(pred niss' oh lone)
P / L : Caution during pregnancy and lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
|Indication & Dosage||Oral route
Allergic and inflammatory disorders
Adult: 5-60 mg daily in 2-4 divided doses. Maintenance: 2.5-15 mg daily. Withdrawal should be gradual after long-term therapy.
Child: 1 mth-18 yr: Autoimmune inflammatory disorders: Initially, 1-2 mg/kg once daily; may reduce dose gradually after a few days if needed. Max: 60 mg daily. Autoimmune hepatitis: Initially, 2 mg/kg once daily, then reduce to minimum effective dose. Max: 40 mg daily.
Poorly controlled, moderate to severe asthma
Adult: Patients with at least 2 exacerbations/yr requiring oral corticosteroids: 40-60 mg daily in 1-2 divided doses; usually given as a short course treatment over 3-10 days until symptom resolution and patient achieves a peak expiratory flow (PEF) of at least 80% of his or her personal best. May be used with maintenance dosages of inhaled corticosteroid and a long-acting inhaled beta2-agonist bronchodilator.
Child: Patients with >3 exacerbations/yr in children â‰¤4 yr or at least 2 exacerbations/yr in children 5-11 yr: 1-2 mg/kg daily for 3-5 days may be used with existing asthma treatment; dose may be given in 1-2 divided doses. Max: 60 mg daily.
Child: 1 mth-18 yr: Initially, 60 mg/m2 (max: 80 mg) once daily for 4 wk until urine is protein-free followed by 40 mg/m2 every other day for 4 wk, then withdraw dose gradually. Prevention of relapse: 0.5-1 mg/kg once daily every other day for 3-6 mth.
Adult: Initially, 5-7.5 mg daily, adjusted as necessary.
Elderly: 5 mg daily.
Adult: 200 mg daily for 1 wk followed by 80 mg every other day for 1 mth.
Child: 1 mth-2 yr: Initially, 10 mg 4 times daily for 14 days; increase to 20 mg 3 times daily for 7 days if seizures are not controlled after 7 days; reduce dose slowly over 15 days until therapy is stopped. For patients taking 40 mg daily, reduce dose in steps of 10 mg every 5 days, then stop; in patients taking 60 mg daily, reduce dose to 40 mg daily for 5 days, then 20 mg daily for 5 days, then 10 mg daily for 5 days, then stop.
Idiopathic thrombocytopenic purpura
Child: 1-10 yr: 1-2 mg/kg daily (max: 14 days) or 4 mg/kg daily (max: 4 days).
Allergic and inflammatory disorders
Adult: Given as sodium phosphate ester: 5-60 mg prednisolone base daily IV inj/infusion or IM. Dose to be individualised based on the severity of the condition and patient's response.
Adult: 5-25 mg (as acetate) or 2-30 mg (as phosphate) or 4-40 mg (as terbutate). The phosphate and tebutate may also be given intralesionally or injected into soft tissue.
Adult: As 1% acetate suspension or 0.12% acetate suspension: Instill 1-2 drops into the affected eye(s) 2-4 times daily. Higher frequency may be used during the initial 24-48 hr, if needed. Re-evaluate if there is no improvement after 2 days of treatment.
Allergic and inflammatory conditions of the ear
Adult: As acetate or phosphate: 0.5 or 1% drops.
Adult: As farnesylate: Apply onto the affected area when necessary.
Special Populations: Increase dose in patients with hyperthyroidism. Use lowest effective dose in elderly patients.
|Administration||Should be taken with food.
|Overdoge||Treatment of acute overdose includes immediate gastric lavage or emesis followed by supportive and symptomatic therapy. For chronic overdose, the dosage of prednisolone may be reduced temporarily, or introduce alternate day treatment.|
|Contraindications||Live vaccines; herpes simplex keratitis, systemic infections.|
|Special Precautions||Patients with hypothyroidism, cirrhosis, ulcerative colitis, CHF, convulsive disorders, thrombophlebitis, peptic ulcer, elderly. DM, hypertension, psychological disturbances, osteoporosis; pregnancy, lactation. Adrenal suppression and infection. May cause irreversible growth retardation, glaucoma, corneal perforation. Topical: Broken or infected skin. Not to be applied over large areas under occlusive dressings.|
|Adverse Drug Reactions||Cushing's syndrome and growth retardation in childn; osteoporosis, fractures. Peptic ulceration; glaucoma, cataracts; hyperglycaemia, pancreatitis; increased appetite, obesity. Topical: Thinning and atrophy, systemic absorption with prolonged use over large surface, broken skin or under occlusive dressing. Rash, allergic reactions, pruritus. Intradermal/Intralesional: Local hypopigmentation of hyperpigmented lesions. Ophthalmic: Raised IOP and reduced visual function.
