Prednisone

Name: Prednisone

Prednisone Drug Class

Prednisone is part of the drug class:

  • Corticosteroids acting locally

Prednisone Usage

  • Take prednisone exactly as prescribed.
  • This medication comes in tablet and oral solution forms and is usually taken one to four times a day or every other day, with food or milk.
  • If prednisone upsets your stomach, you should take the medication along with food or milk.
  • If you miss a dose, consult your doctor or pharmacist to determine the appropriate course of treatment.  Do not take two doses of prednisone at the same time.

Prednisone Dosage and Administration

General

  • Dosage depends on the condition being treated and the patient response.a b f

Alternate-day Therapy

  • Alternate-day therapy, in which a single dose (twice the usual daily dosage) is administered every other morning, is the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions.a c This regimen provides relief of symptoms while minimizing adrenal suppression, protein catabolism, and other adverse effects.a c

  • If alternate-day therapy is preferred, only use a “short-acting” glucocorticoid that suppresses the HPA axis <1.5 days after a single oral dose (e.g., prednisone, prednisolone, methylprednisolone).c

  • Some conditions (e.g., rheumatoid arthritis, ulcerative colitis) require daily glucocorticoid therapy because symptoms of the underlying disease cannot be controlled by alternate-day therapy.c

Discontinuance of Therapy

  • A steroid withdrawal syndrome consisting of lethargy, fever, myalgia can develop following abrupt discontinuance.c Symptoms often occur without evidence of adrenal insufficiency (while plasma glucocorticoid concentrations were still high but were falling rapidly).c

  • If used for only brief periods (a few days) in emergency situations, may reduce and discontinue dosage quite rapidly.c

  • Very gradually withdraw systemic glucocorticoids until recovery of HPA-axis function occurs following long-term therapy with pharmacologic dosages.c d f (See Adrenocortical Insufficiency under Cautions.)

  • Exercise caution when transferring from systemic glucocorticoid to oral or nasal inhalation corticosteroid therapy.c

  • Many methods of slow withdrawal or “tapering” have been described.c

  • In one suggested regimen, decrease by 2.5–5 mg every 3–7 days until the physiologic dose (5 mg) is reached.c

  • Other recommendations state that decrements usually should not exceed 2.5 mg every 1–2 weeks.c

  • When physiologic dosage is reached, single 20-mg oral morning doses of hydrocortisone can be substituted for whatever glucocorticoid the patient was receiving.c After 2–4 weeks, may decrease hydrocortisone dosage by 2.5 mg every week until a single morning dosage of 10 mg daily reached.c

  • For certain acute allergic conditions (e.g., contact dermatitis such as poison ivy) or acute exacerbations of chronic allergic conditions, glucocorticoids may be administered short term (e.g., for 6 days).c Administer a high dose on the first day of therapy, then withdraw therapy by tapering the dosage over several days.c (See Allergic Conditions under Dosage and Administration.)

Administration

Oral Administration

Administered orally as tablets, solution, or solution concentrate; also has been administered as an extemporaneously prepared suspension.b May dilute oral concentrate in juice or other flavored diluent or in semisolid food (e.g., applesauce) prior to administration.b

To prepare an extemporaneous suspension containing prednisone 10 mg/mL, mix 5 g of prednisone as tablets with 200 mL of 0.1% sodium benzoate solution.b Add 100 mL of an aqueous suspension containing 3% tragacanth, 3% acacia, and 0.1% sodium benzoate and stir the mixture until homogeneous.b Dilute to 500 mL with a mixture of 67% simple syrup and 33% cherry syrup to a final concentration of 10 mg/mL.b

May prepare 4 L of the tragacanth-acacia suspension in a container that can be closed for vigorous agitation.b Initially, dissolve 4 g of sodium benzoate in 2 L of purified water.b Add 120 g of powdered tragacanth and 120 g of acacia in that order and shake the container vigorously.b Add additional water gradually over 24–48 hours with agitation at regular intervals until a volume of 4 L and a smooth suspension results.b To mask the odor, may add 1 mL of anise oil.b

Dosage

After a satisfactory response is obtained, decrease dosage in small decrements to the lowest level that maintains an adequate clinical response, and discontinue the drug as soon as possible.b f

Monitor patients continually for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma).b f

High dosages may be required for acute situations of certain rheumatic disorders and collagen diseases.c After a response has been obtained, drug often must be continued for long periods at low dosage.c

