KENALOG INTRA-ARTICULAR/INTRAMUSCULAR INJECTION 40MG/ML

Active substance: TRIAMCINOLONE ACETONIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Kenalog Intra-articular / Intramuscular Injection 40mg/ml

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Kenalog Intra-articular / Intramuscular Injection contains triamcinolone
acetonide 40mg per ml of sterile suspension.

3.

PHARMACEUTICAL FORM
Sterile aqueous suspension for injection.

4.

CLINICAL PARTICULARS

4.1

Therapeutic Indications
Intra-articular use: for alleviating the joint pain, swelling and stiffness
associated with rheumatoid arthritis and osteoarthrosis, with an inflammatory
component; also for bursitis, epicondylitis, and tenosynovitis.
Intramuscular use: Where sustained systemic corticosteroid treatment is
required: Allergic states, e.g. bronchial asthma, seasonal or perennial allergic
rhinitis. In seasonal allergies, patients who do not respond to conventional
therapy may achieve a remission of symptoms over the entire period with a
single intramuscular injection (see Dosage); Endocrine disorders, e.g. primary
or secondary adrenocortical insufficiency. Collagen disorders, e.g. during an
exacerbation of maintenance therapy of selected cases of SLE or acute
rheumatic carditis; Dermatological diseases, e.g. pemphigus, severe
dermatitis and Stevens Johnson Syndrome; Rheumatic, Gastrointestinal or
Respiratory disorders - as an adjunctive, short-term therapy; Haematological
disorders, e.g. acquired (autoimmune) haemolytic anaemia; Neoplastic
diseases, e.g. palliative management of leukaemia and lymphomas; Renal
disease, such as acute interstitial nephritis, minimal change nephrotic
syndrome or lupus nephritis.

4.2

Posology and Method of Administration

Kenalog is for Intra-articular/Intramuscular injection ONLY. The safety and
efficacy of administration by other routes has yet to be established (See
sections 4.3 and 4.4). Strict aseptic precautions should be observed. Since
the duration of effect is variable, subsequent doses should be given when
symptoms recur and not at set intervals.
Intra-Articular Injection: For intra-articular administration or injection into
tendon sheaths and bursae, the dose of Kenalog Injection may vary from 5mg
to 10mg (0.125 - 0.25ml) for smaller joints and up to 40mg (1.0ml) for larger
joints, depending on the specific disease entity being treated. Single injections
into several sites for multiple joint involvement, up to a total of 80mg, have
been given without undue reactions.
It is recommended that, when injections are given into the sheaths of short
tendons, Adcortyl Injection (triamcinolone acetonide 10mg/ml) should be
used. (See under Precautions, re Achilles tendon).
Intramuscular Injection: To avoid the danger of subcutaneous fat atrophy, it
is important to ensure that deep intramuscular injection is given into the
gluteal site. The deltoid should not be used. Alternate sides should be used
for subsequent injections.
Adults and Children over 12 Years:
The suggested initial dose is 40mg
(1.0ml) injected deeply into the upper, outer quadrant of the gluteal muscle.
Subsequent dosage depends on the patient's response and period of relief.
Patients with hay fever or pollen asthma who do not respond to conventional
therapy may obtain a remission of symptoms lasting throughout the pollen
season after a single dose of 40-100mg given when allergic symptoms appear.
(See Warnings and Precautions.)
Elderly: Treatment of elderly patients, particularly if long term, should be
planned bearing in mind the more serious consequences of the common side
effects of corticosteroids in old age, especially osteoporosis, diabetes,
hypertension, susceptibility to infection and thinning of the skin. Close
clinical supervision is required to avoid life-threatening reactions.
Children from 6-12 Years of Age: The suggested initial dose of 40mg (1.0ml
injected deeply into the gluteal muscle should be scaled according to the
severity of symptoms and the age and weight of the child. Kenalog is not
recommended for children under six years. Growth and development of
children on prolonged corticosteroid therapy should be carefully observed.
Caution should be used in the event of exposure to chickenpox, measles or
other communicable diseases.
(See 4.4 Special Warnings and Special
Precautions for Use.)
Triamcinolone withdrawal: In patients who have received more than
physiological doses of Kenalog (more than one injection during a three week
period), withdrawal should not be abrupt. The dose should be reduced and
the dosage interval increased until a dose of not more than 40mg and a dosage

