A-HYDROCORT

A-HYDROCORT- hydrocortisone sodium succinate injection, powder, lyophilized, for solution
Hospira, Inc.

Hydrocortisone Sodium Succinate

for Injection, USP

Rx only

For Intravenous or Intramuscular Administration

DESCRIPTION

A-Hydrocort sterile powder contains hydrocortisone sodium succinate as the active ingredient. Hydrocortisone sodium succinate, is a white, or nearly white, odorless, hygroscopic, amorphous solid. It is very soluble in water and in alcohol, very slightly soluble in acetone and insoluble in chloroform. The chemical name is pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11β)- and its molecular weight is 484.52.

The structural formula is represented below:

structural formula hydrocortisone sodium succinate
(click image for full-size original)

Hydrocortisone sodium succinate is an anti-inflammatory adrenocortical steroid. This highly water-soluble sodium succinate ester of hydrocortisone permits the immediate intravenous administration of high doses of hydrocortisone in a small volume of diluent and is particularly useful where high blood levels of hydrocortisone are required rapidly.

A-Hydrocort sterile powder is available for intravenous or intramuscular administration.

100 mg − Vials containing hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone, also 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate anhydrous.

When necessary, the pH was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.

For intravenous or intramuscular injection, vial should be reconstituted with Bacteriostatic Water for Injection or Bacteriostatic Sodium Chloride.

For intravenous infusion, vial should be reconstituted with Bacteriostatic Water for Injection.

CLINICAL PHARMACOLOGY

Hydrocortisone sodium succinate has the same metabolic and anti-inflammatory actions as hydrocortisone. When given parenterally and in equimolar quantities, the two compounds are equivalent in biologic activity. Following the intravenous injection of hydrocortisone sodium succinate, demonstrable effects are evident within one hour and persist for a variable period. Excretion of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours. This preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection.

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

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