Prednisolone Oral Solution - (5mg/5ml)

Presentation: Each 5 ml contains Prednisolone

Indications: Prednisolone is indicated in:

• Rheumatic Disorders: Psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis.
• Endocrine Disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer.
• Dermatologic Diseases: Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme, exfoliative dermatitis, mycosis fungoides, severe psoriasis.
• Allergic States: Seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.
• Respiratory Diseases: Symptomatic sarcoidosis, berylliosis, fulminating, aspiration pneumonitis.
• Hematologic Disorders: Idiopathic thrombocytopenic purpura, secondary thrombocytopenia, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia).
• Edematous States: To induce diuresis or remission of proteinuria in nephrotic syndrome without uremia (idiopathic or due to lupus erythematosus).
• Gastrointestinal Diseases: Ulcerative colitis, regional enteritis. 

Pharmacology:Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. It inhibits Phospholipase A2, reducing the production of inflammatory mediators like Leukotrienes, SRS-A, and Prostaglandins. Prednisolone is rapidly and well absorbed orally, 70-90% protein-bound in plasma, with a half-life of 2-4 hours. It is mainly metabolized in the liver and excreted in urine.  

Dosage & Administration:

• Adults: Dosage varies widely depending on the condition. Examples include:
  • Nephrotic Syndrome: Initial 2 mg/kg/day (max 80 mg/day) in divided doses until urine is protein-free for 3 days (max 28 days), followed by alternate-day therapy.
  • Anti-inflammatory: 5 to 60 mg per day in divided doses.
  • Acute Asthma: 40-60 mg/day orally in single or divided doses for 3-10 days.
  • Allergic Conditions: Specific tapering dosage schedules are provided.
• Pediatric: Dosage is weight-based and varies by condition. Examples include:
  • Asthma: Specific acute and maintenance doses based on age.
  • Anti-inflammatory/Immunosuppression: 0.05 to 2 mg/kg/day in divided doses. Always follow a registered physician's advice for dosage and administration.

Interaction: Efficacy may be reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone, and Rifampin. Prednisolone can reduce blood potassium levels, potentially leading to cardiac arrhythmias with Digitalis. Exercise caution with immunization.

Contraindications: Systemic infections (unless specific anti-infective therapy is used), hypersensitivity to any ingredient, ocular herpes simplex (risk of perforation).

Side Effects: Fluid and electrolyte disturbances, musculoskeletal weakness and osteoporosis, gastrointestinal issues (peptic ulcer, pancreatitis), dermatologic changes (impaired healing, thin skin), neurological effects (convulsions, headache), endocrine effects (menstrual irregularities, Cushingoid state, growth suppression in children), ophthalmic issues (cataracts, glaucoma), metabolic effects (negative nitrogen balance).

Pregnancy & Lactation: Not recommended during pregnancy unless essential and benefits outweigh risks to the fetus. Corticosteroids appear in breast milk and may cause adverse effects in nursing infants.

Precautions & Warnings: Avoid exposure to chickenpox or measles if on immunosuppressant doses. Seek immediate medical advice if exposed. Increased corticosteroid dosage may be needed during stress. May mask signs of infection and increase susceptibility to new infections. Prolonged use may cause ocular complications. Can elevate blood pressure, cause salt and water retention, and increase potassium excretion (with hydrocortisone or cortisone). Avoid smallpox vaccination and other immunizations while on corticosteroids, especially high doses. Children on immunosuppressants are more susceptible to infections. Monitor growth in children on prolonged therapy.

Use in Special Populations: Pediatric use requires careful consideration, especially for endocrine disorders where mineralocorticoid supplementation may be needed. Observe infants of mothers who received substantial doses during pregnancy for hypoadrenalism. Avoid immunizations. Monitor growth and development during prolonged therapy.

Overdose Effects: Adverse effects usually occur with prolonged use of excessive doses. Treatment is symptomatic, and gradual dose reduction is recommended.

Therapeutic Class: Glucocorticoids

Storage Conditions: Store in a cool and dry place, protected from light. Keep out of the reach of children.

Important Note: This information is for general knowledge and informational purposes only and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.