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  • Hydrocortone Tablets (Merck)

    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 11(beta),17,21-trihydroxypregn-4-ene-3,20-dione. The empirical formula is C 21 H 30 O 5 and the structural formula is:

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

      

    HYDROCORTONE * (Hydrocortisone) tablets contain 10 mg of hydrocortisone in each tablet.

    Inactive ingredients are lactose, magnesium stearate, and starch.

    *Registered trademark of Merck & CO., INC.

    ACTIONS

    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.

    INDICATIONS

    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 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 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. 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

    Hypersensitivity to this product

    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.

    Drug-induced secondary adrenocortical insufficiency may result from too rapid wthdrawal 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 mineralocorticoid should be administered concurrently. (See PRECAUTIONS .)

    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 the 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 a 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 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 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.

    Patients 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 patients on corticosteroids. In such patients who have not had these diseases, particular care should be taken to avoid exposure. The risk of developing a disseminated infection varies among individuals and can be related to the dose, route and duration of corticosteroid administration as well as to the underlying disease. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered. If exposed to measles, prophylaxis with immune globulin (IG) may be indicated. (See the respective package inserts for VZIG and IG for complete prescribing information.)

    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.

    The use of HYDROCORTONE 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.

    PRECAUTIONS

    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.

    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.

    Ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal (see WARNINGS ).

    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 coumarins, 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

    Susceptible patients 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.

    Pediatric Use

    Growth and development of pediatric patients on prolonged corticosteroid therapy should be carefully followed.

    ADVERSE REACTIONS

    Fluid and Electrolyte Disturbances

    Sodium retention

    Fluid retention

    Congestive heart failure in susceptible patients

    Potassium loss

    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 cerebri) 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

    Hyperglycemia

    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

    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 LD 50 of hydrocortisone in female mice was 1740 mg/kg.

    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 HYDROCORTONE 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 dosage 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.

    HOW SUPPLIED

    No. 7604--Tablets HYDROCORTONE, 10 mg each, are white, oval shaped compressed tablets, scored and imprinted MSD 619 on one side and HYDROCORTONE on the other, and are supplied as follows:

    NDC 0006-0619-68 in bottles of 100.

    7920529    Issued November 2001


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