Concise Prescribing Info
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.
Should be taken with food.
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. Patient Counselling 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. Monitoring Parameters 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.
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 administration 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.
ROUTE(S) : Ophth: C
ROUTE(S) : PO: C C/D (manufacturer specific)
ROUTE(S) : PO: D C/D (manufacturer specific)
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.
ATC Classification
C05AA04 - prednisolone ; Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids and anal fissures.
S01CB02 - prednisolone ; Belongs to the class of corticosteroids/antiinfectives/mydriatics combinations. Used in the treatment of eye diseases.
D07XA02 - prednisolone ; Belongs to the class of weak (group I) corticosteroids in other combinations. Used in the treatment of dermatological diseases.
S03BA02 - prednisolone ; Belongs to the class of corticosteroids used in ophthalmologic and otologic 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.
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.
D07AA03 - prednisolone ; Belongs to the class of weak (group I) corticosteroids. Used in the treatment of dermatological diseases.
R01AD02 - prednisolone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Disclaimer: This information is independently developed by CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 CIMS. All rights reserved. Powered by
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