Dosage And Administration
Dosage requirements are variable and must be individualized. The lowest possible dose of corticosteroid should be used to control the condition under treatment; when dosage reduction is possible, the reduction should be gradual. The proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached.
Dosage adjustments may be necessary if there are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient’s condition.
SOLU-CORTEF may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation.
If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually.
Recommended Dosage and Dosage Adjustment
The initial dose of SOLU-CORTEF is 100 mg to 500 mg or more depending on the severity of the condition. Therapy is initiated by administering SOLU-CORTEF intravenously over a period of 30 seconds (e.g., 100 mg) to 10 minutes (e.g., 500 mg or more). This dose may be repeated at intervals of 2, 4, or 6 hours as indicated by the patient's response and clinical condition. If constantly high blood levels are required, SOLU-CORTEF should be injected every 4 to 6 hours. In general, high-dose corticosteroid therapy should be continued only until the patient's condition has stabilized, usually not beyond 48 to 72 hours. When high-dose hydrocortisone therapy must be continued beyond 48 - 72 hours, hypernatremia may occur. Under such circumstances it may be desirable to replace SOLU-CORTEF with a corticosteroid product such as methylprednisolone sodium succinate that causes little or no sodium retention.
Since complications of corticosteroid treatment are dependent on dose size and duration of treatment, a risk/benefit decision must be made with each patient as to whether daily or intermittent therapy should be used.
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 WARNINGS AND PRECAUTIONS) and reduced dosing may be considered.
SOLU-CORTEF comes in a two-compartment vial (Act-O-Vial) containing sterile white powder in the lower compartment and sterile water in the upper compartment. To use SOLU-CORTEF Act-O-Vial reconstitute Act-O-Vial according to DIRECTIONS FOR USING THE ACT-O-VIAL SYSTEM. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
For intravenous/intramuscular injection, reconstitute Act-O-Vials according to instructions. Further dilution is not necessary for intravenous or intramuscular injection.
Intramuscular injections of corticosteroids should be given deep into large muscle masses to avoid local tissue atrophy.
For intravenous infusion, first reconstitute Act-O-Vials according to instructions. The solution can then be combined with a diluent. The following diluents may be used:
5% Dextrose in water or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction.
The 100 mg solution may be added to 100 to 1000 mL of diluent.
The 250 mg solution may be added to 250 to 1000 mL of diluent.
The 500 mg solution may be added to 500 to 1000 mL of diluent.
The 1000 mg solution may be added to 1000 mL of diluent.
In cases where administration of a small volume of fluid is desirable, 100 mg to 3000 mg of SOLU-CORTEF may be added to 50 mL of the above diluents. The resulting solutions may be administered either directly or by I.V. piggyback.
The following table provides the stability data of hydrocortisone in 5% Dextrose in Water USP or 0.9% Sodium Chloride Injection, USP, at room temperature.
0.5 mg/mL - 20 mg/mL
Therefore, after the reconstituted solution has been diluted for intravenous infusion, unused solution should be discarded after 4 hours.
The Act-O-Vial is a single dose vial and once reconstituted solution is used, any remaining portion should be discarded.
Dosing in infants and children is governed more by the severity of the condition and response of the patient than by age or body weight. The daily dose should be not less than 25 mg.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
DIRECTIONS FOR USING THE ACT-O-VIAL SYSTEM
- Press down on plastic activator to force diluent into the lower compartment.
- Gently agitate to effect solution.
- Remove plastic tab covering center of stopper.
- Sterilize top of stopper with a suitable germicide.
- Insert needle squarely through center of stopper until tip is just visible.
- Invert vial and withdraw dose.