Prednisone


Generic Medicine Info
Indications and Dosage
Oral
Acute exacerbations in multiple sclerosis
Adult: Initially, 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 and adjusted according to the disease being treated and patient response. Usual range: Initially, 5-60 mg daily. May consider alternate day therapy for long-term treatment. Refer to the disease-specific product guidelines for detailed dosage recommendations.
Child: Dosage is individualised and adjusted according to the disease being treated and patient response. As immediate-release tab/solution: Usual range: Initially, 0.05-2 mg/kg daily divided every 6-24 hours. May consider alternate day therapy for long-term treatment. Refer to the disease-specific product guidelines for detailed dosage recommendations.

Oral
Rheumatoid arthritis
Adult: In the treatment of moderate to severe active cases, especially when accompanied by morning stiffness: As modified-release tab: Initially, 5-10 mg at bedtime, may be adjusted according to patient response, clinical symptoms, and severity of the disease. Dose may be reduced in increments of 1 mg every 2-4 weeks until appropriate maintenance dose is reached.
Hepatic Impairment
Rheumatoid arthritis:
Dose reduction may be necessary.
Administration
Should be taken with food.
Contraindications
Systemic fungal infections; systemic infection unless treated with specific anti-infective, cerebral malaria. Concomitant administration with live or live attenuated vaccines (particularly immunosuppressive doses).
Special Precautions
Patient with systemic sclerosis; gastrointestinal disease (e.g. active or latent peptic ulcer, non-specific ulcerative colitis, diverticulitis, fresh intestinal anastomoses), hypertension, CHF, recent MI, myasthenia gravis, epilepsy or history of seizure disorders, psychiatric disorders, diabetes mellitus, thyroid disease, cirrhosis, uraemia, osteoporosis or at risk of osteoporosis (e.g. postmenopausal women), osteomalacia, corneal ulcers and injuries, cataract, glaucoma, acute viral infections (e.g. chickenpox, measles, herpetic keratitis), history of ocular herpes simplex, systemic mycoses and parasitosis (e.g. nematodes, Strongyloides infestation), tuberculosis, poliomyelitis, lymphadenitis following BCG inoculation, previous steroid myopathy. Patient subjected to stress conditions (e.g. trauma, infection, surgery). Avoid abrupt withdrawal. Renal and hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Adrenal suppression (e.g. hypercortisolism, suppression of hypothalamic-pituitary-adrenal [HPA] axis), left ventricular free wall rupture, visual disturbances (e.g. cataract, open-angle glaucoma, increased intraocular pressure, central serous chorioretinopathy), corneal perforation, osteoporosis, growth suppression in children, Kaposi sarcoma (prolonged use), acute myopathy, immunosuppression, convulsions, psychiatric disturbances (e.g. insomnia, euphoria, mood swings, personality changes, severe depression, frank psychotic manifestations), withdrawal symptoms (e.g. muscle weakness, hypotension, hypoglycaemia, muscle and joint pain). Rarely, anaphylactoid reactions.
Blood and lymphatic system disorders: Moderate leucocytosis, lymphopenia, eosinopenia, polycythaemia.
Cardiac disorders: Arrhythmia.
Ear and labyrinth disorders: Vertigo.
Eye disorders: Blurred vision.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, abdominal distension, gastric irritation, ulcerative oesophagitis, pancreatitis, peptic ulceration with perforation and haemorrhage.
General disorders and administration site conditions: Impaired wound healing.
Investigations: Increased AST/ALT, weight gain, EEG abnormalities, negative nitrogen balance, reduced glucose tolerance.
Metabolism and nutrition disorders: Cushing’s syndrome, anorexia, sodium and water retention, hypokalaemia, hypokalaemia alkalosis, hypercholesterolaemia, hypertriglyceridaemia, carbohydrate intolerance.
Musculoskeletal and connective tissue disorders: Muscle atrophy, vertebral compression fractures.
Nervous system disorders: Headache, restlessness.
Reproductive system and breast disorders: Menstrual disorders.
Skin and subcutaneous tissue disorders: Hirsutism, acneiform eruption, thinning of skin, purpura, increased sweating, striae rubrae, telangiectasia, petechiae, ecchymoses.
Vascular disorders: Hypertension.
Potentially Fatal: Acute adrenal insufficiency, scleroderma renal crisis.
