Adult: For the short-term treatment of steroid-responsive inflammatory conditions of the eye: As 0.12% or 1% prednisolone acetate susp: Instil 1-2 drops into the conjunctival sac 2-4 times daily, dosing frequency may be increased if needed during the initial 24-48 hours. As 0.5% prednisolone Na phosphate solution: Instil 1 or 2 drops into the eyes 1 or 2 hourly until control is achieved, then reduce the frequency; dosing frequency depends on patient response, use the lowest effective dose for the shortest possible duration. As 1% prednisolone Na phosphate solution: Initially, instil 1 or 2 drops into the conjunctival sac hourly during the day and 2 hourly at night until a satisfactory response is achieved, then reduce dose to 1 drop 4 hourly; further reduction to 1 drop 3-4 times daily may be sufficient. Re-evaluate if symptoms failed to improve after 2 days. Child: As 0.5% prednisolone Na phosphate solution: Same as adult dose.
Oral Nephrotic syndrome
Child: Standard regimen: 60 mg/m2 daily in 3 divided doses for 4 weeks, followed by single dose alternate-day therapy of 40 mg/m2 for 4 weeks. Treatment recommendations may vary among countries and individual products (refer to local treatment and specific product guidelines).
Oral Acute exacerbations in multiple sclerosis
Adult: Usual dose: 200 mg daily for 1 week, followed by 80 mg every other day for 1 month.
Oral Anti-inflammatory or immunosuppressive
Adult: Dosage is individualised according to the disease under treatment and patient response. Usual initial range: 5-60 mg daily, may be given as divided daily doses, a single morning dose, or on alternate days. Use the lowest effective dose for the minimum period. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines). Child: Dose range: 0.14-2 mg/kg daily in 3 or 4 divided doses. Dosage must be based on the disease under treatment and patient response rather than strict adherence to the dose indicated by age or body weight. Use the lowest effective dose for the shortest possible duration. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Otic/Aural Otic inflammation
Adult: As 0.5% prednisolone Na phosphate solution: Instil 2 or 3 drops into the ear 2 or 3 hourly until control is achieved, then reduce the frequency. Dosing frequency depends on patient response, use the lowest effective dose for the shortest possible duration. Child: Same as adult dose.
Rectal Crohn's disease
Adult: As 20 mg enema: 1 enema at bedtime for 2-4 weeks. As 5 mg supp: Insert 1 supp at bedtime and 1 supp in the morning after defaecation. May continue treatment if a good response is obtained. Child: As 5 mg supp: Same as adult dose.
Rectal Ulcerative colitis
Adult: As 20 mg enema: 1 enema at bedtime for 2-4 weeks; may continue if a good response is obtained. As 20 mg metered dose foam: 1 metered dose 1-2 times daily for 2 weeks; may continue for another 2 weeks if a good response is obtained.
Rectal Proctitis
Adult: As 20 mg metered dose foam: 1 metered dose 1-2 times daily for 2 weeks; may continue for another 2 weeks if a good response is obtained. As 5 mg supp: Insert 1 supp at bedtime and 1 supp in the morning after defaecation. Child: As 5 mg supp: Same as adult dose.
Special Patient Group
Oral:
Patient subjected to unusual stress (e.g. surgery, trauma, intercurrent illness): May require a temporary increase in dosage.
Administration
Should be taken with food.
Contraindications
Oral: Untreated systemic infection. Concomitant use with live or live-attenuated virus vaccines (particularly in patients receiving immunosuppressive doses). Ophthalmic: Acute superficial herpes simplex (dendritic keratitis), fungal diseases of the eye, mycobacterial infection of the eye (e.g. TB of the eye), acute infectious stages of vaccinia, varicella, and most viral diseases of the cornea and conjunctiva; use following uncomplicated removal of superficial corneal foreign body. Otic: Perforated tympanic membrane. Rectal: Traumatised mucosa in the anorectal area (e.g. intestinal obstruction, extensive fistulae, perforated bowel, peritonitis).
