PREDNISOLONE- prednisolone oral solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Chartwell RX, LLC

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Prednisolone Oral Solution, USP containing 15 mg of Prednisolone in each 5 mL (teaspoonful) is a clear pinkish-red wild cherry flavored liquid and is supplied in 240 mL bottles (NDC 62135-250-37) and 480 mL (NDC 62135-250-47) bottles. Pharmacist: Dispense 15 mg/5 mL Prednisolone Oral Solution, USP 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. Manufactured for: Chartwell RX, LLC Congers, NY 10920 L71082 Rev. 09/2022

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PREDNISOLONE- PREDNISOLONE ORAL SOLUTION
CHARTWELL RX, LLC
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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 ethyl alcohol 5%
(v/v), citric acid,
edetate disodium, glycerin, propylene glycol, purified water,
saccharin sodium, sucrose,
natural and artificial wild cherry flavor, FD&C 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
anti-inflammatory effects in disorders of many organ systems.
21
28
5
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, 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).
1. Congenital adrenal hyperplasia
2. Nonsuppurative th