Drug reference

Prednisolone

Corticosteroid

Also known as Prednisolone acetate, Prednisolone sodium phosphate, Delta-1-cortisol, Metacortandracin

START

5-60 mg PO daily (indication-dependent)

TYPICAL MAX

1-2 mg/kg/day for acute conditions; taper after stabilization

STOP IF

Systemic fungal infection · live vaccine within 4 weeks · do not stop abruptly after >3 weeks

WATCH

BP · glucose · K⁺ · weight · infection signs · mood

CDSCO approvedSchedule HJan AushadhiATC H02AB06

Dose laddermg/d

Renal dose adjustmenteGFR mL/min/1.73m²

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours

ONSET: 1h · anti-inflammatory action
PEAK: 2h · Cmax
t½: 3h · plasma t½ (biological 18-36h)
DURATION: 1d · once-daily dosing window

EXCRETION

Hepatic CYP3A4 · renal metabolites

route + CYP

INTERACTIONS

12 major

SEVERE in our sources

PREGNANCY

Category C — placental 11β-HSD2 protects fetus; mostly safe

FDA category + note

Top interactionssee all 12 →

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Mechanism

Prednisolone, a synthetic glucocorticoid, exerts its effects by binding to intracellular glucocorticoid receptors. This binding leads to translocation of the receptor-ligand complex into the nucleus, where it modulates gene expression. It upregulates anti-inflammatory proteins and downregulates pro-inflammatory mediators, thereby reducing inflammation and immune responses. It also inhibits phospholipase A2, reducing prostaglandin and leukotriene synthesis.

Indications

Allergic disorders (e.g., severe asthma, allergic rhinitis)Rheumatic disorders (e.g., rheumatoid arthritis, systemic lupus erythematosus)Dermatologic diseases (e.g., pemphigus, severe psoriasis)Endocrine disorders (e.g., primary or secondary adrenocortical insufficiency)Gastrointestinal diseases (e.g., ulcerative colitis, Crohn's disease)Hematologic disorders (e.g., hemolytic anemia, idiopathic thrombocytopenic purpura)Neoplastic diseases (e.g., leukemias, lymphomas, breast cancer) (adjunctive therapy)Nervous system disorders (e.g., multiple sclerosis exacerbations, cerebral edema)Ophthalmic diseases (e.g., severe allergic and inflammatory processes involving the eye)Renal diseases (e.g., nephrotic syndrome)Respiratory diseases (e.g., COPD exacerbations, aspiration pneumonitis)Organ transplant rejection prophylaxis (off-label)rheumatoid arthritisuveitisulcerative colitisvasculitissarcoidosissystemic lupus erythematosuschronic adrenal insufficiency (with careful monitoring for cushingoid features)rheumatic disordersrenal diseasessevere allergic reactionssevere dermatological disorderspemphigusautoimmune hepatitisthrombocytopenianoninflammatory degenerative joint diseases (local injection)lymphoid malignanciesmoderate-to-severe IBDinduction of remission of moderate-to-severe Crohn’s diseaseinduction of remission of moderate-to-severe ulcerative colitissystemic treatment of corticosteroid-responsive eye disordersfollow-up treatment for severe/recurrent allergic reactionsmyasthenia gravis (advanced cases, to induce remission or for maintenance)Severe chronic asthma (not controlled by bronchodilators and inhaled steroids, or frequent recurrences of increasing severity)Acute asthma exacerbationStatus asthmaticusCOPD (during an exacerbation)allergic diseasesinflammatory diseasesautoimmune diseasesmalignanciesautoimmune haemolytic anaemiaidiopathic thrombocytopenic purpuraactive chronic hepatitismyasthenia gravissevere chronic asthmabell's palsyneurocysticercosisinflammatory bowel diseasesSulfone syndromesevere lepra reaction (ENL)reversal reactionAcute childhood leukaemiaLymphomasHodgkin’s disease (palliative)Some hormone responsive breast cancersMalignancy/chemotherapy associated hypercalcaemiaMalignancy/chemotherapy associated haemolysisMalignancy/chemotherapy associated bleeding due to thrombocytopeniaRetinoic acid syndromeIncreased intracranial tensionMediastinal edema due to radiotherapy

