Prednisone

Prednisone is a prescription medication used to treat many conditions including:

• low corticosteroid levels (adrenal insufficiency)
• certain types of arthritis
• allergic conditions
• multiple sclerosis
• lupus and other collagen diseases
• other diseases affecting the lungs, skin, eyes, kidneys, blood, thyroid, stomach, and intestines

Prednisone belongs to a group of drugs called corticosteroids, which replace steroids the body normally makes, leading to overall reduction of inflammation and of the immune system.

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.

Common side effects of prednisone include headache, dizziness, and difficulty falling asleep.  Do not drive or operate machinery until you know how prednisone will affect you.

If you take too much prednisone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Contraindications

• Known hypersensitivity to prednisone, any ingredient in the respective formulation, or any other corticosteroid.a c d f

• Systemic fungal infections.a d f

• Concurrent administration of live or live, attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids.a d f (See Specific Drugs and Laboratory Tests under Interactions.)

Warnings/Precautions

Warnings

When given in supraphysiologic doses for prolonged periods, glucocorticoids may cause decreased secretion of endogenous corticosteroids by suppressing pituitary release of corticotropin (secondary adrenocortical insufficiency).c

The degree and duration of adrenocortical insufficiency is highly variable among patients and depends on the dose, frequency and time of administration, and duration of glucocorticoid therapy.c

Acute adrenal insufficiency (even death) may occur if the drugs are withdrawn abruptly or if patients are transferred from systemic glucocorticoid therapy to local (e.g., inhalation) therapy.c

Withdraw prednisone very gradually following long-term therapy with pharmacologic dosages.c (See Discontinuance of Therapy under Dosage and Administration.)

Adrenal suppression may persist up to 12 months in patients who receive large dosages for prolonged periods.c

Until recovery occurs, may develop signs and symptoms of adrenal insufficiency if subjected to stress (e.g., infection, surgery, trauma, illness) and may require replacement therapy.a c d f Since mineralocorticoid secretion may be impaired, sodium chloride and/or a mineralocorticoid also should be administered.c d f

If the disease flares up during withdrawal, may need to increase dosage and follow with a more gradual withdrawal.c

Increased susceptibility to infections secondary to glucocorticoid-induced immunosuppression.d Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients.d (See Increased Susceptibility to Infection under Cautions.)

Administration of live virus vaccines, including smallpox, is contraindicated in patients receiving immunosuppressive dosages of glucocorticoids.d In addition, if inactivated viral or bacterial vaccines are administered to such patients, expected serum antibody response may not be obtained.a c d The USPHS Advisory Committee on Immunization Practices (ACIP) and American Academy of Family Physicians (AAFP) state that administration of live virus vaccines usually is not contraindicated in patients receiving corticosteroid therapy under the following circumstances:

• short-term (<2 weeks) therapy

• low to moderate dosage

• long-term alternate-day treatment with short-acting preparations

• maintenance physiologic dosages (replacement therapy)

• topical, ophthalmic, intra-articular, bursol, or intratendon administration

Glucocorticoids, especially in large doses, increase susceptibility to and mask symptoms of infection.d

Infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections in any organ system, may be associated with glucocorticoids alone or in combination with other immunosuppressive agents.d

Infections may be mild, but they can be severe or fatal, and localized infections may disseminate.

Do not use, except in life-threatening situations, in patients with viral infections or bacterial infections not controlled by anti-infectives.c

Some infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome, particularly in children.d

Children and any adult who are not likely to have been exposed to varicella or measles should avoid exposure to these infections while receiving glucocorticoids.d

If exposure to varicella or measles occurs in susceptible patients, treat appropriately (e.g., varicella zoster immune globulin [VZIG], immune globulin [IG], acyclovir).d

Fatal outcome (e.g., in those developing hemorrhagic varicella) may not always be avoided even if appropriate therapy is initiated aggressively.

Immunosuppression may result in activation of latent infection or exacerbation of intercurrent infections (e.g., those caused by Candida, Mycobacterium, Toxoplasma, Strongyloides, Pneumocystis, Cryptococcus, Nocardia, Ameba).

