Prednisone

Prednisone
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Overview

Prednisone is a synthetic corticosteroid that is FDA approved for the treatment of thyroiditis, SLE, psoriasis, contact dermatitis, atopic dermatitis, optic neuritis, ulcerative colitis, symptomatic sarcoidosis, multiple sclerosis. Common adverse reactions include osteoporosis, fluid retention,hypokalemia, muscle weakness, hypertension, vertigo, headache, glaucoma, urticaria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Prednisone tablets, USP 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

• Non suppurative thyroiditis

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 non specific 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
• Bronchial asthma
• Contact dermatitis
• Atopic dermatitis
• Serum sickness
• Drug hypersensitivity reactions

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

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

Nervous System

• Acute exacerbations of multiple sclerosis

Miscellaneous

• Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy
• Trichinosis with neurologic or myocardial involvement

Dosage

• The initial dosage of prednisone tablets, USP may vary from 5 mg to 60 mg prednisone 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 1 ¼ to 1 ½ 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:

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

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

• 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.

• 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 (eg, 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.

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

• 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).

• 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.

• 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.

• 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Prednisone in adult patients.

Non–Guideline-Supported Use

Indications

• Bell's palsy
• Myasthenia gravis

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Prednisone FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Prednisone in pediatric patients.

Non–Guideline-Supported Use

Indications

• Henoch-Schönlein nephritis

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, USP 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.

Adverse Reactions

Clinical Trials Experience

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 melliltus
• 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

Postmarketing Experience

There is limited information regarding Prednisone Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Prednisone Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Prednisone in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Prednisone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Prednisone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Prednisone in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Prednisone in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Prednisone in geriatric settings.

Gender

There is no FDA guidance on the use of Prednisone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Prednisone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Prednisone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Prednisone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Prednisone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Prednisone in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Monitoring

There is limited information regarding Prednisone Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Prednisone and IV administrations.

Overdosage

There is limited information regarding Prednisone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Prednisone
Systematic (IUPAC) name
17,21-dihydroxypregna-1,4-diene-3,11,20-trione
Identifiers
CAS number	53-03-2
ATC code	A07EA03 H02AB07 (WHO)
PubChem	5865
DrugBank	DB00635
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	358.428 g/mol
SMILES	eMolecules & PubChem
Synonyms	Deltasone, Liquid Pred, Orasone, Adasone, Deltacortisone, Prednisonum, Prednisolone
Pharmacokinetic data
Bioavailability	70%
Metabolism	prednisolone (liver)
Half life	1 hour
Excretion	Renal
Therapeutic considerations
Pregnancy cat.	C
Legal status	Rx Only (US)(AUS)
Routes	Oral, Nasal, Rectal, Injection, IV

Mechanism of Action

• 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.

Structure

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-

This image is provided by the National Library of Medicine.

Prednisone tablets, USP are available in three strengths: 5 mg, 10 mg, and 20 mg. In addition, each tablet contains the following Inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow #6 aluminum lake HT 15-18%.

Pharmacodynamics

There is limited information regarding Prednisone Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Prednisone Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Prednisone Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Prednisone Clinical Studies in the drug label.

How Supplied

Prednisone Tablets, USP are available in the following strengths and package sizes:

• 5 mg (white, round, scored, imprinted with TL172)

• Bottles of 100 NDC 59746-172-06
• Bottles of 1000 NDC 59746-172-10

• 10 mg (white, round, scored, imprinted with TL173)

• Bottles of 100 NDC 59746-173-06
• Bottles of 500 NDC 59746-173-09
• Bottles of 1000 NDC 59746-173-10

• 20mg (peach, round, scored, imprinted with TL175)

• Bottles of 100 NDC 59746-175-06
• Bottles of 500 NDC 59746-175-09
• Bottles of 1000 NDC 59746-175-10

Storage

Store at 20° to 25° C (68° to 77° F).

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Prednisone in the drug label.

Precautions with Alcohol

• Alcohol-Prednisone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• PREDNISONE ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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