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.

What is in this leaflet

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

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

Ask your doctor or pharmacist if you have any concerns about this medicine.

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

What Tricortone is used for

Tricortone contains the active ingredient triamcinolone acetonide (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 it for another purpose.

Tricortone is not addictive.

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

Before you use it

When you must not use it

Do not use Tricortone if:

  1. you have an allergy to:
  • triamcinolone acetonide
  • any of the ingredients listed at the end of this leaflet.
  1. you have a viral skin infection (such as cold sores, shingles or chicken pox)
  2. you have a fungal skin infection (such as thrush, tinea or ringworm)
  3. tuberculosis of the skin
  4. you have impaired circulation.

Do not use Tricortone if the packaging is torn or shows signs of tampering.

Do not use it if the expiry date (EXP) printed on the pack has passed.

If you are not sure whether you should start using Tricortone, contact your doctor.

Before you start to use it

Tell your doctor if:

  1. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
  2. you are pregnant or plan to become pregnant
Your doctor will discuss the risks and benefits of using Tricortone when pregnant.
  1. you are breast-feeding or plan to breast-feed
Your doctor will discuss the risks and benefits of using Tricortone when breast-feeding.

Do not apply Tricortone to the breasts before breast-feeding.

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

Using other medicines

Tell your doctor 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 Tricortone. You may need to use different amounts of your medicine, or you may need to use different medicines. Your doctor will advise you.

How to use it

Follow all directions given to you by your doctor and pharmacist carefully. These directions may differ from the information contained in this leaflet.

How much to use

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

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.

Wash your hands after using Tricortone.

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.

How long to use it

Your doctor will tell you how long to use Tricortone.

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

If you forget to use it

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 swallow it

Telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have swallowed Tricortone. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using it

Things you must do

Avoid contact with eyes. Tricortone cream and ointment is for external use only.

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

Tell your doctor 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.

Tell your doctor if you become pregnant while using Tricortone.

Things you must not do

Do not use Tricortone just before having a bath, shower or going swimming. If you do, the effectiveness may be reduced.

Do not use Tricortone 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 this medicine to anyone else, even if they have the same symptoms as yours.

Do not use Tricortone for any 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. Ask your doctor if you are concerned about the length of time you have been using Tricortone. 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 of this medicine may cause thinning of the skin and stretch marks, especially on areas of thinner skin, such as the face, joint creases, groin and armpits.

Do not use on skin wounds where the skin is broken or open, unless your doctor tells you to.

Be careful not to get it in your eyes. If you do, flush your eyes with water.

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

Do not bandage or wrap the treated skin unless your doctor tells you to.

Side effects

Tell your doctor if you do not feel well while you are using Tricortone.

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

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

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

Tell your doctor if you notice any of the following and they worry you:

  • itching or irritation
  • redness
  • rash
  • blisters and inflammation under bandages or dressings if these are used
  • eye problems e.g. cataracts, glaucoma and blurred vision.

These side effects are rare.

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 if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some patients.

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

After using it

Storage

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.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines. Heat may cause Tricortone cream to break down and become watery.

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.

Disposal

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

Product description

What it looks like

Tricortone cream is a smooth, white opaque cream. It is packed in a 100 g aluminium tube.

Tricortone ointment is a smooth, off-white, greasy substance with a faint odour of paraffin. It is packed in a 100 g aluminium tube.

Ingredients

Active ingredient:

Tricortone cream and ointment contains 2 mg/g (or 0.02% w/w) triamcinolone acetonide.

Inactive ingredients:

Tricortone cream also contains:

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

Tricortone ointment also contains:

  • white soft paraffin.

Tricortone ointment does not contain lanolin, preservatives or colouring agents.

Sponsor

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

Australian Registration Numbers:

Tricortone cream: AUST R 95811

Tricortone ointment: AUST R 95812

This information was revised in September 2019.

Published by MIMS October 2019

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