Consumer medicine information

Sigmacort 1% cream and ointment

Hydrocortisone acetate

BRAND INFORMATION

Brand name

Sigmacort

Active ingredient

Hydrocortisone acetate

Schedule

S4 | S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sigmacort 1% cream and ointment.

What is in this leaflet

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

All medicines have risks and benefits. Your doctor has weighed the risks of using SIGMACORT 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 your medicine. You may need to read it again.

What is SIGMACORT

The name of your medicine is SIGMACORT. It contains the active ingredient called hydrocortisone acetate.

It is available as a cream and an ointment.

SIGMACORT is a type of cortisone and belongs to the group of medicines called corticosteroids.

It is a topical corticosteroid therapy for non-infective inflammatory conditions of the skin e.g. eczema, dermatitis. It is used to relieve the redness, swelling, itching and other discomforts of the skin.

Your doctor however, may have prescribed SIGMACORT for another purpose.

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

A doctor's prescription is required for the 50 gram tube of SIGMACORT cream or ointment.

The 30 gram tube can be purchased without a doctor’s prescription.

Before you use it

When you must not use it

Do not use SIGMACORT if you have ever had an allergic reaction to:

  • SIGMACORT or hydrocortisone acetate.
  • Any of the ingredients in SIGMACORT listed at the end of this leaflet.

Do not use SIGMACORT if you have:

  • A viral skin infection (such as herpes simplex, cold sores, shingles or chicken pox)
  • A fungal skin infection (such as thrush, tinea or ringworm)
  • Tuberculous condition of the skin
  • Vaccinia (cowpox: a viral disease passed from cattle)
  • Varicella (a rare form of chicken pox).

SIGMACORT should not be used if you suffer from poor circulation of blood in the skin region, as it may result in skin ulcers.

Occlusive dressings should not be used if you have a skin infection.

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

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

Before you start to use it

You must tell your doctor if:

  • You are allergic to any other medicines, foods, dyes or preservatives.
  • You have any other health problems
  • You are pregnant or breast-feeding.

Do not apply SIGMACORT to the breast before breast- feeding.

Using other medicines

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

Some medicines may interfere with SIGMACORT if it is used excessively or for prolonged periods.

Your doctor or pharmacist has a list of medicines that may interfere with SIGMACORT.

If you have not told your doctor about any of the above, tell them before you start using SIGMACORT.

Use in Children

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

How to use it

How to use it

Apply a thin smear to affected areas two to four times a day or as directed.

Occlusive dressings are not necessary unless advised by your doctor.

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

If you use it less 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 SIGMACORT at the same time every day.

How long to use it

Your doctor or pharmacist will tell you how long to use SIGMACORT.

Reduce the number of applications as the disorder subsides.

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

If you forget to use it

If you forget to use SIGMACORT, use it as soon as you remember and then go back to your normal times for application.

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

If you swallow it

Telephone your doctor or the Poisons Information Centre (phone 13 11 26) for advice or go to the Accident and Emergency Centre at your nearest hospital immediately if you or anyone you know swallows SIGMACORT.

While you are using it

Things you must do

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

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

Tell your doctor if, for any reason, you have not used SIGMACORT exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you become pregnant while using SIGMACORT.

Things you must not do

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

Do not use it in or near the eyes.

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

Do not use SIGMACORT to treat other conditions unless your doctor tells you. Your doctor has prescribed SIGMACORT 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 SIGMACORT 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 this medicine.

Only use SIGMACORT 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 SIGMACORT.

This medicine 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 SIGMACORT include:

  • itching
  • burning
  • dryness
  • acne-form eruptions.

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
  • eye problems e.g. cataracts, glaucoma and blurred vision.

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 it

Storage

Keep your medicine 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 SIGMACORT in a cool dry place where the temperature stays below 25°C.

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

Disposal

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

Product description

What it looks like

SIGMACORT cream is a soft white cream with faint odour of chlorocresol.

SIGMACORT ointment is a soft, yellowish-white ointment with a faint odour of paraffin and lanolin.

Both SIGMACORT cream and ointment are packed in 30 g and 50 g tubes.

Ingredients

Hydrocortisone acetate (microfined) 1% or 10 mg/g is the active ingredient in both SIGMACORT cream and ointment.

Inactive Ingredients

SIGMACORT cream:

  • white soft paraffin
  • liquid paraffin
  • cetomacrogol 1000
  • cetostearyl alcohol
  • chlorocresol (preservative)
  • purified water.

SIGMACORT ointment:

  • white soft paraffin
  • hard paraffin
  • liquid paraffin
  • wool fat.

SIGMACORT ointment is preservative free.

The Australian Product Registration numbers are:

SIGMACORT cream: AUST R 19778

SIGMACORT ointment: AUST R 19779.

Sponsor

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

This leaflet was revised in September 2019.

Published by MIMS December 2019

BRAND INFORMATION

Brand name

Sigmacort

Active ingredient

Hydrocortisone acetate

Schedule

S4 | S3

 

1 Name of Medicine

Hydrocortisone acetate.

6.7 Physicochemical Properties

Hydrocortisone acetate is an odourless, white or almost white, crystalline powder. Hydrocortisone acetate 112 mg is approximately equivalent to 100 mg of hydrocortisone. Practically insoluble in water and in ether, soluble in ethanol (1 in 230) and in chloroform (1 in 200).
Hydrocortisone is a corticosteroid and is chemically described as 17-hydroxycorticosterone or 11β, 17, 21-Trihydroxypregn-4-ene-3,20-dione. Hydrocortisone acetate is chemically described as hydrocortisone 21-acetate.
The molecular formula of hydrocortisone acetate is C23H32O6 with a molecular weight of 404.5.

Chemical structure.


CAS number.

50-03-3.

2 Qualitative and Quantitative Composition

Sigmacort 1% cream contains 10 mg/g (1.0% w/w) microfine hydrocortisone acetate in a water miscible, lanolin free cetomacrogol base.
Sigmacort 1% ointment contains 10 mg/g (1.0% w/w) microfine hydrocortisone acetate in a paraffin base.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sigmacort 1% cream is a soft white cream with an odour faintly of chlorocresol.
Sigmacort 1% ointment is a soft, yellowish white ointment with a faint odour of paraffin and lanolin.

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

Absorption.

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 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.
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.

Metabolism.

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

Excretion.

These 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.

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.

4 Clinical Particulars

4.1 Therapeutic Indications

Topical corticosteroid therapy for non-infective inflammatory conditions of the skin e.g. eczema, dermatitis.

4.3 Contraindications

Tuberculous and fungal conditions of the skin, acute Herpes simplex, vaccinia, varicella and all viral infections.
Hypersensitivity to any component of the cream or ointment.
Not to be used in the eye.
Topical steroids should not be used in patients with markedly impaired circulation since skin ulceration has occurred in these patients following the use of corticosteroids.
Topical steroid should be used with caution and occlusive dressings should not be used in patients with primary skin infections.

4.4 Special Warnings and Precautions for Use

For external use only. Avoid contact with eyes.
If irritation develops, Sigmacort 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 diapers 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 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.

Use in the elderly.

No data available.

Paediatric use.

Long term therapy in infants should be avoided as adrenal suppression may occur.

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.

No data available.
(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.

4.8 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.
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, pruritus, 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.

4.2 Dose and Method of Administration

Apply a thin smear to affected areas 2 - 4 times daily. Reduce the number of applications as the disorder subsides. Occlusive dressings are not necessary unless advised by your doctor.

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)).

4.9 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).

7 Medicine Schedule (Poisons Standard)

30 g: S3; 50 g: S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sigmacort 1% cream contains white soft paraffin, liquid paraffin, cetomacrogol 1000, cetostearyl alcohol, chlorocresol and purified water. Chlorocresol 0.1% w/w is used as a preservative.
Sigmacort 1% ointment contains white soft paraffin, hard paraffin, liquid paraffin and wool fat. Sigmacort ointment is preservative free.

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

Sigmacort 1% cream.

30 g and 50 g aluminium tubes with white plastic screw cap.

Sigmacort 1% ointment.

30 g and 50 g aluminium tubes.

6.6 Special Precautions for Disposal

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

Summary Table of Changes