Nosco_pspp06a-co1rev008120_p1_proof a.pdf

PREDNISOLONE SODIUM PHOSPHATE
Prednisolone sodium phosphate oral solution pneumonias; fulminating or disseminated pulmonary disseminated infection is not known. The contribution Endocrine: Drug-induced secondary adrenocortical
ORAL SOLUTION (25 mg prednisolone base
(25 mg prednisolone per 5 mL) produces a 14% tuberculosis when used concurrently with appropriate of the underlying disease and/or prior corticosteroid insuf iciency may be minimized by gradual reduction higher peak plasma level of prednisolone which antituberculous chemotherapy; asthma (as distinct treatment to the risk is also not known. If exposed of dosage. This type of relative insuf iciency may occurs 20% faster than that seen with tablets. Pred- from al ergic asthma listed above under “Al ergic to chicken pox, prophylaxis with varicel a zoster persist for months after discontinuation of therapy; nisolone is 70-90% protein-bound in the plasma, States”), hypersensitivity pneumonitis, idiopathic immune globulin (VZIG) may be indicated. If exposed therefore, in any situation of stress occurring during DESCRIPTION
and it is eliminated from the plasma with a half-life pulmonary fibrosis, acute exacerbations of chronic to measles, prophylaxis with immunoglobulin (IG) that period, hormone therapy should be reinstituted.
Prednisolone sodium phosphate oral solution (25 of 2 to 4 hours. It is metabolized mainly in the liver obstructive pulmonary disease (COPD), and Pneu- may be indicated. (See the respective package inserts Since mineralocorticoid secretion may be impaired, mg prednisolone per 5 mL) is a dye free, pale to and excreted in the urine as sulfate and glucuronide mocystis carini pneumonia (PCP) associated with for complete VZIG and IG prescribing information). If salt and/or a mineralocorticoid should be adminis- light yel ow solution. Each 5 mL (teaspoonful) hypoxemia occurring in an HIV (+) individual who chicken pox develops, treatment with antiviral agents of prednisolone sodium phosphate oral solution The systemic availability, metabolism and elimina- is also under treatment with appropriate anti-PCP Gastrointestinal: Steroids should be used with
contains 33.6 mg prednisolone sodium phosphate tion of prednisolone after administration of single antibiotics. Studies support the ef icacy of systemic Ophthalmic: Use of corticosteroids may produce
caution in nonspecific ulcerative colitis, if there is (25 mg prednisolone base) in a palatable, aqueous weight-based doses (0.8 mg/kg) of intravenous (IV) corticosteroids for the treatment of these conditions: posterior subcapsular cataracts, glaucoma with pos- a probability of impending perforation, abscess or prednisolone and oral prednisone were reported in al ergic bronchopulmonary aspergil osis, idiopathic sible damage to the optic nerves, and may enhance other pyogenic infection; diverticulitis; fresh intestinal Prednisolone sodium phosphate oral solution a smal study of 19 young (23 to 34 years) and 12 bronchiolitis obliterans with organizing pneumonia.
the establishment of secondary ocular infections anastomoses; active or latent peptic ulcer.
(25 mg prednisolone per 5 mL) also contains anti- elderly (65 to 89 years) subjects. Results showed 11. Rheumatic Disorders
due to bacteria, fungi or viruses. The use of oral Signs of peritoneal irritation fol owing gastrointestinal bit er mask, corn syrup, edetate disodium, glycerin, that the systemic availability of total and unbound As adjunctive therapy for short term administration (to corticosteroids is not recommended in the treatment perforation in patients receiving corticosteroids may grape flavor, hydroxyethylcel ulose, methylparaben, prednisolone, as wel as interconversion between tide the patient over an acute episode or exacerbation) of optic neuritis and may lead to an increase in the potassium phosphate dibasic, potassium phosphate prednisolone and prednisone were independent of in: psoriatic arthritis; rheumatoid arthritis, including risk of new episodes. Corticosteroids should not be monobasic, purified water, and sodium saccharin.
