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Triamcinolone acetonide

Presentation

Suspension for intra-articular or intradermal injection containing triamcinolone acetonide 10mg per ml.

Drugs List

  • ADCORTYL INTRA-ARTICULAR/INTRADERMAL 50mg/5ml injection suspension
  • triamcinolone acetonide 50mg/5ml injection suspension
  • Therapeutic Indications

    Uses

    Intra-articular administration:
    Tenosynovitis
    Bursitis
    Epicondylitis
    Joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis with an inflammatory component.

    Intradermal administration:
    Lichen simplex chronicus (neuro-dermatitis)
    Granuloma annulare
    Lichen planus
    Keloids
    Alopecia areata
    Hypertrophic scars

    Dosage

    The lowest possible dose should be employed for the minimum period, in order to minimise adverse effects.

    As the duration of effect is variable subsequent dosage depends on the patient's response and period of relief and should be given when symptoms recur and not at set intervals.

    Adults

    Intra-articular, tendon sheath and intrabursal injection
    Smaller joints: 2.5mg to 5mg (0.25ml to 0.5ml) depending on the size of the joint and the severity of the condition.
    Larger joints: 5mg to 15mg (0.5ml to 1.5ml) depending on the size of the joint and the severity of the condition.
    A preparation containing triamcinolone acetonide 40mg/ml may be used for the administration of larger doses.

    Intradermal injection
    2mg to 3 mg (0.2ml to 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 treated, the total dose administered should not exceed 30mg (3ml).
    The injection may be repeated, if necessary, at one to two week intervals.

    Elderly

    Elderly patients are more susceptible to the 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. The treatment plan should take this into account, particularly if long-term treatment is intended.

    Close clinical supervision is required to avoid life threatening reactions.

    Children

    Growth and development of children on prolonged therapy should be carefully observed.

    Children aged 6 to 18 years
    Intra-articular/intradermal injection may be used in suitably adjusted doses.

    The following alternative dosing schedule may be suitable:
    Children aged 6 to 18 years
    Intra-arterial injection: 2mg/kg (up to 15mg per dose) for larger joints. If appropriate, repeat treatment for relapse.
    Children aged 1 to 6 years (unlicensed)
    Intra-arterial injection: 2mg/kg (up to 15mg per dose) for larger joints. If appropriate, repeat treatment for relapse.

    Additional Dosage Information

    Intra-articular corticosteroid injections may affect the hyaline cartilage and each joint should usually be treated no more than three times in one year.

    Administration

    For intradermal or intra-articular injection using strict aseptic precautions.

    Contraindications

    Infections in the absence of anti-infective therapy
    Children under 1 year
    For administration by the intradermal or intra-articular routes only. Other routes of administration are contraindicated
    Intra-articular injection should not be given into infected joints or where there is infection located near to joints.
    Use in the achilles tendon (which lacks a true tendon sheath) is not recommended.

    Precautions and Warnings

    Intra-articular injection
    Do not administer into unstable joints.
    Take care that injections given into tendon sheaths are not injected into the tendon itself.
    Avoid repeated injection into inflamed tendons as this may cause tendon rupture.

    Warn patients not to overuse joints in which symptomatic benefit has been obtained.

    Repeated intra-articular injections over a long period may lead to severe joint destruction with bone necrosis.

    Not suitable for the relief of pain arising from infectious states such as gonococcal or tubercular arthritis.

    Adequate studies to demonstrate the safety of use by intra-turbinal, subconjunctival, sub-tendons, 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.

    General
    To minimise undesirable effects, the lowest effective dose should be used for the minimum period of time, and by administering the daily requirement, whenever possible, as a single morning dose on alternate days. Review the patient's clinical condition frequently to titrate the dose appropriately against disease activity.

    Adrenal cortical atrophy develops on prolonged treatment and may persist for years after treatment has ceased. After prolonged therapy, withdrawal should be gradual and tapered off over weeks or months according to the dose or duration of treatment.
    During prolonged treatment, any additional stress such as intercurrent illness, trauma or surgical procedure will require a temporary increase in dose. If corticosteroids have been stopped after long term therapy, a temporary reintroduction may be required in such situations.