Use with great care in patients with known or suspected Strongyloides (threadworm) infection.d Immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Not effective and can have detrimental effects in the management of cerebral malaria.c

Can reactivate tuberculosis.c Include chemoprophylaxis in patients with a history of active tuberculosis undergoing prolonged glucocorticoid therapy.c d Observe closely for evidence of reactivation.d f Restrict use in active tuberculosis to those with fulminating or disseminated tuberculosis in which glucocorticoids are used in conjunction with appropriate antimycobacterial chemotherapy.d f

Can reactivate latent amebiasis.c Exclude possible amebiasis in any patient who has been in the tropics or who has unexplained diarrhea prior to initiating therapy.c

Muscle wasting, muscle pain or weakness, delayed wound healing, and atrophy of the protein matrix of the bone resulting in osteoporosis, vertebral compression fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones are manifestations of protein catabolism that may occur during prolonged therapy with glucocorticoids.c These adverse effects may be especially serious in geriatric or debilitated patients.c A high protein diet may help to prevent adverse effects associated with protein catabolism.c

An acute, generalized myopathy can occur with the use of high doses of glucocorticoids, particularly in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis) or in patients receiving concomitant therapy with neuromuscular blocking agents (e.g., pancuronium). Use with caution in patients with myasthenia gravis.f

Tendon rupture, particularly of the Achilles tendon.

Osteoporosis and related fractures are one of the most serious adverse effects of long-term glucocorticoid therapy. The American College of Rheumatology (ACR) currently considers patients receiving or planning to receive at least 5 mg of prednisone daily for 3 months or longer to be at risk for bone loss.

To minimize the risk of glucocorticoid-induced bone loss, should use the smallest possible effective dosage and duration and use topical and inhaled preparations whenever possible. Obtain baseline measurement of bone mineral density (BMD) at the lumbar spine and/or hip when initiating long-term (e.g., exceeding 6 months) glucocorticoid therapy and initiate appropriate preventive therapy. May repeat longitudinal measurements as often as every 6 months to detect possible bone loss. Less frequent (e.g., annually) follow-up probably is sufficient in patients who are receiving therapy to prevent bone loss.

Before initiating glucocorticoid therapy in postmenopausal women, consider that they are especially prone to osteoporosis.c

Skeletal wasting is most rapid during the initial 6 months of therapy, and trabecular bone is affected to a greater degree than is cortical bone.

Withdraw glucocorticoids if osteoporosis develops, unless their use is life-saving.c

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.

Calcitonin may be considered as second-line therapy for patients who refuse or do not tolerate bisphosphonate therapy or for whom the drugs are contraindicated.

Sodium retention with resultant edema, potassium loss, and elevation of blood pressure may occur, but is less common with prednisone than with average or large doses of cortisone or hydrocortisone.d Risk is increased with high-dose synthetic glucocorticoids for prolonged periods.c d Edema and CHF (in susceptible patients) may occur.c

Dietary salt restriction is advisable and potassium supplementation may be necessary.c d

Increased calcium excretion and possible hypocalcemia.c d

Prolonged use may result in posterior subcapsular and nuclear cataracts (particularly in children), exophthalmos, and/or increased intraocular pressure (IOP) which may result in glaucoma or may occasionally damage the optic nerve.d

May enhance the establishment of secondary fungal or viral infections of the eye.d

Do not use in patients with active ocular herpes simplex infections for fear of corneal perforation.a c

With prolonged therapy, may produce various endocrine disorders including hypercorticism (cushingoid state) and amenorrhea or other menstrual difficulties.a c d

Increased or decreased motility and number of sperm in some men.c

May decrease glucose tolerance, produce hyperglycemia, and aggravate or precipitate diabetes mellitus, especially in patients predisposed to diabetes mellitus.c If glucocorticoid therapy is required in patients with diabetes mellitus, may be necessary to change insulin or oral antidiabetic agent dosage or diet.c d

Exaggerated response to glucocorticoids in hypothyroidism.c d

Use with extreme caution in recent MI since an association between use of glucocorticoids and left ventricular free-wall rupture has been suggested.c

