Adcortyl Intra-articular/Intra-Dermal Injection 10mg/ml suspension for injection, 1 ml

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Triamcinolone acetonide
Available from:
Bristol-Myers Squibb Pharmaceuticals uc
ATC code:
H02AB; H02AB08
INN (International Name):
Triamcinolone acetonide
Dosage:
10 milligram(s)/millilitre
Pharmaceutical form:
Suspension for injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Glucocorticoids; triamcinolone
Authorization status:
Marketed
Authorization number:
PA0002/018/002
Authorization date:
1978-04-01

Package leaflet: Information for the user

Adcortyl

Intra-articular / Intradermal Injection 10 mg/ml

Suspension for Injection

Triamcinolone acetonide

Read all of this leaflet carefully before you are given this

medicine because it contains important information for

you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or

pharmacist.

If you get any side effects, talk to your doctor, pharmacist

or nurse. This includes any possible side effects not listed

in this leaflet. See section 4.

Adcortyl IA/ID Injection is a steroid medicine, prescribed

for many different conditions, including serious illnesses.

You need to take it regularly to get the maximum benefit.

Don’t stop using this medicine without talking to your

doctor – you may need to reduce the dose gradually.

Adcortyl IA/ID Injection can cause side effects in

some people (read section 4 below). Some problems

such as mood changes (feeling depressed or ‘high’), or

stomach problems can happen straight away. If you feel

unwell in any way, keep using your medicine, but see

your doctor straight away.

Some side effects only happen after weeks or months.

These include weakness of arms and legs, or developing

a rounder face (read section 4 for more information).

If you are given this medicine for more than 3 weeks,

you will be given a blue ‘steroid card’: always keep it

with you and show it to any doctor or nurse treating you.

Keep away from people who have chicken pox or

shingles, if you have never had them. They could affect

you severely. If you do come into contact with chicken

pox or shingles, see your doctor straight away.

What is in this leaflet

1. What Adcortyl IA/ID Injection is and what it is used for

2. What you need to know before you are given Adcortyl IA/ID Injection

3. Receiving Adcortyl IA/ID Injection

4. Possible side effects

5. How to store Adcortyl IA/ID Injection

6. Content of the pack and other information

1. What Adcortyl IA/ID Injection is and what it is used for

The name of this medicine is Adcortyl IA/ID Injection. Each injection contains

triamcinolone acetonide 10 mg/ml as the active ingredient. Triamcinolone

acetonide belongs to a group of medicines called corticosteroids (steroids).

These corticosteroids occur naturally in the body, and help to maintain

health and well-being. Boosting your body with extra corticosteroid (such as

Adcortyl IA/ID Injection) is an effective way to treat various illnesses involving

inflammation in the body. Adcortyl IA/ID Injection reduces this inflammation,

which could otherwise go on making your condition worse. You must take this

medicine regularly to get maximum benefit from it. Adcortyl IA/ID Injection is

for the treatment of joint pain, swelling and stiffness in inflammatory disorders

such as rheumatoid arthritis, osteoarthritis and psoriasis. It is also used to treat

various forms of allergic dermatitis, skin overgrowths such as thickened scar

tissue, and patchy baldness, which is usually reversible.

2. What you need to know before you are given Adcortyl IA/ID Injection

Do not receive Adcortyl IA/ID Injection if;

You have had an allergic reaction to a similar medicine or any of the

ingredients in this medicine

You are suffering from an infection unless your doctor has also prescribed

a treatment for the infection.

Have had any recent infection (including tuberculosis (TB))

Have had recent bowel surgery

Have, or have had a bowel disorder or stomach ulcer

Suffer from any condition that affects your mind

Adcortyl IA/ID Injection is not recommended for children under 6 years.

You must tell your doctor if you:

Have had liver failure

Have had chickenpox or measles recently

Have an infection or inflammation of the veins in your legs

Have had any mental health disorders or epilepsy

Have had any kidney, liver or thyroid problems as the dose of Adcortyl may

need to be adjusted

Have recently suffered from any form of cancer

Have thin or brittle bones (osteoporosis)

Have myasthenia gravis (a disease which causes weak muscles)

Have a disease that causes a serious rash (exanthematous)

Have high blood pressure or heart failure

Or someone in your family has glaucoma (increased pressure in your eyes).

