Consumer medicine information

KENACORT-A 10

Triamcinolone acetonide

BRAND INFORMATION

Brand name

Kenacort-A 10 Suspension for injection

Active ingredient

Triamcinolone acetonide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using KENACORT-A 10.

What is in this leaflet

This leaflet answers some common questions about KENACORT-A 10. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking KENACORT-A 10 against the benefits they expect it will have for you.

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

Keep this leaflet.

You may need to read it again.

What Kenacort-A 10 is used for

KENACORT-A 10 is a synthetic corticosteroid containing triamcinolone acetonide as the active ingredient.

It is used to treat painful muscles, joints or tendons by injecting directly into the painful site.

KENACORT-A 10 can also be used to treat inflammatory skin lesions, psoriatic plaques & hair loss by injecting directly into the lesion or by sub-cutaneous injection.

KENACORT-A 10 suppresses inflammation and swelling and relieves pain. It does not cure the underlying problem.

Ask your doctor if you have any questions about why KENACORT-A 10 has been prescribed for you.

Your doctor may have prescribed it for another purpose.

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

KENACORT-A 10 is not suitable for intravenous, intramuscular or intraocular use. KENACORT-A 10 is not suitable for injection into the nasal turbinates or intralesional injection about the head.

KENACORT-A 10 is not recommended for use in children under the age of six.

KENACORT-A 10 is not for use in newborn or premature infants.

KENACORT-A 10 is a long-acting preparation and is not suitable for use in acute situations.

Before you are given it

When you must not be given it

Do not use KENACORT-A 10 if you have an allergy to triamcinolone acetonide or to any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include:

  • chills/fever
  • fast heart beat
  • difficulty in breathing shortness of breath
  • dizziness or light headed.

Do not give KENACORT-A 10 to children under the age of six.

Before you are given it

Tell your doctor if you have allergies to any other medicines or any other substances such as foods, preservatives or dyes.

Tell your doctor if you are allergic to benzyl alcohol.

KENACORT-A 10 contains benzyl alcohol as a preservative which has been associated with a condition called “gasping syndrome”. Premature and low weight infants, as well as patients receiving high doses may be more likely to develop toxicity.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • kidneys, liver, heart or eye problems
  • an active infection
  • tuberculosis
  • a tendency to bruise easily
  • existing emotional problems
  • bloody diarrhoea
  • digestive problems (e.g. ulcers)
  • diabetes
  • high blood pressure
  • imminent surgery
  • exposure to chicken pox or measles
  • respiratory problems.

Tell your doctor if you are pregnant or intend to become pregnant.

Like most medicines KENACORT-A 10 is not recommended for use during pregnancy. If there is a need to consider KENACORT-A 10 during your pregnancy, your doctor will discuss with you the benefits & risks of using it.

Tell your doctor if you are breast-feeding or plan to breast-feed.

If you have not told doctor about any of the above, tell them before you start being given KENACORT-A 10.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with KENACORT-A 10. These include:

  • aspirin
  • vaccines - in particularly smallpox vaccine.

These medicines may be affected by KENACORT-A 10, or affect how well it works. You may need different amounts of your medicines, or you may need to have different medicines. Your doctor will advise you.

Your doctor has more information on medicines to be careful with or avoid while you are using KENACORT-A 10.

How KENACORT-A 10 is given

How much is given

Your doctor will decide what dose and the number of treatments you will receive. This depends on your specific condition, how you react to this medicine and where the injection is given.

How is it given

KENACORT-A 10 is given by injection directly into the affected joint or tendon, or by intra-dermal injection into the lesion.

It should not be given intravenously, intramuscularly or intraocularly.

KENACORT-A 10 injection must only be given by a doctor.

Your doctor has the full information about the way KENACORT-A 10 should be given and can answer any questions that you might have.

How long it is given

If you are given KENACORT-A 10 injection over a long time, your doctor will check on how your body is responding. When long term use of the KENACORT-A 10 is to be stopped, it should be stopped gradually not suddenly.

KENACORT-A 10 is a long-acting preparation and is not suitable for use in acute situations.

If you are given too much (overdose)

As you will be given KENACORT-A 10 under the supervision of your doctor, it is unlikely that you will receive too much.