Sodium retention with resultant edema, potassium loss, hypokalemic alkalosis, and hypertension may occur in patients receiving glucocorticoids.c d CHF may occur in susceptible patients.a c d

Should be used with caution in patients with hypertension or CHF.a c d

Sensitivity Reactions

Urticaria and other allergic, anaphylactic, or hypersensitivity reactions reported.a d f

General Precautions

Prior to initiation of long-term glucocorticoid therapy, perform baseline ECGs, blood pressures, chest and spinal radiographs, glucose tolerance tests, and evaluations of HPA-axis function in all patients.c

Perform upper GI radiographs in patients predisposed to GI disorders, including those with known or suspected peptic ulcer disease.c

During long-term therapy, perform periodic height, weight, chest and spinal radiographs, hematopoietic, electrolyte, glucose tolerance, and ocular and BP evaluations.

Increased or decreased motility and number of sperm in some men.c

May precipitate mental disturbances ranging from euphoria, insomnia, mood swings, depression, and personality changes to frank psychoses.a d Use may aggravate emotional instability or psychotic tendencies.a d

Use with caution in patients with diverticulitis, nonspecific ulcerative colitis (if there is a probability of impending perforation, abscess, or pyogenic infection), or those with recent intestinal anastomoses.d

Signs of peritoneal irritation following GI perforation may be absent in patients receiving corticosteroids.c d

Use with caution in patients with active or latent peptic ulcer.d Suggest concurrent administration of antacids between meals to prevent peptic ulcer formation in patients receiving high dosages of corticosteroids.c

Kaposi’s sarcoma has been reported to occur in patients receiving glucocorticoid therapy; discontinuance of such therapy may result in remission of the disease.d

Specific Populations

Category C.d If substantial dosage is received during pregnancy, carefully observe infant for signs of hypoadrenalism.d

Glucocorticoids are distributed into milk and could suppress growth, interfere with endogenous glucocorticoid production, or cause other adverse effects in nursing infants.c d Use with caution.c

The effects of glucocorticoids on the pathophysiology and course of diseases are considered to be similar in adults and children.c

The adverse effects in pediatric patients are similar to those in adults.c As in adults, perform periodic evaluations of height, weight, ocular pressure, and BP.c Children, like adults, also should undergo clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.c

With long-term use, may delay growth and maturation in children and adolescents.c d Monitor carefully the growth and development of pediatric patients receiving prolonged corticosteroid therapy.a c d Titrate dosage to the lowest effective level.c Alternate-day therapy with glucocorticoids that cause shorter HPA-axis suppression than does dexamethasone (e.g., prednisone, prednisolone, methylprednisolone) may minimize growth suppression and should be instituted if growth suppression occurs.c

Glucocorticoid-induced osteoporosis and associated fractures are common in children and adolescents receiving long-term systemic therapy. In addition, may prevent achievement of peak bone mass during adolescence by inhibiting bone formation. Methods for monitoring bone mineralization (e.g., dual-energy x-ray absorptiometry [DEXA]) in children and adolescents are similar to those in adults.

Ensure children and adolescents consistently ingest adequate calcium and vitamin D, either through diet or supplementation.

With prolonged therapy, muscle wasting, muscle pain or weakness, delayed wound healing, atrophy of the protein matrix of the bone resulting in osteoporosis, vertebral compression fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones may occur.c May be especially serious in geriatric or debilitated patients.c

Before initiating glucocorticoid therapy in postmenopausal women, consider that such women are especially prone to osteoporosis.c

Use with caution in patients with osteoporosis.d

Patients with cirrhosis show an exaggerated response to glucocorticoids.c d

Use with caution.d

Common Adverse Effects

Associated with long-term therapy: Bone loss, cataracts, indigestion, muscle weakness, back pain, bruising, oral candidiasis.g h

Prednisone tablets and solutions 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; hypercalcemia associated with cancer; nonsuppurative 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 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; 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.

Miscellaneous

Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.

Prednisone tablets and oral solutions are contraindicated in systemic fungal infections and known hypersensitivity to components.

