Prednisone

PREDNISONE — prednisone tablet
State of Florida DOH Central Pharmacy

Rx only

DESCRIPTION

PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol.

The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy- and its molecular weight is 358.43.

The structural formula is represented below:

This is an image of the structural formula of prednisone

PredniSONE Tablets are available in 5 strengths:

1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg.

Inactive ingredients:

1 mg – lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg – lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg – colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg – colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg – FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

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

PredniSONE 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 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
    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 corneal marginal ulcers
    Herpes zoster ophthalmicus
    Anterior segment inflammation
    Diffuse posterior uveitis and choroiditis
    Sympathetic ophthalmia
    Allergic conjunctivitis
    Keratitis
    Chorioretinitis
    Optic neuritis
    Iritis and iridocyclitis

  7. Respiratory Diseases

    Symptomatic sarcoidosis
    Loeffler’s syndrome not manageable by other means
    Berylliosis
    Aspiration pneumonitis
    Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy

  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 chemotherapyTrichinosis 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 on high dose, because of possible hazards of neurological complications and a lack of antibody response.

The use of PredniSONE 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 anti-tuberculous 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. 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.

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