interval of at least three weeks have been achieved as the dose of systemic
corticosteroid is reduced.
Clinical assessment of disease activity may be
needed.
Abrupt withdrawal of short term systemic corticosteroid treatment is
appropriate if it is considered that the disease is unlikely to relapse. A single
dose, which is not repeated within a three week period, is unlikely to lead to
clinically relevant hpa-axis suppression in the majority of patients. However,
in the following patient groups, gradual withdrawal of systemic corticosteroid
therapy should always be considered:
Patients who have had repeated courses of systemic corticosteroids.
When a course of Kenalog has been prescribed within one year of cessation of
long-term therapy (months or years).
Patients who may have reasons for adrenocortical insufficiency other than
exogenous corticosteroid therapy.

4.3

Contraindications
Hypersensitivity to any of the ingredients.
Systemic infections unless specific anti-infective therapy is employed.
Administration by intravenous, intrathecal, epidural or intraocular injection.

4.4

Special warnings and precautions for use

Warnings
Adequate studies to demonstrate the safety of Kenalog use by intra-turbinal,
subconjunctival, sub-tenons, retrobulbar and intraocular (intravitreal) injections 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
following injection of corticosteroid suspensions into the nasal turbinates and
intralesional injection about the head.
Cases of serious anaphylactic reactions and anaphylactic shock, including death, have
been reported in individuals receiving triamcinolone acetonide injection, regardless of
the route of administration
(Intra-Articular Injection):
Corticosteroids should not be injected into unstable joints.
Patients should be specifically warned to avoid over-use of joints in which
symptomatic benefit has been obtained. Severe joint destruction with necrosis of
bone may occur if repeated intra-articular injections are given over a long period of
time. Care should be taken if injections are given into tendon sheaths to avoid

injection into the tendon itself. Repeated injection into inflamed tendons should be
avoided as it has been shown to cause tendon rupture.
Due to the absence of a true tendon sheath, the Achilles tendon should not be injected
with depot corticosteroids.
(Intramuscular Injection):
During prolonged therapy a liberal protein intake is essential to counteract the
tendency to gradual weight loss sometimes associated with negative nitrogen balance
and wasting of skeletal muscle.
Precautions:
Intra-articular injection should not be carried out in the presence of active infection in
or near joints. The preparation should not be used to alleviate joint pain arising from
infectious states such as gonococcal or tubercular arthritis.
Undesirable effects may be minimised using the lowest effective dose for the
minimum period, and by administering the daily requirement, whenever possible, as a
single morning dose on alternate days. Frequent patient review is required to titrate
the dose appropriately against disease activity. (See dosage section).
Adrenal cortical atrophy develops during prolonged therapy and may persist for years
after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must,
therefore, always be gradual to avoid acute adrenal insufficiency and should be
tapered off over weeks or months according to the dose and duration of treatment.
During prolonged therapy any intercurrent illness, trauma or surgical procedure will
require a temporary increase in dosage. If corticosteroids have been stopped
following prolonged therapy they may need to be reintroduced temporarily.
Patients should carry steroid treatment cards which give clear guidance on the
precautions to be taken to minimise risk and which provide details of prescriber, drug,
dosage and the duration of treatment.
Suppression of the inflammatory response and immune function increases the
susceptibility to infections and their severity. The clinical presentation may often be
atypical and serious infections such as septicaemia and tuberculosis may be masked
and may reach an advanced stage before being recognised.
Chickenpox and measles are of particular concern since these normally minor
illnesses may be fatal in immunosuppressed patients.
Unless they have had chickenpox, patients receiving parenteral corticosteroids for
purposes other than replacement should be regarded as being at risk of severe
chickenpox. Manifestations of fulminant illness include pneumonia, hepatitis and
disseminated intravascular coagulation; rash is not necessarily a prominent feature.
Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by
exposed non- immune patients who are receiving systemic corticosteroids or who
have used them within the previous 3 months; varicella-zoster immunoglobulin

