PREDNISOLONE solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
24-03-2023

Viambatanisho vya kazi:

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

Inapatikana kutoka:

A-S Medication Solutions

INN (Jina la Kimataifa):

PREDNISOLONE

Tungo:

PREDNISOLONE 15 mg in 5 mL

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

Product: 50090-0655 NDC: 50090-0655-0 120 mL in a BOTTLE / 2 in a CARTON NDC: 50090-0655-1 60 mL in a BOTTLE / 4 in a CARTON NDC: 50090-0655-2 240 mL in a BOTTLE / 1 in a CARTON

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

                                PREDNISOLONE- PREDNISOLONE SOLUTION
A-S MEDICATION SOLUTIONS
----------
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 administra
                                
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