PREDNISOLONE solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

MedVantx, Inc.

Designación común internacional (DCI):

PREDNISOLONE

Composición:

PREDNISOLONE 15 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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). 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 erythematosu

Resumen del producto:

Prednisolone oral solution USP, 15 mg per 5 mL containing 15 mg of prednisolone in each 5 mL (teaspoonful) is a red cherry flavored liquid and is supplied in 240 mL bottles (NDC 0093-6118 -87) and 480 mL bottles (NDC 0093-6118 -16). Pharmacist: Dispense prednisolone oral solution USP, 15 mg per 5 mL with suitable calibrated measuring device to assure proper measuring of dose. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not refrigerate. Manufactured In Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA Ontario, Canada L5N 6L6 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. C 4/2011

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PREDNISOLONE- PREDNISOLONE SOLUTION
MEDVANTX, INC.
----------
PREDNISOLONE ORAL SOLUTION USP, 15 MG PER 5 ML
6118
RX ONLY
DESCRIPTION
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
11ß,17,21-trihydroxypregna-1,4-diene-3,20-dione (anhydrous).
Its structural formula is:
C
H O M.W. 360.45
Prednisolone oral solution USP, 15 mg per 5 mL 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,
glycerine, 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
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
Prednisolone oral solution is indicated in the following conditions:
1. ENDOCRINE DISORDERS
21
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5
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 DISORDE