Kenalog Injection 40mg in 1ml (1 x 1ml vial)

Kenalog

Prescription corticosteroid injection

Triamcinolone acetonide depot corticosteroid (IA/IM)

UK marketing authorisation (PL 12038/0005) as a prescription Only medicinal product
Manufactured and controlled under Good Manufacturing Practice (GMP) for medicinal products
Regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA)

UK marketing authorisation (PL 12038/0005) as a prescription Only medicinal product
Manufactured and controlled under Good Manufacturing Practice (GMP) for medicinal products
Regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA)

Triamcinolone acetonide depot corticosteroid (IA/IM)

Description

Kenalog Injection 40mg in 1ml is a sterile aqueous suspension containing triamcinolone acetonide 40 mg/ml, a synthetic glucocorticoid corticosteroid with marked anti-inflammatory and anti-allergic action. It is intended for intra-articular and intramuscular use only. Intra-articularly, it is used to relieve joint pain, swelling and stiffness associated with inflammatory joint disorders. Intramuscularly, it provides sustained systemic corticosteroid activity for a range of allergic, rheumatic, dermatological, endocrine and other inflammatory conditions. The 1 ml single vial (40 mg) presentation is typically used as a single-dose pack.

Bnefits

Provides potent anti-inflammatory and anti-allergic effects from a single depot injection
Intra-articular injection can give rapid relief of joint pain, swelling and stiffness with greater freedom of movement, often within hours
Intramuscular administration offers prolonged systemic corticosteroid effect, reducing the need for frequent dosing compared with oral steroids
Useful in the management of a wide range of inflammatory, allergic and autoimmune conditions when systemic or local steroid therapy is indicated
Sterile aqueous suspension suitable for injection into joints, bursae and muscle by trained healthcare professionals

Indications

Intra-articular use: alleviation of joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis with an inflammatory component
Intra-articular or peri-articular use in bursitis, epicondylitis and tenosynovitis
Intramuscular use where sustained systemic corticosteroid treatment is required in conditions such as:
• Allergic states (e.g. bronchial asthma and other severe allergic disorders)
• Endocrine disorders (e.g. primary or secondary adrenocortical insufficiency when systemic steroids are indicated)
• Collagen disorders (e.g. systemic lupus erythematosus during exacerbations, acute rheumatic carditis)
• Dermatological diseases (e.g. pemphigus, severe dermatitis, Stevens–Johnson syndrome)
• Rheumatic, gastrointestinal or respiratory disorders as an adjunctive short-term therapy
• Haematological disorders (e.g. acquired autoimmune haemolytic anaemia)
• Neoplastic diseases for palliative management of certain leukaemias and lymphomas
• Renal disease such as acute interstitial nephritis, minimal change nephrotic syndrome or lupus nephritis

Composition

Active ingredient: Triamcinolone acetonide 40 mg per ml
Benzyl alcohol 15 mg/ml (preservative)
Carmellose sodium (carboxymethylcellulose sodium)
Polysorbate 80
Sodium chloride
Water for injections
Sodium hydroxide and/or hydrochloric acid may be used to adjust pH

Formulation

Sterile aqueous suspension for injection
Concentration: 40 mg/ml triamcinolone acetonide
Depot corticosteroid formulation suitable for intra-articular and intramuscular use only
Not suitable for intravenous, intrathecal, epidural or intraocular injection

Packaging

Glass vial containing 1 ml sterile aqueous suspension (40 mg triamcinolone acetonide per vial)
Single-dose presentation (often supplied in cartons; original pack type: cartons of 5 x 1 ml vials, of which this product is a single ampoule/vial)
Prescription-only medicine

Usage

Kenalog Injection must only be administered by a suitably trained healthcare professional under strict aseptic conditions.
Route of administration: deep intramuscular injection into the gluteal muscle, or intra-articular/intrabursal injection into the affected joint or bursa; not for intravenous, intrathecal, epidural, intraocular or intradermal injection.
Intra-articular: dose typically ranges from 5–10 mg (0.125–0.25 ml) for small joints up to 40 mg (1 ml) for large joints, depending on disease and joint size; single injections into several joints may be given up to a usual maximum total of 80 mg.
Intramuscular (systemic use): a common initial adult dose is 40 mg (1 ml) deeply into the upper outer quadrant of the gluteal muscle; subsequent dosing and intervals are tailored to the patient’s response and clinical condition.
In children (6–12 years), dosing is generally scaled from 40 mg (1 ml) according to age, weight and severity; Kenalog is not recommended in children under 6 years.
Due to benzyl alcohol content, the product must not be given to premature babies or neonates and used with caution in children up to 3 years of age.
The duration of action is variable; repeat injections should be based on symptom recurrence rather than fixed schedules.
If patients receive more than physiological doses (e.g. repeated injections), systemic corticosteroid therapy should not be stopped abruptly; dose tapering and interval extension may be required according to clinical judgement and official guidance.

Contraindications

Hypersensitivity to triamcinolone acetonide, benzyl alcohol or any excipient in the formulation
Systemic infections unless specific anti-infective therapy is being used
Administration by intravenous, intrathecal, epidural or intraocular routes
Active infection in or near a joint to be injected, or septic arthritis
Unstable joints for intra-articular injection
Premature babies and neonates due to benzyl alcohol content
Generally contraindicated or used with extreme caution in patients where systemic corticosteroids are otherwise contraindicated (e.g. certain uncontrolled infections)

Adverse Effects

Local: injection site pain, irritation, sterile abscess, impaired healing, subcutaneous fat atrophy if not injected deeply intramuscularly, synovitis or joint discomfort after intra-articular use
Musculoskeletal: osteoporosis, osteonecrosis, tendon rupture (especially with repeated injections into tendons), muscle weakness or atrophy, growth retardation in children with prolonged systemic use
Endocrine/metabolic: Cushingoid features, adrenal suppression, hyperglycaemia or worsening diabetes, fluid and sodium retention, hypokalaemia, weight changes
Immune/infectious: increased susceptibility to infections, masking of infection signs, reactivation or worsening of latent infections such as tuberculosis
Gastrointestinal: peptic ulceration, GI bleeding or perforation, dyspepsia
Neuropsychiatric: mood changes, euphoria, depression, anxiety, psychotic reactions, insomnia
Ophthalmic: cataract, glaucoma, blurred vision, central serous chorioretinopathy (with systemic corticosteroid use)
Other systemic: hypertension, thromboembolic events, skin thinning, acneiform eruptions, striae, urticaria, angioedema, anaphylactic and anaphylactoid reactions (including rare severe cases)

Storage Conditions

Do not store above 25°C.
Do not freeze.
Store in an upright position.
Keep the vial in the outer carton to protect from light.
Keep out of the sight and reach of children.
Dispose of any unused product or waste material in accordance with local requirements.

Duration

Highly individualized; a single intra-articular injection may provide benefit for weeks, while systemic intramuscular use may require repeated doses spaced at intervals of several weeks or longer depending on the condition, response and risk of adverse effects.

Onset

Following intra-articular injection, relief of pain and swelling and improved mobility are usually obtained within a few hours. After intramuscular injection, systemic effects and adrenal suppression have been observed to occur within 24\u201348 hours, with therapeutic action often persisting for several weeks.