should preferably be given within 3 days of exposure and not later than 10 days.
Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids
should not be stopped and the dose may need to be increased.
Patients should be advised to avoid exposure to measles and to seek medical advice
without delay if exposure occurs. Prophylaxis with normal immunoglobulin may be
needed.
During corticosteroid therapy antibody response will be reduced and therefore affect
the patient's response to vaccines. Live vaccines should not be administered.
Patients and/or carers should be warned that potentially severe psychiatric adverse
reactions may occur with systemic steroids (see section 4.8). Symptoms typically
emerge within a few days or weeks of starting the treatment. Risks may be higher
with high doses/systemic exposure (see also section 4.5 pharmacokinetic interactions
that can increase the risk of side effects), although dose levels do not allow prediction
of the onset, type, severity or duration of reactions. Most reactions recover after either
dose reduction or withdrawal, although specific treatment may be necessary.
Patients/carers should be encouraged to seek medical advice if worrying
psychological symptoms develop, especially if depressed mood or suicidal ideation is
suspected. Patients/carers should also be alert to possible psychiatric disturbances that
may occur either during or immediately after dose tapering/withdrawal of systemic
steroids, although such reactions have been reported infrequently.
Particular care is required when considering the use of systemic corticosteroids in
patients with existing or previous history of severe affective disorders in themselves
or in their first degree relatives. These would include depressive or manic-depressive
illness and previous steroid psychosis.
Special Precautions:
Particular care is required when considering use of systemic corticosteroids in patients
with the following conditions and frequent patient monitoring is necessary.
Recent intestinal anastomoses, diverticulitis, thrombophlebitis, existing or previous
history of severe affective disorders (especially previous steroid psychosis),
exanthematous disease, chronic nephritis, or renal insufficiency, metastatic
carcinoma, osteoporosis (post-menopausal females are particularly at risk); in patients
with an active peptic ulcer (or a history of peptic ulcer). Myasthenia gravis. Latent or
healed tuberculosis; in the presence of local or systemic viral infection, systemic
fungal infections or in active infections not controlled by antibiotics. In acute
psychoses; in acute glomerulonephritis. Hypertension; congestive heart failure;
glaucoma (or a family history of glaucoma), previous steroid myopathy or epilepsy.
Liver failure.
Corticosteroid effects may be enhanced in patients with hypothyroidism or cirrhosis
and decreased in hyperthyroid patients.
Diabetes may be aggravated, necessitating a higher insulin dosage. Latent diabetes
mellitus may be precipitated.

Menstrual irregularities may occur, and this possibility should be mentioned to female
patients.
Rare instances of anaphylactoid reactions have occurred in patients receiving
corticosteroids, especially when a patient has a history of drug allergies.
All corticosteroids increase calcium excretion
Aspirin should be used cautiously in conjunction with corticosteroids in patients with
hypoprothrombinaemia.
This product contains 15mg/ml benzyl alcohol and must not be given to premature
babies or neonates. Benzyl Alcohol may cause toxic reactions and anaphylactoid
reactions in infants and children up to 3 years old.
Use in Children:
Kenalog is not recommended for children under six years. Corticosteroids cause
dose-related growth retardation in infancy, childhood and adolescence which may be
irreversible, therefore growth and development of children on prolonged
corticosteroid therapy should be carefully observed.
Use in Elderly:
The common adverse effects of systemic corticosteroids may be associated with more
serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia,
diabetes, susceptibility to infection and thinning of the skin. Close clinical
supervision is required to avoid life-threatening reactions.
4.5
Interactions with other Medicinal Products and other Forms of
Interaction
Amphotericin B injection and potassium-depleting agents: Patients should be
observed for hypokalemia.
Anticholinesterases: Effects of anticholinesterase agent may be antagonised.
Anticoagulants, oral: Corticosteroids may potentiate or decrease anticoagulant
action. Patients receiving oral anticoagulants and corticosteroids should
therefore be closely monitored.
Antidiabetics: Corticosteroids may increase blood glucose; diabetic control
should be monitored, especially when corticosteroids are initiated,
discontinued, or changed in dosage.
Antihypertensives, including diuretics: corticosteroids antagonise the effects
of antihypertensives and diuretics. The hypokalaemic effect of diuretics,
including acetazolamide, is enhanced.
Anti-tubercular drugs: Isoniazid serum concentrations may be decreased.

