A-Hydrocort

In the U.S.

• A-Hydrocort
• SoluCORTEF

Available Dosage Forms:

• Solution
• Suspension
• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Acne
• back pain
• bloody or black tarry stools
• bone pain, tenderness, or aching
• chest pain or discomfort
• chills
• cough
• darkening or lightening of skin color
• discouragement
• eye pain and blurred vision
• facial hair growth in females
• fast, pounding, or irregular heartbeat or pulse
• fast, slow, or irregular breathing
• feeling sad or empty
• fever
• fractures
• full or round face, neck, or trunk
• general feeling of illness
• headache
• heartburn, indigestion
• increased appetite
• increased fat deposits on the face, neck, and trunk
• increased hair growth on the face, forehead, back, arms, and legs
• increased sweating, thirst, urination
• irritability
• itching
• lightheadedness, dizziness, or fainting
• loss of appetite
• loss of interest or pleasure
• loss of sexual desire or ability
• menstrual irregularities
• muscle wasting and weakness
• seizures
• severe and continuing nausea
• skin rash
• slow wound healing
• sore throat
• stomach pain and cramping
• swelling of eyes or eyelids
• thinning of the scalp hair
• tightness in chest
• tiredness
• trouble concentrating
• trouble in breathing
• unusual tiredness or weakness
• unusual weight loss
• vomit that looks like coffee grounds

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Hydrocortisone Sodium Succinate

for Injection, USP

Rx only

For Intravenous or Intramuscular Administration

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

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.

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.

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.

A-Hydrocort is part of the drug classes:

• Corticosteroids acting locally

• Corticosteroids for local oral treatment

• Antiinflammatory Corticosteroids

• Corticosteroids, weak group I

• Corticosteroids, weak, other combinations

• Corticosteroids/antiinfectives/mydriatics in combination

• Glucocorticoids

Benefit should outweigh risk Excreted into human milk: Unknown Comments: Single doses, local use, and maternal doses up to 160 mg per day are generally compatible with breastfeeding as it is unlikely to cause systemic effects in the infant; higher doses may cause a degree of adrenal suppression.

Endogenous hydrocortisone (cortisol) is present in the breast milk. Corticosteroids (i.e. prednisone) have been detected in breast milk in low amounts, however, specific information on this drug in breast milk is not known. Theoretically, the presence of exogenous corticosteroids in breast milk could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects in breast fed babies. The use of this drug for replacement therapy is unlikely to have any clinically significant impact, however, it is presumed that breastfed infants of mothers taking high doses of systemic corticosteroids for prolonged periods of time may be at risk of adrenal suppression.

LactMed Record Number

138

Last Revision Date

20170808

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.