Are diabetic as your insulin dose may need to be changed

If you have ever suffered from steroid myopathy (damage to your muscle

fibers caused by treatment with corticosteroids)

If you have an underactive thyroid gland

If you are going through the menopause

Check with your doctor first:

If you have ever had severe depression or manic-depression (bipolar

disorder).

This includes having had depression before or while taking steroid medicines

like Adcortyl IA/ID Injection.

If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before Adcortyl IA/ID

Injection is given to you.

Caution is advised in taking triamcinolone acetonide (Adcortyl IA/ID Injection)

and medicines to control HIV (anti-retrovirals) or fungal infections (anti-fungals)

because you could experience more adverse effects. Refer to list of medicines

mentioned in “Taking other medicines with Adcortyl IA/ID Injection.”

Steroid medicines suppress your body’s natural immune response. Therefore,

if you come into contact with anyone who has an infectious disease such as

chickenpox, shingles or measles, consult your doctor as soon as possible.

While you are being treated with this medicine (or if you have recently stopped

a course of treatment) do not have any vaccination without consulting your

doctor first.

You must take care not to over-use a joint which feels better after you receive

Adcortyl IA/ID Injection. The joint will still need to recover from the inflammation

which caused your symptoms.

Taking other medicines with Adcortyl IA/ID Injection

Please tell your doctor if you are taking, or have recently taken any other

medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Adcortyl and your doctor may

wish to monitor you carefully if you are taking these medicines (including some

medicines for HIV: ritonavir, cobicistat)

This is especially important if you are taking:

Aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)

as corticosteroids can increase the chance of bleeding from the gut.

Anti-retroviral

inhibitors

anti-fungals:

Caution

advised

co-administration

ritonavir,

atazanavir,

clarithromycin,

indinavir,

itraconazole,

nefazodone,

nelfinavir,

saquinavir,

ketoconazole,

telithromycin with triamcinolone because increased adverse effects may

occur, resulting in whole body corticosteroid effects including Cushing’s

syndrome and reduction in hormone production

Warfarin or other medicines to thin the blood

Oral contraceptive pill or hormone replacement therapy (HRT)

Human growth hormone

A medicine called ciclosporin

A medicine called rifampicin

Potassium depleting medicines.

Diuretics

e.g.

acetazolamide,

loop

diuretics,

thiazide

diuretics

carbenoxolone.

Barbiturates, carbamazepine, primidone and aminoglutethimide

Any non-depolarising muscle relaxants to provide relaxation for surgery or

medicines to treat;

Medicine for High blood pressure or irregular heart beat (e.g. digoxin)

Medicine for Myasthenia gravis (a disease which causes weak muscles)

Medicine for Epilepsy or fits (e.g. phenytoin)

Medicine for Tuberculosis (TB)

Medicine for Diabetes

Medicine for Thyroid problems

If you are taking any of these medicines, have had any recent vaccinations,

need to have a vaccine or are not sure, please consult your doctor.

If you are due to have surgery

Before surgery and anaesthesia (even at the dentist) you should tell the doctor

or dentist that you are being treated with Adcortyl IA/ID injection.

Pregnancy and breastfeeding

If you are pregnant, planning to become pregnant, or if you are breast-feeding

you should discuss this with your doctor as soon as possible before receiving

Adcortyl IA/ID Injection.

Driving and using machines

This medicine does not usually affect your ability to drive or operate machinery

but it can affect your eyesight. Tell your doctor immediately if you have any

pain in the eyes or problems with your vision.

Steroid Treatment Card

Your doctor or pharmacist will have given you a Steroid Treatment Card with

your prescription or medicine.

YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be shown

to any of the following persons:

Doctor or Nurse - before having any surgery or emergency treatment or if any

new treatment is prescribed.

