Prednisone
 Prednisone tablets

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Prednisone

Dosage Form: Tablets

Rx only

Prednisone Description

Prednisone 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:

Each tablet, for oral administration, contains 5 mg, 10 mg, or 20 mg Prednisone.

The inactive ingredients are: colloidal silicon dioxide, anhydrous lactose, magnesium stearate, polyplasdone XL, sodium lauryl sulfate, 20 mg also contains FD & C Yellow #6 Lake.

Prednisone - 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 for Prednisone

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
 
Hypercalcemia associated with cancer
 
Nonsuppurative thyroiditis

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
 
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 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.

Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

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.

Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Since concurrent use of these agents results in a mutual inhibition of metabolism, it is possible that adverse events associated with the individual use of either drug may be more apt to occur.

Information for the Patient

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.

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

Metabolic

 
Negative nitrogen balance due to protein catabolism

Neurological

 
Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment
 
Convulsions
 
Vertigo
 
Headache

Endocrine

 
Menstrual irregularities
 
Development of Cushingoid state
 
Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness
 
Suppression of growth in children
 
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

Additional Reactions

 
Urticaria and other allergic, anaphylactic or hypersensitivity reactions

Prednisone Dosage and Administration

The initial dosage of Prednisone tablets may vary from 5 mg to 60 mg 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, Prednisone 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 Prednisone 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 the 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. (Dosage range is the same for Prednisone and prednisolone.)

ADT® (Alternate Day Therapy)

ADT is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.

The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.

A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.

The diurnal rhythm of the HPA axis is lost in Cushing"s disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.

During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, Prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.

The following should be kept in mind when considering alternate day therapy:

1) Basic principles and indications for corticosteroid therapy should apply. The benefits of ADT should not encourage the indiscriminate use of steroids.

2) ADT is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.

3) In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with ADT. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended.

Once control has been established, two courses are available: (a) change to ADT and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable.

4) Because of the advantages of ADT, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on ADT may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.

5) As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone).

6) The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).

7) In using ADT it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of ADT will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed.

8) In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted.

9) Although many of the undesirable features of corticosteroid therapy can be minimized by ADT, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.

How is Prednisone Supplied

Prednisone Tablets are available as scored, compressed tablets in the following strengths and sizes:

5 mg Bottles of 20
NDC 53489-138-60
Bottles of 100
NDC 53489-138-01
Bottles of 500
NDC 53489-138-05
Bottles of 1000
NDC 53489-138-10
Bottles of 5000
NDC 53489-138-50
Marked MP/51
White 8/32" Flat Faced
Beveled Bisect

10 mg Bottles of 100
NDC 53489-139-01
Bottles of 500
NDC 53489-139-05
Bottles of 1000
NDC 53489-139-10
Marked MP/52
White 11/32" Flat Faced
Beveled Bisect

20 mg Bottles of 50
NDC 53489-140-02
Bottles of 100
NDC 53489-140-01
Bottles of 500
NDC 53489-140-05
Bottles of 1000
NDC 53489-140-10
Marked MP/53
Peach 13/32" Flat Faced
Beveled Bisect

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Manufactured by
MUTUAL PHARMACEUTICAL COMPANY, INC.
Philadelphia, PA 19124 USA

Rev: September 2006S


Prednisone (Prednisone)
PRODUCT INFO
Product Code 53489-138 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Prednisone (Prednisone) Active 5 MILLIGRAM  In 1 TABLET
Colloidal silicon dioxide Inactive  
anhydrous lactose Inactive  
magnesium stearate Inactive  
polyplasdone XL Inactive  
sodium lauryl sulfate Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color WHITE (white) Score 2
Shape ROUND (round) Symbol false
Imprint Code MP;/51 Coating false
Size 6mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 53489-138-60 20 TABLET In 1 BOTTLE, PLASTIC None
2 53489-138-01 100 TABLET In 1 BOTTLE, PLASTIC None
3 53489-138-05 500 TABLET In 1 BOTTLE, PLASTIC None
4 53489-138-10 1000 TABLET In 1 BOTTLE, PLASTIC None
5 53489-138-50 5000 TABLET In 1 BOTTLE, PLASTIC None

Prednisone (Prednisone)
PRODUCT INFO
Product Code 53489-139 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Prednisone (Prednisone) Active 10 MILLIGRAM  In 1 TABLET
Colloidal silicon dioxide Inactive  
anhydrous lactose Inactive  
magnesium stearate Inactive  
polyplasdone XL Inactive  
sodium lauryl sulfate Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color WHITE (white) Score 2
Shape ROUND (round) Symbol false
Imprint Code MP;/52 Coating false
Size 9mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 53489-139-01 100 TABLET In 1 BOTTLE, PLASTIC None
2 53489-139-05 500 TABLET In 1 BOTTLE, PLASTIC None
3 53489-139-10 1000 TABLET In 1 BOTTLE, PLASTIC None

Prednisone (Prednisone)
PRODUCT INFO
Product Code 53489-140 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Prednisone (Prednisone) Active 20 MILLIGRAM  In 1 TABLET
Colloidal silicon dioxide Inactive  
anhydrous lactose Inactive  
magnesium stearate Inactive  
polyplasdone XL Inactive  
sodium lauryl sulfate Inactive  
FD&C Yellow #6 Lake. Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color ORANGE (peach) Score 2
Shape ROUND (round) Symbol false
Imprint Code MP;/53 Coating false
Size 10mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 53489-140-02 50 TABLET In 1 BOTTLE, PLASTIC None
2 53489-140-01 100 TABLET In 1 BOTTLE, PLASTIC None
3 53489-140-05 500 TABLET In 1 BOTTLE, PLASTIC None
4 53489-140-10 1000 TABLET In 1 BOTTLE, PLASTIC None

Revised: 02/2007





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