Cyclosporin: Monitor for evidence of increased toxicity of cyclosporin when
the two are used concurrently.
Digitalis glycosides: Co-administration may enhance the possibility of digitalis
toxicity.
Oestrogens, including oral contraceptives: Corticosteroid half-life and
concentration may be increased and clearance decreased.
Hepatic Enzyme Inducers (e.g. barbiturates, phenytoin, carbamazepine,
rifampicin, primidone, aminoglutethimide): There may be increased metabolic
clearance of Adcortyl. Patients should be carefully observed for possible
diminished effect of steroid, and the dosage should be adjusted accordingly.
Human growth hormone: The growth-promoting effect 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
hypothyroid patients and increased in hyperthyroid patients. Changes in
thyroid status of the patient may necessitate adjustment in adrenocorticoid
dosage.
Vaccines: Neurological complications and lack of antibody response may
occur when patients taking corticosteroids are vaccinated. (See 4.4 Special
Warnings and Special Precautions for Use).

4.6

Pregnancy and Lactation
The ability of corticosteroids to cross the placenta varies between individual
drugs, however triamcinolone does cross the placenta.
Administration of corticosteroids to pregnant animals can cause abnormalities
of foetal development including cleft palate, intra-uterine growth retardation
and effects on brain growth and development. There is no evidence that
corticosteroids result in an increased incidence of congenital abnormalities,

such as cleft palate / lip in man. However, when administered for prolonged
periods or repeatedly during pregnancy, corticosteroids may increase the risk
of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in
the neonate following prenatal exposure to corticosteroids but usually resolves
spontaneously following birth and is rarely clinically important.
As with all drugs, corticosteroids should only be prescribed when the benefits
to the mother and child outweigh the risks. When corticosteroids are essential,
however, patients with normal pregnancies may be treated as though they were
in the non-gravid state.
Lactation
Corticosteroids may pass into breast milk, although no data are available for
triamcinolone. Infants of mothers taking high doses of systemic
corticosteroids for prolonged periods may have a degree of adrenal
suppression.

4.7

Effects on Ability to Drive and Use Machines
None known.

4.8

Undesirable effects
Where adverse reactions occur they are usually reversible on cessation of
therapy. The incidence of predictable side-effects, including hypothalamicpituitary-adrenal suppression correlate with the relative potency of the drug,
dosage, timing of administration and duration of treatment. (See Warnings
and Precautions).
Absorption of triamcinolone following injection by the intra-articular route is
rare. However, patients should be watched closely for the following adverse
reactions which may be associated with any corticosteroid therapy:
Anti-inflammatory and immunosuppressive effects: Increased susceptibility
and severity of infections with suppression of clinical symptoms and signs,
opportunistic infections, recurrence of dormant tuberculosis. (See Warnings
and Precautions).
Fluid and electrolyte disturbances: sodium retention, fluid retention,
congestive heart failure in susceptible patients, potassium loss, cardiac
arrhythmias or ECG changes due to potassium deficiency, hypokalaemic
alkalosis, increased calcium excretion and hypertension.
Musculoskeletal: muscle weakness, fatigue, steroid myopathy, loss of muscle
mass, osteoporosis, avascular osteonecrosis, vertebral compression fractures,

delayed healing of fractures, aseptic necrosis of femoral and humeral heads,
pathological fractures of long bones and spontaneous fractures, tendon rupture.
Hypersensitivity: Anaphylactoid reaction, anaphylaxis including anaphylactic
reactions and anaphylactic shock, , angiodema, rash, pruritus and urticaria,
particularly where there is a history of drug allergies.
Dermatological: impaired wound healing, thin fragile skin, petechiae and
ecchymoses, facial erythema, increased sweating, purpura, striae, hirsutism,
acneiform eruptions, lupus erythematous-like lesions and suppressed reactions
to skin tests.
Gastrointestinal: dyspepsia, peptic ulcer with possible subsequent perforation
and haemorrhage, pancreatitis, abdominal distension and ulcerative
oesophagitis, candidiasis.
Neurological: euphoria, psychological dependence, depression, insomnia,
convulsions, increased intracranial pressure with papilloedema (pseudotumour cerebri) usually after treatment, vertigo, headache, neuritis or
paraesthesias and aggravation of pre-existing psychiatric conditions and
epilepsy.
A wide range of psychiatric reactions including affective disorders (such as
irritable, euphoric, depressed and labile mood, and suicidal thoughts),
psychotic reactions (including mania, delusions, hallucinations, and
aggravation of schizophrenia), behavioural disturbances, irritability, anxiety,
sleep disturbances, and cognitive dysfunction including confusion and amnesia
have been reported. Reactions are common and may occur in both adults and
children. In adults, the frequency of severe reactions has been estimated to be
5-6%. Psychological effects have been reported on withdrawal of
corticosteroids; the frequency is unknown.
Endocrine: menstrual irregularities and amenorrhoea; development of the Cushingoid
state; suppression of growth in childhood and adolescence; 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,
weight gain. Negative protein and calcium balance. Increased appetite.
Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure,
glaucoma, exophthalmos, papilloedema, corneal or scleral thinning, exacerbation of
ophthalmic viral or fungal diseases.
Others: necrotising angiitis, thrombophlebitis, thromboembolism, leucocytosis,
insomnia and syncopal episodes.
Withdrawal Symptoms and Signs:
On withdrawal, fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin
nodules and weight loss may occur. Too rapid a reduction in dose following