High or massive dosages may be required in the treatment of pemphigus, exfoliative dermatitis, bullous dermatitis herpetiformis, severe erythema multiforme, or mycosis fungoides.c Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris.c Reduce dosage gradually to the lowest effective level, but discontinuance may not be possible.c

Pediatric Patients

Base pediatric dosage on severity of the disease and patient response rather than on strict adherence to dosage indicated by age, body weight, or body surface area.b

Usual Dosage Oral

0.14–2 mg/kg daily or 4–60 mg/m2 daily in 4 divided doses.b

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia Oral

Adolescents >13 years of age with moderate to severe Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia and acquired immunodeficiency syndrome† (AIDS): 40 mg twice daily for 5 days, followed by 40 mg once daily for 5 days, and then 20 mg once daily for 11 days (or until completion of the anti-infective regimen) currently is recommended. Initiate glucocorticoid therapy within 24–72 hours of initial antipneumocystis therapy. Consult published protocols and the most current clinical guidelines.

Allergic Conditions Oral

For certain conditions (e.g., contact dermatitis, including poison ivy), 30 mg (6 tablets) for the first day, which is then tapered by 5 mg daily until 21 tablets have been administered (see Table 1).b

Table 1. Tapered Dosage Schedule

Day

Dosage Schedule

Day 1

Administer 10 mg twice daily (before breakfast and at bedtime) and 5 mg twice daily (after lunch and dinner).b

Day 2

Administer 5 mg 3 times daily (before breakfast, after lunch, and after dinner) and 10 mg at bedtime.b

Day 3

Administer 5 mg 4 times daily (before breakfast, after lunch, after dinner, and at bedtime).b

Day 4

Administer 5 mg 3 times daily (before breakfast, after lunch, and at bedtime).b

Day 5

Administer 5 mg twice daily (before breakfast and at bedtime).b

Day 6

Administer 5 mg before breakfast.b

Adults

Usual Dosage Oral

Initially, 5–60 mg daily, depending on the disease being treated, usually in 2–4 divided doses.b f

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia Oral

Adults with moderate to severe Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia and acquired immunodeficiency syndrome† (AIDS): 40 mg twice daily for 5 days, followed by 40 mg once daily for 5 days, and then 20 mg once daily for 11 days (or until completion of the anti-infective regimen) currently is recommended. Initiate within 24–72 hours of initial antipneumocystis therapy. Consult published protocols and the most current clinical guidelines.

Allergic Conditions Oral

For certain conditions (e.g., contact dermatitis, including poison ivy), 30 mg (6 tablets) for the first day, which is then tapered by 5 mg daily until 21 tablets have been administered (see Table 2).b

Tapered Dosage Schedule

Day

Dosage Schedule

Day 1

Administer 10 mg twice daily (before breakfast and at bedtime) and 5 mg twice daily (after lunch and dinner)b

Day 2

Administer 5 mg 3 times daily (before breakfast, after lunch, and after dinner) and 10 mg at bedtimeb

Day 3

Administer 5 mg 4 times daily (before breakfast, after lunch, after dinner, and at bedtime)b

Day 4

Administer 5 mg 3 times daily (before breakfast, after lunch, and at bedtime)b

Day 5

Administer 5 mg twice daily (before breakfast and at bedtime)b

Day 6

Administer 5 mg before breakfastb

Advanced Pulmonary or Extrapulmonary Tuberculosis Oral

For severe systemic and respiratory complications of advanced pulmonary tuberculosis: 40–60 mg daily, tapered over 4–8 weeks.101 102

Tuberculous meningitis: 1 mg/kg daily for 30 days, followed by gradual tapering of the dosage over a period of weeks, has been suggested.102

Tuberculous pericarditis: 60 mg daily tapered over 6–12 weeks.

Tuberculous pleurisy: 20–40 mg daily tapered over 4–8 weeks.

Mediastinal lymphadenopathy associated with primary intrathoracic tuberculosis: 2–5 mg/kg per day (or equivalent), with dosage reduction to 1 mg/kg per day over the first week and tapered over the next 5 weeks.

Multiple Sclerosis Oral

For acute exacerbations, the manufacturer recommends 200 mg daily for 1 week followed by 80 mg every other day for 1 month.a Alternatively, 60 mg daily tapering over 12 days following IV methylprednisolone (1 g daily for 3–5 days) has been used.

