PrednisoLONE (Systemic) (Lexi-Drugs)

Special Alerts
  Prednisone and Prednisolone Safety AlertAugust 2018
Pronunciation

(pred NISS oh lone)

Brand Names: US

Millipred; Millipred DP; Millipred DP 12-Day; Orapred ODT; Pediapred; Veripred 20

Brand Names: Canada

Pediapred; PMS-Prednisolone

Pharmacologic Category

Corticosteroid, Systemic

Dosing: Adult

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.

Usual dose (range): Oral: 5 to 60 mg/day

Adrenal insufficiency, chronic (primary, classic congenital adrenal hyperplasia) (off-label dose; alternative agent): Oral: 3 to 6 mg daily in 1 to 2 divided doses; use of a liquid dosage form may be preferable to allow for better dose titration (Endocrine Society [Bornstein 2016]; Endocrine Society [Speiser 2018]).

Alcoholic hepatitis (severe) (Maddrey Discriminant Function [MDF] score ≥32) (off-label use): Oral: 40 mg daily for 28 days, followed by a 2 to 4 week taper (AASLD [O’Shea 2010]; ACG [Singal 2018])

Asthma exacerbations: Oral:

Global Initiative for Asthma guidelines (GINA 2018): Management in primary care or acute care facility: 1 mg/kg/day (maximum: 50 mg/day) as a single daily dose usually given for 5 to 7 days

National Asthma Education and Prevention Program guidelines (NAEPP 2007):

Asthma exacerbations (emergency care or hospital doses): 40 to 80 mg/day in a single dose or in 2 divided doses until peak expiratory flow is 70% of predicted or personal best

Short-course outpatient “burst” (acute asthma): 40 to 60 mg/day in a single dose or in 2 divided doses for 5 to 10 days. Note: Burst should be continued until symptoms resolve and peak expiratory flow is at least 80% of personal best; usually requires 3 to 10 days of treatment; longer treatment may be required

Long-term treatment: 7.5 to 60 mg daily given as a single dose in the morning or every other day as needed for asthma control

Bell’s palsy (off-label use): Oral: 60 mg once daily for 5 days, then taper dose downward by 10 mg daily for 5 days (total treatment duration: 10 days) (Berg 2012; Engstrom 2008) or 50 mg daily (in 1 or 2 divided doses) for 10 days (begin within 72 hours of onset of symptoms) (Baugh 2013; Sullivan 2007)

Chronic obstructive pulmonary disease (acute exacerbation) (off-label use): Oral: 40 mg daily for 5 to 7 days (GOLD 2018).

Gout, acute flares: Oral: 0.5 mg/kg/day for 5 to 10 days followed by discontinuation (ACR [Khanna 2012]) or 30 to 40 mg/day given once daily or in 2 divided doses until symptom improvement, followed by a 7- to 10-day taper (or 14- to 21-day taper in patients with multiple prior flares) (Becker 2018)

Multiple sclerosis:

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

Dosing: Geriatric

Refer to adult dosing; use lowest effective dose.

Dosing: Renal Impairment: Adult

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

Hemodialysis: Slightly dialyzable (7% to 17.5%) (Frey 1990).

Intermittent hemodialysis: Supplemental dose necessary (Aronoff 2007).

Peritoneal dialysis: Supplemental dose is not necessary (Aronoff 2007).

Dosing: Hepatic Impairment: Adult

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

Dosing: Chemotherapy Regimens

Lymphoma, Hodgkin:

ChIVPP (Hodgkin)

IGEV (Hodgkin)

Dosing: Pediatric

Note: Dose depends upon condition being treated and response of patient; dosage for infants and children should be based on disease severity and patient response, rather than by rigid adherence to dosage guidelines by age, weight, or body surface area. Consider alternate day therapy for long-term therapy. Discontinuation of long-term therapy requires gradual withdrawal by tapering the dose.

Bronchopulmonary dysplasia, treatment: Infants: Oral: 2 mg/kg/day divided twice daily for 5 days, followed by 1 mg/kg/day once daily for 3 days, followed by 1 mg/kg/dose every other day for 3 doses was used in 131 former premature neonates (postmenstrual age: ≥36 weeks) with BPD; results showed weaning of supplemental oxygen was facilitated in patients with capillary pCO2 <48.5 mm Hg and pulmonary acuity score <0.5 (Bhandari 2008)

Asthma: NIH Asthma Guidelines (NAEPP 2007):

Infants and Children <12 years: Oral:

Asthma exacerbations (emergency care or hospital doses): 1 to 2 mg/kg/day in 2 divided doses (maximum: 60 mg/day) until peak expiratory flow is 70% of predicted or personal best

Short-course “burst” (acute asthma): 1 to 2 mg/kg/day in divided doses 1 to 2 times/day for 3 to 10 days; maximum dose: 60 mg/day; Note: Burst should be continued until symptoms resolve or patient achieves peak expiratory flow 80% of personal best; usually requires 3 to 10 days of treatment (~5 days on average); longer treatment may be required

Long-term treatment: 0.25 to 2 mg/kg/day given as a single dose in the morning or every other day as needed for asthma control; maximum dose: 60 mg/day

Children ≥12 years and Adolescents: Oral:

Asthma exacerbations (emergency care or hospital doses): 40 to 80 mg/day in divided doses 1 to 2 times/day until peak expiratory flow is 70% of predicted or personal best

Short-course “burst” (acute asthma): 40 to 60 mg/day in divided doses 1 to 2 times/day for 3 to 10 days; Note: Burst should be continued until symptoms resolve and peak expiratory flow is at least 80% of personal best; usually requires 3 to 10 days of treatment (~5 days on average); longer treatment may be required

Long-term treatment: 7.5 to 60 mg daily given as a single dose in the morning or every other day as needed for asthma control

Anti-inflammatory or immunosuppressive dose: Infants, Children, and Adolescents: Oral: 0.1 to 2 mg/kg/day in divided doses 1 to 4 times/day

Kawasaki disease (KD), treatment: Limited data available: Note: Use to transition patients receiving IV corticosteroids for treatment of KD (in combination with IVIG and aspirin). Infants and Children: Oral: 2 mg/kg/day in divided doses every 8 hours until CRP normalizes; maximum daily dose: 60 mg/day; once CRP normalized, decrease dose every 5 days using the following taper: 2 mg/kg/day for 5 days (maximum daily dose: 60 mg/day), then 1 mg/kg/day for 5 days (maximum daily dose: 30 mg/day), then 0.5 mg/kg/day for 5 days (maximum daily dose: 15 mg/day), then discontinue; a longer course, tapering over 2 to 3 weeks, may be considered (AHA [McCrindle 2017]; Kobayashi 2012; Kobayashi 2013)

Nephrotic syndrome; steroid-sensitive (SSNS): Children and Adolescents: Note: Obese patients should be dosed based on ideal body weight: Oral:

Initial episode: 2 mg/kg/day or 60 mg/m2/day once daily, maximum daily dose: 60 mg/day for 4 to 6 weeks; then adjust to an alternate-day schedule of 1.5 mg/kg/dose or 40 mg/m2/dose on alternate days as a single dose, maximum dose: 40 mg/dose (Gipson 2009; KDIGO 2012; KDOQI 2013); duration of therapy based on patient response.

Relapse: 2 mg/kg/day or 60 mg/m2/day once daily, maximum daily dose: 60 mg/day; continue until complete remission for at least 3 days; then adjust to an alternate-day schedule of 1.5 mg/kg/dose or 40 mg/m2/dose on alternate days as a single dose, maximum dose: 40 mg/dose, recommended duration of alternate day dosing is variable: may continue for at least 4 weeks then taper. Longer duration of treatment may be necessary in patients who relapse frequently, some patients may require up to 3 months of treatment (Gipson 2009; KDIGO 2012; KDOQI 2013).

Maintenance therapy for frequently relapsing SSNS: Taper previous dose down to lowest effective dose which maintains remission using an alternate day schedule; usual effective range: 0.1 to 0.5 mg/kg/dose on alternating days; other patients may require doses up to 0.7 mg/kg/dose every other day (KDIGO 2012; KDOQI 2013)

Dosing: Renal Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Use: Labeled Indications

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, and serum sickness.

Dermatologic diseases: Bullous dermatitis herpetiformis; contact dermatitis; exfoliative erythroderma; exfoliative dermatitis; mycosis fungoides; pemphigus; severe erythema multiforme (Stevens-Johnson syndrome); severe psoriasis; severe seborrheic dermatitis.

Endocrine disorders: Congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis; primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable).

GI diseases: During acute episodes of Crohn disease or ulcerative colitis.

Hematologic disorders: Acquired (autoimmune) hemolytic anemia; congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia); erythroblastopenia (RBC anemia); immune thrombocytopenia (formerly known as idiopathic thrombocytopenic purpura), pure red cell aplasia; secondary thrombocytopenia.

Neoplastic diseases: Treatment of acute leukemia and aggressive lymphomas.

Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Note: Treatment guidelines recommend the use of high dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]; NICE 2014).

Ophthalmic diseases: Allergic conjunctivitis; allergic corneal marginal ulcers; anterior segment inflammation; chorioretinitis; diffuse posterior uveitis and choroiditis; herpes zoster ophthalmicus; iritis and iridocyclitises; keratitis; optic neuritis; sympathetic ophthalmia; uveitis and other ocular inflammatory conditions unresponsive to topical corticosteroids.

Renal disorders: To induce diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

Respiratory diseases: Acute exacerbations of chronic obstructive pulmonary disease (COPD); allergic bronchopulmonary aspergillosis; aspiration pneumonitis; asthma; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; hypersensitivity pneumonitis; idiopathic bronchiolitis obliterans with organizing pneumonia; idiopathic eosinophilic pneumonias; idiopathic pulmonary fibrosis; Loeffler syndrome (not manageable by other means); Pneumocystis cariniipneumonia (PCP) associated with hypoxemia occurring in an HIV-positive individual who is also under treatment with appropriate anti-PCP antibiotics; symptomatic sarcoidosis.

Rheumatic disorders: As adjunctive therapy for short-term administration in acute and subacute bursitis, acute gout flares, acute nonspecific tenosynovitis, ankylosing spondylitis, epicondylitis, polymyalgia rheumatica/temporal arteritis, posttraumatic osteoarthritis, psoriatic arthritis, relapsing polychondritis, rheumatoid arthritis (including juvenile rheumatoid arthritis), synovitis of osteoarthritis, acute rheumatic carditis, systemic lupus erythematosus, dermatomyositis/polymyositis, Sjogren syndrome, and certain cases of vasculitis.

Miscellaneous: Acute or chronic solid organ rejection; trichinosis with neurologic or myocardial involvement; tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, tuberculosis with pleural or pericardial effusion (use appropriate antituberculous chemotherapy concurrently when treating any tuberculosis complications).

Use: Off-Label: Adult

  Alcoholic hepatitis (severe)Level of Evidence [G]

Based on the American College of Gastroenterology (ACG) for Alcoholic Liver Disease and American Association for the Study of Liver Diseases (AASLD) guidelines, prednisolone (systemic) given for severe alcoholic hepatitis is effective and recommended in the management of this condition.

  Asthma exacerbationLevel of Evidence [G]

  Bell palsyLevel of Evidence [A, G]

Data from a randomized, double-blind, placebo-controlled, factorial study supports the use of prednisolone (systemic) in the treatment of Bell palsy. Early treatment with prednisolone (systemic) significantly improved the changes of complete recovery at 3 and 9 months Ref. Additional data from a randomized, double-blind, placebo-controlled, multicenter study also supports the use of prednisolone (systemic) in the treatment of Bell palsy. Prednisolone (systemic) shortened the time to complete recovery in patients with Bell’s palsy Ref. In another randomized, double-blind, placebo-controlled, multicenter study the use of prednisolone (systemic) in the treatment of Bell palsy was found to significantly reduce mild and moderate sequelae of Bell’s palsy Ref.

Based on the American Academy of Otolaryngology, Head and Neck Surgery, Clinical Practice Guideline: Bell’s Palsy, prednisolone (systemic) given for Bell’s palsy is effective and recommended in the management of this condition.

  Chronic obstructive pulmonary disease (COPD) (acute exacerbation)Level of Evidence [G]

Based on the Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) guidelines, prednisolone (systemic) given for acute exacerbation of COPD is effective and recommended in the management of this condition. Short-term treatment with systemic corticosteroids has been shown to reduce recovery time, risk of early relapse, treatment failure, and length of hospital stay, as well as to improve lung function. However, long-term use is associated with significant adverse effects Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Alcoholic Liver Disease:

ACG, “American College of Gastroenterology Clinical Guideline: Alcoholic Liver Disease,” January 2018

American Association for the Study of Liver Diseases (AASLD) Practice Guideline, Alcoholic Liver Disease, 2010

Asthma:

Global Strategy for Asthma Management and Prevention (GINA), 2018 Update

NHLBI and NAEPP The Expert Panel Report 3: “Guidelines for the Diagnosis and Management of Asthma,” Full Report 2007

Bell Palsy:

American Academy of Neurology, “Evidence-based Guideline Update: Steroids and Antivirals for Bell Palsy, 2012

American Academy of Otolaryngology, Head and Neck Surgery, Clinical Practice Guideline: Bell’s Palsy, 2013

COPD:

ACCP/CTS, “Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease: American College of Chest Physicians and Canadian Thoracic Society Guideline,” 2014

Canadian Thoracic Society Recommendations for Management of Chronic Obstructive Pulmonary Disease, 2007 Update

Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD), 2013 Update

Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD), 2018 Update

Crohn Disease:

American College of Gastroenterology, “Management of Crohn’s Disease in Adults,” March 2018

Gout:

EULAR, 2016 Updated Recommendations for the Management of Gout, 2016

Hypopituitarism:

Endocrine Society, “Hormonal Replacement in Hypopituitarism in Adults,” 2016

Juvenile Idiopathic Arthritis:

American College of Rheumatology, “2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis,” 2013

Nephrotic Syndrome:

Children’s Nephrotic Syndrome Consensus Conference, Management of Childhood Onset Nephrotic Syndrome, August 2009

Primary Adrenal Insufficiency:

Endocrine Society, “Diagnosis and Treatment of Primary Adrenal Insufficiency”, February 2016

The Endocrine Society, Congenital Adrenal Hyperplasia Due to Steroid 21-Hydroxylase Deficiency, November 2018

Administration: Oral

Administer after meals or with food or milk to decrease GI upset.

Orapred ODT: Do not break, cut, split or use partial tablet. Remove tablet from blister pack just prior to use. May swallow whole or allow to dissolve on tongue.

Administration: Pediatric

Oral: Administer after meals or with food or milk to decrease GI upset.

Flo-Pred: Administer using the provided calibrated syringe (supplied by manufacturer) to accurately measure the dose. Syringe should be washed prior to next use.

Orapred ODT: Do not cut, split, or break tablets; do not use partial tablets. Remove tablet from blister pack immediately prior to use. May swallow tablet whole or allow to dissolve on tongue.

Dietary Considerations

Should be taken after meals or with food or milk to decrease GI upset; increase dietary intake of pyridoxine, vitamin C, vitamin D, folate, calcium, and phosphorus.

Storage/Stability

Millipred: Store at 20°C to 25°C (68°F to 77°F).

Oral solution (generic): Storage recommendations may vary by manufacturer; refer to manufacturer’s labeling for storage requirements.

Orapred ODT: Store at 20°C to 25°C (68°F to 77°F) in blister pack. Protect from moisture.

Orapred, Veripred 20: Store at 2°C to 8°C (36°F to 46°F).

Pediapred: Store at 4°C to 25°C (39°F to 77°F); may be refrigerated.

Medication Patient Education with HCAHPS Considerations

• 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, increased hunger, weight gain, 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 Cushings disease (weight gain in upper back or abdomen; moon face; severe headache; or slow healing), 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), severe loss of strength and energy, irritability, tremors, tachycardia, confusion, sweating a lot, dizziness, passing out, severe headache, shortness of breath, excessive weight gain, swelling of arms or legs, angina, menstrual changes, joint pain, bone pain, vision 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.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity to prednisolone or any component of the formulation; live or attenuated virus vaccines (with immunosuppressive doses of corticosteroids); systemic fungal infections.

Canadian labeling: Additional contraindications (not in US labeling): Chicken pox; measles; uncontrolled active 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.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.

• Anaphylactoid reactions: Rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, cause activation of latent infections, mask acute infection (including fungal infections) or prolong or exacerbate viral infections or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for cerebral malaria or viral hepatitis. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi’s sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Myopathy: Acute myopathy has been reported with high dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatine kinase; recovery may be delayed.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including severe depression, euphoria, insomnia, mood swings, personality changes, and frank psychotic manifestations. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with HF and/or hypertension; use has been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.

• Diabetes: Use corticosteroids with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, ulcerative colitis, abscess or other pyogenic infection) due to perforation risk. Avoid ethanol may enhance gastric mucosal irritation.

• Head injury: Increased mortality was observed in patients receiving high-dose IV methylprednisolone. High-dose corticosteroids should not be used for the management of head injury.

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Use with caution in patients with a history of ocular herpes simplex; corneal perforation has occurred; do not use in active ocular herpes simplex. Not recommended for the treatment of optic neuritis; may increase frequency of new episodes. Consider routine eye exams in chronic users.

• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.

• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.

• Seizure disorders: Use corticosteroids with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use cautiously in elderly patients with the smallest possible effective dose for the shortest duration.

• Pediatric: May affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

Other warnings/precautions:

• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.

• Stress: Patients may require higher doses when subject to stress (ie, trauma, surgery, severe infection).

Geriatric Considerations

Useful in patients with inability to activate prednisone (liver disease). Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in the elderly, in the smallest possible dose, and for the shortest possible time. For long-term use, monitor bone mineral density and institute fracture prevention strategies.

Warnings: Additional Pediatric Considerations

May cause osteoporosis (at any age) or inhibition of bone growth in pediatric patients. Use with caution in patients with osteoporosis. In a population-based study of children, risk of fracture was shown to be increased with >4 courses of corticosteroids; underlying clinical condition may also impact bone health and osteoporotic effect of corticosteroids (Leonard, 2007). Increased IOP may occur, especially with prolonged use; in children, increased IOP has been shown to be dose dependent and produce a greater IOP in children <6 years than older children treated with ophthalmic dexamethasone (Lam, 2005). Corticosteroids have been associated with myocardial rupture; hypertrophic cardiomyopathy has been reported in premature neonates.

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP, 1997; Shehab, 2009).

Pregnancy Risk Factor

C/D (manufacturer specific)

Pregnancy Considerations

Adverse events have been observed with corticosteroids in animal reproduction studies. Prednisolone crosses the placenta; prior to reaching the fetus, prednisolone is converted by placental enzymes to prednisone. As a result, the amount of prednisolone reaching the fetus is ~8 to 10 times lower than the maternal serum concentration (healthy women at term; similar results observed with preterm pregnancies complicated by HELLP syndrome) (Beitins 1972; van Runnard Heimel 2005). Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts or decreased birth weight; however, information is conflicting and may be influenced by maternal dose/indication for use (Lunghi 2010; Park-Wyllie 2000; Pradat 2003). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor.

Prednisolone may be used (alternative agent) to treat primary adrenal insufficiency (PAI) in pregnant women. Pregnant females with PAI should be monitored at least once each trimester (Endocrine Society [Bornstein 2016]). Prednisolone may be used to treat females during pregnancy who require therapy for congenital adrenal hyperplasia (Endocrine Society [Speiser 2018]).

When systemic corticosteroids are needed in pregnancy for rheumatic disorders, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Götestam Skorpen 2016; Makol 2011; Østensen 2009).

For dermatologic disorders in pregnant females, systemic corticosteroids are generally not preferred for initial therapy; should be avoided during the first trimester; and used during the second or third trimester at the lowest effective dose (Bae 2012; Leachman 2006). Topical agents are preferred for managing atopic dermatitis in pregnancy; for severe symptomatic or recalcitrant atopic dermatitis, a short course of prednisolone may be used during the third trimester (Koutroulis 2011).

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy; however, systemic corticosteroids should be used to control acute exacerbations or treat severe persistent asthma (ACOG 2008; GINA 2018; Namazy 2016).

Breast-Feeding Considerations

Prednisolone is present in breast milk.

The relative infant dose (RID) of prednisolone is 4% when calculated using the highest breast milk concentration located and compared to a weight-adjusted maternal dose of 80 mg/day.

In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000).

The RID of prednisolone was calculated using a milk concentration of 317 ng/mL, providing an estimated daily infant dose via breast milk of 0.05 mg/kg/day. This milk concentration was obtained following maternal administration oral prednisolone 80 mg/day to a woman 53 days’ postpartum. Using data from all women in this study, (n=6), milk concentrations were 5% to 25% of the maternal serum concentration with peak concentrations occurring ~1 hour after the maternal dose. The milk/plasma ratio was found to be 0.2 with doses ≥30 mg/day and 0.1 with doses <30 mg/day (Ost 1985).

One manufacturer notes that when used systemically, maternal use of corticosteroids have the potential to cause adverse events in a breastfeeding infant (eg, growth suppression, interfere with endogenous corticosteroid production). Therefore, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Corticosteroids are generally considered acceptable in breastfeeding females when used in usual doses (Götestam Skorpen 2016; WHO 2002); however, monitoring of the infant is recommended (WHO 2002). If there is concern about exposure to the infant, some guidelines recommend waiting 4 hours after the maternal dose of an oral systemic corticosteroid before breastfeeding in order to decrease potential exposure to the breastfed infant (Bae 2012; Butler 2014; Götestam Skorpen 2016; Leachman 2006; Makol 2011; Ost 1985).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not defined.

Cardiovascular: Cardiac failure, cardiomyopathy, edema, facial edema, hypertension

Central nervous system: Headache, insomnia, malaise, myasthenia, nervousness, pseudotumor cerebri, psychological disorder, seizure, vertigo

Dermatologic: Diaphoresis, facial erythema, skin atrophy, suppression of skin test reaction, urticaria

Endocrine & metabolic: Cushing’s syndrome, diabetes mellitus, growth suppression, hirsutism, HPA-axis suppression, hyperglycemia, hypernatremia, hypokalemia, hypokalemic alkalosis, menstrual disease, negative nitrogen balance, weight gain

Gastrointestinal: Abdominal distention, carbohydrate intolerance, dyspepsia, increased appetite, nausea, pancreatitis, peptic ulcer, ulcerative esophagitis

Hematologic & oncologic: Bruise, petechia

Hepatic: Increased liver enzymes (usually reversible)

Neuromuscular & skeletal: Amyotrophy, arthralgia, aseptic necrosis of bones (humeral/femoral heads), bone fracture, rupture of tendon, weakness

Ophthalmic: Cataract, exophthalmos, eye irritation, eyelid edema, glaucoma, increased intraocular pressure

Respiratory: Epistaxis

Miscellaneous: Wound healing impairment

<1%, postmarketing, and/or case reports: Venous thrombosis (Johannesdottir 2013)

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor therapy

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination

Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Risk C: Monitor therapy

Androgens: Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens. Risk C: Monitor therapy

Antacids: May decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Risk D: Consider therapy modification

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Management: No dose adjustment is needed for single 40 mg aprepitant doses. For other regimens, reduce oral dexamethasone or methylprednisolone doses by 50%, and IV methylprednisolone doses by 25%. Antiemetic regimens containing dexamethasone reflect this adjustment. Risk D: Consider therapy modification

Axicabtagene Ciloleucel: Corticosteroids (Systemic) may diminish the therapeutic effect of Axicabtagene Ciloleucel. Management: Avoid use of corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity. Risk D: Consider therapy modification

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Risk D: Consider therapy modification

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Risk C: Monitor therapy

Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Risk C: Monitor therapy

Carbimazole: May decrease the serum concentration of PrednisoLONE (Systemic). Risk C: Monitor therapy

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Risk X: Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Risk C: Monitor therapy

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

Cosyntropin: Corticosteroids (Systemic) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

CycloSPORINE (Systemic): PrednisoLONE (Systemic) may decrease the serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of PrednisoLONE (Systemic). PrednisoLONE (Systemic) may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of PrednisoLONE (Systemic). Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of PrednisoLONE (Systemic). Risk C: Monitor therapy

Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Risk C: Monitor therapy

Desirudin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Risk D: Consider therapy modification

Desmopressin: Corticosteroids (Systemic) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination

DilTIAZem: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification

Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Risk D: Consider therapy modification

Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. Risk D: Consider therapy modification

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider therapy modification

Indacaterol: May enhance the hypokalemic effect of Corticosteroids (Systemic). Risk C: Monitor therapy

Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination

Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Risk C: Monitor therapy

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification

Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy

Macimorelin: Corticosteroids (Systemic) may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

MethIMAzole: May decrease the serum concentration of PrednisoLONE (Systemic). Risk C: Monitor therapy

Mifamurtide: Corticosteroids (Systemic) may diminish the therapeutic effect of Mifamurtide. Risk X: Avoid combination

MiFEPRIStone: May diminish the therapeutic effect of Corticosteroids (Systemic). MiFEPRIStone may increase the serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (e.g., for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Risk X: Avoid combination

Mitotane: May decrease the serum concentration of Corticosteroids (Systemic). Risk D: Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination

Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Risk D: Consider therapy modification

Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Risk C: Monitor therapy

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Risk D: Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Risk C: Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Risk X: Avoid combination

Quinolones: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor therapy

Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Risk C: Monitor therapy

Ritonavir: May increase the serum concentration of PrednisoLONE (Systemic). Management: Consider prednisolone dose reductions in patients receiving ritonavir and monitor for increased adverse effects with concomitant use. Risk D: Consider therapy modification

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Risk D: Consider therapy modification

Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Risk C: Monitor therapy

Sargramostim: Corticosteroids (Systemic) may enhance the therapeutic effect of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim.Risk C: Monitor therapy

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Risk C: Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Risk C: Monitor therapy

Somatropin: Corticosteroids (Systemic) may diminish the therapeutic effect of Somatropin. Risk C: Monitor therapy

Tacrolimus (Systemic): Corticosteroids (Systemic) may decrease the serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase. Risk C: Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Risk X: Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tisagenlecleucel: Corticosteroids (Systemic) may diminish the therapeutic effect of Tisagenlecleucel. Management: Avoid use of corticosteroids as premedication or at any time during treatment with tisagenlecleucel, except in the case of life-threatening emergency (such as resistant cytokine release syndrome). Risk D: Consider therapy modification

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Risk D: Consider therapy modification

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy

Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range.Risk C: Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Risk D: Consider therapy modification

Vaccines (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Risk D: Consider therapy modification

Warfarin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin. Risk C: Monitor therapy

Test Interactions

May decrease response to skin tests.

Monitoring Parameters

Blood pressure; blood glucose, electrolytes; weight; intraocular pressure (use >6 weeks); bone mineral density; growth and development in children; chest x-ray during prolonged therapy; HPA axis suppression.

Advanced Practitioners Physical Assessment/Monitoring

Obtain electrolytes and blood glucose. Monitor blood pressure. Monitor growth with long-term use in pediatric patients. Assess for signs and symptoms of HPA axis suppression/adrenal insufficiency or infection. Assess for ocular changes and obtain IOP with therapy >6 weeks. Obtain chest x-ray at regular intervals in patients on prolonged therapy. Consider bone mineral density monitoring for those on long-term use. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed.

Nursing Physical Assessment/Monitoring

Check ordered labs and tests and report abnormalities. Caution patients with diabetes to monitor glucose levels closely. Educate patient to monitor weight and report excessive gains/losses; signs of infection, or visual changes. Monitor growth in children closely. Educate patient about alerting surgeons and other healthcare providers to use.

Dosage Forms Considerations

Orapred oral solution contains fructose.

Orapred ODT dispersible tablets contain sucrose.

Dosage Forms: US

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

Solution, Oral, as base:

Generic: 15 mg/5 mL (240 mL, 480 mL)

Solution, Oral, as sodium phosphate [strength expressed as base]:

Millipred: 10 mg/5 mL (237 mL) [alcohol free, dye free; contains edetate disodium, methylparaben, saccharin sodium; grape flavor]

Pediapred: 5 mg/5 mL (120 mL) [alcohol free, dye free, sugar free; contains edetate disodium, methylparaben; raspberry flavor]

Veripred 20: 20 mg/5 mL (237 mL) [alcohol free, dye free; contains edetate disodium, methylparaben, saccharin sodium; grape flavor]

Generic: 10 mg/5 mL (237 mL); 15 mg/5 mL (237 mL); 20 mg/5 mL (237 mL); 25 mg/5 mL (30 mL, 237 mL); 5 mg/5 mL (120 mL)

Syrup, Oral, as base:

Generic: 15 mg/5 mL (240 mL [DSC], 480 mL [DSC])

Tablet, Oral, as base:

Millipred: 5 mg [scored; contains fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow), sodium benzoate]

Millipred DP: 5 mg [scored; contains fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow), sodium benzoate]

Millipred DP 12-Day: 5 mg [scored; contains fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow), sodium benzoate]

Tablet Disintegrating, Oral, as sodium phosphate [strength expressed as base]:

Orapred ODT: 10 mg, 15 mg, 30 mg [grape flavor]

Generic: 10 mg, 15 mg, 30 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Oral, as sodium phosphate [strength expressed as base]:

Pediapred: 5 mg/5 mL (120ml) [contains EDETATE DISODIUM, METHYLPARABEN]

Generic: 5 mg/5 mL (120ml)

Anatomic Therapeutic Chemical (ATC) Classification
  • A07EA01
  • H02AB06
Generic Available (US)

May be product dependent

Pricing: US

Solution (Millipred Oral)

10 mg/5 mL (per mL): $4.27

Solution (prednisoLONE Sodium Phosphate Oral)

6.7 (5 Base) mg/5 mL (per mL): $0.82

10 mg/5 mL (per mL): $2.99 – $3.84

15 mg/5 mL (per mL): $0.31

20 mg/5 mL (per mL): $4.24 – $7.82

25 mg/5 mL (per mL): $1.48

Solution (Veripred 20 Oral)

20 mg/5 mL (per mL): $6.06

Tablet Therapy Pack (Millipred DP 12-Day Oral)

5MG (48) (per each): $0.75

Tablet Therapy Pack (Millipred DP Oral)

5MG (21) (per each): $16.75

5MG (48) (per each): $16.76

Tablet, orally-disintegrating (Orapred ODT Oral)

10 mg (per each): $23.76

15 mg (per each): $29.41

30 mg (per each): $37.20

Tablet, orally-disintegrating (prednisoLONE Sodium Phosphate Oral)

10 mg (per each): $14.38

15 mg (per each): $23.97

30 mg (per each): $30.82

Tablets (Millipred Oral)

5 mg (per each): $16.87

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

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

Pharmacodynamics/Kinetics

Duration: 18 to 36 hours (Pickup 1979)

Absorption: Rapid; well-absorbed

Distribution: Vd: 0.22 to 0.7 L/kg

Protein binding (concentration dependent): 70% to 90% (to albumin and corticosteroid binding globulin); decreased in elderly

Metabolism: Primarily hepatic

Half-life elimination: 2 to 4 hours; reduced in children and prolonged in hepatic disease (Pickup 1979)

Time to peak, plasma: 1 to 2 hours; prolonged with food

Excretion: Primarily urine (as sulfate and glucuronide conjugate)

Pharmacodynamics/Kinetics: Additional Considerations

Geriatric: Mean unbound fraction of prednisolone was higher and Vss unbound prednisolone was reduced in elderly patients.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Ulcerative esophagitis.

Effects on Bleeding

No information available to require special precautions

Index Terms

Prednisolone Sod Phosphate; Prednisolone Sodium Phosphate; Prelone

FDA Approval Date
June 21, 1955
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Report of a Workshop by the British Association for Paediatric Nephrology and Research Unit, Royal College of Physicians, “Consensus Statement on Management and Audit Potential for Steroid Responsive Nephrotic Syndrome,” Arch Dis Child, 1994, 70(2):151-7.[PubMed 8129444]

Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017;76(1):29-42. doi: 10.1136/annrheumdis-2016-209707.[PubMed 27457514]

Salem M, Tainsh RE Jr, Bromberg J, et al, “Perioperative Glucocorticoid Coverage. A Reassessment 42 Years After Emergence of a Problem,” Ann Surg, 1994, 219(4):416-25.[PubMed 8161268]

Scott TF, Frohman EM, De Seze J, et al. Evidence-based guideline: clinical evaluation and treatment of transverse myelitis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2011 Dec 13;77(24):2128-2134.[PubMed 22156988]

Singal AK, Bataller R, Ahn J, et al. ACG Clinical Guideline: alcoholic liver disease. Am J Gastroenterol. 2018;113(2):175-194. doi: 10.1038/ajg.2017.469.[PubMed 29336434]

Speiser PW, Arlt W, Auchus RJ, et al. Congenital adrenal hyperplasia due to steroid 21-hydroxylase deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018;103(11):4043-4088. doi: 10.1210/jc.2018-01865.[PubMed 30272171]

Sullivan FM, Swan IR, Donnan PT, et al. Early treatment with prednisolone or acyclovir in Bell’s palsy. N Engl J Med. 2007;357(16):1598-1607.[PubMed 17942873]

van Runnard Heimel PJ, Schobben AF, Huisjes AJ, et al, “The Transplacental Passage of Prednisolone in Pregnancies Complicated by Early-Onset HELLP Syndrome,” Placenta, 2005, 26(10):842-5.[PubMed 16226134]

World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. Available at http://www.who.int/maternal_child_adolescent/documents/55732/en/

Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219.[PubMed 17555487]

Brand Names: International

Aprednislon (AT); Bexiprep (BD); Bronal (CR, DO, GT, HN, NI, PA, SV); Cortisol (BD); Cortope (JO); Decortin H (BG); Deltacortril (GB, MT, PK); Deltasolone (VN); Deltastab (GB); Disprelone (EG); Epicopred (EG); Etisona 3 (PY); Fantil (UY); Fastolone (EG); Gupisone (AE, BH, KW, QA, SA); Hydrocortancyl (FR); Ilocet (PH); Medopred (TR); Metacortelone (CR); Meticortelone (DO, GT, HN, NI, PA, SV); P-Cort (LK); Pediapred (BB); Pevanti (GB); Predalone (LB); Predflam (BD); Predkid (LK); Predmet (IN); Prednimax (EC); Prednisolut (AT); Predo (LB, QA); Predonine (JP); Predsol (IE); Predstad (VN); Prencoid (VN); Prenol (VN); Presol (LK); Pularon (VN); Solone (AE, BD); Solpren (EC); Solupred (FR, MT); Sovepred (VN); Ultracortenol (AR, NO, PY, SE); Vistapred (PH); Xepasone (MY)

Prednisolone (Systemic) (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(pred NISS oh lone)

Brand Names: US

Millipred; Millipred DP; Millipred DP 12-Day; Orapred ODT; Pediapred; Veripred 20

Brand Names: Canada

Pediapred

What is this drug used for?
  • It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to prednisolone or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have a herpes infection of the eye.
  • If you have any of these health problems: A fungal infection or malaria infection in the brain.
  • If you have nerve problems in the eye.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This drug may affect allergy skin tests. Be sure your doctor and lab workers know you take this drug.
  • If you have been taking this drug for many weeks, talk with your doctor before stopping. You may want to slowly stop this drug.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.
  • Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this drug. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
  • This drug may lower how much natural steroid is in your body. If you have a fever, an infection, surgery, or you are hurt, talk with your doctor. You may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you need extra steroids.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
  • Have your eye pressure checked if you are on this drug for a long time. Talk with your doctor.
  • This drug may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • Talk with your doctor before getting any vaccines. Use of some vaccines with this drug may either raise the chance of an infection or make the vaccine not work as well.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Talk with your doctor before you drink alcohol.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • If you used this drug when you were pregnant, tell your baby’s doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of Cushing’s disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped this drug.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Skin changes (pimples, stretch marks, slow healing, hair growth).
  • Chest pain or pressure.
  • Period (menstrual) changes.
  • Bone or joint pain.
  • Change in eyesight.
  • Change in the way you act.
  • Low mood (depression).
  • Seizures.
  • A burning, numbness, or tingling feeling that is not normal.
  • Any unexplained bruising or bleeding.
  • Very bad belly pain.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Upset stomach.
  • More hungry.
  • Weight gain.
  • Not able to sleep.
  • Restlessness.
  • Sweating a lot.
  • Headache.
  • Feeling tired or weak.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take in the morning if taking once a day.
  • Take with food.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
  • You may need to lower how much salt is in your diet and take extra potassium. Talk with your doctor.
  • Oral-disintegrating tablet:
  • Do not take this drug out of the blister pack until you are ready to take it. Take this drug right away after opening the blister pack. Do not store the removed drug for future use.
  • Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your tongue and let it dissolve. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.
  • Liquid (solution):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it, with food.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Liquid (solution):
  • Some brands of this drug need to be stored in a refrigerator. Some brands of this drug need to be stored at room temperature. If you have questions about how to store this drug, talk with your pharmacist.
  • All other products:
  • Store at room temperature.
  • All products:
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Prednisolone (Systemic) (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(pred NISS oh lone)

Brand Names: US

Millipred; Millipred DP; Millipred DP 12-Day; Orapred ODT; Pediapred; Veripred 20

Brand Names: Canada

Pediapred

What is this drug used for?
  • It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has a herpes infection of the eye.
  • If your child has any of these health problems: Malaria infection in the brain or a fungal infection.
  • If your child has nerve problems in the eye.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • This drug may affect allergy skin tests. Be sure the doctor and lab workers know your child takes this drug.
  • If your child has been taking this drug for many weeks, talk with your child’s doctor before stopping. You may want to slowly stop this drug.
  • Your child may have more chance of getting infections. Have your child wash hands often. Avoid crowds and people with infections, colds, or flu.
  • Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this drug. Avoid having your child near anyone with chickenpox or measles if your child has not had these health problems before. If your child has been exposed to chickenpox or measles, talk with the doctor.
  • This drug may lower how much natural steroid is in your child’s body. If your child has a fever, an infection, surgery, or is hurt, talk with the doctor. Your child may need extra doses of oral steroids. These extra steroids will help your child’s body deal with these stresses. Carry a warning card saying that there may be times when your child needs extra steroids.
  • High blood pressure has happened with drugs like this one. Have your child’s blood pressure checked as you have been told by the doctor.
  • Long-term use may raise the chance of cataracts, glaucoma, or weak bones (osteoporosis). Talk with your child’s doctor.
  • Your child may need to have a bone density test. Talk with the doctor.
  • Have your child’s eye pressure checked if your child is on this drug for a long time. Talk with the doctor.
  • Talk with the doctor before your child gets any vaccines. Use of some vaccines with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
  • If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • You may need to lower how much salt is in your child’s diet and give your child extra potassium. Talk with your child’s doctor.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • If your child used this drug when she was pregnant, tell the baby’s doctor.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of Cushing’s disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if a dose was missed or the drug was recently stopped.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Skin changes (pimples, stretch marks, slow healing, hair growth).
  • Chest pain or pressure.
  • Bone or joint pain.
  • Change in eyesight.
  • Change in the way your child acts.
  • Low mood (depression).
  • Seizures.
  • A burning, numbness, or tingling feeling that is not normal.
  • Any unexplained bruising or bleeding.
  • Very bad belly pain.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.
  • If your child has menstrual periods:
  • Period (menstrual) changes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Upset stomach.
  • More hungry.
  • Weight gain.
  • Not able to sleep.
  • Restlessness.
  • Sweating a lot.
  • Headache.
  • Feeling tired or weak.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give in the morning if giving once a day.
  • Give with food.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of signs of withdrawal. If your child needs to stop this drug, you will want to slowly stop it as ordered by the doctor.
  • Oral-disintegrating tablet:
  • Do not remove the tablet from the tablet pack until you are ready to put in this drug. Put in the tablet right away after opening the blister pack. Do not store the removed tablet for future use.
  • Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your child’s tongue and let it dissolve. Water is not needed. Do not let your child swallow it whole. Do not let your child chew, break, or crush it.
  • Liquid (solution):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it, with food.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Liquid (solution):
  • Some brands of this drug need to be stored in a refrigerator. Some brands of this drug need to be stored at room temperature. If you have questions about how to store this drug, talk with your pharmacist.
  • All other products:
  • Store at room temperature.
  • All products:
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.