TRICORTONE 0.02% OINTMENT triamcinolone acetonide 0.2mg/g tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

triamcinolone acetonide, Quantity: 0.2 mg/g

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Triamcinolone acetonide

Pharmaceutical form:

Ointment

Composition:

Excipient Ingredients: white soft paraffin

Administration route:

Topical

Units in package:

100g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 22 October 1998: In the treatment of the following dermatoses: atopic dermatitis, eczematous dermatitis, nummular eczema, contact dermatitis, anal and vulval pruritus, otitis externa, seborrhoeic dermatitis, exzematised psoriasis, neurodermatitis.

Product summary:

Visual Identification: Off-white, smooth , homogeneous, opaque ointment, free of visible contamination.; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2003-07-30

Patient Information leaflet

TRICORTONE
1
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

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
TRICORTONE (TRIAMCINOLONE ACETONIDE)
CREAM AND OINTMENT
1
NAME OF THE 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
T
HERAPEUTIC 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
D
OSE 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
C
ONTRAINDICATIONS
•
Tuberculosis of the skin, fungal infections and viral diseases of the
skin (Herpes simplex,
chicken-pox and baccinia).
•
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
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
2
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 antibac