However, if you experience any side effects after being given it, immediately telephone your doctor or call the Poisons Information Centre (telephone 13 11 26) for advice.

Do this even if there are no signs of poisoning.

You may need urgent medical attention.

While you are using it

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you are being given KENACORT-A 10.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are being treated with this medicine.

Tell your doctor if you become pregnant while having KENACORT-A 10.

Things you must not do

After the injection, do not overuse the joint where the injection was given.

Rest the joint as much as possible for several weeks.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are having KENACORT-A 10.

Ask your doctor to answer any questions you may have.

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

  • pain
  • fluid retention
  • salt retention
  • changes in heart beat
  • sores
  • muscle weakness
  • tiredness
  • slow wound healing
  • sweating
  • headaches
  • irregular menstrual periods
  • stomach upsets
  • dizziness
  • convulsions
  • numbness
  • pins & needles
  • pain in arms or legs
  • insomnia
  • sore eyes
  • vision impairment or loss of vision.

These are the more common side effects of KENACORT-A 10.

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

  • serious heart problems
  • weakening of bones
  • stomach ulcers
  • glandular problems.

These are the less common side effects of KENACORT-A 10.

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

  • worsening psychiatric conditions
  • fracturing of bones
  • stopping of growth in children
  • damage to eyes
  • severe pain, and swelling around the injection site
  • wasting of muscles.

These side effects are rare.

Some side effects can only be detected by your doctor. When KENACORT-A 10 is taken for long periods of time and in high doses, it is important to visit your doctor regularly for check-ups.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed may 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

KENACORT-A 10 must be stored in a dark place below 30°C. It must be kept upright & must not be frozen.

Product description

What it looks like

KENACORT-A 10 is an opaque white suspension in a 1 mL glass vial. Available in packs of 5 vials.

Ingredients

Active:
Each 1 mL contains 10 mg of triamcinolone acetonide.

Inactive ingredients:

  • sodium chloride
  • benzyl alcohol
  • carmellose sodium
  • polysorbate 80
  • water for injections.

Sponsor

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

Australian Registration Number: AUST R 19204.

This leaflet was revised in July 2011.

BRAND INFORMATION

Brand name

Kenacort-A 10 Suspension for injection

Active ingredient

Triamcinolone acetonide

Schedule

S4

 

1 Name of Medicine

Triamcinolone acetonide.

2 Qualitative and Quantitative Composition

Each 1 mL of the sterile, aqueous suspension provides 10 mg of triamcinolone acetonide.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Kenacort-A 10 is a sterile, aqueous opaque white suspension. The pH is adjusted using sodium hydroxide and/or hydrochloric acid. At the time of manufacture, the air in the container is replaced by nitrogen. Kenacort-A 10 is suitable for intradermal, intra-articular and intrasynovial injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Intra-articular.

Kenacort-A 10 Injection is indicated for intra-articular or intrasynovial administration, and for injections into tendon sheaths, as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, post-traumatic osteoarthritis.

Intradermal.

Intralesional administration of Kenacort-A 10 Injection is indicated for the treatment of keloids, discoid lupus erythematosus, necrobiosis lipoidica diabeticorum, alopecia areata and localised hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). Kenacort-A 10 Injection also may be useful in cystic tumours of an aponeurosis or tendon (ganglia).

4.2 Dose and Method of Administration

This preparation contains benzyl alcohol. Not for use in newborn or premature infants (see Section 4.4, Paediatric use).

General.

The initial dose should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Kenacort-A 10 Injection should be discontinued and the patient transferred to other appropriate therapy. It should be emphasised that dosage requirements are variable and must be individualised on the basis of the disease under treatment and the response of the patient. After a favourable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Kenacort-A 10 Injection for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Dosage.