Musculoskeletal: Corticosteroids decrease bone
age. The mean unbound fraction of prednisolone juvenile rheumatoid arthritis (selected cases may used in active ocular herpes simplex.
formation and increase bone resorption both through Prednisolone sodium phosphate occurs as white was higher, and steady-state volume of distribution require low dose maintenance therapy); ankylosing Special pathogens: Latent disease may be acti-
their ef ect on calcium regulation (i.e., decreasing or slightly yel ow, friable granules or powder. It (Vss) of unbound prednisolone was reduced in spondylitis; acute and subacute bursitis; acute vated or there may be an exacerbation of intercurrent absorption and increasing excretion) and inhibition is freely soluble in water; soluble in methanol; elderly patients. Plasma prednisolone concentra- nonspecific tenosynovitis; acute gouty arthritis; infections due to pathogens, including those caused of osteoblast function. This, together with a decrease slightly soluble in alcohol and in chloroform; and tions were higher in elderly subjects, and the higher epicondylitis. For the treatment of systemic lupus by Candida, Mycobacterium, Ameba, Toxoplasma, in the protein matrix of the bone secondary to an very slightly soluble in acetone and in dioxane. The AUCs of total and unbound prednisolone were most erythematosus, dermatomyositis (polymyositis), poly- Pneumocystis, Cryptococcus, Nocardia, etc.
increase in protein catabolism, and reduced sex chemical name of prednisolone sodium phosphate likely reflective of an impaired metabolic clearance, myalgia rheumatica, Sjogren’s syndrome, relapsing Corticosteroids may activate latent amebiasis. There- hormone production, may lead to inhibition of is pregna-1,4-diene-3,20- dione,11,17-dihydroxy- evidenced by reduced fractional urinary clearance of polychondritis, and certain cases of vasculitis.
fore, it is recommended that latent or active amebiasis bone growth in children and adolescents and the 21-(phosphonooxy)- disodium salt, (11ß)-. The 6ß -hydroxyprednisolone. Despite these findings of 12. Miscellaneous
be ruled out before initiating corticosteroid therapy in development of osteoporosis at any age. Special empirical formula is C H Na O P; the molecular higher total and unbound prednisolone concentra- any patient who has spent time in the tropics or in any consideration should be given to patients at increased weight is 484.39. Its chemical structure is: tions, elderly subjects had higher AUCs of cortisol, Tuberculous meningitis with subarachnoid block or risk of osteoporosis (i.e., post-menopausal women) suggesting that the elderly population is less sensitive impending block, tuberculosis with enlarged medi- before initiating corticosteroid therapy.
to suppression of endogenous cortisol or their capac- astinal lymph nodes causing respiratory dif iculty, Similarly, corticosteroids should be used with great ity for hepatic inactivation of cortisol is diminished.
and tuberculosis with pleural or pericardial ef usion care in patients with known or suspected Strongy- Neuro-psychiatric: Although control ed clinical
(appropriate antituberculous chemotherapy must be loides (threadworm) infestation. In such patients, trials have shown corticosteroids to be ef ective in INDICATIONS AND USAGE
used concurrently when treating any tuberculosis corticosteroid-induced immunosuppression may lead speeding the resolution of acute exacerbations of Prednisolone sodium phosphate oral solution (25 mg complications); trichinosis with neurologic or to Strongyloides hyperinfection and dissemination multiple sclerosis, they do not show that they affect prednisolone per 5 mL) is indicated in the fol owing myocardial involvement; acute or chronic solid organ with widespread larval migration, often accompanied the ultimate outcome or natural history of the disease.
rejection (with or without other agents).
by severe enterocolitis and potentially fatal gram- The studies do show that relatively high doses of cor- 1. Allergic States
CONTRAINDICATIONS
ticosteroids are necessary to demonstrate a significant Control of severe or incapacitating al ergic conditions Corticosteroids should not be used in cerebral intractable to adequate trials of conventional treatment An acute myopathy has been observed with the use of Hypersensitivity to the drug or any of its components.
in adult and pediatric populations with: seasonal or high doses of corticosteroids, most often occurring in CLINICAL PHARMACOLOGY
Tuberculosis: The use of prednisolone in active
perennial al ergic rhinitis; asthma; contact dermatitis; WARNINGS
tuberculosis should be restricted to those cases of patients with disorders of neuromuscular transmis- Naturally occurring glucocorticoids (hydrocorti- atopic dermatitis; serum sickness; drug hypersensitiv- General: In patients on corticosteroid therapy
fulminating or disseminated tuberculosis in which sion (e.g., myasthenia gravis), or in patients receiving sone), which also have salt-retaining properties, subjected to unusual stress, increased dosage of the corticosteroid is used for the management of the concomitant therapy with neuromuscular blocking are used as replacement therapy in adrenocortical 2. Dermatologic Diseases
rapidly acting corticosteroids before, during and after disease in conjunction with an appropriate antituber- drugs (e.g., pancuronium). This acute myopathy deficiency states. Their synthetic analogs are the stressful situation is indicated.
