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Logo DEPO-MEDROL™ with Lidocaine Injection
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

DEPO-MEDROL™ with Lidocaine Injection

COMPOSITION:
DEPO-MEDROL with Lidocaine contains the following per mL:
Methylprednisolone acetate         40 mg
Lidocaine hydrochloride         10 mg
Benzyl alcohol (preservative)         0.9% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 21.5.4 Other combinations

PHARMACOLOGICAL ACTION:
Methylprednisolone is an anti-inflammatory steroid. Estimates of the relative potencies of methylprednisolone and prednisolone range from 1,13 to 2,1 with an average of 1,5. In general the required daily dose of methylprednisolone can be estimated to be two-thirds (or 0,7) the required daily dose of prednisolone. While the effect of parenterally administered methylprednisolone acetate is prolonged, it has the same metabolic and anti-inflammatory actions as the orally administered drug.
Cortisol and its synthetic analogues, such as methylprednisolone acetate, exert their action locally by preventing or suppressing the development of local heat, redness, swelling and tenderness by which inflammation is recognized at the gross level of observation. At the microscopic level, such compounds inhibit not only the early phenomena of the inflammatory process (oedema, fibrin deposition, capillary dilation, migration of phagocytes into the inflamed area and phagocytic activity), but also the later manifestations (capillary proliferation, fibroblast proliferation, deposition of collagen, and still later, cicatrization). These compounds inhibit inflammatory response whether the inciting agent is mechanical, chemical or immunological.
Lidocaine is a potent anaesthetic agent widely used both for topical and injection anaesthesia. Lidocaine prevents both the generation and the conduction of the nerve impulse. Its main site of action is the cell membrane, and there is seemingly little action of physiological importance on the axoplasm. The exact mechanism whereby a local anaesthetic influences the permeability of the membrane is unknown. As a general rule, small nerve fibres are more susceptible to the action of local anaesthetics than are large fibres.

INDICATIONS:
DEPO-MEDROL with Lidocaine is recommended for intra-articular and intrabursal injection and for injection into tendon sheaths for local anti-inflammatory and anaesthetic effects.
Rheumatoid and Osteoarthritis:
Following intra-articular administration of DEPO-MEDROL with Lidocaine, relief from pain may be experienced within 5 to 60 minutes in some cases. The duration of relief varies, but averages three weeks with a range of one to five or more weeks.
The intra-articular injection of DEPO-MEDROL with Lidocaine is recommended as an adjuvant to general therapeutic measures to effect suppression of inflammation in one or a few peripheral rheumatoid or osteoarthritic joints when;
(1) the disease is limited to one or a few peripheral joints;
(2) the disease is widespread with one or a few peripheral joints actively inflamed;
(3) systemic therapy with other corticoids or corticotropin controls all but a few of the more actively controlled joints;
(4) systemic therapy with cortisone, hydrocortisone or corticotropin is contra-indicated;
(5) joints show early but actively progressing deformity (to enhance the effect of physiotherapy and corrective procedures); and
(6) surgical or other orthopaedic corrective measures are to be or have been done.

The action of DEPO-MEDROL with Lidocaine injected intrasynovially appears to be well localized since significant metabolic effect characteristic of systemic administration of adrenocorticosteroids are observed only rarely. In a few instances mild and transient improvement of joints other than those injected have been reported. One case of a flare-up of diabetes was noted during clinical trials when a large dose (160 mg) was administered. The possibility of these mild systemic effects occurring following intrasynovial administration of DEPO-MEDROL with Lidocaine is greater the larger the number of joints injected and the higher the total dose employed.
Bursitis:
Intrabursal injections of corticoid suspensions have been found of value in the treatment of various types of bursitis including subdeltoid, prepatellar (housemaid's knee), and olecranon bursitis (tennis elbow). In general, the use of corticoids for this purpose has been found to give better results in acute than in chronic subdeltoid bursitis. In acute subdeltoid bursitis, pain has been alleviated within a few minutes with return of full range of motion within a few hours after one injection. In most cases, additional injections have not been required. In chronic subdeltoid bursitis, partial relief of pain with return of normal range of shoulder motion may be obtained in many cases. In post-traumatic prepatellar bursitis and olecranon bursitis, relief of pain has usually occurred within 5 to 60 minutes, with a return to normal within a week.
Miscellaneous Uses (including ganglion, tendinitis, epicondylitis):
Injections of DEPO-MEDROL with Lidocaine have been found beneficial in a number of conditions including tendinitis, tenosynovitis, epicondylitis, and ganglia of the tendon sheaths.

CONTRA-INDICATIONS:
* Known hypersensitivity to the components.
* Known hypersensitivity to lidocaine or other local anaesthetics of the amide type.
* Intravenous and intrathecal administration.
* Systemic fungal infections.
Intra-articular, intrabursal injections and injections into tendon sheaths with DEPO-MEDROL with Lidocaine for local effect are contra-indicated in the presence of acute infectious conditions. Exacerbation of pain, further loss of joint motion, with fever and malaise following intra-articular injection may indicate that the arthritis has become septic. Appropriate antibacterial therapy should be instituted immediately. Intra-articular injection of a corticosteroid may produce systemic as well as local effects. Corticosteroids should not be injected into unstable joints.
Safety in pregnancy and lactation has not been established.
Paediatric Use:
Growth may be suppressed in children receiving long-term, daily-divided dose glucocorticoid therapy. The use of such a regimen should be restricted to those most serious indications.

WARNINGS:
This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.
Multidose use of DEPO-MEDROL with Lidocaine from a single vial requires special care to avoid contamination. Although initially sterile, any multidose use of vials may lead to contamination unless strict aseptic technique is observed. Particular care, such as use of disposable sterile syringes and needles is necessary.
While crystals of adrenal steroids in the dermis suppress inflammatory reaction, their presence may cause disintegration of the cellular elements and physicochemical changes in the ground substance of the connective tissue. The resultant infrequently occurring dermal and/or subdermal changes may form depressions in the skin at the injection site. The degree to which this reaction occurs will vary with the amount of adrenal steroid injected. Regeneration is usually complete within a few months or after all crystals of the adrenal steroid have been absorbed.
In order to minimize the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections. Multiple small injections into the area of the lesion should be made whenever possible. The technique of intra-articular injection should include precautions against injection or leakage into the dermis.
DEPO-MEDROL with Lidocaine should not be administered by any route other than those listed under Indications. It is critical that, during administration of DEPO-MEDROL with Lidocaine, appropriate technique be used and care taken to ensure proper placement of drug.
Administration by other than indicated routes has been associated with reports of serious medical events including: arachnoiditis, meningitis, paraparesis/paraplegia, sensory disturbances, bowel/bladder dysfunction, seizures, visual impairment including blindness, ocular and periocular inflammation, and residue or slough at injection site. Appropriate measures must be taken to avoid intravascular injection.
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.

DOSAGE AND DIRECTIONS FOR USE:
DEPO-MEDROL with Lidocaine injection should not be diluted or mixed with other solutions.
Intra-articular:
It is recommended that the anatomy of the joint involved be reviewed before attempting intra-articular injection. In order to obtain the full anti-inflammatory effect of DEPO-MEDROL with Lidocaine, 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 - 24 gauge needle (on a dry syringe) is quickly inserted into the synovial cavity. 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 that 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 DEPO-MEDROL with Lidocaine. The plunger is then pulled outward slightly to aspirate synovial fluid and to make sure the needle is still in the synovial space. DEPO-MEDROL with Lidocaine is then injected. 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 not infrequently 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 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. 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.
The dose of DEPO-MEDROL with Lidocaine for intra-articular administration depends upon the size of the joint and varies with the severity of the condition of 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 knee
ankle
shoulder		         0,5 to 2,0 mL
        (20-80 mg)
Medium elbow
wrist		         0,1 to 1,0 mL
        (4-40 mg)
Small metacarpo-phalangeal
interphalangeal
sternoclavicular
acromioclavicular		         0,1 to 0,25 mL
        (4-10 mg)

