Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**4.2 Posology and method of administration** This preparation may be administered by intravenous injection, by intravenous infusion or by intramuscular injection. The preferred method for initial emergency use is intravenous injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation. Therapy is initiated by administering the drug intravenously over a period of 30 seconds (e.g., hydrocortisone sodium succinate equivalent to 100 mg of hydrocortisone) to 10 minutes (e.g., 500 mg or more). Dosage requirements are variable and must be individualized on the basis of the disease under treatment, its severity and the response of the patient over the entire duration of treatment. A risk/benefit decision must be made in each individual case on an ongoing basis. The lowest possible dose of corticosteroid should be used to control the condition under treatment for the minimum period. The proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage, which will maintain an adequate clinical response, is reached. In general, high-dose corticosteroid therapy should be continued only until the patient’s condition has stabilized - usually not beyond 48 to 72 hours. Although adverse effects associated with high dose, short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated. When high-dose hydrocortisone therapy must be continued beyond 48 to 72 hours, hypernatremia may occur. Under such circumstances it may be desirable to replace hydrocortisone sodium succinate with a corticoid product, such as one containing methylprednisolone sodium succinate which causes little or no sodium retention. If after long-term therapy the drug is to be stopped, it needs to be withdrawn gradually rather than abruptly (see section 4.4 Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The initial dose is 100 mg to 500 mg or more (hydrocortisone equivalent of hydrocortisone sodium succinate) depending on the severity of the condition. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient’s responses and clinical condition. 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, the maximum dose being 15 mg/kg. Patients subjected to severe stress following corticosteroid therapy should be observed closely for signs and symptoms of adrenocortical insufficiency. Corticosteroid therapy is an adjunct to, and not a replacement for, conventional therapy. In patients with liver disease, there may be an increased effect (see section 4.4 Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) and reduced dosing may be considered. Preparation of Solutions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 100 mg Plain Vial \- For intravenous or intramuscular injection, prepare solution by aseptically adding not more than 2 mL of Bacteriostatic Water for Injection or Bacteriostatic Sodium Chloride Injection to the contents of one vial. For intravenous infusion, first prepare solution by adding not more than 2 mL of Bacteriostatic Water for Injection to the vial: This solution may then be added to 100 to 1000 mL of the following: 5% dextrose in Water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction).
INTRAVENOUS, INTRAMUSCULAR
Medical Information
**4.1 Therapeutic indications** **1\. Endocrine Disorders** Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogues are used) Pre-operatively, 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 Hypercalcemia associated with cancer **2\. Non-endocrine Disorders** Rheumatic Disorders \- As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritis Synovitis of osteoarthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Epicondylitis Acute non-specific tenosynovitis Acute gouty arthritis Psoriatic arthritis Ankylosing spondylitis Acute and subacute bursitis Collagen Diseases \- During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Allergic States \- Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: Serum sickness Bronchial asthma Drug hypersensitivity reactions Contact dermatitis Atopic dermatitis Urticarial transfusion reactions Acute non-infectious laryngeal edema (epinephrine is the drug of first choice) Ophthalmic Diseases \- Severe acute and chronic allergic and inflammatory processes involving the eye, such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Respiratory Diseases Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis Hematologic Disorders Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated) Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases \- For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States \- To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases \- To tide the patient over a critical period of the disease in: Ulcerative colitis (systemic therapy) Regional enteritis (systemic therapy) Medical Emergencies Shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenal cortical insufficiency may be present. Acute allergic disorders (status asthmaticus, anaphylactic reactions, insect stings, etc.) following epinephrine. Although there are no well controlled (double-blind, placebo) clinical trials, data from experimental animal models indicate that corticosteroids may be useful in hemorrhagic, traumatic and surgical shock in which standard therapy (e.g., fluid replacement) has not been effective (see section 4.4 Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.
**4.3 Contraindications** Hydrocortisone sodium succinate is contraindicated: - in patients who have systemic fungal infections. - in patients with known hypersensitivity to the drug or any component of the formulation. - for use by the intrathecal route of administration, except as part of certain chemotherapeutic regimens (diluents containing benzyl alcohol must not be used). - for use by the epidural route of administration. Administration of live or live-attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.
H02AB09
hydrocortisone
Manufacturer Information
PFIZER PRIVATE LIMITED
PFIZER MANUFACTURING BELGIUM NV
Active Ingredients
Documents
Package Inserts
Solu-cortef for Injection PI and PIL.pdf
Approved: September 26, 2022