Special Precautions
Patient with existing or family (in 1st-degree relatives) or personal history of severe affective disorder (e.g. previous steroid psychosis, depressive or manic-depressive illness), history of, or X-ray changes characteristic of TB; latent TB and/or tuberculin reactivity, known or suspected Strongyloides infection, diabetes mellitus or family history of diabetes; gastrointestinal disease (e.g. diverticulitis, ulcerative colitis, active or latent peptic ulcer, fresh intestinal anastomoses, abscess or other pyogenic infection), glaucoma or family history of glaucoma; cataracts, history of ocular herpes simplex; hypertension, CHF, recent MI (with rupture reported), existing osteoporosis or at risk (e.g. postmenopausal women); existing or history of seizure disorder; systemic sclerosis, Cushing's disease, previous steroid myopathy; myasthenia gravis, thromboembolic disorders, Duchenne's muscular dystrophy, thyroid disease. Patient subjected to unusual stress (e.g. surgery, trauma, intercurrent illness). Avoid exposure to patients with chickenpox or measles. Avoid abrupt withdrawal during long-term therapy. May mask signs of infection. Use in patients with active TB must be restricted to fulminating or disseminated TB cases. Renal and hepatic impairment (including cirrhosis). Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: May precipitate or aggravate Cushing's syndrome; suppression of hypothalamic-pituitary-adrenal (HPA) axis (especially in younger children or in patients receiving chronic high doses); adrenal cortical atrophy, Kaposi's sarcoma (prolonged use); growth retardation in children (dose-related), withdrawal syndrome (following abrupt withdrawal), immunosuppression (including increased incidence of secondary infection and reactivation or exacerbation of latent infection); acute myopathy (high dose); psychiatric disturbances (e.g. euphoria, severe depression, mood swings, insomnia, personality changes, and psychotic manifestations); electrolyte imbalances, fluid retention, hypertension; altered glucose tolerance, hyperglycaemia; increased bone loss, osteoporosis or osteoporotic fractures (high dose and/or prolonged use); increased intracranial pressure with papilloedema (pseudotumour cerebri); increased risk of gastrointestinal perforation (particularly in patients with certain gastrointestinal disorders); visual disturbances (e.g. blurred vision), increased intraocular pressure and/or glaucoma, posterior subcapsular cataracts or nuclear cataracts, corneal and scleral thinning, damage to the optic nerve, visual acuity and field defects (prolonged use), exophthalmos; may delay healing or increase incidence of bleb formation (ophthalmic use after cataract surgery). Rarely, anaphylactoid reactions, central serous chorioretinopathy. Blood and lymphatic system disorders: Leucocytosis. Cardiac disorders: CHF (in susceptible patients), bradycardia. Ear and labyrinth disorders: Vertigo. Endocrine disorders: Manifestations of latent diabetes mellitus. Eye disorders: Ophthalmic: Mydriasis, ptosis, epithelial punctate keratitis, increased risk of corneal or scleral malacia, ocular hyperaemia, foreign body sensation, acute anterior uveitis, eye pain or irritation. Gastrointestinal disorders: Nausea, vomiting, dyspepsia, diarrhoea, abdominal distention or pain, acute pancreatitis, ulcerative oesophagitis; dysgeusia (ophthalmic). General disorders and administration site conditions: Impaired wound healing, malaise; atrophy of the rectal mucosa (rectal). Immune system disorders: Hypersensitivity reactions (ophthalmic). Investigations: Decreased carbohydrate tolerance, increased weight. Metabolism and nutrition disorders: Negative protein and Ca balance, increased appetite. Musculoskeletal and connective tissue disorders: Muscular atrophy, muscle weakness, vertebral compression fractures, avascular osteonecrosis, pathologic fracture of long bones, tendon rupture. Nervous system disorders: Headache, dizziness, convulsions. Reproductive system and breast disorders: Menstrual irregularities. Respiratory, thoracic and mediastinal disorders: Hiccups. Skin and subcutaneous tissue disorders: Skin atrophy or striae, acne, telangiectasia, petechiae, ecchymoses, facial erythema, hyperhidrosis, dermatitis, pruritus, rash. Vascular disorders: Thromboembolism. Potentially Fatal: Acute adrenal insufficiency (particularly upon abrupt withdrawal); increased incidence of scleroderma renal crisis with hypertension and decreased urinary output (in patients with systemic sclerosis).
