Label: HYDROCORTISONE- hydrocortisone tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 6, 2016

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  • SPL UNCLASSIFIED SECTION

    Rx only

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  • 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.

    This is an image of the structural formula for hydrocortisone.

    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.

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  • 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.

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  • 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

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  • CONTRAINDICATIONS

    Systemic fungal infections and known hypersensitivity to components

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  • 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.

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  • 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.

    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.

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

    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.

    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.

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  • 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

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  • 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.

    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).

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  • HOW SUPPLIED

    Product: 68151-4021

    NDC: 68151-4021-1 1 TABLET in a PACKAGE

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    QUALITEST PHARMACEUTICALS
    Huntsville, AL 35811

    8182192
    Rev 5/13
    R2

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  • Hydrocortisone 5 MG TAB
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-4021(NDC:0603-3899)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 8mm
    Flavor Imprint Code 3578;V
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68151-4021-1 1 in 1 PACKAGE; Type 0: Not a Combination Product 07/16/2007
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040761 07/16/2007
    Labeler - Carilion Materials Management (079239644)
    Establishment
    Name Address ID/FEI Business Operations
    Carilion Materials Management 079239644 REPACK(68151-4021)
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