For the control of
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Important Safety Information
INDICATIONS: Prednisolone sodium phosphate oral solution (25 mg prednisolone base per 5 mL) is a corticosteroid indicated in the following conditions:
- Rheumatic Disorders: As adjunctive therapy for short term administration in psoriatic arthritis; rheumatoid arthritis (including juvenile rheumatoid arthritis – low dose maintenance may be required in some cases); ankylosing spondylitis; acute and subacute bursitis; acute non-specific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjögren’s syndrome, relapsing polychondritis, and certain cases of vasculitis.
- Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric patients with seasonal or perennial rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.
For a complete list of indications, please see full Prescribing Information.
CONTRAINDICATIONS: Prednisolone sodium phosphate oral solution is contraindicated in patients:
- With systemic fungal infections
- With known hypersensitivity to prednisolone or any components of the formulation
WARNINGS AND PRECAUTIONS:
- General: In patients subjected to unusual stress, increase dose of rapidly acting corticosteroids before, during, and after the stressful situation. The lowest possible dose should be used to control the condition under treatment. Patients with hypothyroidism or cirrhosis may experience enhanced effect. Kaposi’s sarcoma has been reported, most commonly with chronic use.
- Cardio-renal: Average and large doses can increase blood pressure, salt and water retention, and potassium excretion; these effects are less likely with synthetic derivatives. Dietary salt restriction and potassium supplementation may be required. Calcium excretion may increase. Use with caution in patients with hypertension, congestive heart failure, or renal insufficiency.
- Endocrine: Can cause hypothalamic-pituitary-adrenal (HPA) axis suppression, with the potential for glucocorticosteroid insufficiency after withdrawal. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients; change in thyroid status may require dose adjustment. Drug-induced adrenocortical insufficiency may be minimized by gradual dose reduction.
- Infections (General): May decrease resistance and ability to localize infection and mask some signs of infection. Mild to severe infection with any pathogen, in any location of the body, may be associated with corticosteroids alone, or in combination with other immunosuppressive agents. The rate of infectious complications increases with increasing doses of corticosteroids.
- Infections (Viral): Chicken pox and measles can have a more serious or even fatal outcome. Particular care should be taken to avoid exposure in patients who have not had these diseases. If exposed, prophylaxis may be indicated.
- Neuro-psychiatric: High doses may be effective in speeding the resolution of acute exacerbations of multiple sclerosis, but do not impact outcomes or natural history of the disease. Acute myopathy has been observed with high doses of corticosteroids, most often in patients with disorders of neuromuscular transmission or in those receiving neuromuscular blocking drugs. Behavioral and mood disturbances including euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis may appear. Existing conditions may be exacerbated.
- Ophthalmic: Ophthalmic effects include cataracts, secondary ocular infections, and glaucoma with possible damage to the optic nerves. Monitor intraocular pressure if used for more than 6 weeks. Not recommended for the treatment of optic neuritis or active ocular herpes simplex.
- Special pathogens: Latent disease may be activated or there may be exacerbation of intercurrent infections due to pathogens including Candida, Mycobacterium, Ameba, Toxoplasma, Pneumocystis, Cryptococcus, Nocardia, etc. Use with caution in patients with known or suspected Strongyloides (threadworm) infestation. Should not be used in cerebral malaria. Use in active tuberculosis (TB) should be restricted to cases in which an appropriate antituberculous regimen is used. Close observation is necessary for use in latent TB or tuberculin reactivity.
- Vaccination: Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered, however the response to such vaccines cannot be predicted. Immunization may be undertaken in patients receiving corticosteroids as replacement therapy.
- Gastrointestinal: Use with caution in non-specific ulcerative colitis, if there is probability of impending perforation, abscess, or pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer. May mask signs and symptoms of GI perforation.
- Musculoskeletal: Can decrease bone formation and increase bone resorption. May lead to inhibition of bone growth in children and adolescents and the development of osteoporosis at any age. Special consideration should be given to patients at increased risk of osteoporosis before initiating therapy.
- Pregnancy: In animal studies, prednisolone has been shown to cause fetal harm. Prednisolone should only be used during pregnancy if the potential benefit justifies potential risk to the fetus.
- Pediatric Use: The efficacy and safety of prednisolone in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month of age). However, some of these conclusions and other indications for pediatric use of corticosteroid, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. See full Prescribing Information for additional Pediatric Use and other Precautions. The adverse effects of prednisolone in pediatric patients are similar to those in adults.
ADVERSE REACTIONS: Adverse reactions associated with corticosteroids include the following: cardiovascular (hypertrophic cardiomyopathy in premature infants); dermatologic (facial erythema, increased sweating, may suppress reactions to skin tests, ecchymoses and petechiae, thin fragile skin, urticaria, edema); endocrine (decreased carbohydrate tolerance, development of cushingoid state, hirsutism, increased requirements for insulin or oral hypoglycemic agents in diabetic patients, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, suppression of growth in children); fluid and electrolyte disturbances (congestive heart failure in susceptible patients, fluid retention, hypertension, hypokalemic alkalosis, potassium loss, sodium retention); gastrointestinal (abdominal distension, reversible elevation in liver enzymes, peptic ulcer with possible perforation and hemorrhage, pancreatitis, ulcerative esophagitis); metabolic (negative nitrogen balance due to protein catabolism); musculoskeletal (aseptic necrosis of femoral and humeral heads, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures); neurological (convulsions, headache, pseudotumor cerebri usually following discontinuation of therapy, psychic disorders, vertigo); ophthalmic (exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts); other (increased appetite; malaise, nausea, weight gain). The adverse effects of prednisolone in pediatric patients are similar to those in adults.