PREDNISOLONE solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

PREDNISOLONE (UNII: 9PHQ9Y1OLM) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

متاح من:

Akorn

INN (الاسم الدولي):

PREDNISOLONE

تركيب:

PREDNISOLONE 15 mg in 5 mL

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

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

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

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