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Prednisolone Acetate
Overview
What is Flo-Pred?
Flo-Pred (prednisolone acetate oral suspension) contains prednisolone which is the acetate ester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.
Prednisolone acetate is a white to off-white in color, odorless, crystalline powder. It is insoluble in water, slightly soluble in acetone, in alcohol and in chloroform.
The chemical name for prednisolone acetate is 11β 17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate. Its molecular weight is 402.49. The molecular formula is CHO and the structural formula is:
Flo-Pred (prednisolone acetate oral suspension) is a viscous milky white formulation containing 15 mg of prednisolone (as 16.7 mg of prednisolone acetate) in each 5 mL. Flo-Pred is a spill resistant system that delivers semi-solid products for oral administration from a squeezable container. This system comprises of a liquid base and a thickening agent that ensures product homogeneity during storage. Butylparaben, 0.04% is added as a preservative. It also contains carbomer 934P, disodium edetate, glycerin, masking agent, poloxamer 188, propylene glycol, purified water, sodium hydroxide, sorbitol crystalline, sucralose liquid concentrate and cherry flavor.
What does Flo-Pred look like?
What are the available doses of Flo-Pred?
Oral Suspension:
What should I talk to my health care provider before I take Flo-Pred?
How should I use Flo-Pred?
Flo-Pred (prednisolone acetate oral suspension) is indicated in the treatment of the following diseases or conditions:
Dosage of Flo-Pred should be individualized according to the severity of the disease and the response of the patient. For pediatric patients, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.
The initial dosage of Flo-Pred 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 there is a lack of satisfactory clinical response, Flo-Pred 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's 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 Flo-Pred for a period of time consistent with the patient's condition. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
What interacts with Flo-Pred?
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What are the warnings of Flo-Pred?
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What are the precautions of Flo-Pred?
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What are the side effects of Flo-Pred?
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What should I look out for while using Flo-Pred?
Flo-Pred is contraindicated in patients who are hypersensitive to corticosteroids such as prednisolone, or any components of this product. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy.
What might happen if I take too much Flo-Pred?
The effects of accidental ingestion of large quantities of prednisolone over a very short period of time have not been reported, but prolonged use of the drug can produce mental symptoms, moon face, abnormal fat deposits, fluid retention, excessive appetite, weight gain, hypertrichosis, acne, striae, ecchymosis, increased sweating, pigmentation, dry scaly skin, thinning scalp hair, increased blood pressure, tachycardia, thrombophlebitis, decreased resistance to infection, negative nitrogen balance with delayed bone and wound healing, headache, weakness, menstrual disorders, accentuated menopausal symptoms, neuropathy, fractures, osteoporosis, peptic ulcer, decreased glucose tolerance, hypokalemia, and adrenal insufficiency. Hepatomegaly and abdominal distention have been observed in children.
Treatment of acute overdosage is by immediate gastric lavage or emesis followed by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy the dosage of prednisolone may be reduced only temporarily, or alternate day treatment may be introduced.
How should I store and handle Flo-Pred?
StorageStore at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF) [see USP Controlled Room Temperature].StorageStore at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF) [see USP Controlled Room Temperature].Flo-Pred (prednisolone acetate oral suspension) is a cherry flavored milky white viscous liquid containing 16.7 mg of prednisolone acetate (equivalent to 15 mg prednisolone) in each 5 mL of formulation and is supplied as follows:37 mL (NDC 51672-1338-5) for Professional Samples52 mL (NDC 51672-1338-3)65 mL (NDC 51672-1338-6)Flo-Pred (prednisolone acetate oral suspension) is a cherry flavored milky white viscous liquid containing 16.7 mg of prednisolone acetate (equivalent to 15 mg prednisolone) in each 5 mL of formulation and is supplied as follows:37 mL (NDC 51672-1338-5) for Professional Samples52 mL (NDC 51672-1338-3)65 mL (NDC 51672-1338-6)Flo-Pred (prednisolone acetate oral suspension) is a cherry flavored milky white viscous liquid containing 16.7 mg of prednisolone acetate (equivalent to 15 mg prednisolone) in each 5 mL of formulation and is supplied as follows:37 mL (NDC 51672-1338-5) for Professional Samples52 mL (NDC 51672-1338-3)65 mL (NDC 51672-1338-6)Flo-Pred (prednisolone acetate oral suspension) is a cherry flavored milky white viscous liquid containing 16.7 mg of prednisolone acetate (equivalent to 15 mg prednisolone) in each 5 mL of formulation and is supplied as follows:37 mL (NDC 51672-1338-5) for Professional Samples52 mL (NDC 51672-1338-3)65 mL (NDC 51672-1338-6)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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's immune responses to diverse stimuli.
Prednisolone is a synthetic adrenocortical steroid drug with predominantly glucocorticoid properties. Some of these properties reproduce the physiological actions of endogenous glucocorticosteroids, but others do not necessarily reflect any of the adrenal hormones' normal functions; they are seen only after administration of large therapeutic doses of the drug. The pharmacological effects of prednisolone which are due to its glucocorticoid properties include: promotion of gluconeogenesis; increased deposition of glycogen in the liver; inhibition of the utilization of glucose; anti-insulin activity; increased catabolism of protein; increased lipolysis; stimulation of fat synthesis and storage; increased glomerular filtration rate and resulting increase in urinary excretion of urate (creatinine excretion remains unchanged); and increased calcium excretion.
Depressed production of eosinophils and lymphocytes occurs, but erythropoiesis and production of polymorphonuclear leukocytes are stimulated. Inflammatory processes (edema, fibrin deposition, capillary dilatation, migration of leukocytes and phagocytosis) and the later stages of wound healing (capillary proliferation, deposition of collagen, cicatrization) are inhibited.
Prednisolone can stimulate secretion of various components of gastric juice. Suppression of the production of corticotropin may lead to suppression of endogenous corticosteroids. Prednisolone has slight mineralocorticoid activity, whereby entry of sodium into cells and loss of intracellular potassium is stimulated. This is particularly evident in the kidney, where rapid ion exchange leads to sodium retention and hypertension.
Non-Clinical Toxicology
Flo-Pred is contraindicated in patients who are hypersensitive to corticosteroids such as prednisolone, or any components of this product. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy.Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia. Monitor patients for these conditions with chronic use.
Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. 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. Mineralocorticoid supplementation is of particular importance in infancy.
Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.
Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
Allergic Reactions:
Cardiovascular:
Dermatologic:
Endocrine:
Fluid and Electrolyte Disturbances:
Gastrointestinal:
General:
Metabolic:
Musculoskeletal:
Neurological:
Ophthalmic:
Reproductive:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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