Prednisolone: Dosage, Uses, Side effects and Warnings, A Perfect Guide

Medically reviewed by the ehealthlyf.com and last updated on 27/01/2023

Generic name: Prednisolone

Drug class: Glucocorticoids

Dosage forms: Oral syrup, oral suspension, oral liquid, oral tablet, oral disintegrating tablets    

Brand names: Orapred, Veripred 20, Pediapred, Flo-pred, Millipred, Bubbli-Pred,  Predicort, Medicort, Prelone, Cotolone, Key-Pred, Hydeltra-T.B.A., Hydeltrasol, and others 

Generic availability: Yes      

What is Prednisolone?

Prednisolone, a corticosteroid, is a prescription drug used to reduce inflammation and suppress the hyperactive immune system. It is also an adrenergic agent, an antineoplastic agent, a drug metabolite, an environmental contaminant, and a xenobiotic.

It acts by imitating the effect of cortisol, a hormone released by the adrenal glands that regulate metabolism and stress.

Prednisolone has glucocorticoid activity rather than mineralocorticoid activity.

It treats many inflammatory conditions such as endocrine disorders, allergic disorders, ulcerative colitis, hypersensitivity, arthritis, lupus, and psoriasis, which affect the eyes, skin, lungs, nervous system, blood cells, or stomach.

It can be taken by mouth, injected into veins, or used topically as skin cream, or eye drops.

Chemistry

Prednisolone is a glucocorticoid, similar to its cognate prednisone, in which the oxo group at C11 has been reduced to the corresponding beta hydroxy group. It is a drug metabolite of prednisone. It is an 11,17-Dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,10,11,12,1,3,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one.

Chemical Formula: C12H28O5

Molar Mass: 360.450 g/mol

IUPAC name: (11ꞵ)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione

Mechanism of Action

Glucocorticoids act by altering DNA replication within the nucleus.

The lipophilic structure of prednisolone allows it to easily bypass the cell membrane and bind to the respective glucocorticoid receptor (GCR). The GC-GCR complex translocates inside the nucleus by dissociating chaperone proteins from glucocorticoid receptors. Once inside the nucleus, the GC-GCRb complex binds to a specific DNA binding site called glucocorticoid response elements (GREs), resulting in gene expression or inhibition.

When complexes bind to positive GREs, anti-inflammatory proteins are formed, whereas binding to negative GREs can inhibit the transcription of inflammatory genes.

Prednisone is a prodrug that gets converted into its active form, prednisolone, in the liver.

Pharmacokinetics

Absorption

Bioavailability, orally: 77.6% (20 mg), 84.5% (10 mg)

Tmax, orally: 0.9 – 1 hour

Distribution

14.6 – 19.9 L

Metabolism

• Exclusively metabolized in the liver.
• Poor inducer of CYP3A4.

Excretion

• Dialyzable (hemodialysis): No (Byorck, 1984).
• Total body clearance: 61- 80.6 mL/min.

Elimination Half-Life

2.67 – 4.52 hours; a shorter t(1/2) of 1.28 hours was reported in children with lymphoblastic leukaemia.

How Prednisolone is Supplied?

Oral Solution: 15 mg/ 5 ml

Oral Syrup: 5 mg/ 5ml, 15 mg/5ml

What Are the Ingredients Present in Prednisolone Tablets?

Prednisolone tablets USP 5mg contain

Active ingredient: Prednisolone

Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, D&C Yellow No. 10, docusate sodium, FD&C Yellow No. 6, sodium benzoate, and magnesium stearate.

What Are the Uses of Prednisolone?

FDA-labelled indications include,

Allergic Condition

•  Seasonal or perennial allergic rhinitis
•  Serum sickness
•  Contact dermatitis
•  Atopic dermatitis
•  Bronchial asthma
•  Drug hypersensitivity reactions

Respiratory Disease

•  Aspiration pneumonitis
•  Berylliosis

Collagen Disease

As maintenance therapy in 

• Systemic lupus erythematosus
• Acute rheumatic carditis
• Polymyositis

Disorder of the endocrine system

• Primary or secondary adrenocortical insufficiency 
• Nonsuppurative thyroiditis
• Congenital adrenal hyperplasia
• Hypercalcemia associated with cancer

Disorder of the eyes

• Allergic conjunctivitis
• Herpes zoster ophthalmicus
• Iritis and iridocyclitis
• Keratitis
• Allergic corneal marginal ulcers
• Chorioretinitis
• Optic neuritis
• Diffuse posterior uveitis and choroiditis
• Sympathetic ophthalmia

Disorders of the gastrointestinal tract

• Ulcerative colitis
• Regional enteritis

Disorder of hematopoietic structure

• Idiopathic thrombocytopenic purpura in adults
• Secondary thrombocytopenia in adults
• Erythroblastopenia (RBC anaemia)
• Acquired (autoimmune) hemolytic anaemia
• Congenital (erythroid) hypoplastic anaemia

