PREDNISOLONE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

PREDNISOLONE

Composition:

PREDNISOLONE 15 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 erythematos

Product summary:

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 240 MILLILITER in a bottle/1 bottle in a CARTON (53217-193-01) 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. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISOLONE- PREDNISOLONE SOLUTION
AIDAREX PHARMACEUTICALS LLC
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PREDNISOLONE ORAL SOLUTION USP
15 MG PER 5 ML
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)-
(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
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 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).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration (t