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Drug Details

DEPO-MEDRONE

• Drug Class Description
  Depo-Medrone: Glucocorticoids (corticosteroids, steroids). Depo-Medrone with Lidocaine: Glucocorticoids (corticosteroids, steroids) / local anaesthetics.
• Generic Name
  Methylprednisolone
• Presentation
  White, sterile aqueous suspension for injection
• Description
  Methyprednisolone BP 4%, Lidocaine Hydrochloride BP 1%
• Indications
  

  Corticosteroid (glucocorticoid). Depo-Medrone with Lidocaine is indicated in conditions requiring a glucocorticoid effect: e.g. anti-inflammatory or anti-rheumatic. It is recommended for local use where the added anaesthetic effect would be considered advantageous.

  Depo-Medrone with Lidocaine may be used as follows:

  Intra-articular administration

  Rheumatoid arthritis

  Osteo-arthritis with an inflammatory component

  Periarticular administration

  Epicondylitis

  Intrabursal administration

  Subacromial bursitis

  Prepatellar bursitis

  Olecranon bursitis

  Tendon sheath administration

  Tendinitis

  Tenosynovitis

  Epicondylitis

  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.

• Adult Dosage
  

  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. 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 Contra-indications and Side-effects)

  Adults

  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), 0.5 - 2 ml (20 - 80 mg of steroid); medium joint (elbow, wrist), 0.25 - 1 ml (10 - 40 mg of steroid); small joint (metacarpophalangeal, interphalangeal, sternoclavicular, acromioclavicular), 0.1 - 0.25 ml (4 - 10 mg of steroid).

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

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

  Into the tendon sheath: Tendinitis, tenosynovitis, epicondylitis. For administration directly into the tendon sheath, 0.1 - 0.75 ml (4 - 30 mg of steroid). In recurrent or chronic conditions, repeat injections may be necessary.

• Child Dosage
  

  For infants and children, the recommended dosage should 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.

• Elderly Dosage
  

  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.

  Special precautions should be observed when administering Depo-Medrone with Lidocaine:

  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 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 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.

• Contra Indications
  

  Depo-Medrone with Lidocaine is contra-indicated where there is known hypersensitivity to components or to any local anaesthetics of the amide type and in systemic infection unless anti-infective therapy is employed.

  Due to its potential for neurotoxicity, Depo-Medrone with Lidocaine must not be given by the intrathecal route. In addition, as the product is a suspension it must not be given by the intravenous route (see Side-effects).

• Special Precautions
  Tuberculosis, viral, fungal or active infections, latent or active amoebiasis. Warn patients to avoid contact with chickenpox or herpes zoster while they are receiving steroids and for 3 months post-treatment. In the event of exposure to chickenpox, non-immunised patients should receive varicella-zoster immunoglobulin ideally within 3 days and not later than 10 days from the time of contact. Patients diagnosed with chickenpox should be referred for specialist care. Recent intestinal anastomoses, ulcerative colitis, diverticulitis, active or latent peptic ulcer, thrombophlebitis, psychoses, exanthematous disease, chronic nephritis, acute glomerulonephritis, renal insufficiency, liver failure, cirrhosis, metastatic carcinoma, osteoporosis, hypertension, congestive heart failure, recent MI, glaucoma, epilepsy, diabetes, hypothyroidism, ocular herpes simplex, myasthenia gravis, previous steroid myopathy, cerebral malaria. Limit use in children. Elderly. Pregnancy, lactation. Stress, intercurrent illness, trauma or surgical procedures; monitor patients to avoid life-threatening reactions, (including babies of women who have received large doses of steroids). Use for the shortest length of time at the lowest effective dose, review regularly. Administration in the morning or, if possible, on alternate days helps to reduce risk of adrenal suppression. Advise patient to carry "steroid treatment card". Withrawal: Withdrawal should be  received systemic steroids for more than 3 weeks, or who have taken high doses or repeat courses, or who have repeatedly taken doses in the evening. In some patients treated for less than 3 weeks, withdrawal may be abrupt if the disease is unlikely to relapse or if high or repeated doses have not been given; reinstate if stressed. Caution in patients receiving cardioactive drugs.
• Interactions
  

  1. 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 effects associated with the individual use of either drug may be more apt to occur.