Disorder of skin

• Pemphigus
• Exfoliative dermatitis
• Mycosis fungicides
• Severe psoriasis
• Severe seborrheic dermatitis

Edematous state

• Remission of proteinuria

Neoplastic disease

• Leukemias and lymphomas in adults
• Acute leukaemia of childhood
• Hodgkin’s disease
• Non-Hodgkin’s lymphoma

Inflammatory disorder of the musculoskeletal system

Nephrotic syndrome

Nervous System

• Exacerbation of multiple sclerosis

Miscellaneous

• Tuberculosis-fulminating or disseminated, with concomitant antituberculous chemotherapy.
• Tuberculosis with subarachnoid or impending block.

Rheumatic Disorders

As an adjunctive therapy for short-term use,

• Psoriatic arthritis
• Rheumatoid arthritis including juvenile RA
• Acute and subacute bursitis
• Epicondylitis
• Ankylosing spondylitis
• Post-traumatic osteoarthritis

Miscellaneous

• Tuberculosis-fulminating or disseminated, with concomitant antituberculous chemotherapy
• Tuberculosis with subarachnoid or impending block

Non-FDA labelled indications

• Alcoholic hepatitis- a serious disease
• Breast cancer
• Fever, due to malignancy
• Kawasaki disease
• Leprosy- nerve injury
• Hearing loss
• Bell’s palsy
• Chronic obstructive pulmonary disease
• Idiopathic pulmonary hemosiderosis
• Infantile spasm
• Infantile hemangioma
• Ig A nephropathy
• Intracranial tumour, primary
• Multiple myeloma
• Prostrate cancer
• Pulmonary eosinophilic granuloma
• Liver transplant rejection
• Polymorphous light eruption
• Multiple myeloma
• Thyroid eye disease
• Viral respiratory infection

Dosage in Special Conditions

Adult Dosing

Alcoholic Hepatitis, Severe disease

• 40 mg/day orally for 4 weeks and then reduce the dose over 2–4 weeks or discontinue, according to the development of the health condition. 
• Discontinuation is recommended if there is no response after 7 days (i.e., a Lille score of 0.45 or greater); discontinuation is also recommended if the Lille score is greater than 0.56 (the recommended dosage).

Allergic Condition

• 5 to 60 mg/day taken orally

Aspiration Pneumonitis

• Initially, take 5 to 60 mg orally daily, depending on disease severity; maintain or adjust the initial dosage to achieve the desired result.

Maintenance: Decrease dosage in small amounts at appropriate time intervals to the lowest dosage possible to achieve the desired result; discontinue therapy if the result is not satisfactory.

Asthma

•  40 to 80 mg/day orally in 1 or 2 divided doses until peak expiratory flow (PEF) reaches 70% of the personal best. ( National, Heart, Lung, Blood Institute, NHLBI guidelines).  
• Outpatient burst:  40 to 60 mg orally in 1 or 2 divided doses for a total of 3 to 10 days.

Long-term therapy; NHLBI asthma guidelines:

• 7.5 to 60 mg orally daily in the morning, as needed.

Bell’s palsy

• 25 mg orally twice daily OR 60 mg orally daily for 5 days, then tapered by 10 mg per day to the next 5 days (off-label dosages).

Berylliosis

• Initially, 5 to 60 mg/day is given orally based on disease severity; maintain or adjust the initial dosage to receive the desired result.

Maintenance: Decrease dosage in small amounts at appropriate time intervals to the lowest dosage possible to get the desired result; discontinue therapy if the result is not satisfactory. 

Breast cancer

• Optimal dosing and timing are not yet defined.

Chronic obstructive pulmonary disease

• 30 to 60 mg orally daily with/ without initial IV corticosteroids and with/ without a taper have been used in clinical trials (off-label dosage).

Collagen disease

• Oral dosage ranges from 5 to 60 mg per day.

Disorder of the endocrine system

• Oral dosage ranges from 5 to 60 mg per day.

Disorder of eye

• Oral dosage ranges from 5 to 60 mg per day.

Disorder of the gastrointestinal tract

• Oral dosage ranges from 5 to 60 mg per day.

Disorder of hematopoietic structure

• Orally, 5 to 60 mg per day.

Disorder of skin

• Orally, 5 to 60 mg per day.

Exacerbation of multiple sclerosis (Acute)

• Orally, 5 to 60 mg per day.

Fever, due to malignancy

• Optimal dosing and timing are not yet defined.

Gout 

• Acute, Short-term to tide the patient over acute episodes or exacerbation.
• Initially 5 to 60 mg/day orally (FDA dosage).
• 0.5 mg/kg/day or more for 5 -10 days and then discontinued, or alternatively, 2 to 5 days at full dose, followed by a 7- to 10-day taper and then discontinued (guideline dosage).

