Consumer medicine information

Hysoderm cream

Hydrocortisone acetate

BRAND INFORMATION

Brand name

Hysoderm Cream

Active ingredient

Hydrocortisone acetate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Hysoderm cream.

What is in this leaflet

This leaflet answers some common questions about Hysoderm 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 or pharmacist has weighed the risks of you using Hysoderm cream against the benefits this medicine is expected to have for you.

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

Keep this leaflet with the medicine. You may need to read it again.

What Hysoderm cream is used for

Hysoderm cream contains the active ingredient hydrocortisone acetate. This is a type of cortisone and belongs to the group of medicines called corticosteroids.

Hysoderm cream is a topical therapy for non-infected inflammatory conditions of the skin.

Hysoderm cream is used on the skin to relieve the redness, swelling, itching and discomfort of skin problems such as:

  • itching and rashes due to eczema or dermatitis
  • rashes due to soap, detergent, cosmetics or jewellery
  • insect bites
  • itching anal and genital areas not due to infection
  • sunburn.

Ask your pharmacist or doctor if you have any questions about why Hysoderm cream has been recommended or prescribed for you. Your pharmacist or doctor may have recommended Hysoderm cream for another reason.

Hysoderm cream is only available from your pharmacist.

Before you use Hysoderm cream

When you must not use it

Do not use Hysoderm cream if you have an allergy to:

  • any medicine containing hydrocortisone acetate
  • any of the ingredients in Hysoderm cream listed at the end of this leaflet.

Do not use Hysoderm cream on:

  • untreated bacterial infections
  • parasitic skin infections (such as scabies)
  • viral skin infection (such as herpes simplex, cold sores, shingles or chicken pox)
  • fungal skin infection (such as thrush, tinea or ringworm)
  • tuberculous conditions of the skin
  • vaccinia (cowpox: a viral disease passed from cattle)
  • varicella (a rare form of chicken pox)
  • acne or rosacea
  • cuts or open wounds.

Do not use Hysoderm cream on psoriasis unless recommended by your doctor. Hysoderm cream should not be used if you suffer from poor circulation of blood in the skin region, as it may result in skin ulcers.

Do not use under occlusive dressings or waterproof bandages unless a doctor has told you to.

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

Do not use Hysoderm cream after the expiry date printed on the pack. It may have no effect at all, or worse, it may give an entirely unexpected effect if you use after the expiry date.

Do not use Hysoderm cream if the packaging shows sign of tampering or the seal on the tube is broken, or if the product does not look quite right.

If you are not sure whether you should start using this medicine, talk to 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.

Tell your doctor or pharmacist if you have any of the following medical conditions:

  • diabetes
  • problems with your immune system.

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor or pharmacist will discuss the risks and benefits of using Hysoderm cream when pregnant or breastfeeding.

If Hysoderm cream is to be applied to the breast, do not apply the cream to the breast before breast feeding. Ensure that the breast area is free of the cream before breastfeeding.

Do not use in children under 2 years unless your doctor tells you to do so.

Using other medicines

Tell your doctor or pharmacist if you are using other creams, ointments or lotions or taking any medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Hysoderm cream if it is used excessively or for prolonged periods. Some of these medicines include medicines to treat epilepsy, diuretics, oral contraceptive pills and immunosuppressants.

Your doctor or pharmacist have more information on medicines that may interfere with Hysoderm cream.

If you have not told your doctor or pharmacist about any of the above, tell them before you start using Hysoderm cream.

How to use Hysoderm 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 label, ask your doctor or pharmacist for help.

How to use it

It is important to use Hysoderm cream exactly as your doctor or pharmacist has told you.

How long to use it

Do not use Hysoderm cream for more than 7 days except on the advice of a doctor. If your condition persists, see your pharmacist or doctor.

Reduce the number of applications as the disorder subsides.

If you use Hysoderm cream for a long time, the chance of side effects increases.

If you forget to use it

If you forget to use Hysoderm cream, use it as soon as you remember and then go back to your normal times for applying Hysoderm cream.

Do not try to make up for the amount you missed by using more than you normally use.

If you are not sure what to do, ask your doctor or pharmacist.

If you swallow it

Immediately telephone your doctor or Poisons Information Centre (phone 13 11 26) or go to the accident and emergency centre at your nearest hospital if anyone swallows Hysoderm cream.

While you are using Hysoderm cream

Things you must do

Tell all your doctors and pharmacists who are treating you that you are using Hysoderm cream.

Tell your doctor if you feel that Hysoderm cream is not helping your condition.

Tell your doctor if you become pregnant while using Hysoderm cream.

Things you must not do

Do not use Hysoderm cream in or near the eyes.