is generalized, may involve ocular and respiratory primarily used for their potent anti-inflammatory Pemphigus; bullous dermatitis herpetiformis; severe Cardio-renal: Average and large doses of hydro-
muscles, and may result in quadriparesis. Elevation ef ects in disorders of many organ systems.
erythema multiforme (Stevens-Johnson syndrome); If corticosteroids are indicated in patients with latent of creatinine kinase may occur. Clinical improvement exfoliative erythroderma; mycosis fungoides.
cortisone or cortisone can cause elevation of blood tuberculosis or tuberculin reactivity, close observation Prednisolone is a synthetic adrenocortical steroid pressure, salt and water retention, and increased or recovery after stopping corticosteroids may require is necessary as reactivation of the disease may drug with predominantly glucocorticoid properties.
3. Edematous States
excretion of potassium. These effects are less likely occur. During prolonged corticosteroid therapy, these Some of these properties reproduce the physiologi- To induce diuresis or remission of proteinuria in to occur with the synthetic derivatives except when patients should receive chemoprophylaxis.
Psychic derangements may appear when cortico- cal actions of endogenous glucocorticosteroids, nephrotic syndrome in adults with lupus erythema- used in large doses. Dietary salt restriction and steroids are used, ranging from euphoria, insomnia, but others do not necessarily reflect any of the tosus and in adults and pediatric populations, with Vaccination: Administration of live or live,
potassium supplementation may be necessary. Al mood swings, personality changes, and severe adrenal hormones’ normal functions; they are idiopathic nephritic syndrome, without uremia.
attenuated vaccines is contraindicated in pa-
corticosteroids increase calcium excretion.
depression, to frank psychotic manifestations. Also, seen only after administration of large therapeutic tients receiving immunosuppressive doses of
4. Endocrine Disorders
Endocrine: Corticosteroids can produce reversible
existing emotional instability or psychotic tendencies doses of the drug. The pharmacological ef ects of corticosteroids. Killed or inactivated vaccines
Primary or secondary adrenocortical insuf iciency hypothalamic-pituitary adrenal (HPA) axis sup- may be aggravated by corticosteroids.
prednisolone which are due to its glucocorticoid may be administered, however, the response
(hydrocortisone or cortisone is the first choice; pression with the potential for glucocorticosteroid Ophthalmic: Intraocular pressure may become
properties include: promotion of gluconeogenesis; to such vaccines cannot be predicted. Immuni-
synthetic analogs may be used in conjunction with insufficiency after withdrawal of treatment.
elevated in some individuals. If steroid therapy is increased deposition of glycogen in the liver; zation procedures may be undertaken in patients who mineralocorticoids where applicable; in infancy continued for more than 6 weeks, intraocular pressure inhibition of the utilization of glucose; anti-insulin Metabolic clearance of corticosteroids is decreased are receiving corticosteroids as replacement therapy, mineralocorticoid supplementation is of particular activity; increased catabolism of protein; increased in hypothyroid patients and increased in hyperthyroid importance); congenital adrenal hyperplasia; lipolysis; stimulation of fat synthesis and storage; patients. Changes in thyroid status of the patient may PRECAUTIONS
Information for Patients: Patients should be
hypercalcemia associated with cancer; nonsuppura- increased glomerular filtration rate and resulting warned not to discontinue the use of prednisolone General: The lowest possible dose of corticosteroid
increase in urinary excretion of urate (creatinine Infections (General): Persons who are on drugs
sodium phosphate oral solution (25 mg prednisolone should be used to control the condition under treat- excretion remains unchanged); and increased 5. Gastrointestinal Diseases
which suppress the immune system are more suscep- per 5 mL) abruptly or without medical supervision, ment, and when reduction in dosage is possible, the To tide the patient over a critical period of the disease tible to infections than healthy individuals. There may to advise any medical at endants that they are taking it, and to seek medical advice at once should they Depressed production of eosinophils and lympho- in: ulcerative colitis; regional enteritis.
