ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis HypertensionMusculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bonesGastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitisDermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Facial erythema Increased sweating May suppress reactions to skin testsNeurological Convulsions Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment Vertigo HeadacheEndocrine Menstrual irregularities Development of Cushingoid state Suppression of growth in pediatric patients 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 diabeticsOphthalmic Posterior subcapsular cataracts Increased intraocular pressure Glaucoma ExophthalmosMetabolicNegative nitrogen balance due to protein catabolismTo report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Dosage of prednisolone oral solution should be individualized according to the severity of the disease and the response of the patient. For infants and children, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.Hormone therapy is an adjunct to and not replacement for conventional therapy. Dosage should be decreased or discontinued gradually when the drug has been administered for more than few days.The severity, prognosis, expected duration of the disease, and the reaction of the patient to medication are primary factors in determining dosage. If period of spontaneous remission occurs in chronic condition, treatment should be discontinued.Blood pressure, body weight, routine laboratory studies, including two-hour postprandial blood glucose and serum potassium, and chest X-ray should be obtained at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with known or suspected peptic ulcer disease.The initial dosage of prednisolone oral solution may vary from mg to 60 mg per day 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 initial dosage should be maintained or adjusted until satisfactory response is noted. If after reasonable period of time there is lack of satisfactory clinical response, prednisolone oral solution should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patients individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of prednisolone oral solution for period of time consistent with the patients condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

GENERAL PRECAUTIONS SECTION.

General:. Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or mineralocorticoid should be administered concurrently.There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. Steroids should be used with caution in nonspecific ulcerative colitis if there is probability of impending perforation, abscess or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Prednisolone Oral Solution USP is indicated in the following conditions:1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable: in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Acute rheumatic carditis4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and Iridocyclitis7. Respiratory Disorders Symptomatic sarcoidosis Loefflers syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy Aspiration pneumonitis8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood10. Edematous States To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.11. Gastrointestinal Diseases To tide the patient over critical period of the disease in: Ulcerative colitis Regional enteritis12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.In addition to the above indications, Prednisolone Oral Solution USP is indicated for systemic dermatomyositis (polymyositis).

PRECAUTIONS SECTION.

PRECAUTIONS. General:. Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or mineralocorticoid should be administered concurrently.There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. Steroids should be used with caution in nonspecific ulcerative colitis if there is probability of impending perforation, abscess or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.. Information for Patients:. 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.

WARNINGS SECTION.

WARNINGS. In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Immunosuppression and Increased Risk of InfectionCorticosteroids, including Prednisolone Oral Solution USP, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can:Reduce resistance to new infectionsExacerbate existing infectionsIncrease the risk of disseminated infectionsIncrease the risk of reactivation or exacerbation of latent infectionsMask some signs of infectionCorticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider Prednisolone Oral Solution USP withdrawal or dosage reduction as needed. Do not administer Prednisolone Oral Solution USP by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection.TuberculosisPrednisolone Oral Solution USP is used to treat condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for reactivation. During prolonged Prednisolone Oral Solution USP therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis. Varicella Zoster and Measles Viral InfectionsVaricella and measles can have serious or even fatal course in non-immune patients taking corticosteroids, including Prednisolone Oral Solution USP. In corticosteroids-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles:If Prednisolone Oral Solution USP-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If Prednisolone Oral Solution USP-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated. Hepatitis Virus ReactivationHepatitis Virus reactivation can occur in patients who are hepatitis carriers treated with immunosuppressive dosages of corticosteroids, including Prednisolone Oral Solution USP. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis infection. Screen patients for hepatitis infection before initiating immunosuppressive (e.g., prolonged) treatment with Prednisolone Oral Solution USP. For patients who show evidence of hepatitis infection, recommend consultation with physicians with expertise in managing hepatitis regarding and consideration for hepatitis antiviral therapy. Fungal InfectionsCorticosteroids, including Prednisolone Oral Solution USP, may exacerbate systemic fungal infections; therefore, avoid Prednisolone Oral Solution USP use in the presence of such infections unless Prednisolone Oral Solution USP is needed to control drug reactions. For patients on chronic Prednisolone Oral Solution USP therapy who develop systemic fungal infections, Prednisolone Oral Solution USP withdrawal or dosage reduction is recommended. AmebiasisCorticosteroids, including Prednisolone Oral Solution USP, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating Prednisolone Oral Solution USP in patients who have spent time in the tropics or patients with unexplained diarrhea.Strongyloides InfestationCorticosteroids, including Prednisolone Oral Solution USP, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Cerebral MalariaAvoid corticosteroids, including Prednisolone Oral Solution USP, in patients with cerebral malaria.Kaposis SarcomaKaposis sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposis sarcoma.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. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.While on corticosteroid therapy, patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and lack of antibody response.Use in Pregnancy: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.. Reduce resistance to new infections. Exacerbate existing infections. Increase the risk of disseminated infections. Increase the risk of reactivation or exacerbation of latent infections. Mask some signs of infection. If Prednisolone Oral Solution USP-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If Prednisolone Oral Solution USP-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.