PO: C (manufacturer specific), D (manufacturer specific); Ophth: C
Patient Counseling Information
Ophthalmic: This drug may cause transient blurring of vision, if affected, do not drive or operate machinery. Remove contact lenses before administration of the solution and wait at least 15 minutes before reinsertion.
Monitoring Parameters
Monitor blood pressure, serum glucose, renal function, electrolytes, weight, HPA axis suppression (e.g. ACTH stimulation test, urinary free cortisol test, morning plasma cortisol test), Hb, occult blood loss; BMD (during prolonged use), chest X-ray (regularly during prolonged treatment); growth and development in paediatric patients. Assess for signs and symptoms of infection and ocular changes. Obtain intraocular pressure (with therapy >6 weeks [oral] or ≥10 days [ophthalmic]) and perform eye examinations periodically during therapy.
Overdosage
Symptoms: May aggravate pre-existing disease states (e.g. electrolyte disorders, infections, oedema, ulcers). Management: Symptomatic and supportive treatment. Administer activated charcoal for proper gastric emptying. Perform gastric lavage or induce emesis.
Drug Interactions
CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, primidone, ephedrine) may enhance the metabolism of prednisolone and reduce its therapeutic effects. Antacids (e.g. Mg trisilicate, Al hydroxide) reduce the absorption of oral prednisolone. Decreased metabolism with CYP3A4 inhibitors (e.g. ketoconazole, erythromycin, cobicistat-containing agents), which may increase the risk of systemic adverse effects. May potentiate K-lowering effect with K-depleting agents (e.g. amphotericin B, diuretics, xanthines, β2-agonists). May enhance the efficacy of coumarin anticoagulants. Estrogens may potentiate the effect of prednisolone. Ciclosporin may enhance the seizure-potentiating effect of prednisolone. The risk of gastrointestinal ulceration and bleeding may increase with NSAIDs (including aspirin). May reduce the serum concentration of isoniazid. Concomitant use of high-dose prednisolone with neuromuscular blockers may lead to acute myopathy. May cause severe weakness in patients with myasthenia gravis when given concomitantly with anticholinesterase agents (e.g. pyridostigmine, neostigmine, ambenonium). May diminish the hypoglycaemic effect of antidiabetic agents. Therapeutic effects may be reduced with mifepristone. May inhibit the growth-promoting effect of somatropin. May lead to loss of corticosteroid-induced adrenal suppression with aminoglutethimide. Increased clearance with carbimazole and thiamazole. Potentially Fatal: Diminishes antibody response to live vaccines due to impaired immune system; prednisolone may increase the risk of vaccine-associated infection.
Food Interaction
May delay clearance with glycyrrhizin. Food affects the initial absorption, but not the overall bioavailability. May enhance gastric mucosal irritation with alcohol; avoid concomitant use.
Lab Interference
May suppress the response to skin tests. May produce false-negative results in nitroblue tetrazolium test for systemic bacterial infection.