Dentist - before having any dental surgery

Pharmacist - before buying any medicine

Optician - it is advisable to have regular eye tests

Important information about the ingredients of Adcortyl IA/ID Injection

Adcortyl IA/ID Injection contains 15 mg/ml benzyl alcohol which may cause

harmful or allergic reactions in infants and children up to 3 years old. Adcortyl

IA/ID injection must not be given to premature or newly born babies.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose,

i.e. essentially ‘sodium- free’.

1300993A3

5927

5927

5927

5927

Live Text:

Yes /

Production Site:

Anagni

Country:

CTM:

Parisi Emiliano

Product Name:

INS ADCORTYL INJ 10MG

Printing Colours:

Black

Product Code:

1300993A3

Barcode Type:

2/5 (5927)

Format/Dimension:

130 x 592 (130 x 24) mm

Font Size Text:

9 pt

Technical Colours:

Diecut

Min. Font Size Text:

9 pt

Line Space:

9 pt

3,1 mm

Proof No.:

02.11.2017

Manconi

Pag. 1/2

Approved

3. Receiving Adcortyl IA/ID Injection

The effect of the injection will vary from patient to patient and further injections

may be given to you when symptoms return and not at regular intervals.

Adcortyl is not suitable for injection into the vein, muscle, eye or spine

Use in inflammatory joint disorders:

The dose of injection to be given into a joint or tendon sheath depends upon

the size of the joint to be treated and the severity of the condition which is

being treated. Doses of 2.5 – 5 mg (0.25-0.5 ml) for smaller joints and 5-15 mg

(0.5-1.5 ml) for larger joints usually give relief of symptoms. This medicine

should not be used for injection into the Achilles tendon.

Use in allergic dermatitis:

The dose is usually 2-3 mg (0.2-0.3 ml) depending on the size of the problem

area of the skin but no more than 5 mg (0.5 ml) should be injected at any one

site. If several sites are injected the total dose given should not exceed 30 mg

(3 ml). Further doses may be given if necessary at one or two week intervals.

Your doctor will advise you whether it is wise for you to have further injections.

Treatment with steroids is usually kept as short as possible and must not be

stopped abruptly. Joints may become permanently damaged by repeated

injections over a long period of time.

When the treatment is stopped you may notice flu-like symptoms, runny nose

or itchy eyes or skin.

During times of illness or stress, patients on long-term treatment may require

the addition of oral steroid tablets or, if they have recently finished a course

of Adcortyl IA/ID injections, may need to start taking oral steroid tablets for a

while.

Children

Adcortyl IA/ID injections, is not recommended in children under 6 years. It may

be given to older children in suitably adjusted dosages.

Growth and development should be carefully observed during long term

treatment.

Elderly

Long term treatment should be supervised to avoid life threatening reactions.

Mental health problems while Adcortyl IA/ID injection is given to you

Mental health problems can happen while taking steroids like Adcortyl IA/ID

Injection (see section 4 Possible Side Effects).

These illnesses can be serious.

Usually they start within a few days or weeks of starting the medicine.

They are more likely to happen at high doses.

Most of these problems go away if the dose is lowered or the medicine is

stopped.

However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone who has been given this medicine), shows

any signs of mental health problems. This is particularly important if you are

depressed, or might be thinking about suicide. In a few cases, mental health

problems have happened when doses are being lowered or stopped.

4. Possible side effects

Like all medicines, Adcortyl IA/ID injection can cause side effects, although not

everybody gets them.

Serious cases of anaphylactic reactions (i.e. a serious allergic reaction) and

anaphylactic shock including death have been reported. If you notice any of

the following, contact your doctor immediately:

Swelling of the face, lips or throat

Breathing difficulties

Skin itching, redness or a rash

As these may be signs of an allergic reaction

Tell your doctor immediately if you notice any sticky black stools, get severe

abdominal pain or if you vomit blood.

Steroids including Adcortyl IA/ID injection can cause serious mental health

problems.

These are uncommon in both adults and children. If you notice any of these

problems talk to a doctor straight away:

Feeling depressed, including thinking about suicide.

Feeling high (euphoria and mania) or moods that go up and down.

Feeling anxious/irritable, having problems sleeping, difficulty in thinking or

being confused and losing your memory.

