8246901/0815OS

Rx only

DESCRIPTION

Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is 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 chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below.

Hydrocortisone tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate.

ACTIONS

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

Hydrocortisone tablets are indicated in the following conditions.

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 of osteoarthritis

 

Epicondylitis

3.

Collagen Disease

 

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 Diseases

 

Symptomatic sarcoidosis

 

Loeffler's syndrome not manageable by other means

 

Berylliosis

 

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

 

Aspiration pneumonitis

8.

Hematologic Disorders

 

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.

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.

While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially in high doses, because of possible hazards of neurological complications and lack of antibody response.

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 nonimmune 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.

PRECAUTIONS

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

    Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
    Convulsions
    Vertigo
    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

Ophthalmic

    Posterior subcapsular cataracts
    Increased intraocular pressure
    Glaucoma
    Exophthalmos

Metabolic

    Negative nitrogen balance due to protein catabolism

DOSAGE AND ADMINISTRATION

The initial dosage of hydrocortisone tablets 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 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 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.

HOW SUPPLIED

Hydrocortisone Tablets, USP 5 mg are white, scored, round tablets debossed “3578” on one side and debossed “V” on the reverse side; and are supplied as follows:

Unit dose packages of 30 (5 x 6) NDC 68084-789-25

Hydrocortisone Tablets, USP 20 mg are white, scored, round tablets debossed “3580” on one side and debossed “V” on the reverse side; and are supplied as follows:

Unit dose packages of 30 (5 x 6) NDC 68084-930-25

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Qualitest Pharmaceuticals as follows:

(5 mg / 30 UD) NDC 68084-789-25 packaged from NDC 0603-3899
(20 mg / 30 UD) NDC 68084-930-25 packaged from NDC 0603-3901

Distributed by:
American Health Packaging
Columbus, OH 43217

8246901/0815OS

PRINCIPAL DISPLAY PANEL – 5 mg

NDC 68084-789-25

HYDROCORTISONE
TABLETS, USP

5 mg

30 Tablets (5 x 6)

Each Tablet Contains:
Hydrocortisone, USP……………………… 5 mg

Usual Dosage: See package insert for full
prescribing information

WARNING: This potent drug must be used only
under the direct supervision of a physician.

Store at 20° to 25°C (68° to 77°F); excursions
permitted between 15° to 30°C (59° to 86°F) [see
USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

Rx Only

The drug product contained in this package is from
NDC # 0603-3899, Qualitest Pharmaceuticals.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

078925
Rev. 08/2015OS

PRINCIPAL DISPLAY PANEL – 20 mg

NDC 68084-930-25

HYDROCORTISONE
TABLETS, USP

20 mg

30 Tablets (5 x 6)

Each Tablet Contains:
Hydrocortisone, USP……………………… 20 mg

Usual Dosage: See package insert for full
prescribing information

WARNING: This potent drug must be used only
under the direct supervision of a physician.

Store at 20° to 25°C (68° to 77°F); excursions
permitted between 15° to 30°C (59° to 86°F) [see
USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

Rx Only

The drug product contained in this package is from
NDC # 0603-3901, Qualitest Pharmaceuticals.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

093025
Rev. 08/2015OS