    Patients should carry steroid cards which give clear guidance on the precautions to be taken to minimise risk.

    Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. Serious infections (such as septicaemia and tuberculosis) may be masked and reach an advanced stage before they are recognised.

    Chicken pox and measles may follow a more serious course in patients receiving glucocorticosteroid. Particular care should be taken to avoid exposure in patients who have not previously had these diseases. If exposed the patient should seek urgent medical advice.

    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 chicken pox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and dosage may need to be increased.

    Diabetes may be aggravated, necessitating a higher insulin dosage. Latent diabetes mellitus may be precipitated.

    Menstrual irregularities may occur and female patients should be advised of the possibility.

    Post menopausal women may experience vaginal bleeding.

    Corticosteroid effects may be increased in hypothyroid patients or decreased in hyperthyroid patients.

    Corticosteroid effects may be increased in patients with hepatic cirrhosis.

    Anaphylactoid reactions may occur rarely and this is more likely in patients with a history of drug allergies.

    Corticosteroids increase calcium excretion.

    During corticosteroid therapy antibody response will be reduced and therefore affect the patients response to vaccines. Live vaccines should not be administered.

    Patients should not self administer NSAID's unless under guidance from a clinician.

    Particular care required in patients with existing or a history of severe affective disorders in themselves or in their first degree relatives.

    Potentially severe psychiatric adverse reactions may occur, typically within a few days or weeks of starting treatment. Dose levels do not predict onset, type, severity or duration of reactions. most reactions recover after dose reduction or withdrawal, however specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop.

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

    Children under 6 years (see Dosage - Children ).
    Monitor growth and development of children and adolescents on corticosteroid therapy as they cause dose-related growth retardation which may be irreversible.

    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.

    Elderly - use with caution as they are more susceptible to adverse effects.

    Pregnancy (see Pregnancy ).

    Breastfeeding (see Lactation ).

    Use with caution in patients with the following conditions and monitor the patient frequently:
    Recent intestinal anastomoses
    Diverticulitis
    Thrombophlebitis
    Exanthematous disease
    Existing or history or severe affective disorders (especially previous steroid psychosis)
    Chronic nephritis
    Renal insufficiency
    Metastatic carcinoma
    Osteoporosis (particularly post-menopausal females)
    Active peptic ulcer or history of peptic ulcer
    Myasthenia gravis
    Latent or healed tuberculosis
    Acute psychoses
    Hypertension
    Acute glomerulonephritis
    Congestive heart failure
    Glaucoma or family history of glaucoma
    Previous steroid myopathy
    Epilepsy
    Liver failure
    In presence of local or systemic viral infection
    Systemic fungal infections
    Active infections not controlled by antibiotics

    Pregnancy and Lactation

    Pregnancy

    Contraindicated in pregnancy.

    Administration of corticosteroids to pregnant women may increase the risk of intra-uterine growth retardation. At the time of writing, there is limited published experience concerning exposed pregnancies and their outcomes. Administration in animals has been reported to cause cause abnormalities of foetal development. Triamcinolone crosses the placental barrier but Schaefer (2007) concludes that inadvertent exposure to triamcinolone during the first trimester is not an indication for termination of the pregnancy or invasive diagnostics. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Licensed in pregnancy? - No, Contraindicated

    Recommended for use in pregnancy? - No

    Known human teratogen? - Unknown

    Animal data - Can cause abnormalities in foetal development

    Crosses placenta? - Yes

    Effects on foetus - May increase the risk of intra-uterine growth retardation

    Lactation

    Contraindicated in breastfeeding.

    At the time of writing, there is no published experience concerning the use of triamcinolone during breastfeeding. Alternatives such as prednisolone and prednisone which are compatible with breastfeeding, are the corticosteroids of choice for systemic treatment during breastfeeding. If high doses of triamcinolone are repeatedly given then a 3-4 hour wait before breastfeeding may be preferred, however treatment is unlikely to result in large amounts in breast milk. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression (Schaefer, 2007).

