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DEPO MEDRONE is a brand name for Methylprednisolone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Depo-Medrone may be used locally or systemically, particularly where oral therapy is not feasible. Depo-Medrone may be used by any of the following routes: intramuscular, intra-articular, periarticular, intrabursal, intralesional or into the tendon sheath. It must not be used by the intrathecal or intravenous routes…
Verbatim from this product's MHRA label. Tap a section to expand.
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. 8). 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.
25 ml).
Intrabursal:
Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis. 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. 5 ml). 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. 75 ml) into the affected area.
Into the tendon sheath:
4). MedDRA System Organ Class Frequency Undesirable Effects Infections and infestations Not Known Infection (including increased susceptibility and severity of infections with suppression of clinical symptoms and signs); Opportunistic infection; Injection site infection; Peritonitis; Recurrence of dormant tuberculosis Blood and lymphatic system disorders Not Known Leukocytosis Immune system disorders Not Known Drug hypersensitivity, Anaphylactic reaction, Anaphylactoid reaction MedDRA System Organ Class Frequency Undesirable Effects Endocrine disorders Not Known Cushingoid; Hypothalamic pituitary adrenal axis suppression; Withdrawal symptoms - Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death.
4). A 'withdrawal syndrome' may also occur including, fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight. Metabolism and nutrition disorders Not Known Metabolic acidosis; Glucose tolerance impaired; Sodium retention; Fluid retention; Increased requirements for insulin (or oral hypoglycemic agents in diabetics)*; Alkalosis hypokalaemic; Dyslipidaemia, Increased appetite (which may result in Weight increased); Lipomatosis Psychiatric disorders Not Known Affective disorder (including Depressed mood, Euphoric mood, Affect lability, Drug dependence, Suicidal ideation).
4); Chorioretinopathy; rare instances of blindness associated with intralesional therapy around the face and head*; Increased intra- ocular pressure, with possible damage to the optic nerve; Corneal or scleral thinning; Exacerbation of ophthalmic viral or fungal disease Ear and labyrinth disorders Not Known Vertigo Cardiac disorders Not Known Cardiac failure congestive (in susceptible patients) Vascular disorders Not Known Hypertension; Hypotension; Embolism arterial, Thrombotic events, Flushing Respiratory, thoracic and mediastinal disorders Not Known Pulmonary embolism, Hiccups MedDRA System Organ Class Frequency Undesirable Effects Gastrointestinal disorders Not Known Peptic ulcer (with possible Peptic ulcer perforation and Peptic ulcer haemorrhage); Gastric haemorrhage; Intestinal perforation; Pancreatitis; Oesophagitis ulcerative; Oesophagitis; Abdominal pain; Abdominal distension; Diarrhoea; Dyspepsia; Nausea Hepatobiliary disorders Not known Hepatitis, Increase of liver enzymes Skin and subcutaneous tissue disorders Not Known Angioedema; Hirsutism; Petechiae; Ecchymosis; Skin atrophy; Erythema; Hyperhidrosis; Skin striae; Skin hyperpigmentation; Rash; Pruritus; Urticaria; Acne; Skin hypopigmentation; Panniculitis@ Musculoskeletal and connective tissue disorders Not Known Growth retardation; Osteoporosis; Muscular weakness; Osteonecrosis; Pathological fracture; Muscle atrophy; Myopathy; Rhabdomyolysis; Neuropathic arthropathy; Arthralgia; Myalgia; Post injection pain flare (following intra-articular, periarticular, and tendon sheath injections)* Reproductive system and breast disorders Not Known Menstruation irregular General disorders and administration site conditions Not Known Abscess sterile; Impaired healing; Oedema peripheral; Fatigue; Malaise; Injection site reaction Investigations Not Known Blood potassium decreased; Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Carbohydrate tolerance decreased; Urine calcium increased; suppression of reactions to skin tests*; Blood urea increased Injury, poisoning and procedural complications Not Known Tendon rupture (particularly of the Achilles tendon); Spinal compression fracture.
