SOLU-MEDROL

What it is

SOLU-MEDROL is methylprednisolone sodium succinate, available in several strengths for intravenous or intramuscular administration. Methylprednisolone is a potent anti-inflammatory steroid with greater anti-inflammatory potency than prednisolone and less tendency to induce sodium and water retention. Methylprednisolone sodium succinate has the same metabolic and anti-inflammatory actions as methylprednisolone, and when given parenterally in equimolar quantities, the two compounds are equivalent in biologic activity.

Approved indications

SOLU-MEDROL is indicated for intravenous or intramuscular use when oral therapy is not feasible, in the following conditions: — Primary or secondary adrenocortical insufficiency. — Acute adrenocortical insufficiency. — Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. — Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. — Congenital adrenal hyperplasia. — Non-suppurative thyroiditis. — Hypercalcaemia associated with cancer. — Rheumatic disorders including ankylosing spondylitis, psoriatic arthritis, acute and subacute bursitis, epicondylitis, synovitis of osteoarthritis, acute gouty arthritis, acute non-specific tenosynovitis, post-traumatic osteoarthritis, and rheumatoid arthritis including juvenile rheumatoid arthritis, as adjunctive therapy for short-term administration. — Systemic lupus erythematosus, systemic dermatomyositis (polymyositis), and acute rheumatic carditis during exacerbation or as maintenance therapy in selected cases. — Bullous dermatitis herpetiformis, pemphigus, severe psoriasis, severe seborrhoeic dermatitis, exfoliative dermatitis, mycosis fungoides, and severe erythema multiforme (Stevens-Johnson Syndrome). — Severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment including bronchial asthma, drug hypersensitivity reactions, contact dermatitis, urticarial transfusion reactions, atopic dermatitis, serum sickness, and acute non-infectious laryngeal oedema. — Severe acute and chronic allergic and inflammatory processes involving the eye including allergic corneal marginal ulcers, allergic conjunctivitis, chorioretinitis, anterior segment inflammation, herpes zoster ophthalmicus, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, keratitis, optic neuritis, and sympathetic ophthalmia. — Ulcerative colitis (systemic therapy) and regional enteritis (systemic therapy). — Symptomatic sarcoidosis, berylliosis, aspiration pneumonitis, Loeffler's syndrome not manageable by other means, and fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculous chemotherapy. — Idiopathic thrombocytopenic purpura in adults (intravenous only; intramuscular administration is contraindicated). — Secondary thrombocytopenia in adults, acquired (autoimmune) haemolytic anaemia, erythroblastopenia (red blood cell anaemia), and congenital (erythroid) hypoplastic anaemia. — Leukaemias and lymphomas in adults and acute leukaemia of childhood for palliative management. — Oedematous states to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus. — Acute exacerbations of multiple sclerosis. — Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous chemotherapy. — Trichinosis with neurologic or myocardial involvement. — Moderate to severe Pneumocystis jirovecii pneumonia in acquired immunodeficiency syndrome patients as adjunctive therapy when given within the first 72 hours of initial anti-pneumocystis treatment.

Dosing overview

SOLU-MEDROL may be administered by intravenous or intramuscular injection or by intravenous infusion, with the preferred method for initial emergency use being intravenous injection. Dosage requirements are variable and must be individualised on the basis of the disease under treatment, its severity and the response of the patient; the lowest possible dose should be used to control the condition for the minimum period, and the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements until the lowest dosage which will maintain an adequate clinical response is reached. As adjunctive therapy in life-threatening conditions, 30 mg/kg intravenously is administered over at least 30 minutes, and the dose may be repeated every 4 to 6 hours for up to 48 hours; in general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilised, usually not beyond 48 to 72 hours. Methylprednisolone intravenous pulses consisting of 250 mg/day or above for a few days (usually not exceeding 5 days) may be suitable during exacerbation episodes or conditions unresponsive to standard therapy, such as rheumatic disorders, systemic lupus erythematosus, and oedematous states such as glomerulonephritis or lupus nephritis. In acute exacerbations of multiple sclerosis, intravenous pulses of 500 mg/day or 1 g/day are administered for 3 or 5 days over at least 30 minutes. As adjunctive therapy in other indications, initial dosage will vary from 10 to 500 mg intravenously depending on the clinical condition; larger doses may be required for short-term management of severe, acute conditions, with initial doses up to 250 mg administered intravenously over at least 5 minutes, whilst larger doses should be administered over at least 30 minutes.

Key safety warnings

Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic organisms may be associated with the use of corticosteroids; corticosteroids can reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections and reactivation or exacerbation of latent infections, mask some signs of infection, and make it more difficult to locate the source of infections, and corticosteroid-associated infections may be mild but can be severe and at times fatal. Chicken pox and measles can have a more serious or even fatal course in non-immune children or adults on corticosteroids. Cardiac arrhythmias, circulatory collapse and cardiac arrest have been reported following the rapid administration of large intravenous doses of SOLU-MEDROL (greater than 0.5 g administered over less than 10 minutes), and bradycardia has been reported during or after the administration of large doses of methylprednisolone sodium succinate. Use of systemic corticosteroid is not recommended in patients with congestive heart failure. Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic-pituitary-adrenal suppression (secondary adrenocortical insufficiency), the degree and duration of which is variable among patients and depends on the dose, frequency, time of administration, and duration of glucocorticoid therapy; acute adrenal insufficiency leading to a fatal outcome may occur if glucocorticoids are withdrawn abruptly, and drug-induced secondary adrenocortical insufficiency may be minimised by gradual reduction of dosage. Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes and severe depression to frank psychotic manifestations, and existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Corticosteroid therapy may mask the symptoms of peptic ulcer so that perforation or haemorrhage may occur without significant pain.

Contraindications

Methylprednisolone sodium succinate is contraindicated in patients who have systemic fungal infections and in patients with known hypersensitivity to methylprednisolone or any component of the formulation. The 40 mg ACT-O-VIAL presentation includes lactose produced from cow's milk and may contain trace amounts of milk ingredients, and is therefore contraindicated in patients with a known or suspected hypersensitivity to cow's milk or its components, or to other dairy products. SOLU-MEDROL is contraindicated for intrathecal, epidural or local injection, or any other unspecified route of administration.

Regulatory history

SOLU-MEDROL methylprednisolone 500 mg and 1 g powder for injection vials with diluent vials were first listed on the Australian Register of Therapeutic Goods on 2 August 1991. SOLU-MEDROL methylprednisolone 500 mg and 1 g plain