Predsol Syrup
Predsol Forte Syrup
Steroidal anti-inflammatory Sugar Free with Strawberry Flavour
Composition:
Predsol syrup:
Each 5 ml syrup contains:
Prednisolone sodium phosphate 6.7 mg.
(equivalent to 5 mg prednisolone base)
Predsol Forte syrup:
Each 5 ml syrup contains:
Prednisolone sodium phosphate 20.1 mg.
(equlv31ent to 15 mg prednisolone base)
Properties:
– Prednisolone sodium phosphate is synthetic adrenocortical steroid derivative with predominantly glucocorticoidal properties, possessing anti-inflammatory and immunosuppressive actions. It is well absorbed from the GIT following oral administration with a 20% higher peak plasma level at an earlier time than prednisolone
tablet.
– The administration of prednisolone sodium phosphate in a sugar free syrup with taste enhanced characteristics allows for proper dosage adjustment and better patients acceptability.
Indications:
– Bronchial asthma, allergic rhinitis, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.
– Pemphigus, exfoliative dermatitis, generalized eczema, urticaria, pruritus.
– Idiopathic thrombocytopenic purpura, secondary thrombocytopenia, autoimmune hemolytic anemia.
– Acute leukemia and aggressive lymphomas in adults and children.
– Idiopathic nephrotic syndrome without uremia.
– rheumatoid arthritis and other rheumatic affections, gouty arthritis psoriasis arthropathic, spondylitis, bursitis,tenosynovitis ,epicondylitis, polymylagia rheumatic, sjogrens syndrorne, polychondritis, systemic lupus erythematosus and certain types of vasculitis.
– acute exacerbations of multiple sclerosis.
– ulcerative colitis
Dosage and administration:
– Dosages of the products must be individualized and are variable depending on the nature and severity of the disease, and on patient’s response.lftherapy is continuous for more than 2 weeks, withdrawal must be gradual.
Adults: 5 – 60 mg/ day as a single dose or in 3 or 4 divided doses.
Children: 0.14 – 2 mglkg/day, given in 3 or 4 divided doses.
– The defined product should be administrated with meals.
Side effects:
– Sodium retention and potassium loss occur only very rarely.
– Symptoms of hypercorticoidism only occur after prolonged
therapy with high doses. Milder phenomena of autonomic unbalance which occurs occaslonaliy does not -as a rule- require special measures.
Warnings and precautions:
– Used cautiously in patients with glaucoma, osteoporosis,
hypertension, congestive heart failure and renal insufficiency.
– Avoid exposure to chicken pox or measles during treatment. If exposure occurs, prophylactic measures should be taken.
– Changes in the thyroid status of the patients may necessitate dosage adjustment.
Pregnancy and lactation:
– Pregnant women should take this drug under strict medical
supervision.
– Breast feeding should be avoided during therapy by the product.
Contraindications:
Glucocorticoids are contraindicated in the presence of the following cases:
– Peptic ulcer.
– Patients suffering from infectious diseases specially tuberculosis should take an effective antituberculous.
-In patients with systemic fungal infections.
– Cerebral malaria.
– Vaccination by live or attenuated vaccines.
Drug interactions:
– Increasing the maintenance dose of glucocorticoids is recommended upon concomitant administration of the following drugs: Anticonvulsants, rifampin and bronchodilators.
– Reduction in the glucOCorticoid dose is recommended upon concomitant administration of the following drugs: Erythromycin, ketoconazole, estrogens or preparations containing estrogens.
– Co-administration with digitalis glycosides may enhance the
possibility of digitalis toxicity associated with hypokalemia.
– Co-administration with NSAIDs may increase the risk of
gastrointestinal ulceration.
– Co-administration with warfarin or heparin may result in the inhibition of the ponse to anticoagulants, therefore coagulation indices should be monitored.
– Adjustment of antidiabetic agents is required due to the increase in blood glucose level.
Storage and Presentation:
– Predsol Syrup: a bottle contains 50 ml syrup, and insert leaflet.
– Predsol Forte Syrup: a bottle contains 60 or 100 ml syrup, and insert leaflet.
– Store protected from light at a temperature not exceeding 25′(,
– To be used only under physician’s supervision.
produced by :
BORG pharmacutical ind
بريدسول فورت مضاد استيرويدى للالتهابات لعلاج الربو الشعبى والحساسية الصدرية والالتهابات الروماتيزمية
