Adcortyl Triamcinolone Acetonide Suspension for Iinjection

Adcortyl

Prescription-only corticosteroid medicine (POM)

Intra-articular and intradermal triamcinolone acetonide suspension for injection (multi-dose vial)

Adcortyl Intra Articular / Intradermal Injection 10mg/ml Suspension for Injection (5ml vial and 1ml ampoules) is a licensed medicinal product in the UK and Ireland containing triamcinolone acetonide, with product information published via the MHRA and HPRA (e.g. emc and medicines.ie) and Marketing Authorisation held by Bristol Myers Squibb Pharmaceuticals Unlimited Company.
The MHRA substance entry for triamcinolone acetonide lists Adcortyl IA/ID Injection 10mg/ml among the authorised products, confirming UK regulatory approval as a medicinal product.
The product is classified as a prescription Only medicine (POM) and must be prescribed and administered under the supervision of an appropriate healthcare professional.
Manufacture and quality control are conducted in compliance with EU/UK Good Manufacturing Practice (GMP) requirements, with authorised manufacturing sites named in the SmPC and PIL (e.g. Catalent Anagni S.R.L. and associated Bristol Myers Squibb operations).
Product information, including the Summary of Product Characteristics and Patient Information Leaflet, is approved by the MHRA/HPRA and subject to ongoing pharmacovigilance and periodic review; safety monitoring is supported by national adverse drug reaction reporting systems (e.g. MHRA Yellow Card).

Adcortyl Intra Articular / Intradermal Injection 10mg/ml Suspension for Injection (5ml vial and 1ml ampoules) is a licensed medicinal product in the UK and Ireland containing triamcinolone acetonide, with product information published via the MHRA and HPRA (e.g. emc and medicines.ie) and Marketing Authorisation held by Bristol Myers Squibb Pharmaceuticals Unlimited Company.
The MHRA substance entry for triamcinolone acetonide lists Adcortyl IA/ID Injection 10mg/ml among the authorised products, confirming UK regulatory approval as a medicinal product.
The product is classified as a prescription Only medicine (POM) and must be prescribed and administered under the supervision of an appropriate healthcare professional.
Manufacture and quality control are conducted in compliance with EU/UK Good Manufacturing Practice (GMP) requirements, with authorised manufacturing sites named in the SmPC and PIL (e.g. Catalent Anagni S.R.L. and associated Bristol Myers Squibb operations).
Product information, including the Summary of Product Characteristics and Patient Information Leaflet, is approved by the MHRA/HPRA and subject to ongoing pharmacovigilance and periodic review; safety monitoring is supported by national adverse drug reaction reporting systems (e.g. MHRA Yellow Card).

Intra-articular and intradermal triamcinolone acetonide suspension for injection (multi-dose vial)

Description

Adcortyl IA/ID Injection 10mg/ml is a sterile aqueous suspension of the corticosteroid triamcinolone acetonide for intra-articular and intradermal administration. It is supplied in a 5ml multi-dose glass vial containing 50mg triamcinolone acetonide (10mg/ml) for injection. Adcortyl is licensed for intra-articular use to relieve joint pain, swelling and stiffness in inflammatory joint disorders such as rheumatoid arthritis and osteoarthritis, and for intradermal use in certain skin conditions including some forms of chronic allergic or inflammatory dermatoses, thickened scar tissue (e.g. keloids, hypertrophic scars) and patchy hair loss such as alopecia areata. As a synthetic glucocorticoid, triamcinolone acetonide reduces inflammation and immune-mediated tissue reactions. Adcortyl must only be given by healthcare professionals experienced in local corticosteroid injections and only in settings with access to resuscitation facilities because of the risk of serious systemic reactions.

Bnefits

Provides potent local anti-inflammatory and immunosuppressive effects at the site of injection while limiting systemic exposure compared with long-term systemic corticosteroids.
Intra-articular administration can reduce pain, swelling and stiffness in selected inflamed joints in conditions such as rheumatoid arthritis and osteoarthritis when conventional measures are insufficient.
Intradermal administration allows targeted treatment of certain chronic inflammatory or hypertrophic skin lesions (e.g. keloids/hypertrophic scars, localised psoriatic plaques, lichenified eczema, alopecia areata) when appropriate.
Suspension formulation (10mg/ml) offers prolonged local action, with clinical effect often persisting for several weeks after a single injection, allowing extended symptom relief and reduced injection frequency.
Multi-dose 5ml vial (50mg total triamcinolone acetonide) enables multiple injections in different sites or repeat injections according to clinical need and dosing guidance.
Extensive regulatory documentation (SmPC and PIL) describes dosing, safety, interactions and monitoring, supporting safe use by trained clinicians in hospital and specialist outpatient settings.