Hearing loss

• (Intratympanic) 18.75 mg (0.3 mL of 62.5 mg/mL solution) intratympanic injection once daily for three days.
• (Systemic) 75 mg/day IV for 3 days, 50 mg/day IV for 3 days, and 25 mg/day IV for 3 days, followed by an oral taper for 6 days.

Hodgkin’s disease

• Orally, 5 to 60 mg per day.

IgA Nephropathy

• 0.6 to 1 mg/kg orally for 2 to 4 months followed by a lowering course (off-label dosage).

Inflammatory disorder of a musculoskeletal system 

• Short-term to help the patient get through an acute episode or exacerbation; adjunct.
• Initially, oral doses ranging from 5 to 60 mg/day are administered; dosage should be tailored to the severity of the disease and the patient’s response.

Intracranial tumour, Primary

• Optimal dosing and timing are not yet defined.

Leprosy – Nerve injury

• 40 mg/day orally for 2 weeks, 30 mg/day for 2 weeks, 20 mg/day for 2 weeks, 15 mg/day for 2 weeks, 10 mg/day for 2 weeks, and 5 mg/day for 2 weeks.

Liver transplant rejection; Prophylaxis

• Methylprednisolone, 500 or 1000 mg IV intraoperatively, followed by a switch to oral prednisolone or prednisone when needed. Lower the dose of prednisone or prednisolone until discontinuation at 3 to 6 months post-transplant (off-label dosage)

Multiple myeloma

• Optimal dosing and timing are not yet defined.

Neoplastic disease

• 5 to 60 mg/day, given orally.

Nephrotic syndrome 

• Idiopathic or due to lupus erythematosus.
• 5 to 60 mg/day, given orally.

Non-Hodgkin’s lymphoma

• 5 to 60 mg/day, given orally.

Prostate cancer

• Optimal dosing and timing are not yet defined.

Rheumatoid arthritis

• Orally, 5 to 60 mg per day.

Sarcoidosis, Symptomatic

• Initially, 5 to 60 mg orally daily are given, depending on the severity of the disease; the initial dosage is adjusted to achieve the desired result (FDA dosage).
• Maintenance: Decrease dosage in small amounts at appropriate time intervals to the lowest dosage possible to get results. Discontinue therapy if a satisfactory response is not achieved (FDA dosage).
• Initially, 20 mg orally once daily followed by 5 to 10 mg orally once daily (guideline dosage)

Cardiac sarcoidosis: Base dosage on imaging studies and clinical findings; many patients require long-term treatment (guideline dosage)

Pulmonary sarcoidosis in symptomatic patients with parenchymal infiltrates and abnormal pulmonary function tests: Initially, 20 to 40 mg were given orally daily for 2 to 6 weeks, then lowered by 2.5 to 10 mg/day monthly over 6 to 18 months until discontinuation. 

Maintenance with 5 to 10 mg daily may be required to maintain remission (off-label dosage).

Simple pulmonary eosinophilia

• It is not manageable by other means.
• Initially, 5 to 60 mg orally daily, depending on disease severity; maintain or adjust the initial dosage to achieve the desired response.

Maintenance: Reduce the dosage in small increments at appropriate time intervals to the lowest dosage possible to achieve the desired response. Discontinue therapy if a satisfactory response is not achieved in a reasonable period.

Thyroid eye disease

• In radioactive iodine-treated patients with a risk of progression, Prophylaxis
• Low risk: Initially, 0.1 to 0.2 mg/kg body weight is taken orally daily, then tapered and discontinued after 6 weeks (guideline dosage).
• High risk: Initially, 0.3 to 0.5 mg/kg body weight is taken orally daily, then tapered and discontinued after 3 months (guideline dosage).

Thyroid eye disease (Moderate to Severe), Active

• Initial, 1 mg/kg body weight orally daily (or an initial fixed dose of 100 mg/day); lower gradually by 5 to 10 mg each week until withdrawal for a treatment duration of 4 to 6 months (guideline dosage).

Concomitant medication/procedure

• It can be used in combination with non-steroidal immunosuppressive agents (eg, cyclosporin, azathioprine) or orbital radiotherapy (guideline dosage).

Trichinosis

• With neurologic or myocardial participation.
• 5 to 60 mg/day orally.

Tuberculosis

• Go off with concomitant antitubercular chemotherapy.
• Initially, 5 to 60 mg orally daily, depending on disease severity; maintain or adjust the initial dosage to achieve the desired result.

Maintenance 

Reduce the dosage in small amounts at appropriate time intervals to the lowest dosage possible to achieve the desired clinical response. Discontinue therapy if a satisfactory response is not achieved in a reasonable period.

