Composition: Each 5 ml of XILONE Syrup contains: Prednisolone (as sodium phosphate) 5 mg.
Excipients/Inactive Ingredients: Anhydrous Sodium Dihydrogen Phosphate, Disodium Hydrogen Phosphate, Disodium Edetate, Methylparaben, Propylparaben, Sorbitol, Ponceau 4R color, Strawberry Flavour and Purified Water.
Properties: Prednisolone is an adrenocorticoid with both glucocorticoid and mineralocorticoid properties. Its glucocorticoid potency is four times the potency of equal weight of hydrocortisone. Its mineralocorticoid properties are rather weak and are only one half the potency of hydrocortisone.
Action: Prednisolone acts as follows: Controls the rate of protein synthesis.
Depresses the migration of polymorphonuclear leukocytes and fibroblasts.
Reverses capillary permeability.
Causes lysosomal stabilization at the cellular level to prevent or control inflammation.
Pharmacokinetics: Following oral administration of XILONE Syrup, prednisolone is rapidly and well absorbed from the GIT. Peak plasma concentrations are achieved within 1 - 2 hours. About 50% of prednisolone is bound to plasma proteins. Prednisolone is widely distributed into most body fluids and tissues including muscles, liver, skin, intestine and kidney. Prednisolone is extensively metabolized in the liver into sulfate and glucuronide conjugates which are eliminated in urine. Small amounts of prednisolone are eliminated unchanged in urine. Plasma elimination half-life is 2 - 4 hours. Prednisolone crosses the placenta and appears in breast milk.
Corticosteroid-indicated conditions include: Allergic disorders: bronchial asthma and allergic skin reactions.
Blood disorders.
Selected collagen and rheumatic disorders.
Connective tissue disorders.
Gastrointestinal disorders: inflammatory bowel disease.
Disorders responsive to adrenocortical hormone therapy.
Dosage: Generally: Dosage of XILONE Syrup should be individualized according to the severity of the disease and the response of the patient.
Infants and children: the recommended dosage should be governed by the same consideration rather than strict adherence to the ratio indicated by age or body weight.
Dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in chronic conditions, treatment should be discontinued.
Initial dose: varies from 5 ml to 60 ml/day of XILONE Syrup, depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice, while in selected patients, higher initial doses may be required. The elderly may require lower doses.
Adults: 5 - 60 mg daily of XILONE Syrup in divided doses or as a single dose on alternate days.
In long-term therapy: dosage should be maintained at not more than 7 mg whenever possible.
Children: as directed by the physician.
For short treatment: not more than 2 weeks, as it may lead to growth retardation in children.
Accidental ingestion of large doses rarely occurs, however prolonged use and abuse of the drug causes cushingoid changes, moon face, striae, central obesity, hirsutism, acne, ecchymoses, hypertension, osteoporosis, myopathy, sexual dysfunction, diabetes mellitus, hyperlipidemia, peptic ulcer, GI bleeding, increased susceptibility to infection, electrolyte and fluid imbalance and psychosis. Acute treatment of overdoses nesessitates immediate gastric lavage or emesis followed by supportive and symptomatic treatment.
Osteoporosis, active ulcer, psychoses or severe psychoneuroses, systematic fungal infections, acute infections unless effective, specific concurrent chemotherapy can be administered. Patients should not undergo immunisations. Tuberculosis, except as adjunctive treatment with tuberculostatic drugs.
Warning: Observe growth and development of infants and children as they are affected on prolonged therapy of corticosteroids.
The drug may mask signs of infection and the resistance to infections may be diminished.
Observe for possible delayed wound healing.
Precautions: Psychosis, acute glomerulonephritis, amoebiasis, cerebral malaria, children <2 years, elderly, AIDS, tuberculosis, diabetes mellitus, glaucoma, osteoporosis, ulcerative colitis, congestive heart failure, myasthenia gravis, renal disease, esophagitis, ocular herpes simplex, live virus vaccines and hypertension.
Corticosteroids may mask signs of infection and new infections may appear during their use.
XILONE Syrup should be used during pregnancy only if the potential benefits justifies the potential risk to the fetus. Prednisolone is excreted in breast milk, so caution should be exercised when XILONE is administered to nursing women as it may suppress babies growth.
Fluid and Electrolyte Disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss and sodium retention.
CNS: Vertigo, convulsions, headache and psychic disturbances.
Cardiovascular: Hypertension, thrombophlebitis, thrombo-embolism, tachycardia and congestive heart failure.
Ophthalmology: Exophthalmos, glaucoma, increased intraocular pressure, blurred vision and cataracts.
GIT: Peptic ulcer with possible perforation and hemorrhage, ulcerative esophagitis, diarrhea, nausea, abdominal distention, increased appetite, pancreatitis and perforation of the small and large bowel particularly in patients with inflammatory bowel disease.
Metabolism: Negative nitrogen balance due to protein catabolism, growth suppression in children and decreased glucose tolerance.
Musculoskeletal: Fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures, osteoporosis, aseptic necrosis of femoral and humeral heads, muscle weakness and loss of muscle mass.
Skin: Increased sweating, poor wound healing, ecchymosis, bruising, petechiae, striae, thin fragile skin and suppression of skin test reactions.
Endocrine: Decreased carbohydrate tolerance, development of cushingoid state, hirsutism, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness and suppression of growth in children.
Hepatic microsomal enzyme inducers including barbiturates, phenytoin, ephedrine, carbamezepine and rifampin may decrease the corticosteroids effects.
Aspirin, indomethacin and other NSAIDs may increase the risk of GI distress, bleeding and ulcers.
Thiazides and diuretics may increase the risk of hypokalemia due to potassium wasting effect of prednisolone.
The effects of hypoglycemic agents (including insulin) and antihypertensives are antagonized by corticosteroids.
There is a potential for an increased risk of digitalis toxicity associated with hypokalemia when corticosteroids and cardiac glycosides are used concomitantly.
Corticosteroids may alter the response to coumarin.
H02AB06 - prednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Xilone syr 5 mg/5 mL
(fruity flavour) 100 mL x 1's
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