be decreased resistance and inability to localize infec- Since complications of treatment with glucocorticoids develop fever or other signs of infection.
cytes occurs, but erythropoiesis and production 6. Hematologic Disorders
tion when corticosteroids are used. Infection with any are dependent on the size of the dose and the duration of polymorphonuclear leukocytes are stimulated.
pathogen including viral, bacterial, fungal, protozoan Persons who are on immunosuppressant doses of Idiopathic thrombocytopenic purpura in adults; of treatment, a risk/benefit decision must be made in Inflammatory processes (edema, fibrin deposition, or helminthic infection, in any location of the body, corticosteroids should be warned to avoid exposure selected cases of secondary thrombocytopenia; each individual case as to dose and duration of treat- capil ary dilatation, migration of leukocytes and may be associated with the use of corticosteroids to chicken pox or measles. Patients should also acquired (autoimmune) hemolytic anemia; pure red ment and as to whether daily or intermit ent therapy phagocytosis) and the later stages of wound healing alone or in combination with other immunosuppres- be advised that if they are exposed, medical advice cel aplasia; Diamond-Blackfan anemia.
(capil ary proliferation, deposition of col agen, sive agents that af ect humoral or cel ular immunity, or 7. Neoplastic Diseases
There is an enhanced ef ect of corticosteroids in pa- neutrophil function. These infections may be mild to Drug Interactions: Drugs such as barbiturates,
For the treatment of acute leukemia and aggressive severe, and, with increasing doses of corticosteroids, tients with hypothyroidism and in those with cirrhosis.
Prednisolone can stimulate secretion of various phenytoin, ephedrine, and rifampin, which induce the rate of occurrence of infectious complications Kaposi’s sarcoma has been reported to occur in pa- components of gastric juice. Suppression of the hepatic microsomal drug metabolizing enzyme activity increases. Corticosteroids may also mask some tients receiving corticosteroid therapy, most often for production of corticotropin may lead to suppression 8. Nervous System
may enhance metabolism of prednisolone and require signs of infection after it has already started.
chronic conditions. Discontinuation of corticosteroids of endogenous corticosteroids. Prednisolone has Acute exacerbations of multiple sclerosis.
that the dosage of prednisolone sodium phosphate slight mineralocorticoid activity, whereby entry of Infections (Viral): Chicken pox and measles, for
oral solution (25 mg prednisolone per 5 mL) be 9. Ophthalmic Diseases
sodium into cel s and loss of intracel ular potas- example, can have a more serious or even fatal course Cardio-renal: As sodium retention with resultant
Uveitis and ocular inflammatory conditions unre- sium is stimulated. This is particularly evident in the in non-immune children or adults on corticosteroids.
edema and potassium loss may occur in patients Increased activity of both cyclosporin and corticoste- sponsive to topical corticosteroids; temporal arteritis; kidney, where rapid ion exchange leads to sodium In such children or adults who have not had these receiving corticosteroids, these agents should be used roids may occur when the two are used concurrently.
diseases, particular care should be taken to avoid with caution in patients with hypertension, congestive Convulsions have been reported with this concurrent 10. Respiratory Diseases
exposure. How the dose, route and duration of corti- heart failure, or renal insuf iciency.
Prednisolone is rapidly and wel absorbed from the costeroid administration af ect the risk of developing a gastrointestinal tract following oral administration.
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P/N: PSPP06A-CO1Rev008120
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Estrogens may decrease the hepatic metabolism of and clinical evaluation for the presence of infection, which may make dosage adjustments necessary are certain corticosteroids thereby increasing their ef ect.
