Consumer medicine information

Hydrozole Cream 50g

CMI for Hydrozole Cream: 50g

Hydrocortisone; Clotrimazole

BRAND INFORMATION

Brand name

Hydrozole Cream

Active ingredient

Hydrocortisone; Clotrimazole

Schedule

S4 | S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Hydrozole Cream 50g.

SUMMARY CMI

Hydrozole Cream

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Hydrozole Cream?

Hydrozole Cream contains the active ingredient hydrocortisone 1% and clotrimazole 1%. Hydrozole Cream is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems such as nappy rash, candidal infections (a yeast-like micro-organism) where there is also inflammation on the skin, fungal-infected dermatitis and tinea infections such as jock itch and athlete's foot.

For more information, see Section 1. Why am I using Hydrozole Cream? in the full CMI.

2. What should I know before I use Hydrozole Cream?

Do not use if you have ever had an allergic reaction to hydrocortisone or clotrimazole or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Hydrozole Cream? in the full CMI.

3. What if I am taking other medicines?

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

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Hydrozole Cream?

  • For external use only.
  • Follow all directions given to you by your doctor or pharmacist carefully. Do not exceed the recommended dosage.

More instructions can be found in Section 4. How do I use Hydrozole Cream? in the full CMI.

5. What should I know while using Hydrozole Cream?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Hydrozole Cream.
  • If you become pregnant while using Hydrozole Cream or are pregnant or intend to become pregnant, talk to your doctor or pharmacist.
  • Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Things you should not do
  • Do not use Hydrozole Cream under airtight or waterproof dressings, in the eyes, for acne or on large areas of skin unless your doctor has told you to.
  • Do not use Hydrozole Cream for more than 7 days unless a doctor has told you to or in large amounts for a long time.
  • Do not use Hydrozole Cream on children under 2 years of age unless a doctor has told you to.
Drinking alcohol
  • Tell your doctor or pharmacist if you drink alcohol.
Looking after your medicine
  • Keep Hydrozole Cream in a cool dry place where the temperature stays below 25°C. Do not refrigerate Hydrozole Cream. Heat and dampness can destroy some medicines.
  • Keep it where young children cannot reach it.

For more information, see Section 5. What should I know while using Hydrozole Cream? in the full CMI.

6. Are there any side effects?

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Hydrozole Cream

Active ingredient(s): Hydrocortisone (microfine) 1% w/w and Clotrimazole 1% w/w

Consumer Medicine Information (CMI)

This leaflet provides important information about using Hydrozole 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 Hydrozole Cream.

Where to find information in this leaflet:

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

1. Why am I using Hydrozole Cream?

Hydrozole Cream contains the active ingredient hydrocortisone (it belongs to a group of medicines called corticosteroids) and clotrimazole (it belongs to a group of medicines called antifungals).

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

  • Nappy rash
  • Candidal infections (a yeast-like micro-organism) where there is also inflammation on the skin
  • Fungal-infected dermatitis
  • Tinea infections such as jock itch and athlete's foot.

Hydrozole Cream should only be used on children under 2 years of age (for example nappy rash) if a doctor has told you to.

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

Hydrozole Cream is not addictive.

Hydrozole Cream is only available from your pharmacist.

2. What should I know before I use Hydrozole Cream?

Warnings

Do not use Hydrozole Cream if:

  • you have an allergy to any medicine containing hydrocortisone or clotrimazole, or any of the ingredients listed at the end of this leaflet, or any other similar medicines (such as medicines of the same class).
    Always check the ingredients to make sure you can use this medicine.
  • you have a viral skin infection (such as cold sores, shingles or chicken pox)
  • you have bacterial skin infection such as school sores
  • you have pruritus (itching skin) without any inflammation or redness
  • you have rosacea (skin condition of the face where the nose and cheeks are unusually red)
  • you have acne
  • you have problems with your circulation
  • you have any other serious infections of the skin.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

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

Do not use Hydrozole 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.

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

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

Check with your doctor if you:

  • have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes
  • are taking any medication containing corticosteroids for other conditions (e.g. asthma, arthritis, organ transplants)
  • have a serious illness affecting your immune system
  • have had or have any other medical conditions, including receiving a transplanted organ or HIV.
  • are pregnant or intend to become pregnant.
  • are breastfeeding or intend to breastfeed.

If you have not told your doctor about any of the above, tell your doctor before you use Hydrozole Cream.

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 if you are pregnant or intend to become 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 Hydrozole Cream when pregnant.

Check with your doctor or pharmacist if you are breastfeeding or intend to breastfeed. Your doctor will discuss the risks and benefits of using Hydrozole Cream when breastfeeding.

Do not apply Hydrozole Cream to the breasts before breastfeeding.

3. What if I am taking other medicines?

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

Some medicines and Hydrozole 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 Hydrozole Cream or affect how well Hydrozole 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.