Optic Neuritis Oral

1 mg/kg daily for 11 days following IV methylprednisolone therapy (1 g daily for 3 days).

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

predniSONE

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder

Oral

Solution

5 mg/5 mL

predniSONE Oral Solution (with alcohol 5%)

Roxane

Solution, concentrate

5 mg/mL

predniSONE Intensol (with alcohol 30%)

Roxane

Tablets

1 mg*

predniSONE Tablets

Roxane

2.5 mg*

predniSONE Tablets

Roxane

5 mg*

Sterapred 5 mg Unipak

Merz

Sterapred 5 mg 12 Day Unipak

Merz

predniSONE Tablets

Mutual, Roxane, Trigen, Watson

10 mg*

Sterapred DS Unipak

Merz

Sterapred DS 12 Day Unipak

Merz

predniSONE Tablets

Mutual, Roxane, Trigen, Watson

20 mg*

predniSONE Tablets

Mutual, Roxane, Trigen, Watson

50 mg*

predniSONE Tablets

Roxane, Watson

Commonly used brand name(s)

In the U.S.

  • Deltasone
  • Prednicot
  • predniSONE Intensol
  • Rayos
  • Sterapred
  • Sterapred DS

Available Dosage Forms:

  • Tablet
  • Syrup
  • Solution
  • Tablet, Delayed Release

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

prednisone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Aggression
  • agitation
  • blurred vision
  • decrease in the amount of urine
  • dizziness
  • fast, slow, pounding, or irregular heartbeat or pulse
  • headache
  • irritability
  • mood changes
  • noisy, rattling breathing
  • numbness or tingling in the arms or legs
  • pounding in the ears
  • shortness of breath
  • swelling of the fingers, hands, feet, or lower legs
  • trouble thinking, speaking, or walking
  • troubled breathing at rest
  • weight gain
Incidence not known
  • Abdominal or stomach cramping or burning (severe)
  • abdominal or stomach pain
  • backache
  • bloody, black, or tarry stools
  • cough or hoarseness
  • darkening of the skin
  • decrease in height
  • decreased vision
  • diarrhea
  • dry mouth
  • eye pain
  • eye tearing
  • facial hair growth in females
  • fainting
  • fever or chills
  • flushed, dry skin
  • fractures
  • fruit-like breath odor
  • full or round face, neck, or trunk
  • heartburn or indigestion (severe and continuous)
  • increased hunger
  • increased thirst
  • increased urination
  • loss of appetite
  • loss of sexual desire or ability
  • lower back or side pain
  • menstrual irregularities
  • muscle pain or tenderness
  • muscle wasting or weakness
  • nausea
  • pain in the back, ribs, arms, or legs
  • painful or difficult urination
  • skin rash
  • sweating
  • trouble healing
  • trouble sleeping
  • unexplained weight loss
  • unusual tiredness or weakness
  • vision changes
  • vomiting
  • vomiting of material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Increased appetite
Incidence not known
  • Abnormal fat deposits on the face, neck, and trunk
  • acne
  • dry scalp
  • lightening of normal skin color
  • red face
  • reddish purple lines on the arms, face, legs, trunk, or groin
  • swelling of the stomach area
  • thinning of the scalp hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Precautions

General Precautions

The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual.

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.

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.

Cardio-Renal

As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.

Endocrine

Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; 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.

Gastrointestinal

Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.

Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent.

There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.

Musculoskeletal

Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy.

Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of Prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal.

Neuro-Psychiatric

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 they 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: Multiple Sclerosis.)

An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.

Psychiatric 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.

Ophthalmic

Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.

Information for Patients

Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise.

Persons who are on 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.

Drug Interactions

Amphotericin B Injection and Potassium-Depleting Agents

When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

Antibiotics

Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates).

Anticholinesterases

Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.

Anticoagulants, Oral

Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.

Antidiabetics

Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.

Antitubercular drugs

Serum concentrations of isoniazid may be decreased.

Bupropion

Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.

Cholestyramine

Cholestyramine may increase the clearance of corticosteroids.

Cyclosporine

Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.

Digitalis Glycosides

Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

Estrogens, Including Oral Contraceptives

Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.

Fluoroquinolones

Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.

Hepatic Enzyme Inducers, Inhibitors and Substrates

Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin) may increase their clearance, resulting in decreased plasma concentration.

Ketoconazole

Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.

