Predimax 20 mg

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. ... Read morePrednisolone 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 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 synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

DOSAGE & 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.

SIDE EFFECTS

Fluid and Electrolyte Disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension.Musculoskeletal: Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones.Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, ulcerative esophagitis.Dermatologic: lmpaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, may suppress reactions to skin tests.Neurological: Convulsions, increased intracranial pressure with papilledema (cerebral pseudo-tumor) usually after treatment, vertigo, headache.Endocrine: Menstrual irregularities, development of Cushingoid state, suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress as in trauma surgery or illness, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics.Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.Metabolic: Negative nitrogen balance due to protein catabolism.

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 foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

PRECAUTIONS & WARNINGS

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.ln patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.While on corticosteroid therapy, patient should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, specially on high dose, because of possible hazards of neurological complications and a lack antibody response.Children who are on drugs, which suppress the immune system, are more susceptible to infections than healthy children.Chickenpox and measles, for example, can have more serious or even fatal course in non-immune children or adults on corticosteroids.

USE IN SPECIAL POPULATIONS

Pediatric use: ln the treatment of endocrine disorders such as primary and secondary adrenocortical insufficiency in infancy, mineralocorticoid supplementation is of particular importance. lnfants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. lmmunization procedures should not be undertaken in patients who are on corticosteroids. Pediatric patients who are on drugs which suppress the immune system are more susceptible to infections than healthy pediatric patients. Chickenpox and measles, for example, can have more serious or even fatal course in non-immune patients on corticosteroids. Growth and development in pediatric population on prolonged corticosteroid therapy should be carefully observed. See contraindications and warnings for complete information.

THERAPEUTIC CLASS

Glucocorticoids

STORAGE CONDITIONS

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