Action
Description: Prednisolone, a corticosteroid with primarily glucocorticoid activity, reduces inflammation by reversing increased capillary permeability and suppressing polymorphonuclear leucocyte migration. It also affects the lymphatic system by reducing its activity and volume resulting in the suppression of the immune system. Duration: 12-36 hours. Pharmacokinetics: Absorption: Rapidly and well absorbed from the gastrointestinal tract. Following rectal administration, >20% were absorbed systematically; up to 50% in inflamed or damaged mucosa. Rapidly penetrates the cornea following topical application (ophthalmic susp). Initial absorption (but not overall bioavailability) is affected by food. Time to peak plasma concentration: 1-2 hours (oral); 30-45 minutes (ophthalmic). Distribution: Crosses the placenta; enters breast milk (small amounts). Volume of distribution: 0.22-0.7 L/kg. Plasma protein binding: Oral: 70-90%, mainly to albumin and corticosteroid-binding globulin. Rectal: 90-95%. Metabolism: Metabolised mainly in the liver into a biologically inactive compound. Excretion: Via urine (as glucuronide and sulfate conjugates; small amounts of unchanged drug). Elimination half-life: 2-4 hours (oral); approx 30 minutes (ophthalmic; in aqueous humour).
Chemical Structure
Prednisolone Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5755, Prednisolone. https://pubchem.ncbi.nlm.nih.gov/compound/5755. Accessed Aug. 25, 2022.
Storage
Tab/oral solution: Store below 25°C. Oral syr: Store below 30°C. Protect from light. Ophthalmic/otic susp/solution: Store up to 25°C. Do not freeze. Rectal supp, enema, or foam: Store below 25°C. Protect from light. Storage recommendations may vary among countries and individual products. Refer to detailed product guidelines.
S01BA04 - prednisolone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye. H02AB06 - prednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations. S02BA03 - prednisolone ; Belongs to the class of corticosteroids used in the treatment of inflammation of the ear. A07EA01 - prednisolone ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
References
Anon. Prednisolone (EENT). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/06/2022.Anon. Prednisolone (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/04/2022.Anon. Prednisolone (Systemic). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/06/2022.Anon. Prednisolone (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/04/2022.Anon. Prednisolone (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/04/2022.Buckingham R (ed). Prednisolone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/04/2022.Deltacortril 5 mg Gastro-resistant Tablets (Phoenix Labs). MHRA. https://products.mhra.gov.uk. Accessed 19/08/2022.Flo-pred Suspension (Taro Pharmaceuticals U.S.A., Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/04/2022.Joint Formulary Committee. Prednisolone. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/04/2022.Medsone 20 mg/5 mL Syrup and 20 mg Tablet (Lloyd Laboratories, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 07/04/2022.Millipred Tablet (Avalo Therapeutics Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/04/2022.Orapred ODT (Concordia Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/04/2022.Pedipred Solution (Royal Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/04/2022.Pred Forte 1% w/v, Eye Drops Suspension (Allergan Ltd). MHRA. https://products.mhra.gov.uk. Accessed 07/04/2022.Pred Forte Sterile Ophthalmic Suspension (Allergan Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/04/2022.Pred Forte Suspension/Drops (Allergan, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/04/2022.Pred Mild Suspension/Drops (Allergan, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 19/08/2022.Predenema (Chemidex Pharma Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 07/04/2022.Predfoam (Chemidex Pharma Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 07/04/2022.Prednisolone 2.5 mg Tablets (Accord-UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 07/04/2022.Prednisolone 5 mg Soluble Tablets (Accord-UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 07/04/2022.Prednisolone 5 mg Suppositories (RPH Pharmaceuticals AB). MHRA. https://products.mhra.gov.uk. Accessed 07/04/2022.Prednisolone Sodium Phosphate 0.5% w/v, Eye and Ear Drops, Solution (RPH Pharmaceuticals AB). MHRA. https://products.mhra.gov.uk. Accessed 07/04/2022.Prednisolone Sodium Phosphate Solution/Drops (Bausch & Lomb Incorporated). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/04/2022.Prednisolone Syrup (Lannett Company, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/04/2022.Prelone Syrup (Sunward Pharmaceutical Sdn. Bhd.). MIMS Malaysia. http://www.mims.com/malaysia. Accessed 07/04/2022.
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