SOLU-CORTEF

What it is

Cipla Hydrocortisone is hydrocortisone sodium succinate powder for injection, with each vial containing 133.7 mg of hydrocortisone sodium succinate equivalent to 100 mg of hydrocortisone. The product is a white to off-white lyophilised cake or powder in a clear tubular glass vial with a lyo rubber stopper and yellow coloured flip-off aluminium seal. The preparation may be administered by intravenous injection or infusion, or by intramuscular injection.

Approved indications

When oral therapy is not feasible, hydrocortisone sodium succinate powder for injection is indicated for intravenous or intramuscular use 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. — Nonsuppurative thyroiditis. — Hypercalcaemia associated with cancer. — Rheumatoid arthritis, including juvenile rheumatoid arthritis. — Post-traumatic osteoarthritis, synovitis of osteoarthritis, acute and subacute bursitis, epicondylitis, acute nonspecific tenosynovitis, acute gouty arthritis, psoriatic arthritis, and ankylosing spondylitis as adjunctive therapy for short-term administration. — Systemic lupus erythematosus, systemic dermatomyositis (polymyositis), and acute rheumatic carditis during an exacerbation or as maintenance therapy in selected cases. — Pemphigus, severe erythema multiforme (Stevens-Johnson Syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrhoeic dermatitis, severe psoriasis, and mycosis fungoides. — Bronchial asthma, drug hypersensitivity reactions, contact dermatitis, urticarial transfusion reactions, atopic dermatitis, serum sickness, and acute noninfectious laryngeal oedema as control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. — Severe acute and chronic allergic and inflammatory processes involving the eye, including herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation, allergic conjunctivitis, allergic corneal marginal ulcers, and keratitis. — Ulcerative colitis and regional enteritis (systemic therapy) to tide the patient over a critical period of the disease. — Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, and aspiration pneumonitis. — Acquired (autoimmune) haemolytic anaemia, erythroblastopenia (RBC anaemia), idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated), secondary thrombocytopenia in adults, and congenital (erythroid) hypoplastic anaemia. — Leukaemias and lymphomas in adults and acute leukaemia in childhood for palliative management. — To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus. — Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, and trichinosis with neurological or myocardial involvement.

Dosing overview

The initial dose of hydrocortisone sodium succinate powder for injection is 100 mg to 500 mg or more, depending on the severity of the condition, and this dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient's response and clinical condition. Therapy is initiated by administering the powder for injection intravenously over a period of 30 seconds (e.g., 100 mg) to 10 minutes (e.g., 500 mg or more). Dosage requirements are variable and must be individualised on the basis of the disease under treatment, its severity and the response of the patient, and the lowest possible dose of corticosteroid should be used to control the condition under treatment for the minimum period. While the dose may be reduced for infants and children, it is governed more by the severity of the condition and response of the patient than by age or body weight but should not be less than 25 mg daily.

Key safety warnings

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. There may be decreased resistance and inability to localise infection when corticosteroids are used. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents, and these 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. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic-pituitary-adrenal (HPA) suppression (secondary adrenocortical insufficiency), and acute adrenal insufficiency leading to a fatal outcome may occur if corticosteroids are withdrawn abruptly. Drug-induced secondary adrenocortical insufficiency may be minimised by gradual reduction of dosage, and this type of relative insufficiency may persist for months after discontinuation of therapy. Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes and severe depression to frank psychotic manifestations. Existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Potentially severe psychiatric adverse reactions may occur with systemic steroids. Symptoms typically emerge within a few days or weeks of starting treatment. Corticosteroid therapy may mask the symptoms of peptic ulcer so that perforation or haemorrhage may occur without significant pain. Glucocorticoid therapy may mask peritonitis or other signs or symptoms associated with gastrointestinal disorders such as perforation, obstruction or pancreatitis. In combination with nonsteroidal anti-inflammatory drugs (NSAIDs), the risk of developing gastrointestinal ulcers is increased.

Contraindications

Hydrocortisone sodium succinate is contraindicated in patients who have systemic fungal infections. It is contraindicated in patients with known hypersensitivity to the drug or any component of the formulation. Hydrocortisone sodium succinate is contraindicated for use by the intrathecal route or epidural route of administration. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.

PBS listing

The 100 mg injection (as sodium succinate) with 2 mL solvent is listed on the PBS with both restricted and unrestricted items at an ex-manufacturer price of A$5.09. The 250 mg injection (as sodium succinate) with 2 mL solvent is listed on the PBS with both restricted and unrestricted items at an ex-manufacturer price of A$8.92.

Regulatory history

The SOLU-CORTEF 100 mg powder for injection vial (ARTG 12264) was first listed on 1991-08-02. The SOLU-CORTEF ACT-O-VIAL formulations in both 100 mg and 250 mg strengths (ARTG 167893 and 167894 respectively) were first listed on 2010-03-05.