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Hydrocortisone Tablets

Pronunciation

Dosage Form: tablet

Hydrocortisone Tablets

Rev. 06/14

Rx only

Hydrocortisone Tablets Description

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

Hydrocortisone, USP is a white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform.  The molecular weight is 362.46.  It is designated chemically as pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-.  The molecular formula is C21H30O5 and the structural formula is:

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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.

Hydrocortisone Tablets - Clinical Pharmacology

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.  Their synthetic analogs are primarily 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. 

Indications and Usage for Hydrocortisone Tablets

Hydrocortisone Tablets are indicated in the following conditions:

1. Endocrine Disorders
    
Primary or secondary adrencortical 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
     Non suppurative 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
     Systemic dermatomyositis (polymyositis)
     Acute rheumatic carditis

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
     Serum sickness
     Bronchial asthma
     Contact dermatitis
     Atopic dermatitis
     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 Diseases
     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.  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

Contraindications

Systemic fungal infections and known hypersensitivity to components.

Warnings

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. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function.1

These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.2 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 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 the 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 or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids.

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.

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. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

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 on 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.

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.

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

Kaposi"s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.

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 the 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.

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 Patients:

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.

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, particularly of the Achilles tendon

Gastrointestinal

    Peptic ulcer with possible perforation and hemorrhage
    Pancreatitis
    Abdominal distention
    Ulcerative esophagitis
    Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase have been
    observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and
    are reversible upon discontinuation.

Dermatologic

    Impaired wound healing
    Thin fragile skin
    Petechiae and ecchymoses
    Facial erythema
    Increased sweating
    May suppress reactions to skin tests

Neurological

    Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after
    treatment,Convulsions,Vertigo and Headache.

Endocrine

    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
    Menstrual irregularities
    Decreased carbohydrate tolerance
    Manifestations of latent diabetes mellitus
    Increased requirements for insulin or oral hypoglycemic agents in diabetics

Opthalmic

    Posterior subcapsular cataracts
    Increased intraocular pressure
    Glaucoma
    Exophthalmos

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.

Hydrocortisone Tablets Dosage and Administration

The initial dosage of Hydrocortisone Tablets, USP may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Hydrocortisone Tablets should be discontinued and the patient transferred to other appropriate therapy.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient"s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Hydrocortisone Tablets for a period of time consistent with the patient"s condition.

If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.

Multiple Sclerosis:

In treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (20 mg of hydrocortisone is equivalent to 5 mg of prednisolone).

How is Hydrocortisone Tablets Supplied

Hydrocortisone Tablets, USP are available in the following strengths and package sizes:
Hydrocortisone Tablets USP, 20 mg:

White, Round Scored Tablets; Debossed ; West-ward 254 on one side and Scored on the other side. 
Bottles of 100 Tablets
Unit Dose Boxes of 100 Tablets     

Store at 20-25oC (68-77oF) [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.

REFERENCES

1Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WB Saunders Company 1992:1050–1.

2Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954–63.

                                                                                      Manufactured by:

                                                                        West-Ward Pharmaceutical Corp

                                                                                  Eatontown, NJ  07724
                                                                                    Revised June 2014

PACKAGE DISPLAY PANEL

NDC:0143-1254-01
HYDROCORTISONE
TABLETS, USP
20 mg
100 TABLETS
Rx Only

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) HYDROCORTISONE 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SODIUM STARCH GLYCOLATE TYPE B POTATO  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code Westward;254
Contains         
Packaging
# Item Code Package Description
1 NDC:0143-1254-01 100 TABLET in 1 BOTTLE, PLASTIC
2 NDC:0143-1254-25 100 TABLET in 1 BOX, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083365 06/18/1973
Labeler - West-Ward Pharmaceutical Corp (001230762)
Revised: 06/2014
 
West-Ward Pharmaceutical Corp
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