Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
PREDNISOLONE (UNII: 9PHQ9Y1OLM) (PREDNISOLONE - UNII:9PHQ9Y1OLM)
Akorn
PREDNISOLONE
PREDNISOLONE 15 mg in 5 mL
ORAL
PRESCRIPTION DRUG
PREDNISOLONE Oral Solution 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). 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: 4. Dermatologic Diseases 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means 8. Hematologic Disorders Idiopathic thrombocytopenic pur
Prednisolone Oral Solution containing 15 mg of Prednisolone in each 5 mL (teaspoonful) is a red cherry flavored liquid and is supplied in 240 mL bottles and 480 mL bottles. Pharmacist: Dispense 15 mg/5 mL Prednisolone Oral Solution 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 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DO NOT REFRIGERATE. Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 Rev.042:06 06/22
Abbreviated New Drug Application
PREDNISOLONE- PREDNISOLONE SOLUTION AKORN ---------- PREDNISOLONE ORAL SOLUTION USP 15 MG PER 5 ML RX ONLY DESCRIPTION PREDNISOLONE ORAL SOLUTION 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 Pregna-1,4 -diene -3, 20 - dione, 11, 17, 21- trihydroxy-,(11β). Its molecular weight is 360.45. The molecular formula is C H O and the structural formula is: PREDNISOLONE ORAL SOLUTION 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, glycerin, propylene glycol, purified water, sodium saccharin, sucrose, artificial wild cherry flavor, FD&C blue #1 and red #40. CLINICAL 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 21 28 5 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. INDICATIONS AND USAGE PREDNISOLONE ORAL SOLUTION 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). 2. RHEUMATIC DISORDERS As adjunctive therapy for short-term administration (to tide the p Διαβάστε το πλήρες έγγραφο