For intra-articular or intrabursal administration and for injection into tendon sheaths, the initial dose of Kenacort-A 10 Injection may vary from 2.5 to 5 mg for smaller joints and from 5 to 15 mg for larger joints depending on the specific disease entity being treated. Single injections into several joints for multiple locus involvement (up to a total of 20 mg) have been given without undue reactions.
For intradermal administration, the initial dose of triamcinolone acetonide will vary depending upon the specific disease entity being treated but should be limited to 1.0 mg (0.1 mL) per injection site, since larger volumes are more likely to produce cutaneous atrophy. Multiple sites (separated by one centimetre or more) may be so injected, keeping in mind that the greater the total volume employed, the more corticosteroid becomes available for possible systemic absorption and subsequent corticosteroid effects. Such injections may be repeated if necessary at weekly or less frequent intervals.
The lower dosages in the initial dosage range of triamcinolone acetonide may produce the desired effect when the corticosteroid is administered to provide a localised concentration. The site of the injection and the volume of the injection should be carefully considered when triamcinolone acetonide is administered for this purpose.

Administration.

Strict aseptic technique is mandatory.

General.

Shake the ampoule before use to ensure a uniform suspension. Prior to withdrawal, inspect the suspension for clumping or granular appearance (agglomeration). An agglomerated product results from exposure to freezing temperatures and should not be used. After withdrawal, inject without delay to prevent settling in the syringe. Careful technique should be employed to avoid the possibility of entering a blood vessel or introducing infection.
Ampoule is intended for single dose in one patient only. However, a single patient may require multiple sites to be injected into the affected area. If this is the case, the injections should be completed in a single session, and all product residue remaining in the ampoule(s) discarded.
Routine laboratory studies, such as urinalysis, two hour postprandial blood sugar, determination of blood pressure and bodyweight and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.

For treatment of joints.

The usual intra-articular injection technique, as described in standard textbooks should be followed. If an excessive amount of synovial fluid is present in the joint, some but not all should be aspirated to aid in the relief of pain and to prevent undue dilution of the corticosteroid.
With intra-articular or intrasynovial administration, and with injection of the drug into tendon sheaths, the use of a local anaesthetic may often be desirable. When a local anaesthetic is used, its package insert should be read with care and all the precautions connected with its use should be observed. It should be injected into the surrounding soft tissues prior to the injection of the corticosteroid. A small amount of the anaesthetic solution may be instilled into the joint.
In treating acute nonspecific tenosynovitis, care should be taken to ensure that the injection of the corticosteroid is made into the tendon sheath rather than the tendon substance. Epicondylitis (tennis elbow) may be treated by infiltrating the preparation into the area of the greatest tenderness.

For treatment of dermal lesions.

Kenacort-A 10 Injection is injected directly into the lesion, i.e. intradermally or sometimes subcutaneously. For accuracy of dosage measurement and ease of administration, it is preferable to employ a tuberculin syringe and a small bore needle (23 to 25 gauge). Ethyl chloride spray may be used to alleviate the discomfort of the injection.

4.3 Contraindications

Corticosteroids are contraindicated in patients with systemic infections. Kenacort-A 10 Injection is also contraindicated in patients with a sensitivity to the active or inactive ingredients.

4.4 Special Warnings and Precautions for Use

Because it is a suspension, the preparation should not be administered intravenously. Strict aseptic technique is mandatory. This preparation is not recommended for children under six years of age.
Kenacort-A 10 Injection is not recommended for extradural, epidural or any other route of administration which is not listed, see Section 4.1 Therapeutic Indications.
Adequate studies to demonstrate the safety of Kenacort-A 10 Injection by intraturbinal, subconjunctival, subtenons, retrobulbar, and intraocular (intravitreal) injection have not been performed. Endophthalmitis, eye inflammation, increased intraocular pressure and visual disturbances including vision loss have been reported with intravitreal administration. Several instances of blindness have been reported with intravitreal administration. Several instances of blindness have been reported following injection of corticosteroid suspensions into nasal turbinates and intralesional injection about the head. Administration of Kenacort-A 10 Injection by any of these routes is not recommended.
This product contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with serious adverse events and death, particularly in paediatric patients. The "gasping syndrome" has been associated with benzyl alcohol. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome", the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth-weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity.
When patients who are receiving corticosteroid therapy are subjected to unusual stress, increased dosage of rapidly acting corticosteroids is indicated before, during and after the stressful situation.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used. In addition, patients who are on immunosuppressant drugs including corticosteroids are more susceptible to infections than those not taking these drugs. Moreover, chickenpox and measles can have a more serious or even fatal course in patients on corticosteroids. In such children, or adults receiving corticosteroids who have had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox or herpes zoster develops, treatment with antiviral agents may be considered. Similarly, corticosteroids should be used with great caution in patients with Strongyloides (threadworm) infestation because corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
Kenacort-A 10 Injection is a long-acting preparation and is not suitable for use in acute situations.