  2. Drugs that induce hepatic enzymes, such as rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be reduced.

  3. Drugs such as erythromycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance.

  4. Steroids may reduce the effects of anticholinesterases in myasthenia gravis. The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives and diuretics are antagonised by corticosteroids, and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced.

  5. The efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.

  6. The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication. Salicylates and non-steroidal anti-inflammatory agents should be used cautiously in conjunction with corticosteroids in hypothrombinaemia.

  7. Steroids have been reported to interact with neuromuscular blocking agents such as pancuronium with partial reversal of the neuromuscular block.

• Adverse Drug Reactions
  

  The incidence of predictable undesirable side-effects associated with the use of corticosteroids, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and duration of treatment.

  Side-effects for the Depo-Medrone component may be observed including:

  PARENTERAL CORTICOSTEROID THERAPY - Anaphylactic reaction or allergic reactions, hypopigmentation or hyperpigmentation, subcutaneous and cutaneous atrophy, sterile abscess, post injection flare (following intra-articular use), charcot-like arthropathy.

  GASTRO-INTESTINAL - Dyspepsia, peptic ulceration with perforation and haemorrhage, abdominal distension, oesophageal ulceration, oesophageal candidiasis, acute pancreatitis, perforation of bowel.

  Increases in alanine transaminase (ALT, SGPT) aspartate transaminase (AST, SGOT) and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

  ANTI-INFLAMMATORY AND IMMUNOSUPPRESSIVE EFFECTS - Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, may suppress reactions to skin tests, recurrence of dormant tuberculosis (see Other special warnings and precautions).

  MUSCULOSKELETAL - Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, aseptic necrosis, muscle weakness.

  FLUID AND ELECTROLYTE DISTURBANCE - Sodium and water retention, potassium loss, hypertension, hypokalaemic alkalosis, congestive heart failure in susceptible patients.

  DERMATOLOGICAL - Impaired healing, petechiae and ecchymosis, thin fragile skin, skin atrophy, bruising, striae, telangiectasia, acne.

  ENDOCRINE/METABOLIC - Suppression of the hypothalamo-pituitary-adrenal axis; growth suppression in infancy, childhood and adolescence; menstrual irregularity and amenorrhoea. Cushingoid facies, hirsutism, weight gain, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, negative nitrogen and calcium balance. Increased appetite.

  NEUROPSYCHIATRIC - A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood psychological dependence and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported for all corticosteroids. . Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions was estimated to be 5-6% for corticosteroids in 1983, primarily based upon data from prednisone administration . Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown. Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri) has been reported, usually after treatment withdrawal of methylprednisolone.

  OPHTHALMIC - Increased intra-ocular pressure, glaucoma, papilloedema, cataracts with possible damage to the optic nerve, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal disease, exophthalmos.

  GENERAL - Leucocytosis, hypersensitivity including anaphylaxis, thrombo-embolism, nausea, vertigo.

  WITHDRAWAL SYMPTOMS - Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. However, this is more applicable to corticosteroids with an indication where continuous therapy is given (see Other special warnings and precautions).

  A 'withdrawal syndrome' may also occur including, fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.

  Side-effects for the Lidocaine component include:

  CENTRAL NERVOUS SYSTEM - Lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensation of heat, cold, numbness, twitching, tremors, convulsions, loss of consciousness, respiratory depression, respiratory arrest.

  CARDIOVASCULAR SYSTEM - Bradycardia, hypotension, cardiovascular collapse, cardiac arrest.

  ALLERGIC REACTIONS - Cutaneous lesions, urticaria, oedema, anaphylactic reactions.

   

  CERTAIN SIDE-EFFECTS REPORTED WITH SOME NON RECOMMENDED ROUTES OF ADMINISTRATION:

  Intrathecal: Usual systemic corticoid adverse reactions, headache, meningismus, meningitis, paraplegia, spinal fluid abnormalities, nausea, vomiting, sweating, arachnoiditis, convulsions.

  Extradural: Wound dehiscence, loss of sphincter control.

  Intranasal: Permanent/temporary blindness, allergic reactions, rhinitis.

  Ophthalmic (Subconjunctival): Redness and itching, abscess, slough at injection site, residue at injection site, increased intra-ocular pressure, decreased vision - blindness, infection.

  Miscellaneous: Scalp, tonsillar fauces, sphenopalatine ganglion: blindness.