PREDNISOLONE solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

DIRECT RX

INN (Rahvusvaheline Nimetus):

PREDNISOLONE

Koostis:

PREDNISOLONE 15 mg in 5 mL

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

Prednisolone Oral Solution containing 15 mg of Prednisolone in each 5 mL (teaspoonful) and 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 or 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. Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 042:03 7/09 MG #15089

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

PREDNISOLONE- PREDNISOLONE SOLUTION
DIRECT RX
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PREDNOSOLONE
DESCRIPTION SECTION
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)-
(anhydrous).
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 SECTION
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 & USAGE SECTION
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 ac