Prednisolone


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Allergic and inflammatory disorders Usual range: 5-60 mg/day. Dosage is individualised according to the disease under treatment and patient response. Recommendations: Allergic and skin disorders: Initial: 5-15 mg/day. Collagenosis: Initial: 20-30 mg/day. Rheumatoid arthritis: Initial: 10-15 mg/day. Blood disorders and lymphoma: Initial: 15-60 mg/day. May refer to disease-specific guidelines for detailed dosage recommendations. IM Allergic and inflammatory disorders 25-100 mg once or twice weekly as needed, depending on severity and patient response. Max: 100 mg twice weekly. Intra-articular; Periarticular Inflammatory joint diseases 5-25 mg depending on the size of the joint (Max 3 joints per day), may repeat when relapse occurs. Rectal Rectal and rectosigmoidal disease in Crohn’s disease and ulcerative colitis As enema: 1 enema at bedtime for 2-4 weeks. As supp: Insert 1 supp at bedtime and 1 supp in the morning after defecation. Ophthalmic Inflammatory eye disorders As 1% prednisolone acetate suspension: Instill 1-2 drops into the conjunctival sac 2-4 times/day, may increase to 2 drops hourly during the initial 24-48 hours. As 0.5% prednisolone Na phosphate solution: Instill 1 or 2 drops 1 or 2 hourly until control is achieved. Otic Allergic and inflammatory conditions of the ear As 0.5% prednisolone Na phosphate solution: Instill 2 or 3 drops into the ear 2 or 3 hourly until control is achieved. Frequency depends on patient response. Discontinue if there is no response within 7 days of treatment.
Dosage Details
Intra-articular, Periarticular
Inflammatory joint diseases
Adult: 5-25 mg depending on the size of the joint (Max 3 joints per day) and may be repeated when relapse occurs.

Intramuscular
Allergic and inflammatory disorders
Adult: 25-100 mg once or twice weekly as needed, depending on severity and patient response. Max: 100 mg twice weekly.

Ophthalmic
Inflammatory eye disorders
Adult: As 1% prednisolone acetate suspension: Instill 1-2 drops into the conjunctival sac 2-4 times daily, may be increased to 2 drops hourly during the initial 24-48 hours. As 0.5% prednisolone Na phosphate solution: Instill 1 or 2 drops 1 or 2 hourly until control is achieved.
Child: Same as adult dose.

Oral
Allergic and inflammatory disorders
Adult: Usual range: 5-60 mg daily, may be given as divided daily doses, as a single daily dose, or as a double dose on alternate days. Dosage is individualised according to the disease under treatment and patient response. Recommendations: Allergic and skin disorders: Initially, 5-15 mg daily. Collagenosis: Initially, 20-30 mg daily; higher doses may be required in severe cases. Rheumatoid arthritis: Initially, 10-15 mg daily. Blood disorders and lymphoma: Initially, 15-60 mg daily; may be reduced after adequate clinical response or may be increased when necessary, to induce remission in acute leukaemia. May refer to disease-specific guidelines for detailed dosage recommendations.
Child: Dosage is individualised according to the disease under treatment and patient response. Use only when specifically indicated, at the lowest dose possible and for the shortest possible time. Usual initial dose range: 0.14-2 mg/kg/day. Recommendations: Acute asthma: 1-2 mg/kg/day in single or divided doses for 3-10 days or longer. Nephrotic syndrome: 2 mg/kg/day or 60 mg/m2/day in 3 divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m2/day.

Otic/Aural
Allergic and inflammatory conditions of the ear
Adult: As 0.5% prednisolone Na phosphate solution: Instill 2 or 3 drops into the ear 2 or 3 hourly until control is achieved. Frequency depends on patient response. Discontinue if there is no response within 7 days of treatment.
Child: Same as adult dose.