Do not use Hysoderm cream under dressings or on large areas of skin unless your doctor tells you.

Do not give Hysoderm cream to anyone else even if their symptoms seem similar to yours.

Do not use Hysoderm cream to treat other conditions unless your doctor tells you. Your doctor or pharmacist has recommended Hysoderm cream especially for you and your condition. If you use it for another condition, it may not work or make the condition worse.

Things to be careful of

Do not use large amounts of Hysoderm cream for a long time. If you use large amounts for long time, the chance of systemic absorption through the skin and the chance of side effects increase.

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

Only use Hysoderm cream under the arm or in the groin if your doctor tells you.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Hysoderm cream.

Hysoderm cream helps most people with skin problems but it may have some unwanted side effects in a few people.

Side effects reported by some people using Hysoderm cream include:

  • itching
  • burning
  • dryness
  • acne-form eruptions
  • thinning of the skin.

In addition to the above side effects, prolonged or over-use of this product may cause the following side effects in some people:

  • high blood pressure
  • elevated cholesterol and triglyceride levels in the blood
  • blurred vision
  • cataracts
  • glaucoma.

Hysoderm cream may cause other side effects. If you have any other side effects, check with your doctor.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Hysoderm cream

Storage

Keep Hysoderm cream 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.

Keep Hysoderm cream in a cool dry place where the temperature stays below 25°C.

Do not leave Hysoderm cream in the car or on windowsills. Heat can destroy some medicines.

Disposal

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

Product description

What it looks like

Hysoderm cream is a soft white cream that is packed in 30g tubes.

Ingredients

Hysoderm cream contains 1% w/w or 10 mg/g of hydrocortisone acetate as the active ingredient.

Hysoderm cream also contains the following inactive ingredients:

  • white soft paraffin
  • liquid paraffin
  • cetomacrogol 1000
  • cetostearyl alcohol
  • chlorocresol (preservative)
  • citric acid
  • sodium citrate dihydrate
  • purified water.

Sponsor

Alphapharm Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

Australian registration number:

Hysoderm cream: AUST R 282487

This leaflet was prepared in October 2020.

Hysoderm _cmi\Oct20/00

Published by MIMS December 2020

BRAND INFORMATION

Brand name

Hysoderm Cream

Active ingredient

Hydrocortisone acetate

Schedule

S3

 

1 Name of Medicine

Hydrocortisone acetate.

2 Qualitative and Quantitative Composition

Hydrocortisone acetate 112 mg is approximately equivalent to 100 mg of hydrocortisone.
Hysoderm cream contains 10 mg/g (1.0% w/w) microfine hydrocortisone acetate in a water miscible, lanolin free cetomacrogol base.

Excipients with known effect.

Chlorocresol 1 mg/g (0.1% w/w) is used as a preservative.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Hysoderm Cream is a soft white cream with a faint odour of chlorocresol.

4 Clinical Particulars

4.1 Therapeutic Indications

Topical corticosteroid therapy for the temporary relief of symptoms of non-infective inflammatory conditions of the skin (e.g. minor skin irritations, itching and rashes due to eczema, dermatitis, contact dermatitis [such as rashes due to soap, detergent, cosmetics and jewellery], insect bites, itching anal and genital areas and sunburn).

4.2 Dose and Method of Administration

Adults and children from 2 years of age: apply a thin layer to affected areas 2 - 4 times daily. Reduce the number of applications as the disorder subsides. The cream should not be used under occlusive dressings or waterproof bandages unless advised to by a doctor. This preparation should not be used for more than 7 days except on the advice of a doctor. Rub in gently.

4.3 Contraindications

Tuberculous and fungal conditions of the skin, acute Herpes simplex, vaccinia, varicella and all viral infections.
Untreated bacterial infections.
Parasitic infestations (e.g. scabies).
In patients with markedly impaired circulation since skin ulceration has occurred in these patients following the use of corticosteroids.
Hypersensitivity to any component of the cream.
Not to be used in the eyes.
Not to be used for acne or rosacea.
The cream should not be used under occlusive dressings or waterproof bandages unless advised to by a doctor.

4.4 Special Warnings and Precautions for Use

For external use only. Avoid contact with eyes.
This medicine should not be used in the eyes. Use of the cream near the eyes should be avoided. This is due to the risk of corticosteroid-induced open-angle glaucoma.
If irritation develops Hysoderm Cream should be discontinued and alternative therapy instituted. Prolonged and heavy doses of hydrocortisone may have an immunosuppressant effect and thus decrease resistance to infection as well as mask signs of it. If infection of the skin is present suitable antifungal or antibacterial agents should be used first. Any occlusive dressings should be discontinued. If the infection does not respond promptly to therapy, corticosteroid therapy should be discontinued until the infection has been controlled.
Where very large areas are treated for long periods (e.g. atopic dermatitis), the possibility of systemic absorption exists, particularly if an occlusive dressing is applied. Prolonged use of large quantities of topical corticosteroids may also result in atrophic striae or acne eruptions.
Due to the possible systemic absorption of topical steroids, there may be a need for periodic evaluation of hypothalamo-pituitary-adrenal (HPA)-axis suppression by using the urinary free cortisol test or the corticotrophin stimulation test. If the HPA-axis suppression is evident, withdrawal should be attempted and the frequency of application reduced.
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 Section 5.2 Pharmacokinetic Properties). Manifestations of intracranial hypertension include bulging fontanelles, headache, and bilateral papilloedema. Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development. Parents should be advised not to use tight-fitting nappies or plastic pants on a child being treated in the diaper area, since such garments may constitute occlusive dressings.
Children have a greater surface to mass ratio than adults, and so may be at greater risk of adverse events from increased dosages.
Any corticosteroid therapy tends to elevate blood glucose levels in diabetic patients, and this should be monitored during treatment.
Corticosteroids should be used cautiously in patients with non-specific ulcerative colitis, diverticulitis, colon abscess or other pyogenic infection, colon obstruction, or extensive fistulas and sinus tracts, fresh intestinal anastomoses, active or latent peptic ulcers, renal insufficiency, hypertension, osteoporosis and myasthenia gravis.
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.
Topical corticosteroids should also be used with caution in patients with impaired T cell function or in those patients receiving other immunosuppressive therapy. The immunosuppressive effects of corticosteroids may be associated with impairment of the normal function of T cells and macrophages. The result of this impairment may be the activation of latent infection or exacerbation of intercurrent infections, including those caused by Candida, Mycobacterium, Toxoplasma, Strongyloides, Pneumocystis, Cryptococcus, Nocardia and Amoeba.
Patients on long term therapy, if there is a risk of immunosuppression, should not be given any live attenuated vaccines.

Visual disturbance.

Visual disturbance may be reported with system 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.

Use in the elderly.

No data available.

Paediatric use.

Long term therapy in infants should be avoided as adrenal suppression may occur. The risk of systemic absorption, and hence systemic toxicity, is greater in children due to a larger skin surface to bodyweight ratio than adults. The preparation is not recommended for use in children under 2 years of age except on the advice of a doctor.

Effects on laboratory tests.

The use of corticosteroids has been shown to result in falsely elevated measurements of serum digoxin concentrations, but this occurred at dosages far greater than those likely to be delivered by topical therapy.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There are many potential drug interactions with hydrocortisone, however most are quite unlikely with topical therapy, occurring mainly with prolonged or over-use.
Carbamazepine, phenytoin and rifampicin all induce hepatic enzymes and thus lead to increased metabolism of hydrocortisone.
Concomitant use of diuretics, which also deplete potassium ion concentration in the blood, may cause hypokalaemia.
All corticosteroids antagonise the effects of neuromuscular blocking agents, such as vecuronium.
Oral contraceptives have been shown to prolong the half-life of hydrocortisone and thus potentiate its anti-inflammatory effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Long-term animal studies have not been performed to evaluate the effect on fertility of topical corticosteroids.
(Category A)
Appropriate studies in humans have not been done. In vivo studies using pregnant animals have shown that application of large amounts of topical corticosteroids, especially the more potent ones, over prolonged periods may cause foetal abnormalities. Therefore, topical corticosteroids should be used in pregnancy only when the potential benefits justify the possible risks to the foetus. The drugs should not be used on extensive areas, in large amounts or for prolonged periods in pregnant women.
It is not known whether topical corticosteroids are distributed into milk; however, systemic corticosteroids are distributed into milk. Topical corticosteroids should be used with caution in nursing mothers.

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. However, adverse effects of this medicine include visual disturbances such as blurred vision which could affect the ability to drive or use machines (see Section 4.8 Adverse Effects (Undesirable Effects)).