Ocular effects.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Corticosteroid therapy has been associated with central serous chorioretinopathy, which may lead to retinal detachment.
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.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when they are used in large doses: dietary salt restriction and potassium supplementation may be necessary (see Section 4.4 Special Warnings and Precautions for Use). All corticosteroids increase calcium excretion, which may be associated with osteoporosis or aggravate preexisting osteoporosis.
Patients should not be vaccinated against smallpox while on corticosteroid therapy. Other immunisation procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.
The use of triamcinolone acetonide in patients with active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary since reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroids therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of death, primarily in preterm infants associated with exposure to excessive amounts of benzyl alcohol (see Section 4.4 Special Warnings and Precautions for Use).
Drug-induced secondary adrenocortical insufficiency may be minimised by a gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress (such as trauma, surgery, or severe illness) occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
There is an enhanced corticosteroid effect in patients with hypothyroidism and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
The lowest possible dose of corticosteroid should be used to control the condition being treated. A gradual reduction in dosage should be made when possible.
Psychic derangements may appear when corticosteroids are used. These may range from euphoria, insomnia, mood swings, personality changes and severe depression to frank psychotic manifestations. Existing emotional instability or psychotic tendencies may also be aggravated by corticosteroids. The use of antidepressant drugs does not relieve and may exacerbate adrenocorticoid-induced mental disturbances.
Corticosteroids should be used with caution in patients with nonspecific ulcerative colitis if there is a probability of impending perforation, abscess, or other pyogenic infection. Corticosteroids should also be used cautiously in patients with diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, acute glomerulonephritis, vaccinia, varicella, exanthema, Cushing's syndrome, antibiotic resistant infections, diabetes mellitus, congestive heart failure, chronic nephritis, thromboembolitic tendencies, thrombophlebitis, convulsive disorders, metastatic carcinoma, and myasthenia gravis.
Although therapy with Kenacort-A 10 Injection will ameliorate symptoms, it is in no sense a cure and the hormone has no effect on the cause of inflammation. Therefore, this method of treatment does not obviate the need for the conventional measures usually employed.
Intra-articular injection of a corticosteroid may produce systemic as well as local effects. The inadvertent injection of the suspension into the soft tissues surrounding a joint is not harmful, but may lead to the occurrence of systemic effects, and is the most common cause of failure to achieve the desired local results.
Following intra-articular steroid therapy, patients should be specifically warned to avoid overuse of joints in which symptomatic benefit has been obtained. Negligence in this matter may permit an increase in joint deterioration that will more than offset the beneficial effects of the steroid. To detect deterioration, follow-up X-ray examination is suggested in selected cases.
Overdistension of the joint capsule and deposition of steroid along the needle track should be avoided in intra-articular injection since this may lead to subcutaneous atrophy.
Corticosteroids should not be injected into unstable joints. Repeated intra-articular injection may in some cases result in instability of the joint. In selected cases, particularly when repeated injections are given, X-ray follow-up is suggested.
An increase in joint discomfort has seldom occurred. A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever and malaise are suggestive of a septic arthritis. If these complications should appear, and the diagnosis of septic arthritis is confirmed, administration of triamcinolone acetonide should be stopped and antimicrobial therapy should be instituted immediately and continued for 7 to 10 days after all evidence of infection has disappeared. Appropriate examination of any joint fluid present is necessary to exclude a septic process.
Local injection of a steroid into a previously infected joint is to be avoided. Repeated injection into inflamed tendons has been followed by tendon rupture. Therefore it should be avoided.
Kenacort-A 10 Injection should be administered only with full knowledge of characteristic activity of, and varied responses to, adrenocortical hormones. Like other potent corticosteroids, triamcinolone acetonide should be used under close clinical supervision. Triamcinolone acetonide can cause elevation of blood pressure, salt and water retention, and increased potassium and calcium excretion necessitating dietary salt restriction and potassium supplementation. Oedema may occur in the presence of renal disease with a fixed or decreased glomerular filtration rate.
During prolonged therapy, a liberal protein intake is essential for counteracting the tendency to gradual weight loss sometimes associated with negative nitrogen balance, wasting and weakness of skeletal muscles.
When local or systemic microbial infections are present, therapy with triamcinolone acetonide is not recommended, but may be employed with caution and only in conjunction with appropriate antibiotic or chemo therapeutic medication. Triamcinolone acetonide may mask signs of infection and enhance dissemination of the infecting organism. Hence, all patients receiving triamcinolone acetonide should be watched for evidence of intercurrent infection. Should infection occur, vigorous, appropriate anti-infective therapy should be initiated. If possible, abrupt cessation of steroids should be avoided because of the danger of superimposing adrenocortical insufficiency on the infectious process.
Menstrual irregularities may occur, and this possibility should be mentioned to female patients past menarche.
In peptic ulcer, recurrence may be asymptomatic until perforation or haemorrhage occurs. Long-term adrenocorticoid therapy may evoke hyperacidity or peptic ulcer; therefore, as a prophylactic measure, an ulcer regimen and the administration of an antacid are highly recommended. X-rays should be taken on peptic ulcer patients complaining of gastric distress, or when therapy is prolonged. Whether or not changes are observed, an ulcer regimen is recommended.
As with other corticosteroids, the possibility of other severe reactions should be considered. If such reactions should occur, appropriate corrective measures should be instituted and use of the drug discontinued.
Continued supervision of the patient after termination of triamcinolone acetonide therapy is essential, since there may be a sudden reappearance of severe manifestations of the disease for which the patient was treated.