Indications

Intra-articular injection for the relief of pain, swelling and stiffness in inflammatory joint disorders such as rheumatoid arthritis and osteoarthritis when only one or a few joints are affected and systemic therapy is not required or needs to be supplemented.
Intra-articular use in other arthropathies where a local corticosteroid injection is indicated on specialist advice.
Intradermal injection for certain steroid-responsive dermatoses and localised skin disorders, including various forms of allergic or inflammatory dermatitis, localised psoriatic lesions and some other chronic inflammatory plaques where intradermal corticosteroid therapy is appropriate.
Intradermal treatment of thickened scar tissue (e.g. keloids, hypertrophic scars) where reduction of scar bulk and symptoms is clinically indicated.
Intradermal treatment of patchy alopecia areata (non-scarring alopecia) in selected patients under specialist supervision.
Use strictly within the licensed indications and in line with relevant national formulary and guideline recommendations; Adcortyl is not licensed for systemic intramuscular, intravenous, intrathecal or epidural use.

Composition

Active substance: triamcinolone acetonide 10mg/ml – each 5ml multi-dose vial contains 50mg triamcinolone acetonide as a sterile aqueous suspension.
Excipients (as listed in the MHRA/HPRA product information and patient leaflet): benzyl alcohol, polysorbate 80, carmellose sodium, sodium chloride and water for injections. Small amounts of sodium hydroxide and/or hydrochloric acid may be used for pH adjustment as described in the SmPC.
The suspension is preservative-containing (benzyl alcohol) and is intended as a multi-dose vial; dosing must take into account the total benzyl alcohol exposure, particularly in children and other high-risk groups.

Formulation

Pharmaceutical form: Suspension for injection.
Strength: 10mg/ml triamcinolone acetonide in a sterile aqueous suspension.
Appearance: white or nearly white aqueous suspension for injection.
Presentation: multi-dose 5ml glass vial (Adcortyl Intra-articular / Intradermal Injection 10mg/ml Suspension for Injection, 5ml). Some packs may also include 5 × 1ml ampoules; the DD Group listing specifically refers to the 5ml vial.
Route of administration: intra-articular and intradermal use only; not for intravenous, intramuscular, intrathecal, epidural, intra-ocular or other unapproved routes.
Pharmacotherapeutic group: Corticosteroids for local use – ATC code typically classified under H02AB (glucocorticoids) with local injection use specified in regulatory documentation.

Packaging

Pack containing one 5ml clear glass multi-dose vial of Adcortyl IA/ID Injection 10mg/ml with rubber stopper and aluminium overseal, supplied in an outer cardboard carton.
Regulatory product information also describes an alternative presentation of 5 × 1ml glass ampoules; however, the DD Group dental/aesthetic listing identifies the 5ml vial presentation (Adcortyl Injection 5ml).
Carton and vial labelling include product name, strength, route of administration (intra-articular/intradermal), active ingredient, batch number, expiry date, storage instructions and Marketing Authorisation Holder details.
Supplied to pharmacies, hospitals and specialist clinics as a prescription-only medicine; use is restricted to healthcare professionals experienced in intra-articular and intradermal corticosteroid injections.

Usage

Adcortyl Injection must only be administered by suitably trained healthcare professionals experienced in intra-articular and intradermal injections, using strict aseptic technique.
For intra-articular or intradermal use only; injections by any other route (intravenous, intramuscular, intrathecal, epidural, intra-ocular, intra-lesional into infected tissue, etc.) are contraindicated.
Posology is individualised based on the condition treated, lesion or joint size, and patient factors. Since the duration of effect is variable, repeat injections should be given when symptoms recur and not at fixed time intervals.
Intra-articular injections: doses for large joints (e.g. knee, shoulder) are higher than for small joints (e.g. fingers); representative clinical guidance often uses 5–15mg (0.5–1.5ml) for large joints and lower doses for smaller joints, with the minimum effective dose used to control symptoms. Frequency of injection into a single joint is usually limited to a few times per year to reduce risk of cartilage damage.
Intradermal injections: very small volumes of suspension are injected into or just beneath the lesion (e.g. 0.1–0.2ml per injection point), often using a fine needle, with care to limit total dose and avoid dermal atrophy. Lesions such as keloids, hypertrophic scars or localised dermatoses are usually treated with multiple small injections distributed across the lesion.
Before injection, the vial should be gently shaken to resuspend the triamcinolone acetonide particles; the suspension must not be used if clumps or large particles persist or if there is evidence of contamination.
Aspiration prior to intra-articular injection is recommended to confirm that the needle is correctly positioned in the joint space and not in a blood vessel or soft tissue.
Adcortyl injections should be given in facilities where resuscitation equipment and trained staff are immediately available because serious hypersensitivity and other acute reactions have been reported with injectable corticosteroids.
Dose adjustments and careful monitoring are required in patients with diabetes mellitus, hypertension, cardiovascular disease, peptic ulcer disease, osteoporosis, glaucoma, or other conditions that can be worsened by systemic corticosteroid exposure, even though the product is intended for local use.
Detailed dosing schedules, maximum doses, injection techniques and frequency limits are specified in the official SmPC and national clinical guidelines; these documents must be consulted before use.

