Prednisolone

Should be taken with food.

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).

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. Patient Counselling 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.

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).

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.

Corticosteroid Hormones / Ear Corticosteroids / Eye Corticosteroids / Topical Corticosteroids

A01AC04 - prednisolone ; Belongs to the class of local corticosteroid preparations. Used in the treatment of diseases of the mouth.
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.