(listed alphabetically, under each subsection)

The following adverse reactions have been reported with Prednisone or other corticosteroids:

Allergic Reactions

anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema.

bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria.

Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine), suppression of growth in pediatric patients.

congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema.

abdominal distention, abdominal pain, anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting.

anemia, neutropenia (including febrile neutropenia).

negative nitrogen balance due to protein catabolism.

arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures.

amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, increased motor activity, insomnia, ischemic neuropathy, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditions, restlessness, schizophrenia, verbal memory loss, vertigo, withdrawn behavior.

blurred vision, cataracts (including posterior subcapsular cataracts), central serous chorioretinopathy, establishment of secondary bacterial, fungal and viral infections, exophthalmos, glaucoma, increased intraocular pressure (see PRECAUTIONS: Ophthalmic), optic nerve damage, papilledema.

abnormal fat deposits, aggravation/masking of infections, decreased resistance to infection (see WARNINGS: Infection), hiccups, immunosuppresion, increased or decreased motility and number of spermatozoa, malaise, insomnia, moon face, pyrexia.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Concentrate, Oral:

PredniSONE Intensol: 5 mg/mL (30 mL) [contains alcohol, usp; unflavored flavor]

Solution, Oral:

Generic: 5 mg/5 mL (5 mL [DSC], 120 mL, 500 mL)

Tablet, Oral:

Deltasone: 20 mg [scored; contains fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Generic: 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 50 mg, 10 mg, 5 mg

Tablet Delayed Release, Oral:

Rayos: 1 mg, 2 mg, 5 mg

Tablet Therapy Pack, Oral:

Generic: 10 mg (21 ea, 48 ea); 5 mg (21 ea, 48 ea)

General dosing; anti-inflammatory/immunosuppressive/endocrine disorders: Oral: Initial: 5 to 60 mg daily:

Note: Dose depends upon condition being treated and response of patient. Consider alternate day therapy for long-term therapy. Discontinuation of long-term therapy requires gradual withdrawal by tapering the dose.

Prednisone taper (other regimens also available):

Day 1: 30 mg divided as 10 mg before breakfast, 5 mg at lunch, 5 mg at dinner, 10 mg at bedtime

Day 2: 5 mg at breakfast, 5 mg at lunch, 5 mg at dinner, 10 mg at bedtime

Day 3: 5 mg 4 times daily (with meals and at bedtime)

Day 4: 5 mg 3 times daily (breakfast, lunch, bedtime)

Day 5: 5 mg 2 times daily (breakfast, bedtime)

Day 6: 5 mg before breakfast

Indication-specific dosing:

Acute asthma (off-label dose): Oral: 40 to 60 mg/day for 3 to 10 days; administer as single or 2 divided doses (NAEPP 2007).

Acute exacerbations of chronic obstructive pulmonary disease (COPD) (off-label use for immediate release products; off-label dose): Oral: 40 mg once daily for 5 days (GOLD 2014).

Acute gout (off-label dose): Oral: Initial: ≥0.5 mg/kg for 5 to 10 days (ACR guidelines [Khanna 2012])

Anaphylaxis, adjunctive treatment (off-label dose): Oral: 0.5 mg/kg (Lieberman 2005)

Antineoplastic: Oral: Usual range: 10 mg daily to 100 mg/m2/day (depending on indication). Refer to specific protocol for dosing and administration details.

Autoimmune hepatitis (off-label use): Oral: Initial: 60 mg daily for 1 week, followed by 40 mg daily for 1 week, then 30 mg daily for 2 weeks, then 20 mg daily. Half this dose should be given when used in combination with azathioprine (AASLD [Manns 2010]).

Bell palsy (off-label use): Oral: 60 mg daily for 5 days, followed by a 5-day taper. Treatment should begin within 72 hours of onset of symptoms (OHNS [Baugh 2013]).

Crohn disease, moderate/severe (off-label dose): Oral: 40 to 60 mg daily until resolution of symptoms and resumption of weight gain (usual duration: 7 to 28 days) (Lichtenstein 2009).

