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Prednisolone syrup contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water, soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol, slightly soluble in chloroform.
The chemical name for Prednisolone is 11(beta),17,21-Trihydroxpregna-1,4-diene-3,20-dione (anhydrous). Its molecular weight is 360.45. The molecular formula is C 21 H 28 O 5 , and the structural formula is:
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PRELONE® Syrup 15 mg contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5%, citric acid, edetate disodium, glycerine, propylene glycol, purified water, sodium saccharin, sucrose, artificial wild cherry flavor, FD&C blue #1 and red #40.
PRELONE® Syrup 5 mg contains 5 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains not more than 0.4% alcohol, citric acid, edetate disodium, glycerine, propylene glycol, purified water, sodium saccharin, sorbitol and artificial wild cherry flavor.
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs such as prednisolone are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids such as prednisolone cause profound and varied metabolic effects. In addition, they modify the body' immune responses to diverse stimuli.
PREDNISOLONE Syrup is indicated in the following conditions:
In addition to the above indications PRELONE® Syrup is indicated for systemic dermatomyositis (polymyositis).
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.
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 a lack of antibody response.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intravenous immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
The use of PRELONE® Syrup in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
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.
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 a 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 a 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.
Fluid and Electrolyte Disturbances
Congestive heart failure in susceptible patients
Potassium loss
Hypokalemic alkalosis
Hypertension
Muscle weakness
Osteoporosis
Vertebral compression fractures
Aseptic necrosis of femoral and humeral heads
Pathologic fracture of long bones
Peptic ulcer with possible perforation and hemorrhage
Pancreatitis
Dermatologic
Thin fragile skin
Petechiae and Ecchymoses
Increased sweating
May suppress reactions to skin tests
Neurological
Convulsions
Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment
Vertigo
Endocrine
Menstrual irregularities
Development of Cushingoid state
Suppression of growth in children
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 diabetics
Posterior subcapsular cataracts
Increased intraocular pressure
Glaucoma
Metabolic
Negative nitrogen balance due to protein catabolism
Dosage of PRELONE® Syrup 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 a replacement for conventional therapy.
Dosage should be decreased or discontinued gradually when the drug has been administered for more than a 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 a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued.
Blood pressure, body weight, routine laboratory studies, including two-hour postprandial blood glucose and serum potassium, and a 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 PRELONE® Syrup may vary from 5 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 a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PRELONE® Syrup 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 a 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 patient' 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 PRELONE® Syrup for a period of time consistent with the patient' condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
PRELONE® Syrup containing 15 mg of Prednisolone in each 5 mL (teaspoonful) is a red cherry flavored liquid and is supplied in 240 mL bottles (NDC 0451-1500-08) and 480 mL bottles (NDC 0451-1500-16).
AND
PRELONE® Syrup containing 5 mg of Prednisolone in each 5 mL is a dye-free, sugar free, cherry flavored clear liquid and is supplied in 120 mL bottles (NDC 0451-2201-04).
Pharmacist Dispense 15 mg/5 mL Prelone® Syrup with suitable calibrated measuring device to assure proper measuring of dose. Dispense in tight, light-resistant and child-resistant container as defined in USP/NF.
Store at room temperature. Do not refrigerate.
Pharmacist Dispense 5 mg/5 mL Prelone® Syrup in tight, light-resistant and child-resistant container as defined in USP/NF.
Store at controlled room temperature 15°C to 30°C (59°F to 86°F). Do not refrigerate.
Rx only
Muro
Pharmaceutical, Inc.
an ASTA Medica company
890 East Street · Tewksbury, Massachusetts 01876-1496
I-2201-1500-3 1/99