Label: HYDROCORTISONE tablet

Rev. 07/03

Rx Only

Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.

Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. The molecular weight is 362.47. It is designated chemically as 11B, 17,21-trihydroxy-pregn-4-ene-3,20-dione. The molecular formula is C21H30O5 and the structural formula is:

Hydrocortisone is believed to be the principal hormone secreted by the adrenal cortex.

Each tablet for oral administration contains 20 mg of hydrocortisone.

Inactive Ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose, and Sodium Starch Glycolate.

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. They are also used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

1. Endocrine Disorders

    

   Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)

    

   Congenital adrenal hyperplasia

    

   Nonsuppurative thyroiditis

    

   Hypercalcemia associated with cancer

2. Rheumatic Disorders

    

   As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

    

   Psoriatic arthritis

    

   Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy):

    

   Ankylosing spondylitis

    

   Acute and subacute bursitis

    

   Acute nonspecific tenosynovitis

    

   Acute gouty arthritis

    

   Post-traumatic osteoarthritis

    

   Synovitis or osteoarthritis

    

   Epicondylitis

3. Collagen Diseases

    

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

    

   Systemic lupus erythematosus

    

   Acute rheumatic carditis

    

   Systemic dermatomyositis (polymyositis)

4. Dermatologic Diseases

    

   Pemphigus

    

   Bullous dermatitis herpetiformis

    

   Severe erythema multiforme (Stevens-Johnson syndrome)

    

   Exfoliative dermatitis

    

   Mycosis fungoides

    

   Severe psoriasis

    

   Severe seborrheic dermatitis

5. Allergic States

    

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

    

   Seasonal or perennial allergic rhinitis

    

   Bronchial asthma

    

   Contact dermatitis

    

   Atopic dermatitis

    

   Serum sickness

    

   Drug hypersensitivity reactions

6. Ophthalmic Diseases

    

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

    

   Allergic conjunctivitis

    

   Keratitis

    

   Allergic corneal marginal ulcers

    

   Herpes zoster ophthalmicus

    

   Iritis and iridocyclitis

    

   Chorioretinitis

    

   Anterior segment inflammation

    

   Diffuse posterior uveitis and choroiditis

    

   Optic neuritis

    

   Sympathetic ophthalmia

7. Respiratory Disease

    

   Symptomatic sarcoidosis

    

   Loeffler's syndrome not manageable by other means

    

   Berylliosis

    

   Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy

    

   Aspiration pneumonitis

8. Hematologic Disorder

    

   Idiopathic thrombocytopenic purpura in adults

    

   Secondary thrombocytopenia in adults

    

   Acquired (autoimmune) hemolytic anemia

    

   Erythroblastopenia (RBC anemia)

    

   Congenital (erythroid) hypoplastic anemia

9. Neoplastic Disease

    

   For palliative management of:

    

   Leukemias and lymphomas in adults

    

   Acute leukemia of childhood

10. Edematous States

     

    To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus

11. Gastrointestinal Diseases

     

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

     

    Ulcerative colitis

     

    Regional enteritis

12. Miscellaneous

     

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

     

    Trichinosis with neurologic or myocardial involvement

 

Systemic fungal infections

 

Hypersensitivity to this product

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox 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 chickenpox, 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 chickenpox develops, treatment with antiviral agents may be considered.

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

Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and 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. If the patient is receiving steroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralo-corticoid should be administered concurrently.

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. Moreover, corticosteroids may affect nitroblue-tetrazolium test for bacterial infection and produce false negative results.

In cerebral malaria, a double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and higher incidence of pneumonia and gastrointestinal bleeding.

Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea.

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, use of these drugs in pregnancy or in women of childbearing potential requires that the anticipated benefits be weighed against the possible 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.

Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacologic doses of corticosteroids should be advised not to nurse.

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

Administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained. However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.

The use of hydrocortisone tablets 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 an 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.

Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

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

 

Tendon rupture

Gastrointestinal

 

Peptic ulcer with possible perforation and hemorrhage

 

Perforation of the small and large bowel, particularly in patients with inflammatory

 

bowel disease

 

Pancreatitis

 

Abdominal distention

 

Ulcerative esophagitis

Dermatologic

 

Impaired wound healing

 

Thin fragile skin

 

Petechiae and ecchymoses

 

Erythema

 

Increased sweating

 

May suppress reactions to skin tests

 

Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema

Neurologic

 

Convulsions

 

Increased intracranial pressure with papilledema (pseudotumor cerbri) usually after treatment

 

Vertigo

 

Headache

 

Psychic disturbances

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 for insulin or oral hypoglycemic agents in diabetics

 

Hirsutism

Ophthalmic

 

Posterior subcapsular cataracts

 

Increased intraocular pressure

 

Glaucoma

 

Exophthalmos

Metabolic

 

Negative nitrogen balance due to protein catabolism

Cardiovascular

 

Myocardial rupture following recent myocardial infarction (see WARNINGS)

Other

 

Hypersensitivity

 

Thromboembolism

 

Weight gain

 

Increased appetite

 

Nausea

 

Malaise

Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available, treatment is supportive and symptomatic.

The intraperitoneal LD50 of hydrocortisone in female mice was 1740 mg/kg.

For oral administration

DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT.

The initial dosage varies from 20 to 240 mg a day depending on the disease being treated. In less severe diseases doses lower than 20 mg may suffice, while in severe diseases doses higher than 240 mg may be required. The initial dosage should be maintained or adjusted until the patient's response is satisfactory. If satisfactory clinical response does not occur after a reasonable period of time, discontinue hydrocortisone tablets and transfer the patient to other therapy.

After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response.

Patients should be observed closely for signs that might require adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily.

If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually.

Hydrocortisone Tablets USP 20 mg: White, round, scored tablets; imprinted "West-ward 254".

Bottles of 100 tablets.

Unit Dose Boxes of 100 tablets.

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

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured by:
West-ward Pharmaceutical Corp.
Eatontown, N.J. 07724
Revised July 2003