Dermatomyositis/polymyositis (off-label dose): Oral: 1 mg/kg daily (range: 0.5 to 1.5 mg/kg/day), often in conjunction with steroid-sparing therapies; depending on response/tolerance, consider slow tapering after 2 to 8 weeks depending on response; taper regimens vary widely, but often involve 5 to 10 mg decrements per week and may require 6 to 12 months to reach a low once-daily or every-other-day dose to prevent disease flare (Briemberg 2003; Hengstman 2009; Iorizzo 2008; Wiendl 2008).

Duchenne muscular dystrophy (off-label use): Oral: 0.75 mg/kg/day or 10 mg/kg/weekend, divided over 2 days. When used daily, the dose may be decreased to 0.3 mg/kg/day in patients who experience adverse reactions. Doses as high as 1.5 mg/kg/day have been studied, but there is no evidence that doses above 0.75 mg/kg/day provide greater efficacy (AAN [Gloss 2016]; Escolar 2011; Matthews 2016).

Giant cell arteritis (off-label use): Oral: Initial: 40 to 60 mg daily; typically requires 1 to 2 years of treatment, but may begin to taper after 2 to 3 months; alternative dosing of 30 to 40 mg daily has demonstrated similar efficacy (Hiratzka 2010).

Glucocorticoid remediable aldosteronism, treatment (off-label use): Oral: Initial: 2.5 to 5 mg once daily preferably at bedtime to suppress early morning ACTH surge (Funder 2016)

Graves orbitopathy (off-label use): Oral: 0.4 to 0.5 mg/kg/day, starting 1 to 3 days after radioactive iodine treatment, and continued for 1 month, then gradually taper over 2 months (Ross 2016).

Herpes zoster (off-label use): Oral: 60 mg daily for 7 days, followed by 30 mg daily for 7 days, then 15 mg daily for 7 days (Dworkin 2007).

Immune thrombocytopenia (off-label dose): Oral: 1 to 2 mg/kg/day (American Society of Hematology 1997).

Immune thrombocytopenia in pregnancy: Initial: 10 to 20 mg/day (ACOG 2016). Adjust to the minimum effective dose to achieve response; generally continue for at least 21 days, then taper to the minimum effective dose required to maintain platelet count (ACOG 2016; Neunert 2011).

Lupus nephritis, induction (off-label dose): Oral:

Class III-IV lupus nephritis: 0.5 to 1 mg/kg/day (after glucocorticoid pulse) tapered after a few weeks to lowest effective dose, in combination with an immunosuppressive agent (Hahn 2012).

Class V lupus nephritis: 0.5 mg/kg/day for 6 months in combination mycophenolate mofetil; if not improved after 6 months, use 0.5 to 1 mg/kg/day (after a glucocorticoid pulse) for an additional 6 months in combination with cyclophosphamide (Hahn 2012).

Multiple sclerosis, acute exacerbations:

Note: Treatment guidelines recommend the use of high dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]; NICE 2014).

Oral: 200 mg daily for 1 week, followed by 80 mg every other day for 1 month.

Pericarditis (off-label use):

Recurrent pericarditis: Oral: 1 to 1.5 mg/kg once daily for at least 1 month; taper dose over a 3-month period (Maisch 2004)

Tuberculosis pericarditis: Oral: 1 to 2 mg/kg once daily for 5 to 7 days followed by 6 to 8 weeks of tapering (Maisch 2004) or 60 mg once daily for 4 weeks, followed by 30 mg once daily for 4 weeks, 15 mg once daily for 2 weeks, and 5 mg once daily for 1 week (Reuter 2006).

Pneumocystis pneumonia (adjunctive therapy) in HIV-infected patients (off-label dose): Oral: 40 mg twice daily for 5 days beginning as early as possible and within 72 hours of PCP therapy, followed by 40 mg once daily on days 6 through 10, followed by 20 mg once daily on days 11 through 21 (DHHS [adult] 2015).

Polymyalgia rheumatica (off-label dose): Oral: Evidence to support an optimal dose and duration are lacking; recommendations provided are general guidelines only. Individualize therapy using the minimum effective dose and duration (Dejaco [EULAR/ACR 2015]):

Initial: Dosage range: 12.5 to 25 mg daily; consider higher doses within this range for patients at high risk of relapse and low risk of adverse events; consider lower doses within this range for patients with high risk factors for side effects (eg, diabetes, osteoporosis, glaucoma). Single daily doses are preferred over divided daily doses. Avoid initial doses ≤7.5 mg/day or >30 mg/day.

Tapering: For initial dosing, taper to a dose of 10 mg/day within 4 to 8 weeks. If relapse occurs, increase dosing to the prerelapse dose and gradually taper back to the dose which relapse occurred within 4 to 8 weeks. Once remission is achieved (initial or relapse therapy), taper daily dose by 1 mg every 4 weeks (or by 1.25 mg decrements if using schedules such as 10 mg and 7.5 mg on alternate days) until discontinuation.

Prostate cancer, metastatic (off-label use): Oral: 5 mg twice daily (in combination with abiraterone) until disease progression or unacceptable toxicity (de Bono 2011; Ryan 2015) or 10 mg once daily (in combination with cabazitaxel) for up to 10 cycles (de Bono 2010) or 5 mg twice daily (in combination with docetaxel) for up to 10 cycles (Berthold 2008; Tannock 2004).

Rheumatoid arthritis (off-label dose): Oral: ≤10 mg daily (American College of Rheumatology 2002).

Subacute thyroiditis (off-label use): Oral: Initial: 40 mg/day for 1 to 2 weeks; gradually taper over 2 to 4 weeks or longer depending on clinical response (Ross 2016).

Takayasu arteritis (off-label use): Oral: Initial: 40 to 60 mg daily; taper to lowest effective dose when ESR and CRP levels are normal; usual duration: 1 to 2 years (Hiratzka 2010).

Thyrotoxicosis, type 2 amiodarone-induced (off-label use): Oral: 40 mg once daily for 14 to 28 days; gradually taper over 2 to 3 months depending on clinical response. Note: Use in combination with an antithyroid agent if etiology of thyrotoxicosis (eg type 1 or type 2) cannot be unequivocally determined or if patient is too clinically unstable to allow a trial of monotherapy (Ross 2016).

Tuberculosis, severe, paradoxical reactions (off-label dose): Oral: 1 mg/kg/day, gradually reduce after 1 to 2 weeks (AIDSinfo guidelines 2008).

There are no dosage adjustments provided in the manufacturer’s labeling.

Hemodialysis: Supplemental dose is not necessary.

Blood pressure; weight; serum glucose; electrolytes; growth in pediatric patients; presence of infection, bone mineral density; assess HPA axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test); Hgb, occult blood loss; chest x-ray (at regular intervals during prolonged therapy); IOP with therapy >6 weeks.

Consult your pharmacist.

How to use Prednisone Powder

Consult your pharmacist.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

Prednisone treats many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

You should not take prednisone if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Avoid being near people who are sick or have infections. Do not receive a "live" vaccine while using prednisone.

Call your doctor at once if you have shortness of breath, severe pain in your upper stomach, bloody or tarry stools, severe depression, changes in personality or behavior, vision problems, or eye pain.

You should not stop using prednisone suddenly. Follow your doctor's instructions about tapering your dose.

Usual Adult Dose for Nephrotic Syndrome:

Initial (first three episodes): 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
Maintenance dose for frequent relapses: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Usual Adult Dose of Prednisone for Anti-inflammatory:

5 to 60 mg per day in divided doses 1 to 4 times/day.

Usual Pediatric Dose for Nephrotic Syndrome:

Initial (first three episodes): 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
Maintenance dose for frequent relapses: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Usual Pediatric Dose for Asthma:

< I year:
acute: 10 mg orally every 12 hours.
maintenance: 10 mg orally very other day.

1 to 4 years:
acute: 20 mg orally every 12 hours.
maintenance: 20 mg orally every other day.

5 to 12 years:
acute: 30 mg orally every 12 hours.
maintenance: 30 mg orally every other day.

>12 years:
acute: 40 mg orally every 12 hours.
maintenance: 40 mg orally every other day.

Usual Pediatric Dose of Prednisone for Anti-inflammatory:

0.05 to 2 mg/kg/day divided 1 to 4 times/day

Usual Pediatric Dose for Immunosuppression:

0.05 to 2 mg/kg/day divided 1 to 4 times/day

Applies to prednisone: compounding powder, oral delayed release tablet, oral solution, oral tablet

General

The most commonly reported adverse effects associated with corticosteroid use include fluid retention, alteration in glucose tolerance, high blood pressure, behavior and mood changes, increased appetite and weight gain. Occurrence is often associated with dose and duration of therapy; long-term effects include HPA suppression, Cushingoid appearance, cataracts and increased intraocular pressure/glaucoma, osteoporosis and vertebral compression fractures.[Ref]

Metabolic

Frequency not reported: Decreased carbohydrate and glucose tolerance, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipid abnormal, negative nitrogen balance caused by protein catabolism, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, potassium loss, sodium retention with resulting edema, increased appetite and weight gain, anorexia and weight loss, hypertriglyceridemia, hypercholesterolemia[Ref]

Cardiovascular

Frequency not reported: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypotension, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, necrotizing angiitis, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis[Ref]

Endocrine

Frequency not reported: Adrenal insufficiency associated symptoms including arthralgias, buffalo hump, amenorrhea, postmenopausal bleeding or menstrual irregularities, development of cushingoid state, hyperthyroidism, hypothyroidism, moon face, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress as in trauma, surgery, or illness), increased or decreased motility and number of spermatozoa[Ref]

Ocular

Frequency not reported: Blurred vision, cataracts (including posterior subcapsular cataracts) central serous chorioretinopathy, secondary bacterial, fungal, and viral infections, exophthalmos, glaucoma, increased intraocular pressure[Ref]

Gastrointestinal

Frequency not reported: Abdominal distention, abdominal pain, constipation, diarrhea, gastric irritation, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting[Ref]

Immunologic

Frequency not reported: Immunosuppression, aggravation/masking of infections, decreased resistance to infection[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, aseptic necrosis of femoral and humeral heads, increased risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures, suppression of growth in pediatric patients[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, angioedema, allergic reactions[Ref]

Nervous system

Frequency not reported: Arachnoiditis, benign intracranial hypertension, convulsions, dementia, dizziness, EEG abnormalities, impaired cognition, increased intracranial pressure with papilledema, increased motor activity, ischemic neuropathy, severe tiredness or weakness, meningitis, neuritis, neuropathy, paraparesis/paraplegia, sensory disturbances[Ref]

Psychiatric

Frequency not reported: Amnesia, anxiety, delirium, depression, emotional instability and irritability, euphoria, hallucinations, severe psychiatric symptoms, insomnia, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of preexisting psychiatric conditions, restlessness, schizophrenia, verbal memory loss, withdrawn behavior[Ref]

Hematologic

Frequency not reported: Anemia, neutropenia, febrile neutropenia, moderate leukocytosis, lymphopenia, eosinopenia, polycythemia[Ref]

Dermatologic

Frequency not reported: Acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymosis and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, telangiectasis, thin fragile skin, thinning scalp hair, urticaria, hypertrichosis[Ref]

Hepatic

Frequency not reported: ALT, AST and alkaline phosphatase elevations (usually reversible upon discontinuation), hepatomegaly[Ref]

Respiratory

Frequency not reported: Hiccups, pulmonary edema[Ref]

Oncologic

Frequency not reported: Kaposi's sarcoma[Ref]

Other

Frequency not reported: Vertigo, pyrexia, abnormal fat deposits, malaise[Ref]

Some side effects of prednisone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

• Prednisone takes approximately 60 minutes to be metabolized in the liver to its active form, prednisolone. Liver disease does not appear to affect metabolism. Effects can last from 18-36 hours, meaning that alternate day dosing is possible.
• Temporary dosage increases may be necessary during disease flare-ups or during times of stress or infection.
• Prednisone is five times more potent at relieving inflammation than naturally occurring cortisol.

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