Rectal
Crohn's disease, Ulcerative colitis
Adult: For rectal and rectosigmoidal disease: As enema: 1 enema at bedtime for 2-4 weeks. As supp: Insert 1 supp at bedtime and 1 supp in the morning after defecation.
Administration
Should be taken with food.
Contraindications
Active systemic infections, ocular herpes simplex, mycobacterial infection, fungal disease of the ears, and perforated tympanic membrane. Concomitant administration with live vaccines (especially in patients with impaired immune response).
Special Precautions
Patient with diabetes mellitus or family history of diabetes; hypertension or heart diseases (e.g. congestive heart failure, MI); epilepsy, gastrointestinal disease (e.g. peptic ulceration), myasthenia gravis, chickenpox, measles, thromboembolic disorders, osteoporosis, thyroid disease, tuberculosis and systemic sclerosis, history of corticosteroid induced psychoses or severe affective disorders, previous steroid myopathy, glaucoma, acute purulent infections of the eye, or those who have undergone cataract surgery. Avoid abrupt withdrawal. Renal and hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Adrenal cortical atrophy, increased intraocular pressure, atrophy of rectal mucosa, Kaposi’s sarcoma, depression, psychological dependence, immunosuppression, cataract, glaucoma, corneal or scleral thinning, visual disturbance.
Cardiac disorders: Congestive heart failure.
Gastrointestinal disorders: Abdominal pain, peptic ulceration with perforation and haemorrhage, nausea, oesophageal ulceration.
General disorders and admin site conditions: Impaired healing, withdrawal symptoms, increased sweating.
Immune system disorders: Hypersensitivity.
Infections and infestations: Fungal infections of the cornea.
Injury, poisoning and procedural complications: Tendon rupture.
Investigations: Weight gain, impaired carbohydrate tolerance, negative nitrogen and calcium balance; potassium loss.
Metabolism and nutrition disorders: Hypokalaemic alkalosis, sodium and water retention.
Musculoskeletal and connective tissue disorders: Osteoporosis, vertebral and long bone fractures.
Skin and subcutaneous tissue disorders: Hypertrichosis.
Vascular disorders: Cushingoid facies, hypertension, thromboembolism.
PO: C (C/D (manufacturer specific)), D (C/D (manufacturer specific)); Ophth: C
Patient Counseling Information
Prednisolone ophthalmic solution may cause visual disturbances such as blurred vision, if affected, do not drive or operate machinery. Remove contact lenses prior to instillation of ophthalmic drops and wait at least 15 minutes before reinsertion.
MonitoringParameters
Monitor blood pressure, blood glucose, bone mineral density, electrolytes, intraocular pressure (for usage of >6 weeks), weight, and hypothalamic-pituitary-adrenal (HPA) axis suppression; growth and development in children.
Drug Interactions
Increased systemic adverse effects with CYP3A inhibitors, including. cobicistat-containing products. Increased metabolism rate with CYP3A4 inducers (e.g. phenobarbital, rifampicin, primidone, aminoglutethimide) resulting to reduced therapeutic efficacy. Decreased clearance with CYP3A4 inhibitors (e.g. ketoconazole, troleandomycin). Antagonistic effect with hypoglycaemic agents (e.g. insulin), antihypertensives and diuretics. Enhances hypokalaemic effect of diuretics (e.g. acetazolamide), carbenoxolone, theophylline and sympathomimetic agents (e.g. salbutamol, terbutaline). Increased GI ulceration with concomitant use of ulcerogenic drugs (e.g. indomethacin). Increases renal clearance of salicylates, abrupt corticosteroids withdrawal may result in salicylate intoxication. Oestrogens may potentiate the effect of prednisolone. Reduced effect with mifepristone. Enhances efficacy of anticoagulants which may result to spontaneous bleeding. May antagonise the hypoglycaemic effect of antidiabetics. Decreased plasma clearance with ciclosporin.
Potentially Fatal: Diminishes antibody response to live vaccines due to impaired immune system.
Food Interaction
Alcohol may enhance gastric mucosal irritation.
Lab Interference
May suppress skin test reactions.
Action
Description: Prednisolone is a corticosteroid with primarily glucocorticoid activity. It decreases inflammation by reversal of increased capillary permeability and suppression of polymorphonuclear leukocytes migration. It also affects the lymphatic system by reducing its activity and volume resulting to a suppressed immune system.
Duration: 18-36 hours.
Pharmacokinetics:
Absorption: Rapidly and well absorbed from the gastrointestinal tract after oral administration. >20% may be absorbed systematically after rectal administration. Food affects initial absorption (oral). Time to peak-plasma concentration: 1-2 hours (systemic); 30-45 minutes (ophthalmic).
Distribution: Crosses the placenta and small amounts are present in the breast milk. Volume of distribution: 0.22-0.7 L/kg. Plasma-protein binding: 70-90%, to albumin and corticosteroid binding globulin; 90-95% bound to plasma proteins (rectal).
Metabolism: Mainly hepatic and rapidly converted to prednisone.
Excretion: Via urine (as sulfate and glucuronide conjugate). Elimination half-life: 2-4 hours (oral); approx 30 minutes (prednisolone acetate ophthalmic solution).
Chemical Structure

Chemical Structure Image
Prednisolone

Source: National Center for Biotechnology Information. PubChem Database. Prednisolone, CID=5755, https://pubchem.ncbi.nlm.nih.gov/compound/Prednisolone (accessed on Jan. 23, 2020)

Storage
Tab/oral solution: Store at 25°C. Ophthalmic/otic drops/supp/enema: Store below 25°C. Do not freeze. Suspension for injection: Store at 15-25°C. Protect from light.
ATC Classification
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 (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/01/2019.

Anon. Prednisolone (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/01/2019.

Buckingham R (ed). Prednisolone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/01/2019.

Econopred Suspension (Alcon Laboratories, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 23/01/2019.

Prednisolone Sodium Phosphate Solution (Seton Pharmaceuticals, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 23/01/2019.

Disclaimer: This information is independently developed by MIMS based on Prednisolone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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