Contraindications

Hypersensitivity to triamcinolone acetonide or to any of the excipients (benzyl alcohol, polysorbate 80, carmellose sodium, sodium chloride or other listed ingredients).
Systemic or local infection at the proposed injection site; septic arthritis or suspicion of joint infection – intra-articular injection must not be performed in or near infected joints.
Unstable joints, joint instability or fractures involving the joint; injections should not be made into unstable or mechanically compromised joints.
Intra-articular use in prosthetic joints (prosthetic arthroplasty) is contraindicated.
Use in patients with uncontrolled bleeding disorders, or those on anticoagulant therapy where the risk of bleeding into the joint or injection site is unacceptable.
Administration by routes other than those recommended (e.g. intravenous, intrathecal, epidural, intra-ocular or intramuscular) is contraindicated.
Relative or absolute contraindications associated with systemic corticosteroid exposure, including uncontrolled diabetes mellitus, severe hypertension, severe osteoporosis, active peptic ulcer disease, severe psychosis or uncontrolled heart failure, must be carefully assessed; in many such cases Adcortyl should be avoided or used only with extreme caution under specialist supervision.
Use in premature or newborn infants is contraindicated because of the benzyl alcohol content; benzyl alcohol has been associated with serious adverse events including "gasping syndrome" in neonates.
Vaccination with live attenuated vaccines is generally contraindicated in patients receiving immunosuppressive doses of corticosteroids; although Adcortyl is used locally, cumulative steroid exposure and other systemic steroid therapy must be considered.

Adverse Effects

Local adverse effects at the injection site may include pain, swelling, irritation, bleeding, infection, sterile abscess, and delayed healing.
Musculoskeletal complications from intra-articular or periarticular injections include subchondral bone damage, cartilage degeneration, osteonecrosis, tendon rupture (particularly if injected into or around tendons such as the Achilles tendon), soft tissue atrophy, and weakening of ligaments or joint structures.
Local skin reactions with intradermal injections include dermal and subcutaneous atrophy, skin thinning, hypopigmentation or hyperpigmentation, telangiectasia, striae and localised changes in skin texture.
Systemic corticosteroid effects may occur, particularly with repeated or high-dose injections, including Cushingoid features (moon face, truncal obesity), weight gain, fluid retention, hypertension, glucose intolerance or worsening of diabetes, dyslipidaemia, adrenal suppression and adrenal crisis on withdrawal, menstrual irregularities, growth retardation in children and adolescents, and osteoporosis with increased fracture risk.
Neuropsychiatric reactions known with corticosteroids include mood changes (euphoria, irritability, depression), psychotic reactions, sleep disturbance and increased intracranial pressure (including pseudotumour cerebri) particularly in children.
Gastrointestinal adverse effects include dyspepsia, peptic ulceration and gastrointestinal bleeding or perforation, especially in patients with risk factors or concurrent NSAID use.
Ophthalmic effects such as increased intraocular pressure, glaucoma, cataracts and exophthalmos are known risks of corticosteroid therapy and may be relevant in patients receiving repeated local injections.
Hypersensitivity reactions, including anaphylaxis, angioedema, bronchospasm, urticaria and rash, have been reported with injectable corticosteroids; such reactions may occur rapidly after injection and require urgent treatment.
Other systemic effects associated with glucocorticoids include increased susceptibility to infection, masking of infection, delayed wound healing, skin fragility, acneiform eruptions and changes in fat distribution.
The official SmPC provides a full list of adverse reactions classified by system organ class and frequency; clinicians should review this before prescribing or administering Adcortyl.

Storage Conditions

Do not store above 25°C (as specified in the regulatory product information).
Do not refrigerate or freeze unless explicitly stated otherwise in the current SmPC; freezing may alter the suspension characteristics.
Keep the vial in the outer carton in order to protect it from light.
Do not use after the expiry date stated on the vial and carton; the expiry date refers to the last day of the stated month.
After first opening of the multi-dose vial, use within the period specified in the SmPC and maintain strict aseptic technique when withdrawing doses to minimise the risk of contamination.
Keep out of the sight and reach of children.
Discard any unused suspension in accordance with local requirements for cytotoxic/hazardous pharmaceutical waste or steroid-containing medicines; do not dispose of via wastewater or household waste.

Duration

Adcortyl Injection is used as an intermittent local treatment rather than continuous systemic therapy. Duration of effect after a single intra-articular or intradermal injection is variable and may range from several weeks to a few months depending on the site and condition. Subsequent injections are given when symptoms recur rather than at fixed intervals, and the total number and frequency of injections into a single joint or lesion are limited to minimise local tissue damage. For chronic conditions, the need for repeated injections should be reviewed regularly, and long-term management plans should follow specialist guidance and official SmPC recommendations.

Onset

The SmPC and PIL do not provide a precise, standardised onset-of-action time. Clinically, symptom relief after intra-articular or intradermal injection often begins within a few days, with maximum benefit typically observed over the following days to weeks, but onset and duration vary between patients and indications.