A-hydrocort

A-hydrocort

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Questions & Answers

Side Effects & Adverse Reactions

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.

Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Usage in pregnancy. Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Average and large doses of hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.

The use of A-Hydrocort sterile powder in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with appropriate antituberculous regimen.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Because rare instances of anaphylactoid reactions (eg, bronchospasm) have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents may be considered.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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

History

There is currently no drug history available for this drug.

Other Information

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

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.

A-hydrocort Manufacturers


  • Hospira, Inc.
    A-hydrocort (Hydrocortisone Sodium Succinate) Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]

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