Use in the elderly.

The common adverse effects of systemic corticosteroids such as osteoporosis or hypertension may be associated with more serious consequences in old age. Close clinical supervision is recommended.

Paediatric use.

Because corticosteroids can suppress growth, the development of infants and children on prolonged corticosteroid therapy should be carefully observed. Caution should be used in the event of exposure to chicken pox, measles or other communicable diseases. Children should not be vaccinated or immunised while on corticosteroid therapy (see Section 4.4 Special Warnings and Precautions for Use). Corticosteroids may also affect endogenous steroid production.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Amphotericin B injection and potassium depleting agents.

Patients should be observed for hypokalaemia.

Anticholinesterases.

Effects of the anticholinesterase agent may be antagonised.

Anticoagulants, oral.

Corticosteroids may potentiate or decrease anticoagulant action. Patients receiving oral anticoagulants and corticosteroids should be closely monitored.

Antidiabetics.

Corticosteroids may increase blood glucose; diabetic control should be monitored, especially when corticosteroids are initiated, or discontinued, or changed in dosage.

Antitubercular drugs.

Isoniazid serum concentrations may be decreased.

Cyclosporine.

Monitor for evidence of increased toxicity of cyclosporine when the two are used concurrently.

Digitalis glycosides.

Coadministration may enhance the possibility of digitalis toxicity.

Estrogens, including oral contraceptives.

Corticosteroid half-life and concentration may be increased and clearance decreased.

Hepatic enzyme inducers (e.g. barbiturates, phenytoin, carbamazepine, rifampin).

There may be increased metabolic clearance of Kenacort-A 10. Patients should be carefully observed for possible diminished effect of steroid, and the dosage of Kenacort-A 10 should be adjusted accordingly.

Human growth hormone (e.g. somatrem).

The growth promoting effect of somatrem may be inhibited.

Ketoconazole.

Corticosteroid clearance may be decreased, resulting in increased effects.

Nondepolarising muscle relaxants.

Corticosteroids may decrease or enhance the neuromuscular blocking action.

Nonsteroidal anti-inflammatory agents (NSAIDs).

Corticosteroids may increase the incidence and/or severity of GI bleeding and ulceration associated with NSAIDs. Also, corticosteroids can reduce serum salicylate levels and, therefore, decrease their effectiveness. Conversely, discontinuing corticosteroids during high dose salicylate therapy may result in salicylate toxicity. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.

Thyroid drugs.

Metabolic clearance of adrenocorticoids is decreased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in adrenocorticoid drugs.

Vaccines.

Neurological complications and lack of antibody response may occur when patients taking corticosteroids are vaccinated (see Section 4.4 Special Warnings and Precautions for Use).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Many corticosteroids have been shown to be teratogenic in laboratory animals at low doses. Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy: nursing mothers or women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and the embryo, foetus or nursing infant. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
No data available.

