DEPO-MEDRONE WITH LIDOCAINE Suspension for injection Ref.[50564] Active ingredients: Lidocaine Methylprednisolone

Depo‑Medrone with Lidocaine should not be mixed with any other preparation as flocculation of the product may occur. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever suspension and container permit.

Therapy with Depo-Medrone with Lidocaine does not obviate the need for the conventional measures usually employed. Although this method of treatment will ameliorate symptoms, it is in no sense a cure and the hormone has no effect on the cause of the inflammation.

Depo-Medrone with Lidocaine may be used by any of the following routes: intra-articular, periarticular, intrabursal, and into the tendon sheath. It must not be used by the intrathecal or intravenous routes (see sections 4.3 and 4.8).

Undesirable effects may be minimised by using the lowest effective dose for the minimum period (see section 4.4).

Depo-Medrone with Lidocaine vials are intended for single dose use only.

Intra‑articular: Rheumatoid arthritis, osteo-arthritis. The dose of Depo‑Medrone with Lidocaine depends on the size of the joint and the severity of the condition. Repeated injections, if needed, may be given at intervals of one to five or more weeks depending upon the degree of relief obtained from the initial injection.

A suggested dosage guide is: large joint (knee, ankle, shoulder), 20–80 mg (0.5–2 ml); medium joint (elbow, wrist), 10–40 mg (0.25–1 ml); small joint (metacarpophalangeal, interphalangeal, sternoclavicular, acromioclavicular), 4–10 mg (0.1–0.25 ml).

Periarticular: Epicondylitis. Infiltrate 4–30 mg (0.1–0.75 ml) into the affected area.

Intrabursal: Subacromial bursitis, prepatellar bursitis, olecranon bursitis. For administration directly into bursae, 4–30 mg (0.1–0.75 ml). In most acute cases, repeat injections are not needed.

Into the tendon sheath: Tendinitis, tenosynovitis, epicondylitis. For administration directly into the tendon sheath, 4–30 mg (0.1–0.75 ml). In recurrent or chronic conditions, repeat injections may be necessary. In many cases, a single injection causes a marked decrease in the size of the cystic tumour and may effect a disappearance.

Intra-articular injections should be made using precise, anatomical localisation into the synovial space of the joint involved. The injection site for each joint is determined by that location where the synovial cavity is most superficial and most free of large vessels and nerves. Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal and hip joints. The spinal joints, unstable joints and those devoid of synovial space are not suitable. Treatment failures are most frequently the result of failure to enter the joint space. Intra-articular injections should be made with care as follows: ensure correct positioning of the needle into the synovial space and aspirate a few drops of joint fluid. The aspirating syringe should then be replaced by another containing Depo-Medrone with Lidocaine. To ensure position of the needle synovial fluid should be aspirated and the injection made.

After injection, the joint is moved slightly to aid mixing of the synovial fluid and the suspension. Subsequent to therapy care should be taken for the patient not to overuse the joint in which benefit has been obtained. Negligence in this matter may permit an increase in joint deterioration that will more than offset the beneficial effects of the steroid.

Intrabursal injections should be made as follows: the area around the injection site is prepared in a sterile way and a wheal at the site made with 1% procaine hydrochloride solution. A 20‑24 gauge needle attached to a dry syringe is inserted into the bursa and the fluid aspirated. The needle is left in place and the aspirating syringe changed for a small syringe containing the desired dose. After injection, the needle is withdrawn and a small dressing applied.

In the treatment of tenosynovitis and tendinitis, care should be taken to inject Depo-Medrone with Lidocaine into the tendon sheath rather than into the substance of the tendon. Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with Depo-Medrone with Lidocaine.

The usual sterile precautions should be observed with each injection.

Paediatric population

Dosage should be reduced for infants and children, but should be governed more by the severity of the condition and response of the patient, than by age or size (see section 4.4).

Elderly

When used according to instructions, there is no information to suggest that a change in dosage is warranted in the elderly. Treatment of elderly patients, however, particularly if long term, should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age and close clinical supervision is required (see section 4.4).

Methylprednisolone

Following overdosage the possibility of adrenal suppression should be guarded against by gradual diminution of dose levels over a period of time. Further traumatic episodes during that period may require special supportive therapy.

Reports of acute toxicity and/or death following overdosage of corticosteroids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic.

Methylprednisolone is dialysable.

Lidocaine

Overdose with lidocaine can manifest itself in a transient stimulation of the central nervous system with early symptoms: yawning, restlessness, dizziness, nausea, vomiting, dysarthria, ataxia, hearing and visual disturbances. With moderate intoxication also twitching and convulsions can occur. This can be followed by unconsciousness, respiratory depression and coma. In very severe intoxication due to decreased myocardial contractility and delayed impulse conduction, hypotension and cardiovascular collapse can be expected to be followed by a complete heart block and cardiac arrest; treatment will be symptomatic. Convulsions may be treated with diazepam. Ventilation for respiratory depression. Hypotension can be treated by the administration of fluids and dopamine. With asystole, adrenaline administration and, if necessary, a pacemaker insertion.

Unopened: 2 years.

Once opened, use immediately.

Do not store above 25°C. Do not freeze. Keep the vials in the outer carton in order to protect from light.

Type I flint glass vials with a butyl rubber cap. Each vial contains 1 ml of suspension.

Vials packed singly and in 10 vial packs.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.