prolonged treatment can lead to acute adrenal insufficiency, hypotension and death.
(See Warnings and Precautions.)
Intra-Articular Injection:
Reactions following intra-articular administration have been rare. In a few instances,
transient flushing and dizziness have occurred. Local symptoms such as postinjection flare, transient pain, irritation, sterile abscesses, hyper- or hypopigmentation, Charcot-like arthropathy and occasional increase in joint discomfort
may occur. Local fat atrophy may occur if the injection is not given into the joint
space, but is temporary and disappears within a few weeks to months.
Intramuscular Injection:
Severe pain has been reported following intramuscular administration. Sterile
abscesses, cutaneous and subcutaneous atrophy, hyperpigmentation,
hypopigmentation and Charcot-like arthropathy have also occurred.

4.9

Overdose
Not applicable.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Triamcinolone acetonide is a synthetic glucocorticoid with marked antiinflammatory and anti-allergic actions.
Intra-Articular Injection: Following local injection, relief of pain and swelling
and greater freedom of movement are usually obtained within a few hours.
Intramuscular Injection: Provides an extended duration of therapeutic effect
and fewer side effects of the kind associated with oral corticosteroid therapy,
particularly gastro-intestinal reactions such as peptic ulceration. Studies
indicate that, following a single intramuscular dose of 80mg triamcinolone
acetonide, adrenal suppression occurs within 24 - 48 hours and then gradually
returns to normal, usually in approximately three weeks. This finding
correlates closely with the extended duration of therapeutic action of
triamcinolone acetonide.

5.2.

Pharmacokinetic Properties
Triamcinolone acetonide may be absorbed into the systemic circulation from
synovial spaces. However clinically significant systemic levels after intraarticular injection are unlikely to occur except perhaps following treatment of
large joints with high doses. Systemic effects do not ordinarily occur with
intra-articular injections when the proper techniques of administration and the
recommended dosage regimens are observed.
Triamcinolone acetonide is absorbed slowly, though almost completely,
following depot administration by deep intramuscular injection; biologically
active levels are achieved systemically for prolonged periods (weeks to
months). In common with other corticosteroids, triamcinolone is metabolised
largely hepatically but also by the kidney and is excreted in urine. The main
metabolic route is 6-beta-hydroxylation; no significant hydrolytic cleavage of
the acetonide occurs.
In view of the hepatic metabolism and renal excretion of triamcinolone
acetonide, functional impairments of the liver or kidney may affect the
pharmacokinetics of the drug.

5.3.

Pre-clinical Safety Data
See 4.6 Pregnancy and Lactation.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Benzyl alcohol, polysorbate 80, carmellose sodium, sodium chloride, water.

6.2.

Incompatibilities
The injection should not be physically mixed with other medicinal products.

6.3.

Shelf Life
36 months.

6.4.

Special Precautions for Storage
Do not store above 25°C. Do not freeze. Store in an upright position.

6.5.

Nature and Contents of Container
Carton containing glass ampoules 5 x 1ml or individually cartoned multidose
vials of 5ml or individually cartoned 1ml and 2ml syringes.

6.6.

Instructions for Use, Handling and Disposal
No special handling instructions.

7.

MARKETING AUTHORISATION HOLDER
E.R. Squibb & Sons Limited
Uxbridge Business Park
Sanderson Road,
Uxbridge, Middlesex,
UB8 1DH

8.

MARKETING AUTHORISATION NUMBER(S)
PL 00034/5045R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/11/2002

10

DATE OF REVISION OF THE TEXT
21/11/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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