Your doctor or pharmacist may have more information on medicines to be careful with or avoid while using Hydrozole Cream.

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

4. How do I use Hydrozole Cream?

How much to use

  • Gently rub a small quantity of Hydrozole Cream 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.
  • Do not exceed the recommended dosage.
  • You should use Hydrozole Cream for as long as your doctor or pharmacist tells you to. The usual treatment is up to 7 days.
  • If you use Hydrozole Cream for longer than your doctor or pharmacist tells you, the chance of side effects may increase.
  • You should apply a cream containing a single 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 Hydrozole Cream, talk to your doctor or pharmacist.

When to use Hydrozole Cream

  • 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.
  • Use Hydrozole Cream at the same time every day.

How to use Hydrozole Cream

  • Hydrozole Cream is for external use only.
  • Follow all directions given to you by your doctor or pharmacist carefully.
  • These directions may differ from the information contained in this leaflet.
  • If you do not understand the instructions on the box, tube or this leaflet, ask your doctor or pharmacist for help.
  • Gently rub a small quantity of Hydrozole Cream 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 in an area normally covered with clothing, you should ensure that loose clothing is worn over the affected area to be treated.
  • Follow the instructions provided with the medicine.

If you forget to use Hydrozole Cream

  • If it is almost time for your next application of Hydrozole 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 have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you use too much Hydrozole Cream

If you think that you have used too much Hydrozole 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.

5. What should I know while using Hydrozole Cream?

Things you should do

  • Tell your doctor(s) or pharmacist(s) who is treating you that you are using Hydrozole Cream.
  • If you feel that Hydrozole Cream is not helping your condition, tell your doctor or pharmacist.
  • Tell your doctor or pharmacist if for any reason, you have not used Hydrozole 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 Hydrozole Cream, tell your doctor or pharmacist.

Call your doctor straight away if you:

  • become pregnant while using Hydrozole Cream
  • find the condition worsen

Remind any doctor, dentist or pharmacist you visit that you are using Hydrozole Cream.

Things you should not do

Do not use Hydrozole Cream: -

  • under airtight or waterproof dressings
  • or on large areas of skin unless your doctor has told you to
  • in the eyes
  • to treat other complaints unless your doctor or pharmacist tells you to
  • for acne
  • on children under 2 years of age unless a doctor has told you to
  • for more than 7 days unless a doctor has told you to
  • in large amounts 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 if you are concerned about the length of time you have been using Hydrozole Cream.

  • on skin areas that rub together such as under the arm or in the groin area unless your doctor tells you to.

Do not wear tight fitting clothing in the area being treated with Hydrozole Cream.

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

Do not dilute Hydrozole Cream.

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

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

If you experience blurred vision or other visual disturbances, speak to your doctor.

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

  • If you accidentally get Hydrozole Cream in your eyes, wash them well with water.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Hydrozole Cream affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

  • Keep Hydrozole Cream in a cool dry place where the temperature stays below 25°C.
  • Heat and dampness can destroy some medicines.
  • Do not refrigerate Hydrozole Cream.

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.

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

When to discard your medicine

If your doctor or pharmacist tells you to stop using Hydrozole Cream or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

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 about side effects.

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

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

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

Do not be alarmed by the list of side effects, which follows; you may not experience any of them.

Less serious side effects

Less serious side effectsWhat 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.
  • Changes to the colour of your skin.
  • Rash or blisters.
  • Skin condition getting worse.
  • Other obvious unexpected changes to the skin area treated.
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • if your skin condition gets worse or 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.
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.

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.

Ask your doctor or pharmacist if you don't understand anything in this list.

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.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Hydrozole Cream contains

Active ingredient
(main ingredient)
  • hydrocortisone 1%
  • clotrimazole 1%
Other ingredients
(inactive ingredients)
  • cetomacrogol 1000
  • glycerol
  • cetostearyl alcohol
  • light liquid paraffin
  • white soft paraffin
  • propylene glycol
  • chlorocresol 0.2% (as a preservative)
  • purified water
  • sodium hydroxide
  • lactic acid
Potential allergenschlorocresol 0.2% (as a preservative)

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

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

What Hydrozole Cream looks like

Hydrozole Cream is a smooth, non-greasy white cream, which is available in a 50 gram tube in a carton. (AUST R 10319).

Who distributes Hydrozole Cream

Haleon
Sydney, NSW, Australia.
AU: 1800028533

This leaflet was prepared in March 2023.

Published by MIMS May 2023

BRAND INFORMATION

Brand name

Hydrozole Cream

Active ingredient

Hydrocortisone; Clotrimazole

Schedule

S4 | S3

 

1 Name of Medicine

Hydrozole Cream contains the active ingredients hydrocortisone and clotrimazole.

