Pedipred

A. Inflammatory and Autoimmune Conditions

• Rheumatoid arthritis (moderate to severe)
• Systemic lupus erythematosus (SLE)
• Psoriatic arthritis
• Ankylosing spondylitis
• Vasculitis syndromes (e.g., giant cell arteritis, polyarteritis nodosa)
• Polymyalgia rheumatica
• Sarcoidosis
• Behçet’s disease

B. Respiratory and Allergic Conditions

• Bronchial asthma (acute exacerbation and maintenance)
• Chronic obstructive pulmonary disease (COPD) exacerbations
• Allergic rhinitis
• Urticaria
• Atopic and contact dermatitis
• Drug hypersensitivity reactions
• Serum sickness
• Anaphylaxis (adjunctive therapy after epinephrine)

C. Gastrointestinal Disorders

• Crohn’s disease (moderate to severe; induction phase)
• Ulcerative colitis (moderate to severe flare-ups)

D. Hematologic Conditions

• Autoimmune hemolytic anemia
• Idiopathic thrombocytopenic purpura (ITP)
• Acquired hypoplastic anemia
• Eosinophilic disorders

E. Renal Disorders

• Nephrotic syndrome (especially minimal change disease)

F. Ophthalmic Disorders

• Uveitis
• Iritis
• Optic neuritis
• Allergic conjunctivitis
• Post-operative ocular inflammation

G. Endocrine Disorders

• Congenital adrenal hyperplasia
• Secondary adrenocortical insufficiency

H. Neurological Disorders

• Acute exacerbation of multiple sclerosis
• Cerebral edema associated with tumors

I. Oncologic Uses

• Acute lymphoblastic leukemia (part of chemotherapy protocols)
• Hodgkin and non-Hodgkin lymphoma
• Multiple myeloma (adjunctive)

J. Transplantation

• Prevention and treatment of transplant rejection (as part of immunosuppressive regimens)

General Considerations:

• Administer orally with food to reduce gastrointestinal side effects.
• Dose must be individualized based on disease severity, patient response, and duration of treatment.
• Taper gradually after prolonged use to prevent adrenal suppression.

Adults:

• Anti-inflammatory/immunosuppressive:
  Initial dose: 5–60 mg/day orally in 1–4 divided doses.
  Maintenance dose: Adjust to the lowest effective dose (commonly 5–15 mg/day).
• Acute asthma/COPD exacerbation:
  40–60 mg/day orally in single or divided doses for 5–10 days.
• Multiple sclerosis relapse:
  200 mg/day orally for 7 days, followed by 80 mg every other day for 1 month.

Pediatrics:

• General use:
  0.14–2 mg/kg/day or 4–60 mg/m²/day, divided into 1–4 doses.
• Nephrotic syndrome:
  2 mg/kg/day in divided doses (maximum: 80 mg/day) for 4–6 weeks, then taper or switch to alternate-day therapy.

Elderly:

• Use the lowest effective dose; monitor for osteoporosis, hypertension, and glucose intolerance.

Renal Impairment:

• No dosage adjustment typically needed, but close monitoring is advised due to fluid retention potential.

Hepatic Impairment:

• May require dose adjustment due to altered metabolism; monitor for signs of steroid excess.

Route of Administration:

• Oral: Tablets, oral solution, or syrup
• Parenteral forms (e.g., prednisolone sodium phosphate) are used when oral route is not feasible

Prednisolone is a synthetic glucocorticoid that mimics cortisol, acting through intracellular glucocorticoid receptors. Upon entering cells, it binds to cytoplasmic receptors, forming a receptor-ligand complex that translocates to the nucleus and modulates gene transcription. This results in the suppression of pro-inflammatory cytokines (e.g., IL-1, IL-6, TNF-α), inhibition of leukocyte migration, and reduced capillary permeability. It also exerts immunosuppressive effects by inhibiting lymphocyte proliferation and reducing eosinophil activity. These combined effects reduce inflammation, autoimmunity, and immune overactivity.

