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A-Hydrocort (Hydrocortisone Sodium Succinate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, A-Hydrocort sterile powder is indicated for intravenous or intramuscular use in the following conditions:

1. Endocrine Disorders


  • Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs 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 analogs are used)

  • Preoperatively 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

  • Hypercalcemia associated with cancer

  • Nonsuppurative thyroiditis


2. 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)

  • Acute and subacute bursitis

  • Epicondylitis

  • Acute nonspecific tenosynovitis

  • Acute gouty arthritis

  • Psoriatic arthritis

  • Ankylosing spondylitis

3. Collagen Diseases


During an exacerbation or as maintenance therapy in selected cases of:

  • Systemic lupus erythematosus

  • Systemic dermatomyositis (polymyositis)

  • Acute rheumatic carditis


4. Dermatologic Diseases


  • Pemphigus

  • Severe erythema multiforme (Stevens-Johnson syndrome)

  • Exfoliative dermatitis

  • Bullous dermatitis herpetiformis

  • Severe seborrheic dermatitis

  • Severe psoriasis

  • Mycosis fungoides


5. Allergic States


Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:


  • Bronchial asthma

  • Contact dermatitis

  • Atopic dermatitis

  • Serum sickness

  • Seasonal or perennial allergic rhinitis

  • Drug hypersensitivity reactions

  • Urticarial transfusion reactions

  • Acute noninfectious laryngeal edema (epinephrine is the drug of first choice)


6. Ophthalmic Diseases


Severe acute and chronic allergic and inflammatory processes involving the eye, such as:


  • Herpes zoster ophthalmicus

  • Iritis, iridocyclitis

  • Chorioretinitis

  • Diffuse posterior uveitis and choroiditis

  • Optic neuritis

  • Sympathetic ophthalmia

  • Anterior segment inflammation

  • Allergic conjunctivitis

  • Allergic corneal marginal ulcers

  • Keratitis


7. Gastrointestinal Diseases


To tide the patient over a critical period of the disease in:

  • Ulcerative colitis (systemic therapy)

  • Regional enteritis (systemic therapy)


8. Respiratory Diseases


  • Symptomatic sarcoidosis

  • Berylliosis

  • Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy

  • Loeffler’s syndrome not manageable by other means

  • Aspiration pneumonitis

9. Hematologic Disorders


  • Acquired (autoimmune) hemolytic anemia

  • Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)

  • Secondary thrombocytopenia in adults

  • Erythroblastopenia (RBC anemia)

  • Congenital (erythroid) hypoplastic anemia

10. Neoplastic Diseases


For palliative management of:


  • Leukemias and lymphomas in adults

  • Acute leukemia of childhood

11. 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


12. Nervous System


Acute exacerbations of multiple sclerosis


13. Miscellaneous


  • Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy

  • Trichinosis with neurologic or myocardial involvement

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 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 A-Hydrocort sterile powder intravenously over a period of 30 seconds (eg, 100 mg) to 10 minutes (eg, 500 mg or more). 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 48-72 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 A-Hydrocort 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 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.

Corticoid therapy is an adjunct to, and not a replacement for, conventional therapy.

Preparation of Solutions

100 mg − 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. Further dilution is not necessary for intravenous or intramuscular injection. 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). In cases where administration of a small volume of fluid is desirable, 100 mg 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 piggyback.

When reconstituted as directed, pH’s of the solutions range from 7 to 8 and the tonicities are: 100 mg vial,.36 osmolar. (Isotonic saline =.28 osmolar.)

HOW SUPPLIED

A-Hydrocort sterile powder is available in the following package:

NDC

Container

Concentration

4856–15

Single-Dose Vial

100 mg

STORAGE CONDITIONS

Store unreconstituted product at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Store solution at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Use solution only if it is clear. Unused solution should be discarded after 3 days.

Lyophilized in container.

Revised: April, 2008

Printed in USA

EN-1768

Hospira, Inc., Lake Forest, IL 60045 USA

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