Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2020 Publisher: Pfizer New Zealand Ltd, PO Box 3998, Auckland, New Zealand, 1140
When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of Depo-Medrol is indicated as follows:
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
During an exacerbation or as maintenance therapy in selected cases of:
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:
Severe acute and chronic allergic and inflammatory processes involving the eye, such as:
To tide the patient over a critical period of the disease in:
For palliative management of:
To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus.
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Depo-Medrol is indicated for intralesional use in the following conditions:
Dose
Because complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.
The lowest possible dose of corticosteroid should be used to control the condition under treatment and when reduction in dosage is possible, the reduction should be gradual.
This product is not suitable for multidose use. Following administration of the desired dose, any remaining suspension should be discarded.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
Sterile technique is necessary to prevent infections or contamination.
Depo-Medrol 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, epidural or intravenous routes (see sections 4.3, 4.4 and 4.8).
Therapy with Depo-Medrol 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.
The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. In chronic cases, injections may be repeated at intervals ranging from one to five or more weeks, depending upon the degree of relief obtained from the initial injection. The doses in the following table are given as a general guide:
| Size of Joint | Examples | Range of Dosage |
|---|---|---|
| Large | Knees, Ankles, Shoulders | 20-80 mg |
| Medium | Elbows, Wrists | 10-40 mg |
| Small | Metacarpophalangeal Interphalangeal Sternoclavicular Acromioclavicular | 4-10 mg |
Procedure
It is recommended that the anatomy of the joint involved be reviewed before attempting intraarticular injection. In order to obtain the full anti-inflammatory effect, it is important that the injection be made into the synovial space. Employing the same sterile technique as for a lumbar puncture, a sterile 20 to 24 gauge needle (on a dry syringe) is quickly inserted into the synovial cavity. Procaine infiltration is elective. The aspiration of only a few drops of joint fluid proves the joint space has been entered by the needle.
The injection site for each joint is determined by the location where the synovial cavity is most superficial and most free of large vessels and nerves. With the needle in place, the aspirating syringe is removed and replaced by a second syringe containing the desired amount of DepoMedrol. The plunger is then pulled outward slightly to aspirate synovial fluid and to make sure the needle is still in the synovial space. After injection, the joint is moved gently a few times to aid mixing of the synovial fluid and the suspension. The site is covered with a small sterile dressing.
Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal, and hip joints. Since difficulty is occasionally encountered in entering the hip joint, precautions should be taken to avoid any large blood vessels in the area.
Joints not suitable for injection are those that are anatomically inaccessible,such as the spinal joints and those like the sacroiliac joints that are devoid of synovial space. Treatment failures are most frequently the result of failure to enter the joint space. Little or no benefit follows injection into surrounding tissue. If failures occur when injections into the synovial spaces are certain, as determined by aspiration of fluid, repeated injections are usually futile. Local therapy does not alter the underlying disease process and, whenever possible, comprehensive therapy including physiotherapy and orthopaedic correction should be employed.
Following intra-articular corticosteroid therapy care should be taken to avoid overuse of joints in which symptomatic 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.
Unstable joints should not be injected. Repeated intra-articular injection may in some cases result in instability of the joint. X-ray follow-up is suggested in selected cases to detect deterioration.
If a local anaesthetic is used prior to injection of Depo-Medrol, the anaesthetic package insert should be read carefully and all the precautions observed.
The area around the injection site is prepared in a sterile way, and a wheal at the site made with one percent procaine hydrochloride solution. A 20 to 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 conditions such as tendinitis or tenosynovitis, care should be taken, following application of a suitable antiseptic to the overlying skin, to inject the suspension into the tendon sheath rather than into the substance of the tendon. The tendon may be readily palpated when placed on a stretch.
When treating conditions such as epicondylitis, the area of greatest tenderness should be outlined carefully and the suspension infiltrated into the area. For ganglia of the tendon sheaths, the suspension is injected directly into the cyst. In many cases a single injection causes a marked decrease in the size of the cystic tumour and may effect disappearance.
The dose in the treatment of the various conditions of the tendinous or bursal structures listed above varies with the condition being treated and ranges from 4 to 30 mg. In recurrent or chronic conditions, repeated injections may be necessary.
The usual sterile precautions should be observed with each injection.
Following cleansing with an appropriate antiseptic such as 70% alcohol, 20 to 60 mg is injected into the lesion. It may be necessary to distribute doses ranging from 20 to 40 mg by repeated local injections in the case of large lesions. Care should be taken to avoid injection of sufficient material to cause blanching,since this may be followed by a small slough. One to four injections are usually employed, the intervals between injections varying with the type of lesion being treated and the duration of improvement produced by the initial injection.
The intramuscular dosage will vary with the condition being treated. When a prolonged effect is desired, the weekly dose may be calculated by multiplying the daily oral dose by seven and given as a singular intramuscular injection.
Dosage must be individualised according to the severity of the disease and response of the patient. For infants and children, the recommended dosage will have to be reduced, but dosage should be governed by the severity of the condition rather than by strict adherence to the ratio indicated by age or body weight. Use in children should be limited to the shortest possible time.
Hormone therapy is adjunct to, and not a replacement for, conventional therapy. Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. The severity, prognosis and expected duration of the disease and the reaction of the patient to medication are primary factors in determining dosage. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.
In patients with the adrenogenital syndrome, a single intra-muscular injection of 40 mg every two weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40 to 120 mg of methyl-prednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following intramuscular administration of a single dose of 80 mg to 120 mg. In chronic contact dermatitis repeated at five to ten day intervals may be necessary. In seborrhoeic dermatitis, a weekly dose of 80 mg may be adequate to control the condition.
Following intramuscular administration of 80 to 120 mg to asthmatic patients, relief may result within six to 48 hours and persist for several days to two weeks.
If signs of stress are associated with the condition being treated, the dosage of the suspension should be increased. If a rapid hormonal effect of maximum intensity is required, the intra-venous administration of highly soluble methylprednisolone sodium succinate is indicated.
Depo-Medrol sterile aqueous suspension in doses of 40 to 120 mg administered as retention enemas or by continuous drip three to seven times weekly for periods of two or more weeks, have been shown to be a useful adjunct in the treatment of some patients with ulcerative colitis. Many patients can be controlled with 40 mg of Depo-Medrol sterile aqueous suspension administered in from 30- 300 mL of water depending upon the degree of involvement of the inflamed colonic mucosa. Other accepted therapeutic measures should, of course, be instituted.
There is no clinical syndrome of acute overdosage with Depo-Medrol (methylprednisolone acetate).
Repeated frequent doses (daily or several times per week) over a protracted period may result in a Cushingoid state, and other complications of chronic steroid 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.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
36 months.
Store below 30ºC.
Depo-Medrol is for single use in a single patient only. Discard any unused product.
40 mg/mL – 1 × 1 mL vial; 5 × 1 mL
No special requirement.
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