PO: C, D (for delayed-release tab)
MonitoringParameters
Monitor blood pressure, serum creatinine, serum glucose, Hb, and electrolytes; occult blood loss, intraocular pressure (>6 weeks therapy), bone mineral density, weight; growth and development in children. Perform eye examination periodically during treatment; chest x-ray at regular intervals (prolonged use). Assess for signs and symptoms of HPA axis suppression, infection, or ocular changes.
Drug Interactions
May reduce the hypoglycaemic effects of antidiabetics. Increased risk of arrhythmias with digitalis glycosides. May either enhance or reduce the efficacy of coumarin anticoagulants. Increased risk of gastrointestinal ulceration or haemorrhage with NSAIDs, salicylates. May cause additional increased intraocular pressure with anticholinergic agents (e.g. atropine). Decreased serum concentrations of praziquantel, isoniazid. May reduce the therapeutic effects of somatropin. Increased risk of myopathies or cardiomyopathies with antimalarials (e.g. chloroquine, hydroxychloroquine, mefloquine). Efficacy may be potentiated by oestrogens. May reduce the therapeutic efficacy with mifepristone, CYP3A4 inducers (e.g. phenobarbital, rifampicin, primidone, carbamazepine). May decrease the clearance and increase serum concentration with CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, erythromycin). Increased serum levels of ciclosporin. Increased risk of hypokalaemia with K-depleting agents (e.g. amphotericin B, diuretics). Decreased absorption with Al- and Mg-containing antacids. Increased risk of tendon rupture with fluoroquinolones (e.g. ciprofloxacin, levofloxacin).
Potentially Fatal: May diminish the therapeutic effects of live vaccines.
Food Interaction
Metabolism may be inhibited by liquorice. Increased risk of gastrointestinal ulceration or haemorrhage with alcohol.
Lab Interference
May suppress skin test reactions. May cause false-negative result to nitroblue tetrazolinium tests for systemic bacterial infections.
Action
Description: Prednisone is a synthetic corticosteroid with glucocorticoid and anti-inflammatory activity. It decreases inflammation by reversal of increased capillary permeability and suppression of polymorphonuclear leukocytes migration; suppresses the immune system by reduction of lymphatic system activity and volume. Its anti-tumour activity may be due to inhibition of glucose transport, phosphorylation, or cell death induction in immature lymphocytes.
Pharmacokinetics:
Absorption: Readily absorbed from the gastrointestinal tract. Time to peak plasma concentration: 2 hours (immediate-release); 6-6.5 hours (modified-release).
Distribution: Crosses the placenta; enters breastmilk (small amounts). Plasma protein binding: <50% (concentration dependent).
Metabolism: Metabolised in the liver to active metabolite, prednisolone.
Excretion: Via urine (as conjugates). Elimination half-life: 2-3 hours.
Chemical Structure

Chemical Structure Image
Prednisone

Source: National Center for Biotechnology Information. PubChem Database. Prednisone, CID=5865, https://pubchem.ncbi.nlm.nih.gov/compound/Prednisone (accessed on Jan. 23, 2020)

Storage
Store between 15-30°C. Protect from light and moisture.
ATC Classification
A07EA03 - prednisone ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
H02AB07 - prednisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
References
Anon. Prednisone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/09/2019.

Apotex NZ Ltd. Apo-Prednisone Tablet data sheet 11 June 2018. Medsafe. http://www.medsafe.govt.nz/. Accessed 11/09/2019.

Buckingham R (ed). Prednisone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/09/2019.

Lodotra Modified-Release Tablet (Napp Pharmaceuticals Limited). MHRA. https://products.mhra.gov.uk/. Accessed 11/09/2019.

Prednisone Tablet (Par Pharmaceutical). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 10/09/2019.

Prednisone Tablet; Solution; Solution Concentrate (West-Ward Pharmaceuticals Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 14/04/2020.

Rayos Delayed Release Tablet (Horizon Therapeutics USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 14/04/2020.

Disclaimer: This information is independently developed by MIMS based on Prednisone 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 © 2021 MIMS. All rights reserved. Powered by MIMS.com
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