Feeling, seeing or hearing things which do not exist. Having strange and

frightening thoughts, changing how you act or having feelings of being

alone.

Common: may affect up to 1 in 10 people

Increased risk of infection

Headache

Injection site reactions, including temporary worsening of pain in the injected

joint

Uncommon: may affect up to 1 in 100 people

Changes in blood chemicals which can cause fluid retention

Heart failure or irregular heart beat

High blood pressure

Abnormal blood clots

Weak or fragile bones or muscles, bone fracture, poor healing of broken

bones, decrease in muscle mass, muscle or bone pain, destruction of the

ends of bones, tendon rupture

Thin/fragile

skin,

rashes,

inflamed/itchy

skin,

skin

swelling,

flushing,

loss/darkening of skin colour, acnes, stretch marks, bruising, sweating,

increased hair growth

Fits or epilepsy, fainting, dizziness and increased pressure in the brain.

Indigestion

Stomach ulcers and perforation, bloating, inflammation of the pancreas,

inflammation and ulceration of the oesophagus.

Eye problems including inflammation, glaucoma and cataracts, blindness,

bulging of the eye, damage to the cornea or white of the eye

Fungal or Viral eye infections

Yeast infections e.g. thrush

Vertigo

Tiredness, tingling and numbness

Pain, swelling and skin colour changes around the injection site

Impaired wound healing

Loss of bone tissue (osteoporosis) or death of bone tissue caused by loss

of blood supply to the bone (osteonecrosis)

Development of a red moon shaped face or wasting of the limbs

Treatment with steroids can stop the body from producing some hormones

and may slow or stop children’s growth.

Hormone production by certain glands may be increased or decreased.

Increased appetite and weight gain

Less tolerance to carbohydrates

Mild form of diabetes with no obvious symptoms

Inadequately controlled diabetes mellitus, high blood sugar

Irregular periods/Postmenopausal women may also experience vaginal

bleeding.

Worsening of existing mental health disorders and feeling dependent on the

medicine

Effect on tissue fat at injection site (can appear as dimples)

Longstanding chronic infections such as tuberculosis could be made worse

Withdrawal symptoms which can include, psychiatric effects, fever, joint and

muscle pain, runny nose, eye infection, painful itchy skin nodules and weight

loss may occur.

A rapid reduction in dose following prolonged treatment can lead to acute

adrenal insufficiency, low blood pressure and death.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This

includes any possible side effects not listed in this leaflet. You can also report

side effects directly via:

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety

of this medicine.

5. How to store Adcortyl IA/ID Injection

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date shown on the label and carton.

The expiry date refers to the last day of that month. The expiry date refers to

the last day of that month.

Do not store above 25°C. Do not freeze or refrigerate. Store in the outer carton

to protect from light.

Store in an upright position. Shake well before use.

Once opened, Adcortyl IA/ID Injection (1 ml) is for single-use only. Discard any

unused contents immediately after use.

Adcortyl IA/ID Injection (5 ml) once opened, the product may be stored for a

maximum of 28 days below 25°C.

Other in-use storage times and conditions are the responsibility of the user.

Do not throw away any medicines via wastewater or household waste. Ask

your pharmacist how to throw away medicines you no longer use. These

measures will help to protect the environment.

6. Content of the pack and other information

What Adcortyl IA/ID injection contains

The active substance is triamcinolone acetonide 10 mg/ml.

The other ingredients are; benzyl alcohol, polysorbate 80, carmellose sodium,

sodium chloride and water for injection.

What Adcortyl IA/ID injection looks like and contents of the pack

Adcortyl IA/ID injection is a white sterile aqueous suspension with a slight

odour.

It is supplied in packs of 5 x 1 ml glass ampoules or a single 5 ml glass vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bristol-Myers Squibb Pharmaceuticals uc

Plaza 254, Blanchardstown Corporate Park 2, Ballycoolin,

Dublin 15, D15 T867

Ireland.

Tel: 01 483 3625

Manufacturer

Bristol-Myers Squibb Srl,

Contrada Fontana del Ceraso,

03012 Anagni (FR),

Italy

This leaflet was last revised in November 2017

1300993A3

Live Text:

Yes /

Production Site:

Anagni

Country:

CTM:

Parisi Emiliano

Product Name:

INS ADCORTYL INJ 10MG

Printing Colours:

Black

Product Code:

1300993A3

Barcode Type:

2/5 (5927)

Format/Dimension:

130 x 592 (130 x 24) mm

Font Size Text:

9 pt

Technical Colours:

Diecut

Min. Font Size Text:

9 pt

Line Space:

9 pt

3,1 mm

Proof No.:

02.11.2017

Manconi

Pag. 2/2

Approved

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Adcortyl Intra-articular/Intra-Dermal Injection 10mg/ml suspension for injection, 1 ml.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Triamcinolone acetonide 10 mg per ml (10 mg per 1 ml ampoule).

Excipient(s) with known effect: Benzyl alcohol 15 mg/ml

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Suspension for Injection (injection).

White, Sterile aqueous suspension with a slight odour.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Intra-articular use:

in the local

management

of inflammation involving joints,

bursae or tendon sheaths such as occurs in rheumatoid

arthritis, osteoarthritis, bursitis, synovitis, tendinitis, epicondylitis and trauma.

Intradermal use:

for inflammatory dermal lesions such as lichen simplex, lichen planus, psoriasis, granuloma annulare, keloids and for

alopecia.

4.2 Posology and method of administration

Adcortyl Injection is only for intra-articular or intra-dermal use and should not be given by any other route.

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.

Adcortyl Injection should only be given in an appropriate setting where there is access to emergency medical care.

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 - 5 mg (0.25 - 0.5 ml) for smaller joints and 5 - 15 mg (0.5 - 1.5 ml) for larger joints usually alleviate the

symptoms.

Triamcinolone acetonide 40 mg/ml (Kenalog) is available to facilitate administration of larger doses.

(see

section 4.4 re Achilles tendon.)

Intradermal dosage is usually 2 - 3 mg (0.2 - 0.3 ml), depending on the size of the lesion.

No more than 5 mg (0.5 ml)

should be injected at any one site.

If several sites are injected the total dosage administered should not exceed 30 mg

(3 ml).

The injection may be repeated if necessary, at one or two week intervals.

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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.

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.

4.3 Contraindications

In patients with an active peptic ulcer (or a history of peptic ulcer).

Active or latent or healed tuberculosis; in the

presence of local or systemic viral infection, systemic fungal infections or in active bacterial infections not controlled

by antibiotics.

In acute psychoses.

In those with allergy or hypersensitivity to the active substance(s) or to any of the

excipients listed in section 6.1.

Administration by intravenous, intrathecal or intraocular injection.

4.4 Special warnings and precautions for use

Adcortyl is not suitable for intravenous, intramuscular, intraocular, epidural or intrathecal use.

In common with other steroids, Adcortyl Injection should be used with caution in patients with recent intestinal

anastomoses, thrombophlebitis, psychotic tendencies, exanthematous disease, chronic nephritis, metastatic carcinoma,

osteoporosis (post-menopausal females are particularly at risk); in acute glomerulonephritis, hypertension, congestive

heart failure, glaucoma (or a family history of glaucoma), previous steroid myopathy or epilepsy; liver failure.

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.

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.

Patients on long-term systemic therapy with Adcortyl may require supportive corticosteroid therapy in times of stress,

general anaesthesia or during surgery, both during the treatment period and for a year afterwards.

During

corticosteroid therapy antibody response will be reduced and therefore affect the patient’s response to vaccines.

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.Appropriate precautionary

measures should be taken prior to administration, especially when the patient has a history of allergy to any drug (see

section 4.2).

All corticosteroids increase calcium excretion.

Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.

Corticosteroid administration will result in certain effects, the severity, significance and extent of which vary with the

dosage and duration of treatment and the particular corticosteroid used.

These include disturbance in electrolyte

balance, mineral metabolism, glucose metabolism and gluconeogenesis, nitrogen depletion, diminished lymphoid tissue

and immune response, inhibition of pituitary function, Cushingoid syndrome, increase in blood coagulability,

diminished response.

