Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
PREDNISOLONE (UNII: 9PHQ9Y1OLM) (PREDNISOLONE - UNII:9PHQ9Y1OLM)
Lannett Company, Inc.
ORAL
PRESCRIPTION DRUG
Prednisolone Syrup (Prednisolone Oral Solution, USP) 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). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. In addition to the above indications Prednisolone Syrup (Prednisolone Oral Solution, USP) is indicated for systemic dermatomyositis (polymyositis). Systemic fungal infections.
Prednisolone Syrup (Prednisolone Oral Solution, USP) is a cherry flavored red liquid containing 15 mg of prednisolone in each 5 mL (teaspoonful) and is supplied as follows: NDC 0527-5406-68 240 mL NDC 0527-5406-70 480 mL Dispense with a suitable calibrated measuring device to assure proper measuring of dose. DOSE/VOLUME CHART 15 mg prednisolone = 1 teaspoon 10 mg prednisolone = 2/3 teaspoon 7.5 mg prednisolone = 1/2 teaspoon 5 mg prednisolone = 1/3 teaspoon Dispense in tight, light-resistant and child-resistant containers as defined in the USP/NF. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do Not Refrigerate.
Abbreviated New Drug Application
PREDNISOLONE- PREDNISOLONE SYRUP LANNETT COMPANY, INC. ---------- PREDNISOLONE SYRUP (PREDNISOLONE ORAL SOLUTION, USP) 15 MG/5 ML RX ONLY DESCRIPTION Prednisolone Syrup (Prednisolone Oral Solution, USP) 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). Prednisolone Syrup (Prednisolone Oral Solution, USP) contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5% v/v, cherry flavor, citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, glycerin, propylene glycol, purified water, sodium saccharin, and sucrose. Prednisolone Syrup (Prednisolone Oral Solution, USP) may contain sodium citrate for pH adjustment. 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 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 Syrup (Prednisolone Oral Solution, USP) 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). Կարդացեք ամբողջական փաստաթուղթը