Consumer medicine information

Tricortone cream and ointment

Triamcinolone acetonide

BRAND INFORMATION

Brand name

Tricortone

Active ingredient

Triamcinolone acetonide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Tricortone cream and ointment.

SUMMARY CMI

TRICORTONE cream and ointment

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 TRICORTONE?

TRICORTONE contains the active ingredient triamcinolone acetonide. TRICORTONE is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems.

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

2. What should I know before I use TRICORTONE?

Do not use if you have ever had an allergic reaction to TRICORTONE 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 TRICORTONE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with TRICORTONE 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 TRICORTONE?

TRICORTONE is applied to the affected area three or four times daily.

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

5. What should I know while using TRICORTONE?

Things you should do
  • Remind any doctor or pharmacist you visit that you are using TRICORTONE
  • Tell your doctor if you feel that TRICORTONE is not helping your condition or you have not used it exactly as prescribed.
Things you should not do
  • Do not use TRICORTONE just before having a bath, shower or going swimming.
  • Do not use this medicine under dressings or on large areas of skin
  • Do not use TRICORTONE in or near the eyes.
Looking after your medicine
  • Store below 25°C. Do not refrigerate.

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

6. Are there any side effects?

All medicines can have side effects. If they do occur, they are usually minor and temporary. Do not be alarmed by this list. Rare side effects that require medical attention include itching or irritation, redness, rash, blister and inflammation under bandages or dressings if these are used and eye problems.

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

TRICORTONE cream and ointment

Active ingredient: triamcinolone acetonide


Consumer Medicine Information (CMI)

This leaflet provides important information about using TRICORTONE. 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 TRICORTONE.

Where to find information in this leaflet:

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

1. Why am I using TRICORTONE?

TRICORTONE contains the active ingredient triamcinolone acetonide. TRICORTONE is a type of cortisone and belongs to the group of medicines called corticosteroids. It is available as both a cream and an ointment.

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

  • psoriasis (a stubborn skin disorder with raised, rough, reddened areas covered with dry, fine silvery scales)
  • eczema (an often itchy skin condition with redness, swelling, oozing of fluid, crusting which may lead to scaling)
  • other types of skin disease (dermatitis)
  • itching on the anus or vulva
  • inflammation of the external part of the ear.

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

Your doctor may have prescribed this medicine for another purpose.

TRICORTONE is not addictive.

2. What should I know before I use TRICORTONE?

Warnings

Do not use TRICORTONE if:

  • you are allergic to triamcinolone acetonide or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • you have a viral skin infection (such as cold sores, shingles or chicken pox)
  • you have a fungal skin infection (such as thrush, tinea or ringworm)
  • you have tuberculosis of the skin.

Check with your doctor if you:

  • have any of these conditions.

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 if you are breastfeeding or intend to breastfeed.

Do not apply TRICORTONE 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 may interfere with TRICORTONE. You may need to use different amounts of your medicine or you may need to use different medicines. Your doctor will advise you.

4. How do I use TRICORTONE?

How much to use

TRICORTONE is applied to the affected area three or four times daily.

It is important to use TRICORTONE exactly as your doctor has told you.

If you use it less often than you should, it may not work as well and your skin problem may not improve. Using it more often than you should may not improve your skin problem any faster and may cause or increase side effects.

When to use TRICORTONE

TRICORTONE should be used at the same time every day.

How long to use TRICORTONE

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

  • do not use TRICORTONE for longer than your doctor tells you.
  • if you use TRICORTONE for longer than your doctor tells you, the chance of side effects may increase.

How to use TRICORTONE

  • smooth a little TRICORTONE on the problem area three or four times a day.
  • use just enough to cover the area without forcing or causing discomfort. Do not rub or stretch the skin.
  • if you are using TRICORTONE cream, use enough to disappear into the skin without leaving any on the skin.
  • if you are using TRICORTONE ointment, use enough for a fine layer over the affected area.
  • do not use on skin wounds where the skin is broken or open, unless your doctor tells you to.
  • wash your hands after using TRICORTONE. Be careful not to get TRICORTONE in your eyes. If you do, flush your eyes with water.
  • do not bandage or wrap the treated skin unless your doctor tells you to.

If you forget to use TRICORTONE

TRICORTONE should be used regularly at the same time each day.

If you have missed one application of TRICORTONE, use it as soon as you remember. If it is almost time for your next application, skip the dose you missed and apply it when you are next meant to.