4.8 Adverse Effects (Undesirable Effects)

An itching or burning sensation may be experienced when using this medication.
Topical corticosteroids may cause adverse dermatological effects. Adverse dermatological effects are most likely to occur in intertriginous and facial areas. Local adverse corticosteroid effects occur most frequently with occlusive dressings, especially with prolonged therapy, and may require discontinuation of the dressings. Atrophy of the epidermis, subcutaneous tissue and dermal collagen; drying and cracking or tightening of the skin may occur. Epidermal thinning, telangiectasia, increased fragility of cutaneous blood vessels, purpura and atrophic striae are also reported.
Other adverse dermatologic effects of topical corticosteroids include acneiform eruption, vesiculation, irritation, pruritis, hypertrichosis, rosacea-like eruptions on the face, erythema, hyperaesthesia, perioral dermatitis, burning or stinging sensation, folliculitis, and hypopigmentation.
Adverse dermatological effects usually improve when the drug is discontinued but may persist for long periods; atrophic striae may be permanent. In addition to the other adverse dermatological effects of topical corticosteroid therapy, maceration of the skin and miliaria may occur, especially when occlusive dressings are used. Topically applied steroids are generally nonsensitising, but allergic contact dermatitis may occur rarely.
Topical corticosteroids should be used with caution in the management of psoriasis (see Section 4.4 Special Warnings and Precautions for Use).
Topical corticosteroids should also be used with caution in patients with impaired T cell function or in those patients receiving other immunosuppressive therapy. The result of this impairment may be the activation of latent infection or exacerbation of intercurrent infections (see Section 4.4 Special Warnings and Precautions for Use).
Any cardiovascular adverse events are unlikely with topical hydrocortisone therapy, however, prolonged prolific use may result in a transient hypertension as a result of fluid retention.
Long term corticosteroid use has resulted in benign intracranial hypertension, with most reports occurring in children.
Corticosteroids have documented effects on serum lipids, including increased total cholesterol, increased low density lipoproteins and increased triglyceride levels.
Topical and systemic corticosteroid therapy has been implicated in posterior subcapsular cataract formation, elevated intraocular pressure, optic nerve damage, papilloedema and blurred vision (see Section 4.4 Special Warnings and Precautions for Use).
Cataracts, although primarily reported with systemic corticosteroid use, have been reported with use of topical preparations.
Hydrocortisone has least potential for causing glaucoma, but reports have demonstrated this complication in patients using topical preparations on the face.

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.

4.9 Overdose

Acute ingestion or accidental poisoning, even in massive doses, is rarely a clinical problem. Treatment should be symptomatic and supportive. Excessive chronic exposure results in adverse systemic effects. In such cases the use of topical corticosteroid should be discontinued, with the consideration to tapering the dose. Emesis or activated charcoal is not usually indicated unless multiple ingestion is suspected. Support the patient as necessary and treat symptomatically.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

On topical application, corticosteroids 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. Corticosteroids decrease inflammation by stabilising leukocyte lysosomal membranes, preventing release of destructive acid hydrolyses from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and oedema formation; decreasing complement components; antagonizing 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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

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 dermo-epidermal layer (viable epidermis + dermis) and subsequently the systemic circulation.

Absorption.

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 of the epidermal barrier (e.g. psoriasis, eczema) may result in increased absorption. Hydrocortisone is absorbed to a greater degree from the skin behind and around the ear region, scrotum, axilla, eyelid, face and scalp than forearm, knees, 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 dermo-epidermal layer.

Distribution.

Corticosteroids are rapidly distributed to all body tissues. They cross the placenta and may be excreted in small amounts in breast milk. Corticosteroids in the circulation are bound to plasma proteins in varying degrees, mainly to globulin and less so to albumin.

Metabolism.

Hydrocortisone is metabolised in the liver and most tissues to biologically inactive compounds, mainly glucuronides and sulfates.

Excretion.

The metabolites are excreted in urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone. Some of the topical corticosteroids and their metabolites are also excreted in the bile.
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.

5.3 Preclinical Safety Data

Genotoxicity.

There is no reliable evidence of induction of mutagenicity in humans by hydrocortisone.

Carcinogenicity.

There is no reliable evidence of induction of carcinogenicity in humans by hydrocortisone.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hysoderm Cream contains the following excipients: white soft paraffin, liquid paraffin, cetomacrogol 1000, cetostearyl alcohol, chlorocresol, citric acid, sodium citrate dihydrate, purified water.

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

Hysoderm Cream 10 mg/g: hydrocortisone acetate 10 mg/g (1.0% w/w) cream, Epoxy-coated Al tube containing 30 g.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

Structural formula:
Chemical name: hydrocortisone: 17-hydroxycorticosterone or 11,17,21-Trihydroxypregn-4-ene-3,20-dione; hydrocortisone acetate: hydrocortisone 21-acetate.
Molecular formula: C23H32O6. Molecular weight: 404.5.

CAS number.

50-03-3.
Hydrocortisone acetate is an odourless, white or almost white, crystalline powder.
Solubility: Practically insoluble in water and in ether, soluble in ethanol (1 in 230) and in chloroform (1 in 200).

7 Medicine Schedule (Poisons Standard)

S3 (Pharmacist Only Medicine).

Summary Table of Changes