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.

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.

Following administration by any route.

Since systemic absorption may occasionally occur with intra-articular or other local administration, patients should be watched closely for the following adverse reactions which may be associated with any corticosteroid therapy:

General.

Anaphylactoid reactions; aggravation or masking of infections.

Cardiovascular.

Hypertension, syncope, congestive heart failure, arrhythmias, necrotising angiitis, thromboembolism, thrombophlebitis.

Fluid and electrolyte disturbances.

Sodium retention, fluid retention associated with hypertension and congestive heart failure, potassium loss, cardiac arrhythmias or ECG changes due to potassium deficiency, hypokalaemic alkalosis and hypertension.

Musculoskeletal.

Muscle weakness, fatigue, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, delayed healing of fractures, aseptic necrosis of femoral and humeral heads, pathologic fractures of long bones and spontaneous fractures.

Gastrointestinal.

Peptic ulcer with possible subsequent perforation and haemorrhage, pancreatitis, abdominal distension and ulcerative esophagitis.

Dermatological.

Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, purpura, striae, hirsutism, acneiform eruptions, lupus erythematosus-like lesions, hives, rash and suppressed reactions to skin tests.

Neurological.

Convulsions, increased intracranial pressure with papilloedema (pseudotumour cerebri) usually after treatment, vertigo, headache, neuritis, paraesthesias, aggravation of pre-existing psychiatric conditions, depression (sometimes severe), euphoria, mood swings, psychotic symptoms and personality changes.

Endocrine.

Menstrual irregularities, development of the cushingoid state, suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness particularly in times of stress (e.g. trauma, surgery or illness), decreased carbohydrate tolerance, manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycaemic agents in diabetes.

Ophthalmic.

Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos and blurred vision (see Section 4.4 Special Warnings and Precautions for Use).

Metabolic.

Hyperglycaemia, glycosuria, and negative nitrogen balance due to protein catabolism.

Others.

Necrotising angiitis, thrombophlebitis, thromboembolism, aggravation or masking of infections, insomnia, syncopal episodes and anaphylactoid reactions.

Following intra-articular administration.

Undesirable reactions have included postinjection flare, transient pain, occasional irritation at the injection site, sterile abscess formation, hyperpigmentation and hypopigmentation, Charcot-like arthropathy and occasional brief increase in joint discomfort.

Following intradermal administration.

Rare instances of blindness associated with intralesional therapy around the face and head, transient local discomfort, sterile abscesses, hyperpigmentation and hypopigmentation, and subcutaneous and cutaneous atrophy (which usually disappears, unless the basic disease process is itself atrophic) have occurred.

4.9 Overdose

Chronic.

The symptoms of glucocorticoid overdose may include confusion, anxiety, depression, gastrointestinal cramping or bleeding, ecchymosis, moon face and hypertension. After long-term use, rapid withdrawal can result in acute adrenal insufficiency (which also may occur in times of stress). Cushingoid changes can result from continued use of large doses.

Acute.

There is no specific treatment for overdose, but supportive therapy should be instituted and, if gastrointestinal bleeding occurs, it should be managed.
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.

Kenacort-A 10 Injection provides a synthetic glucocorticoid corticosteroid with marked antiinflammatory action.
This formulation is not suitable for intravenous, intramuscular or intraocular use.
Naturally occurring glucocorticoids (hydrocortisone), which also have salt retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogues are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each 1 mL of the sterile, aqueous suspension contains the following excipients: 6.6 mg sodium chloride for isotonicity, 15 mg benzyl alcohol as a preservative, 6.4 mg carmellose sodium, 0.4 mg polysorbate 80 and water for injections qs to 1 mL.

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 30°C. Avoid freezing. Store upright. Protect from light.

6.5 Nature and Contents of Container

1 mL glass ampoule. 5 ampoules per pack.

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

The chemical name for triamcinolone acetonide is 9-fluoro-11β, 16α, 17, 21-terahydroxypregna- 1,4-diene-3, 20-dione cyclic 16, 17-acetal with acetone.

Chemical structure.


CAS number.

76-25-5.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes