Data from FDA - Curated by Toby Galbraith - Last updated 19 December 2016

Indication(s)

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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Advisory information

contraindications

CONTRAINDICATIONS The use of A-Hydrocort sterile powder is contraindicated in premature infants because the 100 mg vial is reconstituted with Bacteriostatic Water for Injection or Bacteriostatic Sodium Chloride Injection containing benzyl alcohol.

Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.

A-Hydrocort sterile powder is also contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents.

Special warnings and precautions

PRECAUTIONS General Precautions Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.

This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.

Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.

Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation.

The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction must be gradual.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.

Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection, also in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed.

Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease.

The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect.

(See DOSAGE AND ADMINISTRATION).

Since complications of treatment with glucocorticoids are dependent on the size of the dose and duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

Adverse reactions

ADVERSE REACTIONS Fluid and Electrolyte Disturbances Sodium retention, Fluid retention, Congestive heart failure in susceptible patients, Potassium loss, Hypokalemic alkalosis, Hypertension Musculoskeletal Muscle weakness, Steroid myopathy, Loss of muscle mass, Osteoporosis, Vertebral compression fractures, Aseptic necrosis of femoral and humeral heads, Pathologic fracture of long bones Gastrointestinal Peptic ulcer with possible perforation and hemorrhage, Pancreatitis, Abdominal distention, Ulcerative esophagitis Dermatologic Impaired wound healing, Thin fragile skin, Petechiae and ecchymoses, Facial erythema, Increased sweating, May suppress reactions to skin tests Neurological Convulsions, Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment

Vertigo, Headache Endocrine Menstrual irregularities, Development of Cushingoid state, Suppression of growth in children, Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness, Decreased carbohydrate tolerance, Manifestations of latent diabetes mellitus, Increased requirements of insulin or oral hypoglycemic agents in diabetics Ophthalmic Posterior subcapsular cataracts, Increased intraocular pressure, Glaucoma, Exophthalmos Metabolic Negative nitrogen balance due to protein catabolism The following additional reactions are related to parenteral corticosteroid therapy: Allergic, anaphylactic or other hypersensitivity reactions, Hyperpigmentation or hypopigmentation, Subcutaneous and cutaneous atrophy, Sterile abscess

Usage information

Dosing and administration

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.)

Interactions

DRUG INTERACTIONS The pharmacokinetic interactions listed below are potentially clinically important.

Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response.

Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance.

Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity.

Corticosteroids may increase the clearance of chronic high-dose aspirin.

This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.

Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia.

The effect of corticosteroids on oral anticoagulants is variable.

There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids.

Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

Information for the Patient Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles.

Patients should also be advised that if they are exposed, medical advice should be sought without delay.

More information

Category Value
Authorisation number ANDA040666
Orphan designation No
Product NDC 0409-4856
Date Last Revised 12-05-2011
Type HUMAN PRESCRIPTION DRUG
RXCUI 208947
Marketing authorisation holder Hospira, Inc.