Prednisone

PREDNISONE- prednisone tablet
Golden State Medical Supply, Inc.

DESCRIPTION

Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The molecular formula for prednisone is C21 H26 O5 . Chemically, it is 17, 21-dihydroxypregna-1, 4-diene-3,11,20-trione and has the following structural formula:

Chemcial Structure -- Prednisone

Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.44. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 2.5 mg, 5 mg, 10 mg, or 20 mg of prednisone.

Inactive ingredients:
2.5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.
5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.
10 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.
20 mg: anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, and 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, such as prednisone, cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.

INDICATIONS

Prednisone tablets are indicated in the following conditions:

  • 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
  • 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
  • Collagen Diseases
    During an exacerbation or as maintenance therapy in selected cases of:
    Systemic lupus erythematosus
    Systemic dermatomyositis (polymyositis)
    Acute rheumatic carditis
  • Dermatologic Diseases
    Pemphigus
    Bullous dermatitis herpetiformis
    Severe erythema multiforme (Stevens-Johnson syndrome)
    Exfoliative dermatitis
    Mycosis fungoides
    Severe psoriasis
    Severe seborrheic dermatitis
  • 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
  • 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
    pneumonitis
  • 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
  • Hematologic Disorders
    Idiopathic thrombocytopenic purpura in adults
    Secondary thrombocytopenia in adults
    Acquired (autoimmune) hemolytic anemia
    Erythroblastopenia (RBC anemia)
    Congenital (erythroid) hypoplastic anemia
  • Neoplastic Diseases
    For palliative management of:
    Leukemias and lymphomas in adults
    Acute leukemia of childhood
  • 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
  • Gastrointestinal Diseases
    To tide the patient over a critical period of the disease in:
    Ulcerative colitis
    Regional enteritis
  • Miscellaneous
    Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
    Trichinosis with neurologic or myocardial involvement

CONTRAINDICATIONS

Prednisone tablets are contraindicated in 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 child-bearing 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.

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 prednisone 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. 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.

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