Brand name: Depo-medrol
Active ingredient (generic name): Methyl Prednisolone
Manufacturer: Pfizer
Importer: Behestan Darou
Pharmacotherapeutic group: Corticosteroid
Pharmaceutical form: 40mg/1ml Vial
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Methylprednisolone acetate is a synthetic glucocorticoid. An aqueous suspension may be injected directly into joints and soft tissues in the treatment of rheumatoid arthritis, osteoarthritis, bursitis and similar inflammatory conditions. For prolonged systemic effect it may be administered intramuscularly. |
Pharmacokinetics:
Methylprednisolone acetate is absorbed from joints in a few days, with peak serum levels being reached 2-12 hours after injection.
It is more slowly absorbed following deep intramuscular injection with plasma levels detected up to 17 days afterwards.
Methylprednisolone acetate is less soluble than methylprednisolone.
Dosage and administration:
Depo-Medrole has many different indications such as 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-Medrole 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 .
Undesirable effects may be minimized by using the lowest effective dose for the minimum period .
Depo-Medrone vials are intended for single dose use only.
Intramuscular - for sustained systemic effect: Allergic conditions (severe seasonal and perennial allergic rhinitis, 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.
Note: Depo-Medrone is not intended for the prophylaxis of severe seasonal and perennial allergic rhinitis or other seasonal allergies and should be administered only when symptoms are present.
The frequency of intramuscular injections should be determined by the duration of clinical response.
In the case of seasonal allergic rhinitis a single injection is frequently sufficient. If necessary, however, a second injection may be given after two to three weeks.
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-Medrole. 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 localization 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-Medrole. 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 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 care should be taken to inject Depo-Medrole 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-Medrole.
Adverse reaction:
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 . Most important are:
peptic ulceration, acute pancreatitis, osteoporosis, muscle weakness,Sodium and water retention, potassium loss, Impaired healing, Increased intra-cranial pressure, glaucoma, Leucocytosis, hypersensitivity including anaphylaxis, thrombo-embolism, nausea, vertigo.
Medicinal Interaction:
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.
Contraindication:
Depo-medrole is contra-indicated where there is known hypersensitivity to components and in systemic infection unless specific anti-infective therapy is employed.
Due to its potential for neurotoxicity, Depo-Medrole must not be given by the intrathecal route. In addition, as the product is a suspension it must not be given by the intravenous.
Special warnings:
In patients who should receive huge doses, the injection should be slowly. Also injection in injured and wounded places of skin is prohibited.
Pregnancy and lactation:
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The ability of corticosteroids to cross the placenta varies between individual drugs, however, methylprednisolone does cross the placenta, therefore should only be prescribed when the benefits to the mother and child outweigh the risks. Corticosteroids are excreted in small amounts in breast milk, however, doses of up to 40 mg daily of methylprednisolone are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression, but the benefits of breastfeeding are likely to outweigh any theoretical risk. |
Storage temperature:
Room temperature (15-25 C) . Should be protected from freezing.
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