings or on large areas of the skin unless your doctor tells you to.

Do not use large amounts of Myxazole cream for a long time. The chance of absorption through the skin and the chance of side effects may increase.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Myxazole Cream.

Myxazole Cream helps most people with skin problems but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and side effects near or on the area you apply Myxazole Cream and they worry you.

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
Changes to the colour of your skin
Rash or blisters
Skin condition getting worse
Other obvious unexpected changes to the skin area treated.

These side effects are usually mild.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

If your skin becomes swollen during treatment, you may be allergic to the medicine, have an infection or need other treatment
Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could be a symptom of an allergic reaction.

The above list includes very serious side effects. You may need urgent medical attention. These side effects are very rare.

Very rare side effects that may show up in blood tests or when your doctor gives you a medical examination:

A decrease in the level of the hormone cortisol in your blood
Increased levels of sugar in your blood or urine
High blood pressure
Cloudy lens in the eye (cataract)
Increased pressure in the eye (glaucoma)
Weakening of the bones through gradual loss of mineral (osteoporosis) - additional tests may be needed after your medical examination to confirm if you have this condition.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using Myxazole Cream

Storage

Keep Myxazole Cream in a cool dry place where the temperature stays below 25 degrees Celsius.

Do not store Myxazole Cream or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Myxazole Cream is a smooth white cream available in a 30g tube.

Ingredients

Myxazole contains 1% clotrimazole and hydrocortisone acetate equivalent to 1% hydrocortisone as the active ingredients.

Light liquid paraffin
Soft white paraffin
Cetostearyl alcohol
Benzyl alcohol
Cetomacrogol 1000
Propylene glycol
Sodium hydroxide
Purified water

Manufacturer/Distributor/ Supplier

Myxazole is made in Australia by:

Mayne Pharma International Pty Ltd
1538 Main North Rd
Salisbury South
South Australia 5106

™ = Trademark

This leaflet was prepared in December 2015.

AUST R 267272

Version 1.0

BRAND INFORMATION

Brand name

Myxazole Cream

Active ingredient

Clotrimazole; Hydrocortisone

Schedule

Name of the medicine

Clotrimazole 1% and hydrocortisone acetate (equivalent to 1% hydrocortisone).

Excipients.

Light liquid paraffin, soft white paraffin, cetostearyl alcohol, benzyl alcohol, cetomacrogol 1000, propylene glycol, sodium hydroxide and purified water.

Description

Hydrocortisone acetate: CAS No. 50-03-3.
Clotrimazole: CAS No: 23593-75-1.
Myxazole contains the active ingredients clotrimazole and hydrocortisone acetate.
Myxazole also contains light liquid paraffin, soft white paraffin, cetostearyl alcohol, benzyl alcohol, cetomacrogol 1000, propylene glycol, sodium hydroxyide and purified water.

Pharmacology

Hydrocortisone.

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.

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.

Pharmacokinetics.

Hydrocortisone.

The rate and extent of hydrocortisone 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. psoriases, 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 glucoronides, 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.

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.

Indications

Myxazole cream is indicated 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

Myxazole cream is contraindicated for use:
in patients with known history of hypersensitivity to hydrocortisone acetate, 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 exernal use only.

Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression.

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.

Impaired hepatic or renal function.

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

Use in pregnancy.

(Category A)
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established.
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. Myxazole 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 Myxazole during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation, Myxazole should not be applied to the breasts to avoid accidental ingestion by the infant.

Paediatric use.

Hydrocortisone.

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 Pharmacology, 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.

Clotrimazole.

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

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.

Adverse events reported during post marketing experience with clotrimazole/hydrocortisone cream.

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.

Frequency 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, foliculitis, 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 Myxazole 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.

Nonocclusive 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 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 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 131 126).

Presentation

White to off white cream filled into aluminium tubes containing 30 g cream.

Storage

Store below 25 degree Celsius.

Poison Schedule

S3.

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Consumer medicine information

Myxazole Cream

Clotrimazole; Hydrocortisone

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BRAND INFORMATION