Corticosteroid effects may be enhanced in patients with hypothyroidism or cirrhosis.

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Co – treatment with CYP3A inhibitors including cobicistat containing products is expected to increase the risk of

systemic side effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic

corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects (see

section 4.8). During post marketing use, there have been reports of clinically significant drug interactions in patients

receiving triamcinolone acetonide and ritonavir, resulting in systemic corticosteroid effects including Cushing’s

syndrome and adrenal suppression (see section 4.8). Therefore, caution is advised in co-administration of triamcinolone

acetonide and ritonavir (see section 4.5).

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 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.

Prolonged use in children may lead to growth retardation.

Some recovery may occur on discontinuing therapy.

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.

corticosteroids have been stopped following prolonged therapy they may need to be reintroduced temporarily.

Patients

on prolonged therapy should obtain and carry with them a steroid treatment card from their pharmacist which gives

clear guidance on the precautions to be taken to minimise risk and which provides details of prescriber, drug, dosage

and the duration of treatment.

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 section 4.5), 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.

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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.

This product contains 15 mg/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.

Intra-articular Injection:

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.

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 agents 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.

hypokalaemic effect of diuretics, including acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone, 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.

CYP 3A4 inhibitors: Triamcinolone acetonide is a substrate of CYP3A4. Caution is advised in co-administration with

strong CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir,

saquinavir, ketoconazole, telithromycin) with triamcinolone because increased systemic corticosteroid adverse effects

may occur (see section 4.8). During post marketing use, there have been reports of clinically significant drug

interactions in patients receiving triamcinolone acetonide and ritonavir, resulting in systemic corticosteroid effects

including Cushing’s syndrome and adrenal suppression (see section 4.4 and 4.8).

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Non-depolarising muscle relaxants: Corticosteroids may decrease or enhance the neuromuscular blocking action.

Non-steroidal 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 section 4.4).

4.6 Fertility, pregnancy and lactation

Pregnancy

Corticosteroids are not recommended for pregnant patients, particularly in the first trimester, or for nursing mothers,

except when the disease for which they are indicated warrants their use.

When corticosteroids are essential however,

patients with normal pregnancies may be treated as though they were in the non-gravid state.

There is evidence of harmful effects in pregnancy in animals.

There may be a small risk of cleft palate and intra-

uterine growth retardation.

Hypoadrenalism may occur in the neonate.

Patients with pre-eclampsia or fluid retention

require close monitoring.

Breast-feeding

Corticosteroids are found in breast milk.

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 <1/100); rare (

1/10,000 to

<1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Where adverse reactions occur they are usually reversible on cessation of therapy.

The incidence of predictable side-

effects, including hypothalamic-pituitary-adrenal suppression correlate with the relative potency of the drug, dosage,

timing of administration and duration of treatment (see section 4.4).

Absorption of triamcinolone following Adcortyl injection, especially when given 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:

