Adverse Reactions
Fluid and Electrolyte Disturbances
Sodium retention
Fluid retention
Congestive heart failure in susceptible patients
Potassium loss
Hypokalemic alkalosis
Hypertensio
Increase calcium excretion
Muscuskeletal
Muscle weakness
Steroid myopathy
Osteoporosis
Tendon rupture, particularly of the Achilles tendon
Vertebral compression fractures
Aseptic necrosis
Pathologic fractures
Gastrointestinal
Peptic ulcer with possible perforation and hemorrhage
Pancreatitis
Ulcerative esophagitis
Gastric hemorrhage
Esophagitis
Perforation of the bowel
Increases in alanine transaminase (ALT,SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.
Dermatologic
Impaired wound healing
Thin fragile skin
Petechiae and ecchymoses
Kaposi’s sarcoma has been reported in patients receiving corticosteroid therapy.
Neurological
Increase intracranial pressure
Seizures
Pseudotumor cerebri
Psychi derangements/psychotic manifestations including euphoria, insomnia, mood swings, personality changes depression: exacerbation of pre-existing emotional instability or psychotic tendencies.
Endocrine
Menstrual irregularities
Development of Cushingoid state
Suppression of growth in children
Suppression of pituitary-adrenal axis
Decreased carbohydrate tolerance
Manifestations of latent diabetes mellitus
Increased requirements of insulin or oral hypoglycemic agents in diabetics
Ophthalmic
Posterior subcapsular cataracts
Increased intraocular pressure
Exophthalmos
Metabolic
Negative nitrogen balance due to protein catabolism
Immune system
Masking of infections
Latent infections becoming active, including reactivation of tuberculosis
Opportunistic infections with any pathogen, in any location in the body, from mild to fatal
Hypersensitivity reactions including anaphylaxis and anaphylatoid reaction (e.g. bronchospasm, laryngeal edema, urticaria)
May suppress reactions to skin tests
Miscellaneous
This prouct contains benzyl alcohol which has been associated with a fatal “Gasping Syndrome” in premature infants.
Dosage and Administration
This preparation may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intraveous 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 Hydrocortisone sodium succinate Sterile Powder intravenously over a period of 30 seconds (e.g. 100 mg) to 10 minutes (e.g. 500 mg or more). In general, high dose corticosteroid thearpy should be continued only until the patient’s condition has stabilied - usually not beyond 48 to 72 hours. Although adverse effects associated with high dose, short-term corticosteroid thearpy are uncommon, peptic ulceration may occur. Prophylactic antacid thearpyp may be indicated.
When high dose hydrocortisone therapy must be continued beyond 48-72 hours, hypernatremia may occur. Under such circumstances it may be desirable to replace Hydrocortisone sodium succinate with a corticoid such as methylprednisolone sodium succinate which causes little or no sodium retention.
The initial dose of Hydrocortisone sodium succiate Sterile Powder is 100 mg to 500 mg, 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 response and clinical response of the patient than by age or body weight but should not be less than 25 mg daily.
Patients subjected to severe stress following corticosteroid therapy should be observed closely for signs and symptoms of adrenocortical insufficiency.
Corticosteroid therapy is an adjunt to, and ot a replacement for, conventional therapy.
Preparation of Solution
100 mg Plain - For intravenous or intramuscular injection, prepare solution by aseptically adding not more than 2 mL of Bacteriostatic Water for Injection or Bacteriostatic Sodium Chloride to the conetnts 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).