• Absorption: Rapid oral absorption; peak plasma levels within 1–2 hours
• Bioavailability: 80–100% (oral)
• Distribution: Widely distributed; 70–90% protein-bound; crosses placenta and into breast milk
• Metabolism: Hepatic, primarily via CYP3A4
• Half-life: Plasma half-life: 2–4 hours; biological effect: 18–36 hours
• Excretion: Renally excreted as inactive glucuronide and sulfate metabolites

• Pregnancy:
  FDA Category C
  Use only when potential benefit justifies the potential risk. First trimester use may be associated with a small risk of orofacial clefts. Monitor fetal growth and adrenal function with prolonged use.
• Lactation:
  Excreted in small amounts in breast milk. Short-term or low-dose use is generally considered safe. High-dose or long-term therapy may pose risks of infant growth suppression or adrenal insufficiency—monitoring is advised.

• Primary Class: Glucocorticoid (Systemic Corticosteroid)
• Subclass: Intermediate-acting corticosteroid

• Hypersensitivity to prednisolone or its excipients
• Systemic fungal infections
• Administration of live or live-attenuated vaccines during immunosuppressive therapy
• Untreated serious infections (e.g., tuberculosis)
• Ocular herpes simplex (risk of corneal perforation)

• Infection risk: May mask symptoms; use cautiously in patients with latent infections (e.g., TB, herpes)
• Adrenal suppression: Taper gradually after long-term use
• Osteoporosis: Common with chronic use—consider prophylaxis
• Psychiatric effects: May cause insomnia, mood swings, or psychosis
• GI perforation: Increased risk with concurrent NSAID use or in peptic ulcer disease
• Growth suppression: Possible in pediatric patients
• Ophthalmic complications: Monitor for glaucoma or cataracts in long-term users
• Metabolic effects: Hyperglycemia, hypertension, fluid retention

Common:

• Endocrine/Metabolic: Weight gain, hyperglycemia, Cushingoid appearance
• Neuropsychiatric: Insomnia, mood changes, anxiety
• Gastrointestinal: Indigestion, nausea, increased appetite
• Musculoskeletal: Myopathy, osteopenia/osteoporosis
• Dermatologic: Acne, skin thinning, delayed wound healing
• Ophthalmic: Blurred vision, elevated intraocular pressure

Serious/Rare:

• Adrenal insufficiency
• Avascular necrosis (hip, shoulder)
• GI perforation or bleeding
• Severe infections (opportunistic or masked)
• Psychosis or severe depression
• Glaucoma, cataracts
• Hypokalemia, arrhythmias

• Enzyme inducers (e.g., rifampin, phenytoin): ↓ Prednisolone levels (↓ efficacy)
• Enzyme inhibitors (e.g., ketoconazole, clarithromycin): ↑ Prednisolone levels (↑ toxicity)
• NSAIDs: ↑ Risk of GI bleeding or ulceration
• Live vaccines: Risk of vaccine-related infection
• Diuretics (loop/thiazide): ↑ Risk of hypokalemia
• Warfarin: Altered INR; monitor coagulation closely
• Diabetic medications: ↓ Glycemic control; insulin or antidiabetic dose adjustments may be needed

• ACR (American College of Rheumatology) 2023: Recommends minimizing long-term corticosteroid use in RA; emphasize DMARD use for sustained control.
• FDA Updates: Reinforced warnings for adrenal suppression, infection risk, and psychiatric side effects with high-dose or prolonged use.
• Pediatric Care Guidelines: Recommend routine growth monitoring and bone health assessment for children on chronic corticosteroids.

• Oral tablets/syrup: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15–30°C
• Protect from light and moisture
• Oral solution: Shake well before use
• Injectables (e.g., sodium phosphate): Store at 2°C to 8°C (refrigerated); do not freeze
• Keep out of reach of children
• Do not use beyond expiration date