Consumer medicine information

Kenalog in Orabase

Triamcinolone acetonide

BRAND INFORMATION

Brand name

Kenalog in Orabase Paste

Active ingredient

Triamcinolone acetonide

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Kenalog in Orabase.

What is in this leaflet

Read this leaflet carefully before using Kenalog in Orabase.

This leaflet answers some common questions about this medicine. It does not contain all the available information. Some of the information in this leaflet may not apply to you. It does not take the place of talking to your doctor, dentist or pharmacist.

Do not throw this leaflet away. You may need to read it again later.

Always follow the instructions that your doctor, dentist or pharmacist gives you about Kenalog in Orabase.

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

What Kenalog in Orabase is used for

Kenalog in Orabase is a paste that contains the medicine triamcinolone acetonide. Triamcinolone acetonide belongs to a class of drugs known as corticosteroids. Corticosteroids, including triamcinolone acetonide, are used to relieve itching, burning, inflammation and allergies.

Kenalog in Orabase is used for relieving tenderness, pain, inflammation and ulceration of the inside of the mouth or the gums. This can include sores caused by injury or by dentures (false teeth)

rubbing on the gums. Kenalog in Orabase is a sticky paste which keeps the medicine on the sore area, and protects it while the medicine relieves the soreness, reduces the swelling and accelerates the healing process.

Kenalog in Orabase is not addictive or habit forming. It may be prescribed by your doctor or bought at a pharmacy when recommended by your dentist or pharmacist.

Before you use it

When you must not use it

Do not use Kenalog in Orabase if you have an allergy to triamcinolone acetonide or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction to triamcinolone acetonide may include:

  • Shortness of breath, wheezing, or difficulty breathing
  • Swelling of the face, lips, tongue or other parts of the body
  • Rash, itching or hives on the skin

You should not use Kenalog in Orabase if you are pregnant or may become pregnant, unless you have discussed this with a doctor first.

Your doctor will advise you if you should use Kenalog in Orabase.

You should not use this medicine if you have an infection in your mouth, or if you have tuberculosis, stomach ulcers or diabetes.

If you think that the packaging is faulty or has been tampered with, do not use it and show it to your pharmacist.

Before you start to use it

Tell your doctor, dentist or pharmacist if you:

  • are pregnant or may become pregnant
  • are allergic to any food or drugs
  • have any infections in the mouth or throat, especially herpes (cold sores)
  • have tuberculosis (TB), stomach ulcers or diabetes
  • take any other medications or drugs

Taking other medicines

It is unlikely that other medicines will affect the way Kenalog in Orabase works. Nevertheless, you should always tell your doctor, dentist or pharmacist about other medicines you are taking, even if those medicines have been bought without a prescription.

How to use it

Where to use it

Kenalog in Orabase is only for use in your mouth.

You should not swallow this medicine.

You should not put it in your eyes.

How to use it

You should press a small dab (about the size of a five cent coin) onto the sore area in your mouth until a thin film develops. You may need to use a little more if the sore is large. For the best results, use only enough to coat the sore with a thin film. Do not rub it in. Do not attempt to spread the paste, as it might cause a gritty sensation in the mouth, and cause the paste to crumble. After applying it correctly, a smooth, slippery film should develop.

When to use it

Apply the preparation at bedtime, to allow the medication to work overnight. Sometimes it may be necessary to apply the preparation two or three times a day, preferably after meals.

If you forget to use Kenalog in Orabase

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Do not use a double dose to make up for the dose that you missed.

How long to use it

Use Kenalog in Orabase until all symptoms have resolved or for as long as your doctor, pharmacist or dentist tells you to.

If you take too much (overdose)

Telephone a doctor or Poisons Information Centre (phone 13 11 26) or go to the accident and emergency centre at your nearest hospital immediately if anyone swallows a large quantity of Kenalog in Orabase.

While you are using it

Things you must do

You must tell your doctor if you become pregnant while you are using Kenalog in Orabase.

You should stop using this medicine if the condition for which you have been using it is getting worse, or if you feel any weakness or dizziness while using it. Speak to your doctor or pharmacist if you notice any of these things.

Wipe the neck of the tube and replace the cap tightly after use.

Things you must not do

You should not swallow Kenalog in Orabase.

You should not put it in your eyes.

The expiry date is marked on its packaging. Do not use Kenalog in Orabase after this date.

Things to be careful of

Be careful driving or operating machinery until you know how this medicine affects you.

Side effects

All medications can sometimes cause unwanted effects. Side effects of Kenalog in Orabase are extremely rare, and usually only occur where the paste is being applied.

The side effects that may occur are: worsening of sores inside the mouth; new patches of irritation or sensitivity inside the mouth; weakness or dizziness.

If corticosteroids are used for long periods during pregnancy, the mother may develop fluid retention or the baby may be affected. However, these effects occur very rarely and usually with much higher doses of corticosteroids than the triamcinolone acetonide in Kenalog in Orabase.

