Solu-Cortef Dosage/Direction for Use

This preparation may be administered by intravenous injection or 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 is 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If after long-term therapy the drug is to be stopped, it needs to be withdrawn gradually rather than abruptly (see Precautions).
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. 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 Precautions) 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 or with Bacteriostatic Water for Injection: 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).
Directions for using Act-O-Vial Two-Compartment Vial: 1. Press down on plastic activator to force diluent into the lower compartment.
2. Gently agitate to effect solution.
3. Remove plastic tab covering center of stopper.
4. Sterilize top of stopper with a suitable germicide.
Note: Steps 1-4 must be completed before proceeding.
5. Insert needle squarely through center of plunger-stopper until tip is just visible.
6. Invert vial and withdraw dose.
Further dilution is not necessary for intravenous or intramuscular injection. For intravenous infusion, first prepare solution as just described. The 100 mg solution may then be added to 100 to 1000 mL of 5% dextrose in Water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction). The 250 mg solution may be added to 250 to 1000 mL, the 500 mg solution may be added to 500 to 1000 mL, and the 1000 mg solution to 1000 mL of the same diluents. In cases where administration of a small volume of fluid is desirable, 100 mg to 3000 mg (hydrocortisone equivalent of hydrocortisone sodium succinate) may be added to 50 mL of the above diluents. The resulting solutions are stable for at least 4 hours and may be administered either directly or by IV "piggy-back."