Nonsteroidal Anti-Inflammatory Agents (NSAIDS)

Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.

Phenytoin

In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.

Quetiapine

Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.

Skin Tests

Corticosteroids may suppress reactions to skin tests.

Thalidomide

Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.

Vaccines

Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination).

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.

The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

Geriatric Use

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.

How is Prednisone Supplied

Prednisone Tablets USP

1 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 092” debossed on the other side.

NDC 0054-8739-25: 10x10 Unit-Dose

NDC 0054-4741-25: Bottle of 100 Tablets

NDC 0054-4741-31: Bottle of 1,000 Tablets

2.5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 339” debossed on the other side.

NDC 0054-8740-25: 10x10 Unit-Dose

NDC 0054-4742-25: Bottle of 100 Tablets

5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 612” debossed on the other side.

NDC 0054-8724-25: 10x10 Unit-Dose

NDC 0054-4728-25: Bottle of 100 Tablets

NDC 0054-4728-31: Bottle of 1,000 Tablets

10 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 899” debossed on the other side.

NDC 0054-0017-20: 10x10 Unit-Dose

NDC 0054-0017-25: Bottle of 100 Tablets

NDC 0054-0017-29: Bottle of 500 Tablets

20 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 760” debossed on the other side.

NDC 0054-0018-20: 10x10 Unit-Dose

NDC 0054-0018-25: Bottle of 100 Tablets

NDC 0054-0018-29: Bottle of 500 Tablets

50 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 343” debossed on the other side.

NDC 0054-0019-20: 10x10 Unit-Dose

NDC 0054-0019-25: Bottle of 100 Tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, child-resistant container as defined in the USP/NF.

PROTECT FROM MOISTURE.

Prednisone Oral Solution USP, 5 mg per 5 mL

Clear, colorless, slightly viscous solution.

NDC 0054-3722-50: Bottle of 120 mL

NDC 0054-3722-63: Bottle of 500 mL

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF.

Prednisone Intensol™ Oral Solution (Concentrate), 5 mg per mL

Clear, colorless, slightly viscous solution.

NDC 0054-3721-44: Bottle of 30 mL with calibrated dropper (graduations of 0.25 mL [1.25 mg] to
1.0 mL [5 mg] on the dropper)

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense only in the bottle and only with the calibrated dropper provided.

Discard opened bottle after 90 days.

References

1. Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WBSaunders Company 1992:1050-1. 2. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

  10002424/09

Revised January 2017

Index Terms

  • Deltacortisone
  • Deltadehydrocortisone
  • Deltasone

Pharmacologic Category

  • Corticosteroid, Systemic

Pharmacology

Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability; suppresses the immune system by reducing activity and volume of the lymphatic system; suppresses adrenal function at high doses. Antitumor effects may be related to inhibition of glucose transport, phosphorylation, or induction of cell death in immature lymphocytes. Antiemetic effects are thought to occur due to blockade of cerebral innervation of the emetic center via inhibition of prostaglandin synthesis.

Absorption

50% to 90% (may be altered in hepatic failure, chronic renal failure, inflammatory bowel disease, hyperthyroidism, and in the elderly) (Frey 1990)

Metabolism

Hepatic to metabolite prednisolone (active)

Excretion

Urine (as conjugates)

Time to Peak

Oral: Immediate-release tablet: 2 hours; Delayed-release tablet: 6 to 6.5 hours

Half-Life Elimination

2 to 3 hours

Protein Binding

Concentration dependent: <50% (Frey 1990)

Contraindications

Hypersensitivity to prednisone or any component of the formulation; administration of live or live attenuated vaccines with immunosuppressive doses of prednisone; systemic fungal infections

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, insomnia, or agitation. Have patient report immediately to prescriber signs of infection; signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit); signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss); signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat); signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting); signs of skin changes (acne, stretch marks, slow healing, or hair growth); signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities); severe loss of strength and energy; irritability; tremors; tachycardia; confusion; sweating a lot; dizziness; shortness of breath; excessive weight gain; swelling of arms or legs; round face; buffalo hump; severe headache; bradycardia; abnormal heartbeat; angina; menstrual changes; joint pain; bone pain; vision changes; mood changes; behavioral changes; depression; seizures; burning or numbness feeling; bruising; bleeding; severe abdominal pain; black, tarry, or bloody stools; or vomiting blood (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Precautions

Consult your pharmacist.

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