If you have any of these side effects or any other problem which worries you while you are using this medicine, tell a doctor as soon as possible.

After using it

Storage

Keep it in a cool, dry place where the temperature stays below 25 degrees C.

Do not store it in the bathroom or near a sink. Do not leave it in the car on hot days or on window sills.

Heat and dampness can destroy some medicines.

Keep all medicines out of reach of children.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor, pharmacist or dentist tells you to stop using Kenalog in Orabase, or if the ointment has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

Kenalog in Orabase is an off-white sticky paste.

Ingredients

Active ingredient:
0.1% triamcinolone acetonide

Other ingredients:
"Orabase" which contains gelatin, pectin, carmellose sodium, liquid paraffin and polyethylene resin.

Distributor & Sponsor

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

Registration Number:

AUST R 19205

This leaflet was revised in May 2012

BRAND INFORMATION

Brand name

Kenalog in Orabase Paste

Active ingredient

Triamcinolone acetonide

Schedule

S3

 

Name of the medicine

Triamcinolone acetonide.

Excipients.

Emollient dental paste containing gelatin, pectin and sodium carboxymethylcellulose in Plastibase (plasticised hydrocarbon gel), a polyethylene and mineral oil gel base.

Actions

Kenalog is a corticosteroid with anti-inflammatory, antipruritic and antiallergic action, which may provide prompt relief of oral tenderness, pain, inflammation and ulceration. The emollient dental paste is an adhesive vehicle for applying medication to the oral surfaces. This adhesive maintains the medication in close contact with the lesion and provides a protective covering which augments the effects of the steroid.

Indications

Acute and chronic lesions of the oral mucosa including recurrent ulcerative aphthous stomatitis; erosive lichen planus; denture stomatitis; traumatic lesions including denture sore spots; desquamative gingivitis and stomatitis. Lesions of traumatic origin and most nonrecurring conditions heal rapidly and permanently. Chronic and recurrent lesions are promptly relieved, but symptoms usually recur after termination of therapy. However, Kenalog in Orabase is effective in suppressing subsequent recurrences.

Contraindications

Patients with a history of hypersensitivity to any of its components. Because it contains a corticosteroid, it is contraindicated in the presence of fungal or bacterial infections of the mouth or throat. It should not be used in herpetic lesions of known viral origin such as herpes labialis, or intraoral lesions such as primary herpetic gingival stomatitis and herpanginas.

Warnings

Use in pregnancy.

(Category C)
Safe use of this preparation during pregnancy has not been established with respect to possible adverse reactions upon fetal development. Use during pregnancy is not recommended unless the physician or dentist feels that the benefits outweigh the risks.
In animal experiments, corticosteroids have been found to cause malformations of various kinds (cleft palate, skeletal malformations) and abortion. These findings do not seem to be relevant to humans. Reduced placental and birthweight have been recorded in animals and humans after long-term treatment. Since the possibility of suppression of the adrenal cortex in the newborn baby after long-term treatment must be considered, the needs of the mother must be carefully weighed against the risk to the fetus when prescribing these drugs. The short-term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk for the newborn infant. Maternal pulmonary oedema has been reported wih tocolysis and fluid overload.

Precautions

The small amount of steroid released when the preparation is used as recommended makes systemic effects very unlikely; however they are a possibility when topical corticosteroid preparations are used over a long period of time, and any unusual symptoms such as weakness or dizziness should be called to the physician's attention by the patient.
If local irritation or sensitisation should develop, the preparation should be discontinued and appropriate therapy instituted.
Patients with tuberculosis, peptic ulcer or diabetes mellitus should not be treated with any corticosteroid preparation without the advice of the patient's physician.
It should be borne in mind that the normal defensive responses of the oral tissues are depressed in patients receiving topical corticosteroid therapy. Virulent strains of oral microorganisms may multiply without producing the usual warning symptoms of oral infections.
If significant regeneration or repair of oral tissues has not occurred in seven days, additional investigation into the oral lesions is advised.

Adverse Effects

Intolerance to the preparation is extremely rare. No topical reactions to the corticosteroid have been observed with intraoral application.
Prolonged administration may elicit the adverse reactions known to occur with systemic steroid preparations, for example adrenal suppression, alteration of glucose metabolism, protein catabolism, peptic ulcer activation and others.
These are usually reversible and disappear when the hormone is discontinued.

Directions For Use

Press a small dab (about 1 cm) to the lesion until a thin film develops. A larger quantity may be required for coverage of some lesions. For optimal results use only enough to coat the lesion with a thin film. Do not rub in. Attempting to spread this preparation may result in a granular, gritty sensation and cause it to crumble. After application, however, a smooth, slippery film develops.
The preparation should be applied at bedtime to permit steroid contact with the lesion throughout the night. Depending on the severity of symptoms, it may be necessary to apply the preparation two or three times a day, preferably after meals.

Presentation

Paste, 0.1%: 5 g (tube, AUST R 19205).

Storage

Store below 25°C.

Poison Schedule

S3.