psychosocial disturbances, thromboembolism, peptic Endocrine: Decreased carbohydrate tolerance;
changes in clinical status secondary to remissions or Ketoconazole has been reported to decrease the ulcers, cataracts, and osteoporosis. Children who are development of cushingoid state; hirsutism; increased exacerbations in the disease process, the patient’s in- metabolism of certain corticosteroids by up to 60% treated with corticosteroids by any route, including requirements for insulin or oral hypoglycemic agents dividual drug responsiveness, and the ef ect of patient leading to an increased risk of corticosteroid side systemically administered corticosteroids, may in diabetic patients; manifestations of latent diabetes exposure to stressful situations not directly related to experience a decrease in their growth velocity. This mel itus; menstrual irregularities; secondary adreno- the disease entity under treatment; in this latter situ- negative impact of corticosteroids on growth has been ation it may be necessary to increase the dosage of Coadministration of corticosteroids and warfarin cortical and pituitary unresponsiveness, particularly observed at low systemic doses and in the absence prednisolone sodium phosphate oral solution (25 mg usual y results in inhibition of response to warfarin, in times of stress, as in trauma, surgery or il ness; of laboratory evidence of HPA axis suppression (i.e., prednisolone per 5 mL) for a period of time consistent although there have been some conflicting reports.
cosyntropin stimulation and basal cortisol plasma with the patient’s condition. If after long term therapy Therefore, coagulation indices should be monitored Fluid and Electrolyte Disturbances: Congestive
levels). Growth velocity may therefore be a more sen- the drug is to be stopped, it is recommended that it be frequently to maintain the desired anticoagulant effect.
heart failure in susceptible patients; fluid retention; sitive indicator of systemic corticosteroid exposure in withdrawn gradual y rather than abruptly.
Concomitant use of aspirin (or other non-steroidal hypertension; hypokalemic alkalosis; potassium loss; children than some commonly used tests of HPA axis In the treatment of acute exacerbations of multiple anti nflammatory agents) and corticosteroids function. The linear growth of children treated with sclerosis, daily doses of 200 mg of prednisolone for a increases the risk of gastrointestinal side ef ects.
corticosteroids by any route should be monitored, and Gastrointestinal: Abdominal distention; elevation
week fol owed by 80 mg every other day or 4 to 8 mg Aspirin should be used cautiously in conjunction with the potential growth effects of prolonged treatment in serum liver enzyme levels (usual y reversible dexamethasone every other day for one month have corticosteroids in hypoprothrombinemia. The clear- should be weighed against clinical benefits obtained upon discontinuation); pancreatitis; peptic ulcer with ance of salicylates may be increased with concurrent and the availability of other treatment alternatives.
possible perforation and hemorrhage; ulcerative In pediatric patients, the initial dose of prednisolone In order to minimize the potential growth effects of sodium phosphate oral solution (25 mg prednisolone When corticosteroids are administered concomitantly corticosteroids, children should be titrated to the Metabolic: Negative nitrogen balance due to protein
per 5 mL) may vary depending on the specific disease with potassium-depleting agents (i.e., diuretics, entity being treated. The range of initial doses is 0.14 amphotericin-B), patients should be observed closely Geriatric Use: Clinical studies of prednisolone
Musculoskeletal: Aseptic necrosis of femoral
to 2 mg/kg/day in three or four divided doses (4 to 60 for development of hypokalemia. Patients on digitalis sodium phosphate oral solution did not include and humeral heads; loss of muscle mass; muscle glycosides may be at increased risk of arrhythmias sufficient numbers of subjects aged 65 and over weakness; osteoporosis; pathologic fracture of long The standard regimen used to treat nephrotic syn- to determine whether they respond differently from bones; steroid myopathy; tendon rupture; vertebral drome in pediatric patients is 60 mg/m2/day given in Concomitant use of anticholinesterase agents and younger subjects. Other reported clinical experience three divided doses for 4 weeks, followed by 4 weeks corticosteroids may produce severe weakness in with prednisolone sodium phosphate has not identi- Neurological: Convulsions; headache; increased
of single dose alternate-day therapy at 40 mg/m2/day.
patients with myasthenia gravis. If possible, anticho- fied dif erences in responses between the elderly intracranial pressure with papilledema (pseudotumor linesterase agents should be withdrawn at least 24 and younger patients. However, the incidence of The National Heart, Lung, and Blood Institute (NHLBI) cerebri) usual y following discontinuation of treat- hours before initiating corticosteroid therapy.
corticosteroid-induced side ef ects may be increased recommended dosing for systemic prednisone, pred- nisolone or methylprednisolone in children whose Due to inhibition of antibody response, patients in geriatric patients and appear to be dose-related.