Dosing

Adult: Highly individualized. Typically 5-60 mg/day orally in single or divided doses. For acute conditions, higher doses (e.g., 40-60 mg/day) for short durations (3-7 days) may be used, followed by tapering. For chronic conditions, the lowest effective dose should be used, often tapered slowly.
Pediatric: Highly individualized. Usually 0.1-2 mg/kg/day orally in single or divided doses. Max 60 mg/day or 15 mg/m2/day, depending on the condition and response.
Renal adjustment: No specific dose adjustment is generally required for renal impairment, as prednisolone is primarily metabolized in the liver. However, monitor for fluid retention and electrolyte disturbances.
Hepatic adjustment: In severe hepatic impairment (e.g., cirrhosis), prednisolone clearance may be reduced, potentially necessitating a dose reduction. Monitor clinical response and adverse effects closely.
Geriatric: Start at the lower end of the dosing range due to increased susceptibility to adverse effects such as osteoporosis, hyperglycemia, fluid retention, and skin thinning. Close monitoring for side effects is crucial.
Max dose: Highly variable based on indication and duration of therapy; typically, daily doses for most anti-inflammatory/immunosuppressive uses rarely exceed 80-100 mg for extended periods. Short-term pulse therapy may involve higher doses.

Pharmacokinetics

Onset

1-2 hours (oral)

Peak effect

1-2 hours (oral)

Duration

12-36 hours (biological effect)

Half-life

2-4 hours (plasma elimination half-life)

Bioavailability

Approximately 70-90% (oral)

Protein binding

90-95% (to albumin and corticosteroid-binding globulin)

Metabolism

Hepatic, primarily converted to inactive metabolites (e.g., 20-dihydrocortisol) and also undergoes 11-beta-hydroxysteroid dehydrogenase metabolism to prednisone, which is then converted back to prednisolone in the liver. Partially metabolized by CYP3A4.

Excretion

Primarily renal (as inactive metabolites)

Contraindications

Systemic fungal infections
Known hypersensitivity to prednisolone or any component
Administration of live or live-attenuated vaccines in patients receiving immunosuppressive doses
Untreated active infections (relative)
Active peptic ulcer disease (relative)
peptic ulcer
diabetes mellitus
hypertension
viral infections
fungal infections
tuberculosis
other infections
osteoporosis
herpes simplex keratitis
psychosis
epilepsy
congestive heart failure
renal failure

Side effects

Common

Increased appetiteWeight gainFluid retentionHyperglycemiaInsomniaMood changes (nervousness, euphoria)Indigestion/dyspepsiaSkin thinningAcneIncreased blood pressureHeadachefluid retention (with high doses)Hypercorticism (with high doses)

Serious

Adrenal suppression/insufficiency
Cushing's syndrome
Osteoporosis and fractures
Peptic ulceration and gastrointestinal bleeding
Opportunistic infections
Glaucoma
Cataracts
Severe psychiatric disturbances (e.g., psychosis, depression)
Avascular necrosis
Growth retardation in children
Severe allergic reactions
Cardiovascular events (e.g., heart failure exacerbation)
HPA axis suppression (with long-term use)
adrenal insufficiency (upon withdrawal)
fluid and electrolyte abnormalities
hypertension
hyperglycemia
increased susceptibility to infection
peptic ulcers
osteoporosis
myopathy
behavioral disturbances
growth arrest (in children)
fat redistribution
striae
ecchymoses
osteonecrosis
pseudotumor cerebri (upon withdrawal)
posterior subcapsular cataracts
secondary infections
secondary open-angle glaucoma
Adverse effects with long-term systemic steroid therapy
pituitary-adrenal suppression

Pregnancy & lactation

Pregnancy

Category C — placental 11β-HSD2 protects fetus; mostly safe

Lactation

Prednisolone is excreted into breast milk. While generally considered safe at usual therapeutic doses, infants should be monitored for signs of adrenal suppression or growth abnormalities. For high doses, a brief interruption of breastfeeding (e.g., 3-4 hours after the dose) may be considered.