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Drug excreted in breast milk? - Unknown

    Considered suitable or recommended by manufacturer? - No

    Drug substance licensed in infants? - No

    Effects on Ability to Drive and Operate Machinery

    None known.

    Counselling

    Advise patients not to overuse joints in which symptomatic benefit has been obtained.

    Advise female patients that menstrual irregularities may occur.

    Advise patients that they should carry steroid cards which give clear guidance on the precautions to be taken to minimise risk.

    Advise patients to avoid exposure to chicken pox and measles in patients who have not previously had these diseases. If exposed the patient should seek urgent medical advice.

    Advise patients should not self administer with NSAID's unless under guidance from a clinician.

    Side Effects

    Suppression of the hypothalamic-pituitary-adrenal axis
    Immunosuppression
    Increased susceptibility and severity of infections
    Suppression of clinical signs of infection
    Opportunistic infections
    Recurrence of dormant tuberculosis
    Fluid and electrolyte disturbances
    Congestive cardiac failure
    Cardiac arrhythmias
    Hypokalaemic alkalosis
    Increased calcium excretion
    Hypertension
    Musculoskeletal disturbances
    Hypersensitivity reactions
    Dermatological disturbances
    Gastro-intestinal symptoms
    Dyspepsia
    Peptic ulceration with perforation and haemorrhage
    Pancreatitis
    Ulcerative oesophagitis
    Candidiasis (gastro-intestinal)
    Neurological disorders
    Psychiatric disorders
    Aggravation of pre-existing psychiatric conditions
    Psychotic reactions
    Behavioural disturbances
    Endocrine disturbances
    Secondary adrenocortical and pituitary unresponsiveness
    Ophthalmic disturbances
    Increased intra-ocular pressure
    Necrotising angiitis
    Thrombophlebitis
    Thromboembolism
    Leucocytosis
    Insomnia
    Syncope
    Withdrawal symptoms
    Facial flushing (transient)
    Dizziness
    Post-injection flare
    Transient pain and swelling
    Irritation (localised)
    Abscess (sterile)
    Hyperpigmentation
    Hypopigmentation
    Charcot-like arthropathy
    Joint discomfort
    Lipoatrophy at injection site
    Cutaneous atrophy
    Subcutaneous atrophy
    Rare instances of blindness with intralesional therapy around face and head
    Menstrual disturbances
    Muscle weakness
    Fatigue
    Myopathy
    Osteoporosis
    Osteonecrosis
    Fractures
    Tendon rupture
    Wound healing retarded
    Petechiae
    Ecchymosis
    Facial erythema
    Increased sweating
    Purpura
    Striae
    Hirsutism
    Lupus erythematosus
    Euphoria
    Depression
    Convulsions
    Vertigo
    Headache
    Neuritis
    Anxiety
    Sleep disturbances
    Confusion
    Amnesia
    Weight gain
    Increased appetite
    Glaucoma
    Exophthalmos
    Papilloedema
    Corneal thinning
    Amenorrhoea
    Postmenopausal bleeding

    Withdrawal Symptoms and Signs

    On withdrawal, the following effects may be seen:
    Fever
    Myalgia
    Arthralgia
    Rhinitis
    Conjunctivitis
    Painful itchy skin nodules
    Weight loss

    Rapid dose reduction after prolonged treatment may lead to acute adrenal insufficiency, hypotension and death.

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Shelf Life and Storage

    Store in an upright position.
    Do not store above 25 degrees C.
    Do not freeze.

    Further Information

    Last Full Review Date: August 2012

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Adcortyl Intra-articular/Intradermal Injection 10mg/ml. E. R. Squibb & Sons Limited. Revised March 2014.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 September 2017

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Triamcinolone Last revised: July 10, 2012
    Last accessed: August 10, 2012

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