Potentially Fatal: Acute adrenal insufficiency precipitated by infection, trauma or surgery in patients on long-term therapy or following cessation of such therapy. CV collapse following rapid IV injection.
|Drug Interactions||Increased requirement of insulin and oral hypoglycaemics. Actions blunted by barbiturates, phenytoin, rifampicin. Increased bioavailability with estrogens and oral contraceptives. Increases plasma salicylate levels. Increased risk of convulsions when used with ciclosporin, increased clearance by carbimazole or carbamazepine. Increased risk of GI bleeding and ulceration when used with NSAIDs. May decrease methotrexate clearance. Please consult detailed drug interactions before prescribing.|
|Food Interaction||Limit caffeine.|
|Lab Interference||May interfere with response to skin test.|
|Pregnancy Category (FDA)||ROUTE(S) : OPHTH
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Category C: D in 1st trimester. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
|Storage||All formulations: Store at 20-25°C.
|Pharmacology||Prednisolone decreases inflammation by inhibition of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It suppresses the immune system by reducing the activity and production of the lymphocytes and eosinophils.
Absorption: Readily absorbed from the GI tract with peak plasma concentrations after 1-2 hr (oral); initial absorption is affected by food.
Distribution: Inactivated as it crosses the placenta; enters the breast milk. Protein-binding: Extensive.
Excretion: Via urine (as free and conjugated metabolites); 1-2 hr (elimination half-life).
|ATC Classification||S01CB02 - prednisolone Belongs to the class of corticosteroids/antiinfectives/mydriatics combinations. Used in the treatment of eye diseases.
D07AA03 - prednisolone Belongs to the class of weak (group I) corticosteroids. Used in the treatment of dermatological diseases.
S02BA03 - prednisolone Belongs to the class of corticosteroids used in the treatment of inflammation of the ear.
H02AB06 - prednisolone Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
S03BA02 - prednisolone Belongs to the class of corticosteroids used in ophthalmologic and otologic preparations.
C05AA04 - prednisolone Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids.
A07EA01 - prednisolone Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
D07XA02 - prednisolone Belongs to the class of weak (group I) corticosteroids in other combinations. Used in the treatment of dermatological diseases.
R01AD02 - prednisolone Belongs to the class of topical corticosteroids used as nasal decongestants.
S01BA04 - prednisolone Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|ADAM 33||Nuvista Pharma Limited||Prednisolone USP 5mg (micronised)||Tablet||5mg x300's: 342.00 MRP|
|CORTAN 10||Incepta Pharmaceuticals Limited||Prednisolone BP 10mg||Tablet||100's: 207.00 MRP|
|CORTAN 100ml||Incepta Pharmaceuticals Limited||Prednisolone 5mg/5ml Solution||Oral Solution||100ml: 95.00 MRP|
|CORTAN 20||Incepta Pharmaceuticals Limited||Prednisolone BP 20 mg||Tablet||50's: 186.50 MRP|
|CORTAN 5||Incepta Pharmaceuticals Limited||Prednisolone BP 5mg||Tablet||200's: 230.00 MRP|