Ophthalmic: Exophthalmos; glaucoma; increased
asthma is uncontrol ed by inhaled corticosteroids on prolonged corticosteroid therapy may exhibit a Osteoporosis is the most frequently encountered intraocular pressure; posterior subcapsular cataracts.
and long-acting bronchodilators is 1-2 mg/kg/day in diminished response to toxoids and live or inactivated complication, which occurs at a higher incidence Other: Increased appetite; malaise; nausea; weight
single or divided doses. It is further recommended vaccines. Corticosteroids may also potentiate the rate in corticosteroid-treated geriatric patients as that short course, or “burst” therapy, be continued un- replication of some organisms contained in live compared to younger populations and in age-matched til a child achieves a peak expiratory flow rate of 80% attenuated vaccines. If possible, routine administra- controls. Losses of bone mineral density appear to OVERDOSAGE
of his or her personal best or symptoms resolve. This tion of vaccines or toxoids should be deferred until be greatest early on in the course of treatment and The ef ects of accidental ingestion of large quantities usually requires 3 to 10 days of treatment, although it corticosteroid therapy is discontinued.
may recover over time after steroid withdrawal or of prednisolone over a very short period of time use of lower doses (i.e., ≤5 mg/day). Prednisolone can take longer. There is no evidence that tapering the Because corticosteroids may increase blood glucose have not been reported, but prolonged use of the doses of 7.5 mg/day or higher have been associated dose after improvement wil prevent a relapse.
concentrations, dosage adjustments of antidiabetic drug can produce mental symptoms, moon face, with an increased relative risk of both vertebral and For the purpose of comparison, 5 mL of prednisolone abnormal fat deposits, fluid retention, excessive nonvertebral fractures, even in the presence of higher appetite, weight gain, hypertrichosis, acne, striae, sodium phosphate oral solution (33.6 mg predniso- Corticosteroids may suppress reactions to skin tests.
bone density compared to patients with involutional ecchymosis, increased sweating, pigmentation, lone sodium phosphate) is equivalent to the fol owing Pregnancy: Teratogenic Effects:
dry scaly skin, thinning scalp hair, increased blood mil igram dosage of the various glucocorticoids: I058200 R08/12
Routine screening of geriatric patients, including pressure, tachycardia, thrombophlebitis, decreased Prednisolone has been shown to be teratogenic in regular assessments of bone mineral density and resistance to infection, negative nitrogen balance with many species when given in doses equivalent to the institution of fracture prevention strategies along with delayed bone and wound healing, headache, weak- human dose. Animal studies in which prednisolone regular review of prednisolone sodium phosphate ness, menstrual disorders, accentuated menopausal has been given to pregnant mice, rats, and rabbits indication should be undertaken to minimize com- symptoms, neuropathy, fractures, osteoporosis, peptic have yielded an increased incidence of cleft palate plications and keep the dose at the lowest acceptable ulcer, decreased glucose tolerance, hypokalemia, and in the of spring. There are no adequate and wel - level. Co-administration of bisphosphonates has been adrenal insuf iciency. Hepatomegaly and abdominal These dose relationships apply only to control ed studies in pregnant women. Prednisolone shown to retard the rate of bone loss in corticosteroid- distention have been observed in children.
oral or intravenous administration of these sodium phosphate oral solution (25 mg prednisolone treated males and postmenopausal females, and Treatment of acute overdosage is by immediate compounds. When these substances or their PREDNISOLONE
per 5 mL) should be used during pregnancy only if these agents are recommended in the prevention and gastric lavage or emesis fol owed by supportive and derivatives are injected intramuscularly or into SODIUM PHOSPHATE
the potential benefit justifies the potential risk to the treatment of corticosteroid-induced osteoporosis.
symptomatic therapy. For chronic overdosage in the joint spaces, their relative properties may be ORAL SOLUTION
fetus. Infants born to mothers who have received It has been reported that equivalent weight-based face of severe disease requiring continuous steroid corticosteroids during pregnancy should be carefully doses yield higher total and unbound prednisolone therapy, the dosage of prednisolone may be reduced HOW SUPPLIED
observed for signs of hypoadrenalism.
plasma concentrations and reduced renal and only temporarily, or alternate day treatment may be Each 5 mL (teaspoonful) of Prednisolone Sodium Nursing Mothers: Systemically administered corti-
non-renal clearance in elderly patients compared to Phosphate Oral Solution contains 33.6 mg predniso- costeroids appear in human milk and could suppress younger populations. However, it is not clear whether DOSAGE AND ADMINISTRATION
lone sodium phosphate (25 mg prednisolone base) in growth, interfere with endogenous corticosteroid dosing reductions would be necessary in elderly The initial dosage of prednisolone sodium phosphate a pale yel ow, grape flavored solution.
production, or cause other untoward ef ects. Caution patients, since these pharmacokinetic alterations may oral solution (25 mg prednisolone per 5 mL) may vary NDC 0178-0582-08 8 fl oz (237 mL) bot le
should be exercised when prednisolone sodium be offset by age-related differences in responsiveness from 1 mL to 12 mL (5 to 60 mg prednisolone base) phosphate oral solution (25 mg prednisolone per 5 of target organs and/ or less pronounced suppression Dispense in tight, light-resistant glass or PET plastic per day depending on the specific disease entity being mL) is administered to a nursing woman.
of adrenal release of cortisol. Dose selection for an treated. In situations of less severity, lower doses wil Pediatric Use: The ef icacy and safety of pred-
elderly patient should be cautious, usual y starting at Store refrigerated, 2° to 8°C (36° to 46°F).
generally suffice while in selected patients higher nisolone in the pediatric population are based on the the low end of the dosing range, reflecting the greater initial doses may be required. The initial dosage well-established course of ef ect of corticosteroids frequency of decreased hepatic, renal, or cardiac should be maintained or adjusted until a satisfactory NDC 0178-0582-01 1 fl oz (30 mL) sample bot le
which is similar in pediatric and adult populations.
function, and of communicant disease or other drug response is noted. If after a reasonable period of Published studies provide evidence of ef icacy Dispense in tight, light-resistant glass or PET plastic time, there is a lack of satisfactory clinical response, and safety in pediatric patients for the treatment This drug is known to be substantial y excreted by prednisolone sodium phosphate oral solution (25 of nephrotic syndrome (>2 years of age), and the kidney, and the risk of toxic reactions to this mg prednisolone per 5 mL) should be discontinued Store at 20° to 25°C (68° to 77°F).
aggressive lymphomas and leukemias (>1 month of drug may be greater in patients with impaired renal and the patient placed on other appropriate therapy.
Keep tightly closed and out of the reach of children.
age). However, some of these conclusions and other function. Because elderly patients are more likely to IT SHOULD BE EMPHASIZED THAT DOSAGE
indications for pediatric use of corticosteroid, e.g., have decreased renal function, care should be taken in REQUIREMENTS ARE VARIABLE AND MUST
severe asthma and wheezing, are based on adequate dose selection, and it may be useful to monitor renal BE INDIVIDUALIZED ON THE BASIS OF THE
and well-controlled trials conducted in adults, on the function (see CLINICAL PHARMACOLOGY).
DISEASE UNDER TREATMENT AND THE
premises that the course of the diseases and their ADVERSE REACTIONS (listed alphabetically
RESPONSE OF THE PATIENT. After a favorable
pathophysiology are considered to be substantial y under each subsection)
response is noted, the proper maintenance dosage Cardiovascular: Hypertrophic cardiomyopathy in
should be determined by decreasing the initial drug The adverse ef ects of prednisolone in pediatric dosage in small decrements at appropriate time patients are similar to those in adults (see ADVERSE intervals until the lowest dosage which will maintain Dermatologic: Facial erythema; increased sweating;
REACTIONS). Like adults, pediatric patients should an adequate clinical response is reached. It should impaired wound healing; may suppress reactions to be careful y observed with frequent measurements of be kept in mind that constant monitoring is needed skin tests; petechiae and ecchymoses; thin fragile blood pressure, weight, height, intraocular pressure, in regard to drug dosage. Included in the situations 651 S ML King Jr Ave • Waukegan, IL 60085 • Phone 847.336.4200 • Fax 847.360.4924 complete packaging | individual solutionsSM
1100 Venture Court • Suite 100 • Carrollton, Texas 75006 • Phone 972.478.6400 • Fax 972.478.6401 Product Information
Specified Colors
Approved By
P/N: PSPP06A-CO1Rev008120
J/N: 233580
Cust: MISSION PHARMACAL
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