System Organ Class

Frequency

MedDRA Terms

Infections and

infestations

Common

infection, increased susceptibility

and severity of infections such as

sepsis, necrotising fasciitis

Uncommon

injection site abscess sterile,

candida infection, eye infection

viral, eye infection fungal,

infection masked, tuberculosis

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Metabolism and

nutrition disorders

Uncommon

sodium retention, fluid retention,

alkalosis hypokalaemic,

hyperglycaemia, diabetes mellitus,

diabetes mellitus inadequate

control, calcium deficiency,

increased appetite

Musculoskeletal

connective tissue and

bone disorders

Uncommon

muscular weakness, myopathy,

muscle atrophy, osteoporosis,

osteonecrosis, fracture delayed

union, pathological fractures,

neuropathic arthropathy,

musculoskeletal discomfort,

growth retardation

Immune system

disorders

Uncommon

Aanaphylactoid reaction,

anaphylactic reactions,

anaphylactic shock

Gastrointestinal

disorders

Uncommon

peptic ulcer with possible

subsequent perforation and

haemorrhage, pancreatitis,

abdominal distension, oesophagitis

ulcerative, dyspepsia

Skin and subcutaneous

tissue disorders

Uncommon

rash, pruritus, urticaria

(particularly where there is a

history of drug allergies), skin

hyperpigmentation, skin

hypopigmentation, skin atrophy,

skin fragility, petechiae,

ecchymosies, erythema,

hyperhidrosis, purpura, skin striae,

hirsutism, dermatitis acneiform,

cutaneous lupus erythematous,

angioedema

Nervous system

disorders

Common

headache

Uncommon

convulsion, syncope, benign

intracranial hypertension usually

after treatment, neuritis,

paraesthesia, epilepsy

Reproductive system

and breast disorders

Uncommon

menstrual irregularities,

amenorrhoea and postmenopausal

vaginal bleeding

Endocrine disorder

Uncommon

cushingoid, adrenal suppression,

secondary adrenocortical and

pituitary unresponsiveness

Eye disorders

Uncommon

blindness,

cataract, glaucoma,

exophthalmos, papilloedema,

corneal or scleral thinning, corneal

perforation

Ear and labyrinth

disorders

Uncommon

vertigo

Cardiac disorders

Uncommon

cardiac failure congestive,

arrhythmia

Vascular disorders

Uncommon

hypertension, vasculitis

necrotising, thrombophlebitis,

embolism,leucocytosis, flushing

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Psychiatric disorders may occur in both adults and children.

Withdrawal Symptoms and Signs:

On withdrawal, psychological effects have been reported with corticosteroids, fever, myalgia, arthralgia, rhinitis,

conjunctivitis, painful itchy skin nodules and weight decreased may occur, the frequency is uncommon.

Too rapid a

reduction in dose following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (see

section 4.4).

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: HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2.

Tel: +353 1 6764971;

Fax: +353 1 6762517; Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Not applicable.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Glucocorticoids, ATC code: H02AB08

Triamcinolone acetonide is a synthetic glucocorticoid, with marked anti-inflammatory and anti-allergic actions.

Following local injection of Adcortyl, relief of pain and swelling and greater freedom of movement are usually

obtained within a few hours; such administration avoids the more severe side-effects which may accompany parenteral

or oral corticosteroid administration.

Psychiatric disorders

Uncommon

irritability, euphoric mood,

depression, mood swings,suicidal

ideation), psychotic

disorders,personality changes,

anxiety, insomnia, cognitive

disorders including amnesia,

psychiatric symptom

General disorders and

administration site

conditions

Common

injection site reaction

Uncommon

synovitis, pain, injection site

irritation, injection site discomfort,

fatigue, impaired wound healing

Investigations

Uncommon

blood potassium decreased,

electrocardiogram change,

carbohydrate tolerance decreased,

weight increase, nitrogen balance

negative, blood calcium abnormal,

intraocular pressure increased,

laboratory test interference

Injury and poisoning

Uncommon

spinal compression fracture,

tendon rupture

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5.2 Pharmacokinetic properties

Triamcinolone acetonide may be absorbed into the systemic circulation from synovial

spaces.

However clinically

significant

systemic levels after intra-articular injection are unlikely to occur except perhaps following treatment

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.

risk of systemic absorption, though minimal, should be taken into consideration especially when repeated intralesional

administrations may be necessary.

5.3 Preclinical safety data

See section 4.6

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol

Polysorbate 80

Carmellose sodium

Sodium chloride

Water for injection

6.2 Incompatibilities

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

6.3 Shelf life

Unopened: 3 years

Once opened: For single use only. Discard any unused contents immediately after use.

6.4 Special precautions for storage

Do not store above 25°C. Do not freeze or refrigerate. Protect from light.

For storage conditions after first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Carton containing 5 x 1 ml clear Type I glass ampoules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Store in an upright position.

Shake well before use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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7 MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb Pharmaceuticals uc

Plaza 254, Blanchardstown Corporate Park 2, Ballycoolin

Dublin 15, D15 T867

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0002/018/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1

April 1978

Date of last renewal: 20

October 2007

10 DATE OF REVISION OF THE TEXT

November 2017

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