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ADCORTYL INTRA-ARTICULAR/INTRADERMAL INJECTION 10MG/ML

Active substance(s): TRIAMCINOLONE ACETONIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
AdcortylTM Intra-articular/Intradermal Injection 10mg/ml

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
AdcortylTM Intra-articular/Intradermal Injection contains triamcinolone acetonide
10mg per ml of sterile suspension.

3

PHARMACEUTICAL FORM
Sterile aqueous suspension for injection.

4
4.1

CLINICAL PARTICULARS
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.
Intradermal use: for lichen simplex chronicus (neuro-dermatitis), granuloma
annulare, lichen planus, keloids, alopecia areata and hypertrophic scars.

4.2

Posology and method of administration
Adcortyl is for intra-articular or intra-dermal 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.
Adults: The dose of Adcortyl injection for intra-articular administration, and
injection into tendon sheaths and bursae, is dependent on the size of the joint
to be treated and on the severity of the condition. Doses of 2.5-5mg (0.250.5ml) for smaller joints and 5-15mg (0.5-1.5ml) for larger joints usually
alleviate the symptoms. Triamcinolone acetonide 40mg/ml (Kenalog) is

available to facilitate administration of larger doses.
Achilles tendon).

(See Precautions re

Intradermal dosage is usually 2-3mg (0.2-0.3ml), depending on the size of the
lesion. No more than 5mg (0.5ml) should be injected at any one site. If
several sites are injected the total dosage administered should not exceed
30mg (3ml). The injection may be repeated if necessary, at one or two week
intervals.
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, hypokalaemia, susceptibility to infection and thinning of the
skin. Close supervision is required to avoid life-threatening reactions.
Children: Adcortyl is not recommended in children under 6 years. Adcortyl
intra-articular/intradermal may be used in older children in suitably adjusted
dosages. 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.)

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
Adequate studies to demonstrate the safety of Adcortyl 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
Warnings (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.
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 is needed for
exposed non-immune patients receiving systemic corticosteroids or for those
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 dosage 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 in postmenopausal women vaginal
bleeding has been observed. This possibility should be mentioned to female
patients but should not deter appropriate investigations as indicated.
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.

4.5

Interaction 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 nongravid 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
The list of undesirable effects shown below is presented by system organ
class, MedDRA preferred term, and frequency. Very common (≥1/10);
common (≥1/100 to <1/10); uncommon (≥1/1000 to 6 <1/100); rare
(≥1/10,000 to <1/1000); very rare (≥1/10,000); Not known (cannot be
estimated from the available data).

System Organ Class

Frequency
Common

Infections and
infestations
Nervous system disorders
Musculoskeletal
connective tissue and
bone disorders
General disorders and
administration site
conditions

MedDRA Terms

Infection
Headache
Arthralgia

Injection site reaction

Uncommon
Infections and
infestations

Injection site abscess
sterile
Infection masked
Tuberculosis
Candida infection
Eye infection viral
Eye infection fungal
Rhinitis

Conjunctivitis
Immune system
disorders

Endocrine disorders

Metabolism and
nutrition disorders

Anaphylactoid reaction
Anaphylactic reaction
Anaphylactoid shock
Cushingoid
Adrenal suppression
Secondary
adrenocortical
insufficiency
Hypopituitarism
Sodium retention
Fluid retention
Alkalosis hypokalaemic
Hyperglycaemia
Diabetes mellitus
inadequate control
Calcium deficiency
Increased appetite

Psychiatric disorders

Psychiatric symptom
Depression
Euphoric mood
Mood swings
Psychotic disorder
Personality change
Insomnia
Drug dependence
Mental disorder
Epilepsy
Irritability
Suicidal ideation
Psychotic disorder
Anxiety
Cognitive disorder

Nervous system disorders

Convulsion
Syncope
Benign intracranial
hypertension
Neuritis
Paraesthesia
Intracranial pressure
increased
Dizziness

Eye disorders

Blindness
Cataract
Glaucoma
Exophthalmos
Corneal perforation
Papilloedema

Ear and labyrinth
disorders

Vertigo

Cardiac disorders

Cardiac failure
congestive
Arrhythmia

Vascular disorders

Hypertension
Embolism
Thrombophlebitis
Vasculitis necrotising
Hypotension
Flushing

Gastrointestinal
disorders

Peptic ulcer
Peptic ulcer perforation
Peptic ulcer haemorrhage
Pancreatitis
Abdominal distension
Oesophagitis ulcerative
dyspepsia

Skin and subcutaneous
tissue disorders

Urticaria
Rash
Skin hyperpigmentation
Skin hypopigmentation
Skin atrophy
Skin fragility
Petechiae
Ecchymosis
Erythema
Hyperhidrosis
Purpura
Skin striae
Hirsutism
Dermatitis acneiform
Cutaneous lupus
erythematosus
Angioedema
Pruritus

Musculoskeletal
connective tissue and
bone disorders

Osteoporosis

Osteonecrosis
Pathological fracture
Fracture delayed union
Musculoskeletal
discomfort
Muscular weakness
Myopathy
Muscle atrophy
Growth retardation
Neuropathic arthropathy
Myalgia

Renal and urinary
disorders

Glycosuria

Reproductive system and
breast disorders

Menstruation irregular
Postmenopausal
haemorrhage

General disorders and
administration site
conditions

Synovitis

Pain
Injection site irritation
Injection site discomfort
Fatigue
Impaired healing
Hyperthermia
Investigations

Blood potassium
decreased
Electrocardiogram
change
Carbohydrate tolerance
decreased
Nitrogen balance
negative
Intraocular pressure
increased
Laboratory test
interference
Weight decreased

Blood calcium abnormal
Protein total abnormal
Injury and poisoning

Spinal compression
fracture

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Triamcinolone acetonide is a synthetic glucocorticoid with marked anti-inflammatory
and anti-allergic actions. Following local injection, relief of paln and swelling and
greater freedom of movement are usually obtained within a few hours; such
administration avoids the more severe systemic side-effects which may accompany
parenteral or oral corticosteroid administration.

5.2

Pharmacokinetic properties
Triameinolone 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.
The systemic effects of intradermally administered triamcinolone acetonide
have not been extensively studied. The risk of systemic absorption, though
minimal, should be taken into consideration especially when repeated
intralesional administrations may be necessary.
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. This may become clinically
significant if large or frequent doses of intradermal or intra-articular
triamcinolone acetonide are given.

5.3

Preclinical safety data
See 4.6 Pregnancy and Lactation.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Benzyl alcohol. polysorbate 80, sodium carboxymethylcellulose, 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
In an upright position. Do not store above 25°C. Avoid freezing.

6.5

Nature and contents of container
Carton containing glass ampoules 5 x imi or individually cartoned multidose
vials of 5ml.

6.6

Special precautions for 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 00034/5002R

9

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

10

DATE OF REVISION OF THE TEXT
15/06/2015

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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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