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Manufacturer
LINEAGE/IMPAX G
SKU
54505033210

hydrocortisone 10 mg tablet

Generic
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Uses

Hydrocortisone or cortisone is usually the corticosteroid of choice for replacement therapy in patients with adrenocortical insufficiency, because these drugs have both glucocorticoid and mineralocorticoid properties. Concomitant administration of a more potent mineralocorticoid (fludrocortisone) may be required in some patients. For anti-inflammatory or immunosuppressive uses, synthetic glucocorticoids which have minimal mineralocorticoid activity are preferred.

Dosage and Administration

Administration

The route of administration and dosage of hydrocortisone and its derivatives depend on the condition being treated and the response of the patient.

Hydrocortisone

Hydrocortisone is administered orally; the drug also was previously administered by IM injection, but absorption of the drug from the injection site is slow (4-8 hours) and a parenteral dosage form currently is not commercially available in the US.

Hydrocortisone Sodium Succinate

Hydrocortisone sodium succinate may be administered by IM or IV injection or by IV infusion. Hydrocortisone sodium succinate is reconstituted for IM or IV injection with bacteriostatic water for injection or bacteriostatic 0.9% sodium chloride injection according to the manufacturer's instructions. When the drug is administered by direct IV injection, it should be administered over a period of at least 30 seconds. For IV infusion, the reconstituted hydrocortisone sodium succinate should be further diluted with 5% dextrose, 0.9% sodium chloride, or 5% dextrose in 0.9% sodium chloride injection to a concentration of 0.1-1 mg/mL.

Dosage

Dosage of hydrocortisone sodium succinate is expressed in terms of hydrocortisone. IM or IV therapy is generally reserved for patients who are unable to take the drug orally or for use in emergency situations. Hydrocortisone sodium succinate is absorbed rapidly, and peak plasma concentrations are attained within 1 hour following IM administration. Parenteral injection of hydrocortisone sodium succinate must be given at 4- to 6-hour intervals if constant high blood concentrations of hydrocortisone are required. After the initial emergency period, a longer-acting injectable corticosteroid preparation or oral administration of a corticosteroid should be considered. Dosage for infants and children should be based on the severity of the disease and the response of the patient rather than on strict adherence to dosage indicated by age, body weight, or body surface area. After a satisfactory response is obtained, dosage should be decreased in small decrements to the lowest level that maintains an adequate clinical response. Patients should be continually monitored for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma). If hydrocortisone is used orally for prolonged anti-inflammatory therapy, an alternate-day dosage regimen should be considered. Following long-term therapy, hydrocortisone should be withdrawn gradually.

Hydrocortisone

The initial adult oral dosage of hydrocortisone as the free alcohol may range from 10-320 mg daily, depending on the disease being treated, and is usually administered in 3 or 4 divided doses. Some clinicians state that children may be given an oral dosage of 0.56-8 mg/kg daily or 16-240 mg/m daily, administered in 3 or 4 divided doses.

Hydrocortisone Sodium Succinate

The IM or IV dosage of hydrocortisone as the sodium succinate may range from 100 mg to 8 g daily. The usual dosage is 100-500 mg IM or IV initially and every 2-10 hours as needed. Some clinicians state that the usual IM or IV dosage for children is 0.16-1 mg/kg or 6-30 mg/m administered 1 or 2 times daily.

In life-threatening shock, massive IV doses of hydrocortisone as the sodium succinate (such as 50 mg/kg initially and repeated in 4 hours and/or every 24 hours if needed, or 0.5-2 g IV initially and repeated at 2- to 6-hour intervals as required) have been recommended by some clinicians. In such cases, the drug is administered by direct IV injection over a period of one to several minutes. High-dose therapy should be continued only until the patient's condition has stabilized and usually should not be continued beyond 48-72 hours. If massive corticosteroid therapy is needed beyond 72 hours, a corticosteroid which causes less sodium retention (such as methylprednisolone sodium succinate or dexamethasone sodium phosphate) should be used to minimize the risk of hypernatremia.

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