2 Qualitative and Quantitative Composition

Hydrozole contains the active ingredients hydrocortisone (microfine) 1% w/w and clotrimazole 1% w/w.
Hydrozole also contains cetomacrogol 1000, glycerol, cetostearyl alcohol, light liquid paraffin, soft white paraffin, propylene glycol, purified water and chlorocresol 0.2% as a preservative. The cream (nonionic) is lanolin free and does not contain parabens preservatives.

3 Pharmaceutical Form

Hydrozole Cream is a smooth, non-greasy white cream.

4 Clinical Particulars

4.1 Therapeutic 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.

4.2 Dose and Method of 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 Hydrozole 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.

Paediatric use.

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 Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

Hydrozole 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.

4.4 Special Warnings and Precautions for Use

Identified precautions.

For external 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 Section 4.8 Adverse Effects (Undesirable 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.

Visual disturbance.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

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 Section 4.8 Adverse Effects (Undesirable 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.

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 Mechanism of action; see Section 5.2 Pharmacokinetic Properties). 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.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no data in humans to evaluate the effect of topical hydrocortisone with clotrimazole on fertility.
(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. Hydrozole should not be used on extensive areas in pregnant women. The minimum quantity should be used for the minimum duration.
 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 Hydrozole during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation, Hydrozole should not be applied to the breasts to avoid accidental ingestion by the infant.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration. There have been no studies to investigate the effect of hydrocortisone with clotrimazole on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical hydrocortisone with clotrimazole.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.
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.

Eye disorders.

Not known: Vision blurred.

General disorders and administration site conditions.

Very rare: Application site irritation/pain.
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.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

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 Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable 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).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Topical corticosteroid/ antifungal.

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.
On topical application, corticosteroids (hydrocortisone) 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.

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.

5.2 Pharmacokinetic Properties

Absorption.

No data are available on the absorption of hydrocortisone with clotrimazole, however, there is no indication that absorption of hydrocortisone and clotrimazole in combination differs from that of each active alone.

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. 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.
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.

Distribution.

Hydrocortisone.

Once absorbed into the systemic circulation, corticosteroids are rapidly distributed to all body tissues.

Clotrimazole.

Once absorbed into the systemic circulation, clotrimazole is 90% protein bound.

Metabolism.

Hydrocortisone.

Hydrocortisone is metabolised by the liver and most other tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol.

Clotrimazole.

Clotrimazole is metabolised in the liver to inactive substances.

Excretion.

Hydrocortisone.

These are excreted in urine mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.

Clotrimazole.

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.

5.3 Preclinical Safety Data

Genotoxicity.

Hydrocortisone.

Hydrocortisone was not mutagenic in a bacterial mutagenicity assay (Salmonella typhimurium) in the absence or presence of metabolic activation, and was not genotoxic in an unscheduled DNA synthesis (UDS) assay in rat primary hepatocytes. Hydrocortisone was genotoxic in a chromosome aberration assay in human lymphocytes, and a mouse bone marrow micronucleus/sister chromatid exchange assay.

Clotrimazole.

Clotrimazole was not mutagenic in the fluctuation assay with Klebsiella pneumonia and Escherichia coli K12 and was not mutagenic in the plate-incorporation assay with and without metabolic activation in S. typhimurium strains TA98 and TA100. Clotrimazole was not mutagenic in an in vivo study in Chinese hamsters.

Carcinogenicity.

Hydrocortisone.

Hydrocortisone was not carcinogenic in rats when administered via the subcutaneous route for 52 weeks.

Clotrimazole.

Clotrimazole was not carcinogenic in rats when administered orally for 18 months.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Hydrozole cream contains hydrocortisone 1% w/w and clotrimazole 1% w/w. The product is presented in tubes of 2 g and 5 g (samples), 30 g and 50 g. [AUST R 10319].
Not all pack sizes may be distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Hydrocortisone.

Chemical name: 11β, 17α, 21-trihydroxypregn-4-ene-3,20-dione. Molecular formula: C21H30O5. MW: 362.5. CAS: 50-23-7. Hydrocortisone is an odourless, white or almost white crystalline powder. It is practically insoluble in water, sparingly soluble in acetone and in alcohol, slightly soluble in methylene chloride, very slightly soluble in ether.

Clotrimazole.

Chemical name: 1-(o-chloro-αα-diphenylbenzyl) 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.
The structural formula is given below.

Chemical structure.

Hydrocortisone.


Clotrimazole.


CAS number.

Hydrocortisone.

50-23-7.

Clotrimazole.

23593-75-1.

7 Medicine Schedule (Poisons Standard)

Schedule 3 - Pharmacist Only Medicine (2 g, 5 g and 30 g).
Schedule 4 - Prescription Only Medicine (50 g).

Summary Table of Changes