Label: HYDROCORTISONE- hydrocortisone tablet

  • NDC Code(s): 0143-1252-01, 0143-1254-25
  • Packager: West-ward Pharmaceutical Corp.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status:

Drug Label Information

Updated 07/08

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rev. 07/03

    Rx Only

    Close
  • DESCRIPTION

    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:

    Image from Drug Label Content

    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.

    Close
  • CLINICAL PHARMACOLOGY

    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.

    Close
  • INDICATIONS AND USAGE

    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
    Close
  • CONTRAINDICATIONS

     
    Systemic fungal infections
     
    Hypersensitivity to this product
    Close
  • WARNINGS

    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.

    Close
  • PRECAUTIONS

    General: Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency.

    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 because of possible 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 should 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, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. Fat embolism has been reported as a possible complication of hypercortisonism.

    When large doses are given, some authorities advise that corticosteroids be taken with meals and antacids taken between meals to help to prevent peptic ulcer.

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

    Steroids may increase or decrease motility and number of spermatozoa in some patients.

    Phenytoin, phenobarbital, ephedrine, and rifampin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage.

    The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to courmarins, although there have been some conflicting reports of potentiation not substantiated by studies.

    When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia.

    Information for Patients: Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

    Close
  • 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
     
    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
    Close
  • OVERDOSAGE

    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.

    Close
  • DOSAGE AND ADMINISTRATION

    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.

    Close
  • HOW SUPPLIED

    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

    Close
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0143-1252
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone (Hydrocortisone) 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    Microcrystalline Cellulose  
    Sodium Starch Glycolate  
    Anhdrous Lactose  
    Colloidal Silicon Dioxide  
    Anhydrous Lactose  
    Magnesium Stearate  
    Product Characteristics
    Color white (WHITE) Score 2 pieces
    Shape ROUND (ROUND) Size 9mm
    Flavor Imprint Code WW;254
    Contains     
    Coating true Symbol true
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0143-1252-01 100 in 1 BOTTLE, PLASTIC
    HYDROCORTISONE 
    hydrocortisone tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0143-1254
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone (Hydrocortisone) 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    Microcrystalline Cellulose  
    Sodium Starch Glycolate  
    Anhdrous Lactose  
    Colloidal Silicon Dioxide  
    Anhydrous Lactose  
    Magnesium Stearate  
    Product Characteristics
    Color white (WHITE) Score 2 pieces
    Shape ROUND (ROUND) Size 9mm
    Flavor Imprint Code WW;254
    Contains     
    Coating true Symbol true
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0143-1254-25 100 in 1 BOX, UNIT-DOSE
    Labeler - West-ward Pharmaceutical Corp.
    Close