Prednisolone

Dosage of prednisolone tablets should be individualized depending on the severity of the disease and the response of the patient. For pediatric patients, the standard dosage should be governed by identical considerations instead of strict adherence to the ratio indicated by body weight or age.

Initial Dose:The initial dose of Prednisolone may vary from 10-60 mg (as 13.4-80.6 mg of prednisolone sodium phosphate) daily, depending on the specific disease entity being treated.

Maintenance Dose:Use reduced dosage of Prednisolone that will maintain an apt clinical response. Withdraw gradually in case discontinuing long-term or high-dose therapy.

Prednisolone is packaged in a blister. Do not remove the tablet from the blister until just prior to dosing. Blister pack should then be peeled open, and the disintegrating tablet placed on the tongue, where tablets may be swallowed whole as any conventional tablet, or allowed to dissolve in the mouth, with or without water. Dosage forms of disintegrating tablets are friable and are not intended to be split, cut, or broken. Take with meals to avoid gastrointestinal (GI) irritation.

The most commonly reported side effects due to Prednisolone include: weight gain, alteration in glucose tolerance, fluid retention, elevation in blood pressure, behavioral and mood changes, and increased appetite.

• Corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of calcium and potassium. Dietary salt restriction and potassium supplementation may be required. Use these agents with caution in patients with congestive heart failure, hypertension, or renal insufficiency.
• Gastrointestinal (GI) perforation may occur in patients with certain GI disorders. Signs/symptoms of Gastrointestinal perforation, such as peritoneal irritation, may be masked in patients taking corticosteroids. Use these agents with caution if there is a probability of impending perforation, abscess or other pyogenic infections; fresh intestinal anastomosis; diverticulitis; and active or latent peptic ulcer.
• The prednisolone use may be associated with central nervous system effects ranging from mood swings, euphoria, insomnia, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by this medicine.
• Corticosteroids reduce bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. Give special consideration to patients at increased risk of osteoporosis (e.g., postmenopausal women) prior to initiating corticosteroid therapy and monitor bone density in patients on long term therapy with corticosteroid.
• Use corticosteroids cautiously in patients with ocular herpes simplex because of probable corneal perforation. Do not use Corticosteroids in active ocular herpes simplex.
• Do not prescribe live or live attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be used; however, the response to such vaccines cannot be predicted.
• Throughout the therapy with corticosteroid, avoid vaccinating patients against smallpox. Do not undertake other immunization procedures in patients who are on corticosteroids, mainly on high dose, due to possible hazards of neurological complications and a lack of antibody response.
• Long-term use of prednisolone 10 mg can have negative effects on growth and development in children. Growth and development of pediatric patients on prolonged prednisolone therapy need to be carefully monitored.
• Prednisolone can cause fetal harm if used by a pregnant woman. Studies suggest that use of this medication during the 1’st trimester of pregnancy is associated with an increased risk of orofacial clefts, intrauterine growth restriction and decreased birth weight.

Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). Protect from the moisture. Avoid breaking or using partial Prednisolone tablets. Keep out of the access of children.

• Co-administration of corticosteroids and anticoagulant agents may enhance or diminish anticoagulant effects. Monitor coagulation indices.
• Co-administration of corticosteroids and antidiabetic agents may increase blood glucose concentrations. Dose adjustments of antidiabetic agents may be required.
• Concomitant use of corticosteroids and CYP3A4 inducers and inhibitors may, respectively, increase or decrease clearance of corticosteroids, necessitating dose adjustment.
• Cyclosporine may increase in activity of both, cyclosporine and corticosteroid when used concurrently. Convulsions have been seen with concurrent use.
• Co-administration of corticosteroids and NSAIDS including aspirin and salicylates may increase the risk of gastrointestinal side effects.