Warnings and Precautions:
Undesirable effects may be minimised by using the lowest effective dose for the minimum period. 2). Depo-Medrone vials are intended for single dose use only. Any multidose use of the product may lead to contamination. 8). Appropriate measures must be taken to avoid intravascular injection.
Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with Depo-Medrone. While crystals of adrenal steroids in the dermis suppress inflammatory reactions, their presence may cause disintegration of the cellular elements and physiochemical 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 and intramuscular injection should include precautions against injection or leakage into the dermis.
Injection into the deltoid muscle should be avoided because of a high incidence of subcutaneous atrophy. Intralesional doses should not be placed too superficially, particularly in easily visible sites in patients with deeply pigmented skins, since there have been rare reports of subcutaneous atrophy and depigmentation.
Systemic absorption of methylprednisolone occurs following intra-articular injection of Depo-Medrone. Systemic as well as local effects can therefore be expected. Adrenal cortical atrophy develops during prolonged therapy and may persist for months after stopping treatment.
8) • for use by the intravenous route Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Tenosynovitis, epicondylitis. 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).
Systemic corticosteroids are not indicated for, and therefore should not be used to treat, traumatic brain injury. † Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Not known (frequency cannot be estimated from the available data).
* Not a MedDRA PT. 4). @ Panniculitis may occur following dose reduction or discontinuation of methylprednisolone and has been more frequently reported in the paediatric population. CERTAIN SIDE EFFECTS REPORTED WITH SOME CONTRAINDICATED AND NON-RECOMMENDED ROUTES OF ADMINISTRATION.
Intrathecal/Epidural:
Usual systemic corticoid adverse reactions, headache, meningismus, meningitis, paraparesis/paraplegia, spinal fluid abnormalities, nausea, vomiting, sweating, arachnoiditis, functional gastrointestinal disorder/bladder dysfunction, seizure, sensory disturbance.
Extradural:
Wound dehiscence, loss of sphincter control.
Intranasal:
Permanent/temporary blindness, rhinitis. Ophthalmic: (Subconjunctival) - Redness and itching, abscess, slough at injection site, residue at injection site, increased intra-ocular pressure, decreased vision - blindness, infection.
Miscellaneous injection sites:
Scalp, tonsillar […]
In patients who have received more than physiological doses of systemic corticosteroids (approximately 6 mg methylprednisolone) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.
Clinical assessment of disease activity may be needed during withdrawal. If the disease is unlikely to relapse on withdrawal of systemic corticosteroids, but there is uncertainty about HPA suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses.
Once a daily dose of 6 mg methylprednisolone is reached, dose reduction should be slower to allow the HPA-axis to recover.
The following precautions apply for parenteral corticosteroids:
Following intra-articular injection, the occurrence of a marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.
Local injection of a steroid into a previously infected joint is to be avoided. Intra-articular corticosteroids are associated with a substantially increased risk of inflammatory response in the joint, particularly bacterial infection introduced with the injection.
Charcot-like arthropathies have been reported particularly after repeated injections. Appropriate examination of any joint fluid present is necessary to exclude any bacterial infection, prior to injection. Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infections or contamination. The slower rate of absorption by intramuscular administration should be recognised. Immunosuppressant Effects/Increased Susceptibility to Infections Corticosteroids may increase susceptibility to infection, may mask some signs of infection, exacerbate existing infections, increase the risk of reactivation or exacerbation of latent infections and new infections may appear during their use.
Suppression of the inflammatory response and immune function increases the susceptibility to fungal, viral and bacterial infections and their severity. The clinical presentation may often be atypical and may reach an advanced stage before being recognised.
With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Do not use intra-synovially, intrabursally or intratendinous administration for local effect in the presence of acute infection.
Monitor for the development of infection and consider withdrawal of corticosteroids or dosage reduction as needed. Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals.
Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. Chickenpox is of serious concern since this normally minor illness may be fatal in immunosuppressed patients.
Patients (or parents of children) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. Passive immunization with varicella/zoster immunoglobin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox.
If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased. Live vaccines should not be given to individuals with […]