Tuberculosis 

• With subarachnoid or impending block; Adjunct 5 to 60 mg/day orally

Pediatric Dosing

Asthma

• Mild to moderately severe exacerbation in children aged 12 and under: 1 to 2 mg/kg/day orally in two divided doses (a maximum of 60 mg/day) until peak expiratory flow (PEF) reaches 70% of the personal best. 
• Outpatient burst: 1 to 2 mg/kg/day orally in two divided doses (maximum of 60 mg/day) for  3 to 10 days (National, Heart, Lung, Blood Institute [NHLBI] asthma guidelines).
• Long-term therapy, 11 years of age and younger: 0.25 to 2 mg/kg orally daily in the morning  as required for control of asthma (NHLBI asthma guidelines)
• Moderate and severe exacerbations, greater than 12 years of age: 40 to 80 mg/day orally in one or two divided doses until PEF reaches 70% of the predicted or personal best. 
• Outpatient burst: 40 to 60 mg orally in one or two divided doses for 3–10 days  (NHLBI asthma guidelines)
• Long-term therapy, 12 years of age and older: As needed, take 7.5 to 60 mg orally in the morning. (NHLBI asthma guidelines)

IgA nephropathy

• 1 to 2 mg/kg/day orally for four weeks followed by alternate day tapering over 4 to 6 months (guideline dosage)

Infantile hemangioma

• 2 to 3 mg/kg/day, given orally for 4 to 12 weeks, followed by moderate tapering to finish therapy by 9 to 12 months of age. Some clinicians prefer shorter treatment durations (eg, 1 to 6 weeks) with multiple intermittent courses as needed (off-label dosage)

Infantile spasm

• 10 mg orally 4 times a day or 15 mg orally 3 times daily, if spasms continue after 1 week, you can rise the dosage to 20 mg 3 times daily or 15 mg 4 times daily (off-label dosage)

Discontinuing Therapy 

If a 30-minute EEG procedure performed 2–4 weeks after therapy initiation shows resolution of hypsarrhythmia, antagonistic for 2–3 weeks. If hypsarrhythmia is reported, treat for a week before starting second-line therapy (eg, vigabatrin, topiramate, ketogenic diet) (off-label dosage).

Kawasaki disease

IV immunoglobulin-resistant disease

• Administer orally once the patient is symptomatic following the second infusion of IV immunoglobulin 2 g/kg (given at least 36 hours after the first dose) plus prednisolone 2 mg/kg/day IV divided every 8 hours. Continue until C-reactive protein is normalised, and then reduce gradually over 2–3 weeks (guideline dosage).
• In addition to primary therapy: Administer orally once the patient is afebrile following the infusion of IV immunoglobulin 2 g/kg plus prednisolone 2 mg/kg/day IV divided every 8 hours; continue until the C-reactive protein is normalised, and then taper gradually over 2 to 3 weeks (off-label dosage).

Leprosy – Nerve injury

• 1 mg/kg/day orally for 1 month followed by 0.5 mg/kg/day for 3 months with further lowering of 5 mg over a month thereafter for 6 to 8 months.

Liver transplant rejection; Prophylaxis

• No standardized immunosuppression choice or dose; steroids can often be reserved within 3 to 6 months and should not be part of maintenance therapy after the first year, with consideration of the risk of rejection (guideline dosage)

Nephrotic syndrome 

Idiopathic or due to lupus erythematosus

• 30 kg or less, or body surface area (BSA) less than 1 m2: 2 mg/kg/day daily (maximum 60 mg/day) in 2 divided doses for 6 weeks, followed by 1.5 mg/kg on the different periods (maximum 40 mg) as a single dose in the morning for 6 weeks (off-label dosage).
• 30 kg or less or BSA less than 1 m(2) relapse: 2 mg/kg/day daily (max 60 mg/day) in 2 divided doses until subsidence, followed by 1.5 mg/kg on alternate days (max 40 mg) as a single dose in the morning for 4 weeks (off-label dosage)
• 2-month regimen: 60 mg/m(2) orally daily in 3 divided doses for 4 weeks (max 80 mg/day), then 40 mg/m(2) orally on alternate days for 4 weeks (max 50 mg/day); relapse dosing, 60 mg/m(2) orally daily until urinary protein is negative on 3 sequential days with urine dipstick test, then 60 mg/m(2) orally on alternate days for 2 weeks, 30 mg/m(2) on alternate days for 2 weeks, and 15 mg/m(2) on alternate days for 2 weeks (off-label dosage).
• 3-month regimen: 2 mg/kg orally daily for 6 weeks, then 1.5 mg/kg orally on alternate days for 6 weeks; relapse dosing, 2 mg/kg/day orally until subsidence (negative or trace proteinuria on dipstick analysis for 3 sequential days), then 1.5 mg/kg on alternate days for 4 weeks; usual relapses (2 relapses in 6 months): taper to 0.5 mg/kg on alternate days for 12 to 18 months (off-label dosage).

Sarcoidosis, Symptomatic

Pulmonary sarcoidosis: For the first 6 to 8 weeks, take 1 mg/kg/day orally; gradually reduce to 15 mg/day for at least 6 months; then continue daily or alternate day dosing. Decrease over several months to 5 mg/day. Patients received treatment for at least 18 months (off-label dosage).

Relapse: Dosage was increased up to 1 mg/kg/day orally until the disease was controlled then tapered (off-label dosage).

Monitoring

• Rheumatoid arthritis: Clinical improvement designated by lowering of erythrocyte sedimentation rate (ESR).
• Allergic reactions: Clinical improvement designated by decreased difficulty in breathing, chest tightness, rhinitis, pruritus, rash, erythema, urticaria, angioedema, nausea, vomiting, diarrhoea, and abdominal pain.
• Asthma: Clinical improvement designated by Pulmonary Function Tests especially Peak Expiratory Flow Rate (PEFR), decreased wheezing, dyspnea, respiratory rate, and a number of exercise-induced asthma attacks.
• Pulmonary sarcoidosis: Clinical improvement designated by spirometry tests during treatment, and after stopping treatment for up to 2 years; decreased wheezing and cough.
• Systemic lupus erythematosus: Clinical improvement designated by a decrease in a rash (eg, red, butterfly-shaped rash over the bridge of nose and cheeks); discoid rash (eg, red, thick, scaly patches which are disc-shaped, photosensitivity; painless oral ulcers, and arthritis symptoms in peripheral joints.
• Ulcerative colitis: Clinical improvement designated by a reduction in diarrhoea, rectal bleeding, and abdominal pain; improved appetite, increased weight, and decreased fatigue.
• Prothrombin time in patients receiving concomitant aspirin therapy: Routine laboratory checkups are done during prolonged therapy including 2-hour postprandial blood glucose and serum potassium blood pressure, body weight, and check X-ray are studied at regular intervals during prolonged therapy.
• Dual-energy X-ray absorptiometry (DXA) gives bone density with 24-hour urine for calcium and creatinine measurement in patients who receive systemic corticosteroids for more than 4 continuous weeks or more than four 7-day bursts per year due to a high risk for osteoporosis.
• The growth and development of infants and children are also monitored
• Ophthalmic exams may be required especially in prolonged corticosteroid use.

Contraindications

• Prednisolone is contraindicated in patients with systemic fungal infections.

Precaution/ Warning

• Cardiovascular: A rise in blood pressure may occur; use caution in patients with hypertension.
• Concurrent use: Smallpox vaccine and other immunization procedures are not advised, especially for patients on high-dose of corticosteroids. May cause neurologic complications or a lack of antibody response.
• Endocrine and metabolic: Adrenocortical insufficiency may occur and persist after termination; tapering dose is recommended.
• Endocrine and metabolic: This may cause salt and water retention, and increased excretion of potassium and calcium.
• Endocrine and metabolic: The impact of corticosteroids may be increased in patients with hypothyroidism.
• Gastrointestinal: Use caution in patients with nonspecific ulcerative colitis (if there is a risk of perforation, abscess, or other pyogenic infection), diverticulitis, fresh intestinal anastomoses, or active or hidden peptic ulcer.
• Hepatic: Corticosteroid impact may be increased in patients with preexisting cirrhosis.
• Immunologic: New-onset or aggravation of existing infections may occur. May decrease resistance or create an inability to localize infections.
• Immunologic: Unvaccinated or people without a history of chickenpox, measles, and other infections should avoid exposure. Immunosuppression may lead to an increase in severity. Prevention or treatment may be required.
• Immunologic: May aggravate active or latent tuberculosis or tuberculin reactivity; monitoring is required. Use in active tuberculosis is recommended only for the management of the disease and with an appropriate antituberculous regimen. Prophylaxis may be necessary for latent disease.
• Musculoskeletal: Employ with caution in patients with myasthenia gravis and osteoporosis
• Ophthalmic: May cause a corneal puncture in patients with ocular herpes simplex infections
• Ophthalmic: Prolonged use may result in glaucoma with possible optic nerve damage, posterior subcapsular cataract formation, or a rise in secondary ocular infections (eg, fungal or viral)
• Psychiatric: Derangements comprising euphoria, insomnia, mood swings, personality changes, and frank psychotic manifestations, may occur
• Psychiatric: Emotional instability or psychotic tendencies may be aggravated
• Renal: Use with caution in people with renal insufficiency
• Special populations: Tracking of growth and development is recommended in infants and children on prolonged therapy

Prednisolone in Pregnancy

• Foetal risk cannot be ruled out.
• Infants born to mothers who took corticosteroids during pregnancy should be monitored, as there is a chance of hypoadrenalism.

Prednisolone in Breast Feeding

• Infant risk cannot be ruled out.

How To Take Prednisolone?

• Unless your doctor or pharmacist gives you special instructions, it is best to take prednisolone in a single dose. You should consume it once a day, after breakfast.
• For example, if your doctor prescribes you 40 mg daily, then he will instruct you to take 8 tablets (8 x 5 mg).
• Take prednisolone with your breakfast so that it does not upset your stomach. It will not affect your sleep if taken in the morning.
• If your prednisolone tablet is labelled as enteric-coated or gastro-resistant, you can take it with or without food, but you should ensure that you have consumed it wholly and do not crush or chew it.
• Also, it’s important that you do not take any indigestion remedies like antacids for two hours before and after the dose has been taken.
• Some prednisolone tablets can be dissolved in water. You can inquire with your doctor if you are incapable of swallowing.
• Sometimes your doctor may instruct you to take it on alternate days only.

How Long to Take It?

• This may depend on your health condition and disease progress.
• One week is considered a short-term course. Sometimes you may have to take it for longer.

Prednisolone Side Effects

Serious Side Effects

Cardiovascular: Congestive heart failure

Dermatologic: Kaposi’s sarcoma, bruising and skin thinning, or any wound that will not heal.

Endocrine metabolic: Diabetic ketoacidosis, Hyperglycemia, Hyperosmolar coma due to diabetes mellitus, Hypocortisolism secondary to another disorder, Iatrogenic Cushing’s disease

Gastrointestinal: Gastrointestinal perforation, pancreatitis, coughing up blood or vomit that looks like coffee grounds, and bloody or tarry stools.

Musculoskeletal: Drug-induced myopathy, pain in arms, legs, or arms

Neurologic: Pseudotumor cerebri, seizures, severe depression, unusual thoughts, and behaviour.

Respiratory: Pulmonary tuberculosis, shortness of breath

• Low potassium may lead to irregular heartbeat, fluttering in your chest, leg cramps, constipation, increased thirst or urination, numbness, or tingling.

Common Side Effects

Cardiovascular: Fluid retention (swelling in hands or ankles), Hypertension

Dermatologic: Acne, Ecchymosis, Superinfection

Endocrine and metabolic: decreased body growth, abnormality of lipids, changes in your menstrual periods, 

Gastrointestinal: Superinfection, stomach discomfort, or weakness

Musculoskeletal: Osteoporosis

Neurologic: Headache, dizziness, spinning sensation

Ophthalmic: Cataract, Glaucoma, increased intraocular pressure

Psychiatric: Euphoria, Psychotic disorder

Other: Superinfection, General

When Should I Speak to My Doctor?

You should speak to your doctor if you

• Have signs of any allergic reactions
• Are taking any medication that may interact with prednisolone?
• Feels any troublesome side effects
• Became pregnant or planning

What Happens if I Miss a Dose?

If you miss a dose of prednisolone, try to take it as soon as you remember. If the next dose is closed, skip the missed dose and continue with the next dose. Try not to double the dose if you have missed any of them.

You can seek help from your doctor or pharmacist if you regularly forget any of the doses.

What Happens If I Take Too Much?

Attempt emergency medical attention if you overdose. You can seek help by calling the Poison Help Line at 1-800-222-1222.

An overdose of prednisolone can lead to life-threatening side effects like

• Thinning of skin
• Bruising
• Increased acne or facial hair
• Impotence
• Irregular menstruation
• Changes in shape or location of body fat

Stopping Prednisolone

Stopping prednisolone suddenly can be dangerous, especially if you are on a higher dose.

You may experience withdrawal symptoms like

• Weakness
• Body pain
• Joint pain
• Tiredness

Drug Interactions

Contraindicated

• Desmopressin (theoretical): Usage of desmopressin along with prednisolone may increase the case of hyponatremia (low levels of salt in the blood), which can lead to seizures, coma, and even death.
• Rotavirus Vaccine, Live (established): You may be at risk of developing an infection from the vaccine if you use it along with prednisolone. Your doctor may instruct you to delay the vaccine intake. As a result, once you begin prednisolone therapy, you should inform your doctor about all medications you have taken.

Major Drug Interactions

• Aldesleukin (theoretical): Prednisolone may interfere with the effectiveness of aldesleukin in the treatment of cancer.
• Aceclofenac (theoretical):  When this medicament is given along with prednisolone, there is a higher risk of gastrointestinal bleeding.
• Amtolmetin Guacil (theoretical)
• Asparaginase Escherichia coli (theoretical): This combination will lead to a rise in your blood sugar level. Also, it may lead to osteonecrosis, bleeding, or blood clots. Contact your doctor if you experience tarry stools, coughing up blood, bruising, etc. Your doctor will adjust the dosage.
• Bromfenac (theoretical): This combination will increase gastrointestinal side effects like inflammation, bleeding, ulceration, perforation, etc.
• Bufexamac (theoretical)
• Bupropion (theoretical): Seizures can occur when Bupropion is combined with prednisolone. You may be more susceptible if you are elderly, undergoing alcohol consumption or drug withdrawal, have a seizure history or have CNS diseases like brain tumours, or trauma.
• Balofloxacin (established)
• Bemiparin (theoretical)
• Besifloxacin (established)
• Bisoprolol
• Brewer’s yeast
• Bisacodyl
• Calcium carbonate: Antacids and acid-neutralising agents may impair prednisone, prednisolone, and dexamethasone absorption.
• Celecoxib (theoretical): Increases the risk of side effects in the gastrointestinal tract such as bleeding, and ulceration.
• Ceritinib (theoretical): Will increase the blood levels of prednisolone.
• Choline Salicylate (theoretical)
• Ciprofloxacin (established): Tendinitis and tendon ruptures will result.
• Cisplatin: This combination can cause muscle pain, dizziness, weakness, loss of appetite, or confusion.
• Clonixin (theoretical)
• Cyclosporin
• Darunavir (theoretical): Increase blood levels of prednisolone.
• Diazepam: The plasma concentration of some benzodiazepines may decrease in response to specific corticosteroids. This is related to the induction of hepatic cytochrome P450 enzymes responsible for benzodiazepine metabolism.
• Desmopressin: Increases the risk of hyponatremia, which can lead to seizures in severe cases.
• Dexibuprofen (theoretical)
• Dexketoprofen (theoretical)
• Diclofenac (theoretical): Increases the risk of side effects in the gastrointestinal tract such as bleeding, ulceration, inflammation
• Diflunisal (theoretical)
• Dipyrone (theoretical)
• Droxicam (theoretical)
• Enoxacin (established): Will cause tendinitis and tendon rupture.
• Etodolac (theoretical)
• Efavirenz: It may reduce blood levels of prednisolone, thereby reducing its effectiveness.
• Enalapril: When combined with prednisolone, reduces the effect of enalapril in lowering blood pressure
• Etofenamate (theoretical)
• Etoricoxib (theoretical)
• Estradiol: Increased blood levels of prednisolone can result in swelling, electrolyte abnormalities, high blood pressure, and a high blood glucose level.
• Felbinac (theoretical)
• Felodipine: Prednisolone decreases the effects of felodipine in lowering blood pressure
• Fenoprofen (theoretical): Increases the risk of side effects in the gastrointestinal tract such as bleeding, ulceration, and inflammation
• Foscarnet: This combination can cause muscle pain, dizziness, weakness, loss of appetite, or confusion. Thus, you should inform your doctor that he may provide you with a dosage adjustment.
• Furosemide: This combination can cause muscle pain, dizziness, weakness, loss of appetite, or confusion. Thus, you should inform your doctor that he may provide you with a dosage adjustment.
• Fluconazole: Increases the blood levels of prednisolone.
• Fepradinol (theoretical)
• Feprazone (theoretical)
• Fleroxacin (established)
• Floctafenine (theoretical)
• Flufenamic Acid (theoretical)
• Flumequine (established)
• Flurbiprofen (theoretical)
• Gatifloxacin (established): It will cause tendinitis and tendon rupture. People over the age of 60, as well as those who have had a kidney, heart, or lung transplant, are particularly vulnerable to this effect.
• Glipizide: This can interfere with the blood glucose level by altering the effect of glipizide and other diabetic medications.
• Guanethidine: Reduce the effect of guanethidine in lowering blood pressure.
• Gemifloxacin (established): Will cause tendinitis and tendon rupture. Elderly people over 60 and those who received a kidney/heart/lung transplant are easily prone to this effect.
• Ibuprofen (theoretical): Increases the risk of side effects in the gastrointestinal tract such as bleeding, ulceration, and inflammation, and rarely perforation which is a serious effect.
• Indinavir: Increase blood levels of prednisolone. Side effects include swelling, high blood pressure, weight gain, acne, thinning skin, stretch marks, depression, muscle weakness, high blood glucose, abnormal distribution of body fat, menstrual irregularities, cataract, loss of bone density, etc.
• Indomethacin (theoretical): Increases the risk of side effects in the gastrointestinal tract such as bleeding, ulceration, and inflammation, and rarely perforation which is a serious effect.
• Infliximab
• Influenza virus vaccine live, inactivated, trivalent
• Insulin: This can interfere with the blood glucose level by altering the effect of insulin and other diabetic medications.
• Isoniazid
• Itraconazole
• Ketoprofen (theoretical): Increases the risk of side effects in the gastrointestinal tract such as bleeding, ulceration, and inflammation, and rarely perforation which is a serious effect.
• Ketorolac (theoretical): Increases the risk of side effects in the gastrointestinal tract such as bleeding, ulceration, and inflammation, and rarely perforation which is a serious effect.
• Levofloxacin (established)
• Lomefloxacin (established)
• Lornoxicam (theoretical)
• Loxoprofen (theoretical)
• Lumiracoxib (theoretical)
• Lutetium Lu 177 Dotatate (theoretical)
• Macimorelin (theoretical)
• Meclofenamate (theoretical)
• Mefenamic Acid (theoretical)
• Meloxicam (theoretical)
• Morniflumate (theoretical)
• Moxifloxacin (established)
• Nabumetone (theoretical)
• Nadifloxacin (established)
• Nadroparin (theoretical)
• Naproxen (theoretical)
• Nepafenac (theoretical)
• Niflumic Acid (theoretical)
• Nimesulide (theoretical)
• Nimesulide Beta Cyclodextrin (theoretical)
• Norfloxacin (established)
• Ofloxacin (established)
• Oxaprozin (theoretical)
• Oxyphenbutazone (theoretical)
• Parecoxib (theoretical)
• Pazufloxacin (established)
• Pefloxacin (established)
• Phenylbutazone (theoretical)
• Piketoprofen (theoretical)Piroxicam (theoretical)
• Pranoprofen (theoretical)
• Proglumetacin (theoretical)
• Propyphenazone (theoretical)
• Proquazone (theoretical)
• Prulifloxacin (established)
• Rofecoxib (theoretical)
• Rufloxacin (established)
• Salicylic Acid (theoretical)
• Salsalate (theoretical)
• Sargramostim (theoretical)
• Sodium Salicylate (theoretical)
• Sparfloxacin (established)
• Sulindac (theoretical)
• Tenoxicam (theoretical)
• Tiaprofenic Acid (theoretical)
• Tolfenamic Acid (theoretical)
• Tolmetin (theoretical)
• Tosufloxacin (established)
• Valdecoxib (theoretical)

Moderate Drug Interactions

• Alcuronium (probable)
• Amobarbital (probable)
• Aspirin (probable)
• Atracurium (probable)
• Auranofin (probable)
• Desogestrel (established)
• Dienogest (established)
• Drospirenone (established)
• Estradiol (established)
• Ethinyl Estradiol (established)
• Fosphenytoin (probable)
• Gallamine (probable)
• Gestodene (established)
• Hexafluorenium (probable)
• Levonorgestrel (established)
• Licorice (probable)
• Mestranol (established)
• Metocurine (probable)
• Nomegestrol (established)
• Norethindrone (established)
• Norgestimate (established)
• Norgestrel (established)
• Phenytoin (probable)
• Primidone (probable)
• Rifampin (probable)
• Saiboku-To (probable)
• Vecuronium (probable)

TOXICOLOGY

Corticosteroids decrease calcium absorption, increase calcium excretion, and decrease the formation of osteoblasts, which leads to a decrease in bone formation and an increase in bone resorption, thereby contributing to the development of osteoporosis. 

• EPIDEMIOLOGY: Acute toxicity is rare. 
• OVERDOSE: Acute ingestion is a rare clinical problem. Acute adrenal insufficiency is rarely reported after an overdose. 
• ADVERSE EFFECTS: Seizures (methylprednisolone), anaphylaxis. 
• CHRONIC EXPOSURE: Cushingoid appearance, muscle weakness, hypertension, hyperglycemia, cataracts and glaucoma, osteoporosis, psychosis. 
• ABRUPT WITHDRAWAL: Dysphoria, irritability, emotional liability, depression, fatigue, anxiety, depersonalization, myalgia, and arthralgia.

Treatment

• Supportive care: Treatment is symptomatic and supportive. With the use of IV pulse methylprednisolone therapy, seizures have been reported. If seizures occur, administer IV benzodiazepines, or barbiturates.

• Decontamination: Serious toxicity is not likely caused by a large intake of corticosteroids alone, Activated charcoal should be considered after extremely large ingestions or if more toxic contestants are involved.

• Airway management: Patients who experience severe allergic reactions may need endotracheal intubation and mechanical ventilation.

Antidote: None

How Can I Store Prednisolone?

• Store in a dry, cool place away from direct light and heat
• Keep all the medicines out of the reach of children

Clinical Teaching

• Advise patients using immunosuppressive doses to avoid immunizations, as they can lead to drug-induced immunosuppression.
• Instruct the patient using immunosuppressive doses to detail any exposure to chickenpox or measles during therapy.
• Instruct the patient to report signs or symptoms of adrenocortical insufficiency or hypercortisolism, especially with prolonged therapy.
• Tell the patient to report any signs or symptoms of a new or exacerbating infection, including an eye infection.
• Guide the patient who is chronically using the drug against sudden discontinuation due to the potential for adrenocortical insufficiency.

References

• Micromedex
• http://www.drugs.com/prednisolone.html
• https://www.rxlist.com/prednisolone-drug.htm
• https://www.healthline.com/health/ulcerative-colitis/prednisone-vs-prednisolone