|CORTAN 50ml||Incepta Pharmaceuticals Limited||Prednisolone 5mg/5ml Solution||Oral Solution||50ml: 60.00 MRP|
|CORTAN Drop||Incepta Pharmaceuticals Limited||Prednisolone 1% Eye Drop||Eye Drops||5ml:100.00 MRP|
|CORTISOL||Aristopharma Ltd.||Prednisolone 5mg,10mg & 20mg||Tablet||5mg x200's, 10mg x100's, 20mg x50's: 228.00 & 208.00 & 187.50 MRP|
|CORTISOL Drop||Aristopharma Ltd.||Prednisolone acetate USP 1% w/v||Eye Drop||5ml: 100.00 MRP|
|CORTISOL Solution||Aristopharma Ltd.||Prednisolone 5mg/5ml||Oral Solution||50ml: 60.00 MRP|
|DELTA||Bristol Pharma Limited||Prednisolone 5mg||Tablet||500's: 350.00 MRP|
|DELTACORT||Desh Pharmaceuticals (Pvt) Ltd||Prednisolone 5mg||Tablet||500's: 350.00 MRP|
|DELTAPRED||Ziska Pharmaceuticals Ltd.||Prednisolone 5mg,10mg & 20mg||Tablet||5mg x500's, 10mg x100's, 20mg x40's: 500.00, 200.00 & 120.00 MRP|
|DELTASONE||Renata Limited||Prednisolone 1mg, 5mg,10mg & 20mg||Tablet||1mg x100's, 5mg x500's, 10mg x100's, 20mg x50's: 33.00, 570.00, 207.00 & 186.50 MRP|
|EDRUSON||Edruc Limited||Prednisolone 5mg||Tablet||100's: 77.00 IP|
|G-PREDNISOLONE||Gonoshasthaya Pharmaceuticals Ltd||Prednisolone 5mg||Tablet||30's: 21.30 MRP|
|INFLAGIC 20||Square Pharmaceuticals Ltd.||Prednisolone 20mg||Tablet||5x10's: 199.50 MRP|
|INFLAGIC 5||Square Pharmaceuticals Ltd.||Prednisolone 5mg||Tablet||10x10's: 172.00 MRP|
|ISOLON Drop||IBN SINA Pharmaceutical Industry Ltd.||Prednisolone acetate USP 1% w/v||Eye Drop||5ml: 100.00 MRP|
|OCUSOL Drop||Popular Pharmaceuticals Ltd.||Prednisolone acetate USP 1% w/v||Eye Drop||5ml: 175.00 MRP|
|PEDIPRED||Ziska Pharmaceuticals Ltd.||Prednisolone sodium phosphate 5mg/5ml||Oral Solution||100ml: 95.00 MRP|
|PEDNISOL Drop||Drug International Ltd||Prednisolone acetate USP 1% w/v||Eye Drop||5ml: 175.00 MRP|
|PRECODIL||Opsonin Pharma Limited||Prednisolone 5mg, 10mg & 20mg||Tablet||5mg x200's, 10mg x100's, 20mg x60's: 230.00, 207.00 & 223.80 MRP|
|PRECODIL 15||Opsonin Pharma Limited||Prednisolone 15mg/5ml||Oral Solution||50ml, 100ml: 80.00 & 130.00 MRP|
|PRECODIL 5||Opsonin Pharma Limited||Prednisolone 5mg/5ml||Oral Solution||50ml, 100ml: 65.00 & 95.00 MRP|
|PRED||Eskayef Bangladesh Ltd||Prednisolone BP 5mg, 10mg & 20mg||Tablet||5mg x500's, 10mg x100's & 20mg x50's MRP: 228.00, 200.00 & 185.00|
|PREDNELAN||GlaxoSmithKline Bangladesh Limited||Prednisolone 5mg & 20mg||Tablet||5mg x500's, 20mg x100's: 571.90 & 250.94 MRP|
|PREDNICORT Drop||Asiatic Laboratories Ltd.||Prednisolone acetate USP 1% w/v||Eye Drop||5ml: 150.00 MRP|
|PREDNISOLONE||Ambee Pharmaceuticals Ltd.||Prednisolone 5mg||Tablet||500's: 335.00 MRP|
|PREDNOL Drop||Reman Drug Laboratories Ltd.||Prednisolone acetate USP 1% w/v||Eye Drop||5ml: 200.75 MRP|
|PREXAN||Chemist Laboratories Ltd.||Prednisolone 5mg||Tablet||500's: 350.00 MRP|
|RENISOL Drop||Apex Pharmaceuticals Ltd.||Prednisolone acetate USP 1% w/v||Eye Drop||5ml: 200.00 MRP|
|ZENILON||Zenith Pharmaceuticals Ltd.||Prednisolone 5mg||Tablet||250's: 175.00 MRP|
|| See FDA approved Prescribing Information from Brand Manufacturer |||Manufacturer's|
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*Trademark name & prescribing information are the property of their respective Manufacturers.