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 TRICORTONE

If you think that you have used too much TRICORTONE, 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 TRICORTONE?

Things you should do

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

Tell your doctor:

  • if you feel that TRICORTONE is not helping your condition
  • if, for any reason, you have not used TRICORTONE exactly as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

  • if you become pregnant while using TRICORTONE, tell your doctor.

Things you should not do

Do not use TRICORTONE just before having a bath, shower or going swimming.

If you do, you may reduce the effectiveness of TRICORTONE.

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

Do not use TRICORTONE in or near the eyes.

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

Do not use it for other skin problems unless your doctor tells you to.

Things to be careful of

Do not use large amounts of TRICORTONE for a long time.

If you use large amounts for a long time, it may be absorbed through the skin and increase the chance of side effects.

Using too much TRICORTONE may cause thinning of the skin and stretch marks, especially on areas of thinner skin, such as the face, joint creases, groin and armpits.

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

Do not use TRICORTONE on skin areas that rub together such as under the arm or in the groin area unless your doctor tells you to.

Looking after your medicine

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

TRICORTONE ointment may become too hard to squeeze easily from the tube if it is too cold.

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.

Heat and dampness can destroy some medicines. Heat may cause TRICORTONE cream to break down and lose a watery liquid.

Do not refrigerate TRICORTONE.

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.

Less serious side effects

Less serious side effectsWhat to do
Skin:
  • Itching or irritation
  • Redness
  • Rash
  • Blisters and inflammation under bandages or dressings if these are used

These side effects are rare.

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
Eye problems:
  • For example, cataracts, glaucoma and blurred vision.
These side effects are rare.
Speak to your doctor if you have any of these less serious side effects and they worry you.

If TRICORTONE is used for too long the skin may become thin and weak or pigmented. Healing of the skin may be slower.

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 TRICORTONE contains

Active ingredient
(main ingredient)
Triamcinolone acetonide:
2 mg/g or 0.02% w/w
Other ingredients
(inactive ingredients)

TRICORTONE cream contains:

  • benzyl alcohol
  • emulsifying wax
  • isopropyl palmitate
  • glycerol
  • sorbitol solution (70% non-crystallising)
  • lactic acid
  • water-purified.

TRICORTONE ointment contains white soft paraffin.

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

What TRICORTONE looks like

TRICORTONE cream is a smooth, white opaque homogenous cream. It comes in a 100 g aluminium tube.

TRICORTONE ointment is an off-white, smooth, greasy ointment with a faint odour of paraffin. It comes in a 100 g aluminium tube.

Australian Registration Numbers:
TRICORTONE cream: AUST R 95811
TRICORTONE ointment: AUST R 95812

Who distributes TRICORTONE

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

This leaflet was prepared in February 2022.

Published by MIMS December 2022

BRAND INFORMATION

Brand name

Tricortone

Active ingredient

Triamcinolone acetonide

Schedule

S4

 

1 Name of Medicine

Triamcinolone acetonide.

2 Qualitative and Quantitative Composition

Tricortone cream and ointment contain 0.02% w/w triamcinolone acetonide.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tricortone cream is a soft, white, opaque homogeneous cream, free of visible contamination.
Tricortone ointment is an off-white, smooth, homogeneous, opaque ointment free of visible contamination.

4 Clinical Particulars

4.1 Therapeutic Indications

In the treatment of the following dermatoses: atopic dermatitis, eczematous dermatitis, nummular eczema, contact dermatitis, anal and vulval pruritus, otitis externa, seborrhoeic dermatitis, eczematised psoriasis, neurodermatitis.

4.2 Dose and Method of Administration

Apply in small quantities to the affected area three or four times daily. Some cases of eczematised psoriasis may be treated more effectively by the application of Tricortone under an occlusive nonpermeable dressing.

4.3 Contraindications

Tuberculosis of the skin, fungal infections and viral diseases of the skin (herpes simplex, chicken-pox and vaccinia).
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, Tricortone should be discontinued and alternative therapy instituted.
Prolonged and heavy doses of triamcinolone acetonide 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 hypothalamopituitary 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 nonspecific 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.
Generalised dermatological conditions may require systemic corticosteroid therapy.
It must be remembered that steroid therapy, although responsible for remissions of dermatoses, especially of allergic origin, cannot be expected to prevent recurrence.

