Deltasone 20 mg

Description

Deltasone (Prednisolone) Tablet

Indications
Deltasone is prescribed for the management of various conditions, including:

• 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 linked to cancer.
• Dermatologic Conditions: Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme, exfoliative dermatitis, mycosis fungoides, severe psoriasis.
• Allergic Reactions: Seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug-induced hypersensitivity reactions.
• Respiratory Conditions: Symptomatic sarcoidosis, berylliosis, fulminating and aspiration pneumonitis.
• Hematologic Disorders: Idiopathic thrombocytopenic purpura, secondary thrombocytopenia, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia).
• Edematous Conditions: Used to induce diuresis or remission of proteinuria in nephrotic syndrome (idiopathic type or lupus erythematosus-related), without uremia.
• Gastrointestinal Diseases: Ulcerative colitis, regional enteritis.

Use under the supervision of a registered physician.

Pharmacology
Prednisolone, the active component of Deltasone, is a synthetic adrenocortical hormone primarily exhibiting glucocorticoid activity. It functions by inhibiting the enzyme Phospholipase A2, reducing the production of inflammatory mediators such as leukotrienes, SRS-A, and prostaglandins. Prednisolone is rapidly absorbed through the gastrointestinal tract after oral administration, with 70-90% binding to plasma proteins. It has a plasma half-life of approximately 2 to 4 hours and is primarily metabolized in the liver before being excreted through urine.

Dosage & Administration
Dosage varies based on the condition being treated and patient-specific factors.

• Adults:
  • Nephrotic Syndrome:
    • Initial: 2 mg/kg/day (maximum 80 mg/day) divided into 3 to 4 doses until urine remains protein-free for 3 consecutive days (up to 28 days).
    • Follow-up: 1 to 1.5 mg/kg/dose every other day for 4 weeks.
    • Maintenance: 0.5 to 1 mg/kg/dose every other day for 3 to 6 months.
  • Anti-inflammatory Treatment: 5 to 60 mg per day, divided into 1 to 4 doses.
  • Acute Asthma: 40-60 mg/day in a single or divided dose every 12 hours for 3-10 days.
  • Allergic Conditions:
    • Day 1: 10 mg before breakfast, 5 mg after lunch and dinner, 10 mg at bedtime.
    • Day 2: 5 mg before breakfast, after lunch and dinner, 10 mg at bedtime.
    • Day 3: 5 mg before breakfast, after lunch, dinner, and bedtime.
    • Day 4: 5 mg before breakfast, after lunch, and bedtime.
    • Day 5: 5 mg before breakfast and bedtime.
    • Day 6: 5 mg before breakfast.
• Pediatric:
  • Asthma:
    • 1 year: Acute – 10 mg every 12 hours; Maintenance – 10 mg every other day.
    • 1 to 4 years: Acute – 20 mg every 12 hours; Maintenance – 20 mg every other day.
    • 5 to 12 years: Acute – 30 mg every 12 hours; Maintenance – 30 mg every other day.
    • 12 years and above: Acute – 40 mg every 12 hours; Maintenance – 40 mg every other day.
  • Anti-inflammatory & Immunosuppression: 0.05 to 2 mg/kg/day in 1 to 4 divided doses.

Use under the supervision of a registered physician.

Drug Interactions

• The effectiveness of Deltasone may be reduced when taken with aminoglutethimide, antacids, barbiturates, carbamazepine, griseofulvin, mitotane, phenylbutazone, phenytoin, primidone, or rifampin.
• It may cause potassium loss, increasing the risk of cardiac arrhythmias when used with digitalis.
• Patients on corticosteroids should be cautious with immunizations.

Contraindications

• Systemic infections unless treated with specific anti-infectives.
• Hypersensitivity to any ingredient.
• Ocular herpes simplex due to the risk of corneal perforation.

Side Effects
Common adverse effects include:

• Fluid & Electrolyte Imbalance: Sodium and fluid retention, hypertension, potassium loss, hypokalemic alkalosis, congestive heart failure in at-risk patients.
• Musculoskeletal: Muscle weakness, steroid myopathy, osteoporosis, fractures, aseptic necrosis of bones.
• Gastrointestinal: Peptic ulcers (with possible bleeding or perforation), pancreatitis, esophagitis, abdominal distension.
• Dermatologic: Slow wound healing, thin skin, petechiae, excessive sweating, suppressed skin test reactions.
• Neurological: Headache, dizziness, increased intracranial pressure, convulsions.
• Endocrine: Menstrual irregularities, Cushingoid appearance, growth suppression in children, altered glucose metabolism.
• Ophthalmic: Glaucoma, increased intraocular pressure, cataracts.
• Metabolic: Negative nitrogen balance due to protein breakdown.

Pregnancy & Lactation
Deltasone should only be used in pregnancy if the benefits outweigh the risks. It is excreted in breast milk and may affect infant growth and hormonal balance.

Precautions & Warnings

• Patients on immunosuppressive doses should avoid exposure to measles or chickenpox and seek immediate medical advice if exposed.
• Higher doses may be required in patients under unusual stress (e.g., surgery, trauma, severe illness).
• Long-term use can lead to glaucoma, cataracts, secondary infections, and reduced infection resistance.
• Patients should avoid live vaccinations while on corticosteroid therapy, particularly at high doses.

Use in Special Populations

• Pediatric Use: Growth suppression and increased infection risk should be monitored closely in children on prolonged corticosteroid therapy. Infants exposed to corticosteroids in utero should be observed for adrenal insufficiency.

Overdose Effects
Long-term use of high doses may lead to adverse effects. Management includes symptom-based treatment and gradual dose reduction where possible.

Therapeutic Class
Glucocorticoids

Storage Conditions
Store in a cool, dry place, away from light. Keep out of reach of children.