DEPO-MEDRONE Suspension for injection Ref.[50000] Active ingredients: Methylprednisolone

Depo-Medrone should not be mixed with any other suspending agent or solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever suspension and container permit. Depo-Medrone may be used by any of the following routes: intramuscular, intra-articular, periarticular, intrabursal, intralesional 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 vials are intended for single dose use only.

Intramuscular – for sustained systemic effect:

Allergic conditions (asthma, drug reactions), 80 – 120 mg (2 – 3 ml).

Dermatological conditions, 40 – 120 mg (1 – 3 ml).

Rheumatic disorders and collagen diseases (rheumatoid arthritis, SLE), 40 – 120 mg (1 – 3 ml) per week.

Dosage must be individualized and depends on the condition being treated and its severity.

The frequency of intramuscular injections should be determined by the duration of clinical response.

On average the effect of a single 2 ml (80 mg) injection may be expected to last approximately two weeks.

Intra-articular: Rheumatoid arthritis, osteo-arthritis. The dose of Depo-Medrone depends upon 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).

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

Intralesional: Keloids, localised lichen planus, localized lichen simplex, granuloma annulare, alopecia areata, and discoid lupus erythematosus. For administration directly into the lesion for local effect in dermatological conditions, 20 – 60 mg (0.5 – 1.5 ml). For large lesions, the dose may be distributed by repeated local injections of 20 – 40 mg (0.5 – 1 ml). One to four injections are usually employed. Care should be taken to avoid injection of sufficient material to cause blanching, since this may be followed by a small slough.

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

Into the tendon sheath: 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.

Special precautions should be observed when administering Depo-Medrone. Intramuscular injections should be made deeply into the gluteal muscles. The usual technique of aspirating prior to injection should be employed to avoid intravascular administration. Doses recommended for intramuscular injection must not be administered superficially or subcutaneously.

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. 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 per cent 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 care should be taken to inject Depo-Medrone 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.

The usual sterile precautions should be observed, with each injection.

Paediatric population

Dosage may 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.

Elderly

When used according to instructions, there is no information to suggest that a change in dosage is warranted in the elderly. However, treatment of elderly patients, 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 Special warnings and special precautions for use).

Following overdosage the possibility of adrenal suppression should be guarded against by gradual diminution of dose levels over a period of time. In such event the patient may require to be supported during any further traumatic episode.

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.

5 years.

Do not store above 25°C.

Do not freeze.

Type I flint glass vial with a butyl rubber plug and metal seal. Each vial contains 1 ml, 2 ml, or 3 ml of Depo-Medrone 40 mg/ml.

Depo-Medrone should not be mixed with any other fluid. Discard any remaining suspension after use.