Intrabursal and into tendon sheaths:
The dose of DEPO-MEDROL with Lidocaine in the treatment of the various conditions of the tendinous or bursal structures listed above varies with the conditions being treated and ranges from 0,1 to 1,0 mL. In recurrent or chronic conditions, repeated injections may be necessary.
The area around the injections site is prepared in a sterile way. 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 of DEPO-MEDROL with Lidocaine. After injection, the needle is withdrawn and a small dressing applied.
Ganglia:
The dosage for injection into tendon sheath ganglia varies from 0,1 to 0,5 mL (4 to 20 mg), depending on the size of the cyst.
Epicondylitis:
The dosage of infiltration around inflamed epicondyles varies depending on the severity of the condition being treated and the area involved. In general, doses from 0,5 to 1,0 mL (20 to 40 mg) are used.
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 DEPO-MEDROL with Lidocaine 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 usual sterile precautions should be observed, of course, with each injection.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Fluid and electrolyte disturbances:
Sodium retention, fluid retention, potassium loss, electrolyte imbalance. Congestive heart failure may occur in susceptible patients, as well as hypertension.
Musculoskeletal:
Steroid myopathy, muscle weakness, osteoporosis, pathological fractures, aseptic necrosis.
Gastro-intestinal:
Peptic ulceration with possible perforation and haemorrhage, gastric haemorrhage, pancreatitis, oesophagitis, perforation of the bowel.
Dermatologic:
Impaired wound healing, petechiae and ecchymosis, thin fragile skin, purpura, allergic reactions, facial erythema, thinning of hair and scalp.
Metabolic:
Negative nitrogen balance due to protein catabolism. Hypokalemic alkalosis.
Neurological:
Increased intracranial pressure, pseudotumor cerebri, psychic derangements, seizures, insomnia, nervousness, vertigo, sweating.
Endocrine:
Menstrual irregularities, development of cushingoid state, suppression of pituitary-adrenal axis, suppression of growth in children.
Decreased carbohydrate tolerance:
Manifestation of latent diabetes mellitus
Increased requirements for insulin or oral hypoglycaemic agents in diabetics.
Ophthalmic:
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, exophthalmos, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Immune System
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance, and inability to localize infection, opportunistic infections and hypersensitivity reactions including anaphylaxis. Reactions to skin tests may be suppressed.
Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, moodswings, personality changes, and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Central Nervous System:
Lightheadedness, vomiting, nervousness, sensation of heat, cold, numbness, apprehension, twitching, euphoria, tremors, confusion, convulsions, dizziness, loss of consciousness, drowsiness, respiratory depression, tinnitus, respiratory arrest, blurred or double vision.
Cardiovascular System:
Bradycardia, cardiovascular collapse, hypotension, cardiac arrest.
Allergic Reactions:
Cutaneous lesions, oedema, urticaria, anaphylactic reactions.

Precautions:
When multidose vials are used, special care to prevent contamination of the contents is essential. There is some evidence that benzalkonium chloride is not an adequate antiseptic for sterilizing multidose vials. A povidone-iodine solution is recommended to cleanse the vial top prior to aspiration of contents. (See Warnings).
Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation.
Corticosteroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection. Caution must also be used in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis.
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Since concurrent administration of these agents results in a mutual inhibition of metabolism, it is possible that convulsions and other adverse events associated with individual use of either drug may be more apt to occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
An increased incidence of post-injection flare may occur when greater than 2,0 mL (80 mg of steroid) are injected. No specific therapy for overdosage is known. Treatment should be symptomatic and supportive.

IDENTIFICATION:
White suspension.

PRESENTATION:
DEPO-MEDROL with Lidocaine is available in 1 mL, 2 mL and 5 mL vials.

STORAGE INSTRUCTIONS:
Store at room temperature (15° - 30°C)
Keep out of reach of children.

REGISTRATION NUMBER:
F/21.5.4/228

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
Midrand 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 July 1992

New addition to this site: February 2005
Source: Pharmaceutical Industry

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