TRISPAN Suspension for injection Ref.[27800] Active ingredients: Triamcinolone

Dosing Considerations

Trispan contains benzyl alcohol (see CONTRAINDICATIONS, and WARNINGS AND PRECAUTIONS – Special Populations, Pediatrics).

At each session, several injections may be given into multiple joints. Do not administer into unstable joints.

This formulation is intended for intra-articular, periarticular and intrasynovial use. It must not be used for intravenous, intra-ocular, epidural or intrathecal use.

Patients should be monitored for undesirable effects related to triamcinolone, and the dose should be adjusted if necessary.

Recommended Dose and Dosage Adjustment

The lowest effective dose should be used, and injections should not be repeated unless clinically indicated.

Intra-Articular Injection (dosage for adults and adolescents) for all indications

Average Dose: 2 to 20 mg (0.1 mL to 1.0 mL)

The dose depends on the size of the joint to be injected, the degree of inflammation and the amount of articular fluid present. In general, large joints (such as knee, hip, shoulder) require 10 to 20 mg (0.5 – 1.0 mL) and medium-sized joints require 5-10 mg (0.25 – 0.5 mL). For small joints, (such as interphalangeal, metacarpophalangeal), 2 to 6 mg may be employed. When the amount of synovial fluid is increased, aspiration may be performed before administering Trispan. Subsequent dosage and frequency of injections can best be judged by clinical response.

The usual frequency of injection into a single joint is every three to four weeks (although in many cases patients may experience longer relief of symptoms), and injection more frequently than that is generally not advisable. Triamcinolone hexacetonide is long-acting, and therefore administration of injections into individual joints more frequently than at 3-4 week intervals is not recommended. To avoid possible joint destruction from repeated use of intra-articular corticosteroids, injection should be as infrequent as possible, consistent with adequate patient care. Attention should be paid to avoid deposition of drug along the needle path, which might produce atrophy of surrounding tissues.

Dosage for intra-articular use in children aged 3 to 12 years with Juvenile Idiopathic Arthritis: The dosage regime for triamcinolone hexacetonide intra-articular injection for JIA in children (3- 12 years old) is 1 mg/kg for large joints (knees, hips, and shoulders) and 0.5 mg/kg for smaller joints (ankles, wrists and elbows). For the hands and feet, 1-2 mg/joint for metacarpophalangeal/ metatarsophalangeal (MCP/MTP) joints, and 0.6-1 mg/joint for proximal interphalangeal (PIP) joints may be used.

Peri-Articular Injection (dosage for adults and adolescents only)

Bursitis/Epicondylitis: Generally the dose is 10-20 mg (0.5-1.0 mL) depending on the size of the bursa and the severity of the disease. In the majority of cases a single treatment is sufficient.

Synovitis/Tendinitis: Generally the dose is 10-20 mg (0.5-1.0 mL). The need for additional injections should be determined on the basis of response to treatment.

Administration

Strict aseptic administration technique is mandatory. The injection site should be sterilised using the same technique as for lumbar puncture. Topical ethyl chloride spray may be used locally before injection. Over-distention of the joint capsule and deposition of the steroid along the needle track should be avoided. Do not administer into unstable joints.

The product is a milky white suspension in which some white or grey crystals may be visible before use. No filter should be used during administration.

The vial should be shaken before use to ensure a uniform suspension. Prior to withdrawal, the suspension should be inspected for clumping or granular appearance. The presence of visible crystals is normal as the product is a suspension. To open, firmly grasp the top portion in your dominant hand, between thumb and forefinger. Hold the bottom of the ampoule in the other hand. Apply firm but gentle pressure near the blue dot to break the neck of the ampoule.

If necessary, Trispan may be mixed with 1% or 2% lidocaine hydrochloride. Trispan should be drawn into the syringe before drawing in the lidocaine to prevent contamination of triamcinolone hexacetonide. The syringe should then be shaken gently, and the resulting solution used immediately thereafter. Since Trispan has been designed for ease of administration, a small bore needle (25 or 26 gauge) may be used.

The use of solvents containing methylparaben, propylparaben, phenol, etc. should be avoided, since they may cause precipitation of the steroid.

The ready-to-use crystal suspension should be used immediately after opening. Any unused portion should be discarded after use and must not be reused.

Treatment of acute overdosage is by supportive and symptomatic therapy. Excess dosage or toofrequent administration of injections into the same site may cause local subcutaneous atrophy. If this occurs, recovery may take several months due to the long-term effect of the drug.

There is no satisfactory treatment or antidote known.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Keep out of the reach or sight of children.

Store between 15°C-30°C.