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.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The drug interactions that can occur with triamcinolone acetonide are those that are common to corticosteroids. There are many potential drug interactions with corticosteroids, 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 triamcinolone acetonide.
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 triamcinolone acetonide and thus potentiate its anti-inflammatory effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
Like other corticoids, triamcinolone acetonide has demonstrated potent teratogenic effects in pregnant animals after inhalation, subcutaneous and intramuscular administration during organogenesis. Dose related teratogenic effects in rats and rabbits at ≥ 20 microgram/kg/day included cleft palate and/or internal hydrocephaly and axial skeletal defects, while teratogenic effects observed in monkeys at ≥ 500 microgram/kg/day were predominantly CNS and/or cranial malformations.
In vivo studies using pregnant animals have also shown that application of large amounts of topical corticosteroids over prolonged periods may cause fetal abnormalities. There are no adequate and well controlled studies in pregnant women. Therefore, topical corticosteroids should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus. These drugs should not be used on extensive areas, in large amounts or for prolonged periods in pregnant women. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
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)

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.
Local intolerance to the drug is rare, but may be manifested by itching and/or irritation at the site of application. Local intolerance may result from idiosyncrasy to other components.
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. Localised atrophy and striae have been reported with the use of steroids by the occlusive technique. 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, pupura and atrophic striae are also reported.
Other adverse dermatologic effects of topical corticosteroids include acneform eruption, vesiculation, irritation, pruritus, hypertrichosis, rosacea-like eruptions on the face, erythema, hyperthesia, 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.

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.

Triamcinolone is a corticosteroid with mainly glucocorticoid activity. The anti-inflammatory activity of 4 mg triamcinolone is equivalent to about 5 mg of prednisolone. 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 lysomal 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 triamcinolone acetonide 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 (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. Topical corticosteroids are 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 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.

Distribution.

Triamcinolone acetonide is reported to have a half-life in plasma of about 2 to over 5 hours. It is bound to plasma albumin to a much smaller extent than hydrocortisone.

Metabolism.

Triamcinolone acetonide is metabolised mainly in the liver and most tissues, and excreted in urine.

5.3 Preclinical Safety Data

Genotoxicity.

No genotoxicity studies have been conducted with triamcinolone acetonide.
Triamcinolone acetonide had no adverse effect on fertility in male or female rats given oral doses up to 15.0 microgram/kg/day. However, developmental toxicity, including increases in fetal resorptions and stillbirths, and decreases in pup body weight and survival occurred at oral doses ≥ 5.0 microgram/kg/day, with dystocia and prolonged delivery also observed at doses ≥ 8.0 microgram/kg/day.

Carcinogenicity.

Long term animal studies have not been performed to evaluate the carcinogenic potential of topical triamcinolone acetonide.
There was no evidence of drug related carcinogenicity in rats or mice given triamcinolone acetonide for 2 years at oral doses up to 1.0 microgram/kg/day, respectively. In another 2 year carcinogenicity study, rats given triamcinolone acetonide (4.8 microgram/kg/day) budesonide (50 microgram/kg/day) or prednisolone (368 microgram/kg/day) in the drinking water demonstrated an increased incidence of hepatic tumours for all three drugs. These tumours are likely to represent a class effect, potentially involving glucocorticoid receptors.

6 Pharmaceutical Particulars

6.1 List of Excipients

Tricortone cream contains the following excipients: emulsifying wax, isopropyl palmitate, glycerol, sorbitol solution (70 per cent)(non-crystallising), lactic acid, benzyl alcohol and purified water. Benzyl alcohol 2% w/w is used as a preservative.
Tricortone ointment contains the following excipients: white soft paraffin. Tricortone ointment does not contain lanolin, preservatives or colouring agents.

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

Tricortone cream: 100 g aluminium tube.
Tricortone ointment: 100 g aluminium tube.
(Note: Not all pack sizes may be marketed.)

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

Triamcinolone acetonide is a white or almost white, crystalline powder. Triamcinolone acetonide 11 mg is approximately equivalent to 10 mg of triamcinolone. Practically insoluble in water, sparingly soluble in alcohol, very slightly soluble in ether.
Triamcinolone is a corticosteroid and is chemically described as 9α-fluoro-11β,16α,17α,21- tetrahydroxypregna-1,4- diene-3,20-dione.
The molecular formula of triamcinolone acetonide is C24H31FO6 with a molecular weight of 434.5.

Chemical structure.


CAS number.

76-25-5.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes