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Orapred
Overview
What is Orapred?
Orapred ODT (prednisolone sodium phosphate disintegrating tablets) is a sodium salt of the phosphoester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.
Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane.
The chemical name of prednisolone sodium phosphate is pregna-1, 4-diene-3, 20-dione, 11, 17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11ß)-. The empirical formula is CHNaOP; the molecular weight is 484.39. Its chemical structure is:
Each orally disintegrating tablet also contains the following inactive ingredients: citric acid, colloidal silicon dioxide, crospovidone, grape flavor, hypromellose, magnesium stearate, mannitol, methacrylate copolymer, microcrystalline cellulose, sodium bicarbonate, sucralose, and sucrose.
What does Orapred look like?
What are the available doses of Orapred?
Orally Disintegrating Tablets:
What should I talk to my health care provider before I take Orapred?
How should I use Orapred?
Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions:
Dosage of Orapred ODT 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.
Do not break or use partial Orapred ODT tablets.
The initial dose of Orapred ODT may vary from 10 to 60 mg (prednisolone base) 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, Orapred should be discontinued and the patient placed on other appropriate therapy. 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 that 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 Orapred ODT for a period of time consistent with the patient's condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Orapred ODT are packaged in a blister. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. The blister pack should then be peeled open, and the orally disintegrating tablet placed on the tongue, where tablets may be swallowed whole as any conventional tablet, or allowed to dissolve in the mouth, with or without the assistance of water. Orally disintegrating tablet dosage forms are friable and are not intended to be cut, split, or broken.
Multiple Sclerosis
Pediatric
Nephrotic Syndrome
Asthma
prednisone, prednisolone or methylprednisolone
It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.
What interacts with Orapred?
Sorry No Records found
What are the warnings of Orapred?
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What are the precautions of Orapred?
Sorry No Records found
What are the side effects of Orapred?
Sorry No records found
What should I look out for while using Orapred?
Orapred ODT 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 Orapred?
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 Orapred?
Keep testosterone topical solution out of reach of children.Store upright at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Used testosterone topical solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets. Keep testosterone topical solution out of reach of children.Store upright at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Used testosterone topical solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets. Keep testosterone topical solution out of reach of children.Store upright at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Used testosterone topical solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets. Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) 13.4 mg prednisolone sodium phosphate (equivalent to 10 mg prednisolone base) is a white, flat faced, bevelled tablet, debossed with ORA on one side and 10 on the other. Supplied as:Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) 20.2 mg prednisolone sodium phosphate (equivalent to 15 mg prednisolone base) is a white, flat faced, bevelled tablet, debossed with ORA on one side and 15 on the other. Supplied as:Orapred ODT: (prednisolone sodium phosphate orally disintegrating tablets) 40.3 mg prednisolone sodium phosphate (equivalent to 30 mg prednisolone base) is a white, flat faced, beveled tablets, debossed with ORA on one side and 30 on the other. Supplied as:Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) 13.4 mg prednisolone sodium phosphate (equivalent to 10 mg prednisolone base) is a white, flat faced, bevelled tablet, debossed with ORA on one side and 10 on the other. Supplied as:Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) 20.2 mg prednisolone sodium phosphate (equivalent to 15 mg prednisolone base) is a white, flat faced, bevelled tablet, debossed with ORA on one side and 15 on the other. Supplied as:Orapred ODT: (prednisolone sodium phosphate orally disintegrating tablets) 40.3 mg prednisolone sodium phosphate (equivalent to 30 mg prednisolone base) is a white, flat faced, beveled tablets, debossed with ORA on one side and 30 on the other. Supplied as:Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) 13.4 mg prednisolone sodium phosphate (equivalent to 10 mg prednisolone base) is a white, flat faced, bevelled tablet, debossed with ORA on one side and 10 on the other. Supplied as:Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) 20.2 mg prednisolone sodium phosphate (equivalent to 15 mg prednisolone base) is a white, flat faced, bevelled tablet, debossed with ORA on one side and 15 on the other. Supplied as:Orapred ODT: (prednisolone sodium phosphate orally disintegrating tablets) 40.3 mg prednisolone sodium phosphate (equivalent to 30 mg prednisolone base) is a white, flat faced, beveled tablets, debossed with ORA on one side and 30 on the other. Supplied as:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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
Orapred ODT 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.When given concurrently the following drugs may interact with thiazide diuretics.
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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