Generic

Prednisolone

Indications

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 a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

Gastrointestinal Diseases: Ulcerative colitis, regional enteritis.

Pharmacology

Prednisolone is a glucocorticoid-like synthetic adrenocortical medication. Prednisolone inhibits the Phospholipase A2 enzyme, which is responsible for the generation of inflammatory mediators such as leukotrienes, SRS-A, and prostaglandins. Following oral ingestion, prednisolone is swiftly and thoroughly absorbed from the Gl tract. Prednisolone is 70-90 percent protein-bound in the plasma and has a half-life of 2 to 4 hours before it is removed. It is primarily processed in the liver and eliminated through the urine.

Dosage and Administration

Adult-

Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-

Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.
• Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.
• Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Interaction

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

Contraindications

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Side Effects

Increased hunger, indigestion, agitation, and restlessness are all common adverse effects. Darkening or lightening of skin color, dizziness or lightheadedness, flushing of the face or cheeks, hiccups, increased sweating, and the impression of spinning is less common or rare adverse effects.

Pregnancy & Lactation

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the fetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Precautions & Warnings

Diabetes, hypertension, psychological disorders, osteoporosis, postmenopausal women, pregnancy, and chronic nephritis all require vigilance. Cushing's syndrome, hyperglycemia, muscle weakness, increased susceptibility to infection, delayed wound healing, and psychological disorders are all possible side effects of long-term Prednisolone use.

Therapeutic Class

Glucocorticoids.

Storage Conditions

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

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.