Kenalog 40mg/1ml Injection (5 x 1ml amps) Ampoules

Kenalog

Prescription corticosteroid injection

Triamcinolone acetonide depot corticosteroid (intramuscular/intra-articular)

UK marketing authorisation as a prescription Only medicine (Kenalog Intra Articular / Intramuscular Injection 40mg/ml)
Manufactured in compliance with Good Manufacturing Practice (GMP) for medicinal products
Regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA)

UK marketing authorisation as a prescription Only medicine (Kenalog Intra Articular / Intramuscular Injection 40mg/ml)
Manufactured in compliance with Good Manufacturing Practice (GMP) for medicinal products
Regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA)

Triamcinolone acetonide depot corticosteroid (intramuscular/intra-articular)

Description

Kenalog 40mg/1ml Injection is a long-acting corticosteroid (triamcinolone acetonide 40mg/ml) presented as a sterile aqueous suspension for intramuscular (IM) and intra-articular (IA) injection. In routine clinical practice it is used to treat a wide range of inflammatory, allergic, rheumatic and autoimmune conditions. In private UK clinics and aesthetic/medical practices it is also used off-label as a single-dose hay fever injection for patients with severe seasonal allergic rhinitis that has not responded to standard therapies. The pack contains 5 x 1ml glass ampoules, each providing 40mg triamcinolone acetonide for deep IM or IA administration by a suitably trained healthcare professional.

Bnefits

Provides prolonged anti-inflammatory and immunosuppressive effect from a single depot injection
Can offer extended relief from severe hay fever symptoms (off-label use), including nasal congestion, sneezing and itchy or watery eyes
Reduces inflammatory responses in a wide range of systemic and joint conditions where corticosteroids are indicated
Long duration of action may reduce the need for frequent repeat dosing compared with short-acting steroids
Suitable for intramuscular administration for systemic effect or intra-articular injection for local joint symptom relief (when used according to the licensed indications)
Well-established corticosteroid with decades of clinical experience

Indications

Licensed indications (UK):
• Intra-articular use for alleviating joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis with an inflammatory component
• Peri-articular use in bursitis, epicondylitis and tenosynovitis
• Intramuscular use where sustained systemic corticosteroid therapy is required in conditions such as allergic states, rheumatic disorders, collagen diseases, dermatologic diseases, endocrine disorders, gastrointestinal and respiratory diseases, haematologic disorders, and neoplastic diseases (as outlined in the Summary of Product Characteristics)
Common off-label use in UK private practice:
• Severe seasonal allergic rhinitis (hay fever) that has not responded adequately to conventional treatments (e.g. antihistamines and intranasal steroids); Kenalog is not licensed for hay fever in the UK and guidance from allergy and ENT societies generally advises against routine use of depot steroid injections for allergic rhinitis

Composition

Triamcinolone acetonide 40 mg/ml (active ingredient)
Benzyl alcohol 15 mg/ml (preservative)
Carboxymethylcellulose sodium (carmellose sodium)
Polysorbate 80
Sodium chloride
Water for injections
Sodium hydroxide and/or hydrochloric acid (for pH adjustment)

Formulation

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

Packaging

Carton containing 5 x 1 ml glass ampoules (each ampoule contains 40 mg triamcinolone acetonide in 1 ml suspension)
Prescription-only medicine (POM)

Usage

Kenalog Injection must only be administered by an appropriately trained prescriber or healthcare professional using strict aseptic technique.
Route of administration: deep intramuscular injection (e.g. upper outer quadrant of the gluteal muscle) for systemic effect, or intra-articular/peri-articular injection for local joint/tendon conditions, in line with the licensed indications.
Typical adult systemic dose for IM use is around 40 mg (1 ml) given as a single deep intramuscular injection; precise dose, route and frequency must be determined by the prescribing clinician based on the indication, patient factors and official product information.
For intra-articular use, dosing depends on the size of the joint and severity of the condition; small joints usually require lower volumes than large joints.
Use for severe seasonal allergic rhinitis (hay fever) is an off-label indication in the UK and should only be considered after a careful risk–benefit assessment, once standard therapies (oral/non-sedating antihistamines and intranasal corticosteroids) have failed and in line with local clinical governance.
Because Kenalog is a long-acting depot steroid, repeat injections should not be given routinely; the interval between doses should be guided by clinical response and risk of systemic side effects.
If repeated or high-dose systemic corticosteroid therapy is given, treatment should not usually be stopped abruptly; tapering or supportive dosing during periods of physiological stress may be necessary according to clinical judgement and official guidance.
Always consult and follow the full Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for detailed dosing, administration, precautions and monitoring requirements.

Contraindications

Hypersensitivity to triamcinolone acetonide, benzyl alcohol or any of the excipients
Systemic fungal infections or uncontrolled systemic infections unless appropriate anti-infective therapy is in place
Infection in or around a joint to be injected (septic arthritis) or unstable joints for intra-articular injection
Administration by intravenous, intrathecal, intraocular, epidural or intradermal routes
Premature babies and neonates due to benzyl alcohol content
Generally contraindicated or requires extreme caution in patients where systemic corticosteroid therapy is otherwise contraindicated (e.g. certain peptic ulcer disease, severe osteoporosis, uncontrolled diabetes or hypertension, Cushing’s syndrome), as per SmPC and clinician judgement

Adverse Effects

Local reactions: pain, irritation, bruising, sterile abscess, tissue atrophy or depigmentation at the injection site, especially if not injected deeply intramuscularly
Musculoskeletal: osteoporosis, osteonecrosis, myopathy, muscle weakness, tendon rupture (particularly with local injections into tendons), growth suppression in children with prolonged systemic exposure
Endocrine and metabolic: adrenal suppression, Cushingoid features, weight gain, fluid retention, sodium retention and potassium loss, worsening of diabetes or hyperglycaemia, menstrual irregularities
Immune and infectious: increased susceptibility to infections, masking of infection signs, reactivation or exacerbation of latent infections (e.g. tuberculosis, herpes), impaired wound healing
Gastrointestinal: dyspepsia, peptic ulceration, GI bleeding or perforation, pancreatitis
Neuropsychiatric: mood changes (euphoria, depression, irritability), insomnia, anxiety, psychotic reactions, confusion, seizures (rare)
Ophthalmic: cataracts, glaucoma, raised intraocular pressure, central serous chorioretinopathy (with systemic corticosteroid use)
Cardiovascular and thromboembolic: hypertension, fluid overload, increased risk of thromboembolic events in susceptible patients
Dermatologic: skin thinning, striae, acneiform eruptions, bruising, delayed wound healing, urticaria, angioedema, anaphylactic or anaphylactoid reactions (rare but potentially serious)

Storage Conditions

Do not store above 25°C.
Do not freeze.
Store ampoules in an upright position in the original carton to protect from light.
Keep out of the sight and reach of children.
Do not use after the expiry date stated on the pack.
Discard any unused suspension in an opened ampoule; single-use only.

Duration

Highly variable and indication-dependent; a single intramuscular depot dose may provide symptomatic benefit for several weeks (often 3\u20138 weeks) and, in the context of hay fever, may cover a significant part of the pollen season. For chronic inflammatory conditions, repeat injections may be required at intervals determined by clinical response and safety considerations.

Onset

Following intramuscular injection, systemic corticosteroid effects typically emerge within 24\u201348 hours, with anti-inflammatory benefits often persisting for several weeks. After intra-articular injection, relief of joint pain and swelling may occur within hours to a few days.