PREDNISOLONE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ETHEX Corporation

INN (International Name):

PREDNISOLONE

Composition:

PREDNISOLONE 15 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prednisolone syrup 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 erythematosus Acute

Product summary:

Prednisolone Syrup, USP is a cherry flavored red liquid containing 15 mg of Prednisolone in each 5 mL (teaspoonful) and is supplied in 240 mL bottles (NDC 58177-910-05) and 480 mL bottles (58177-910-07). Pharmacist : Dispense with a suitable calibrated measuring device to assure proper measuring of dose. Dispense in tight, light-resistant and child-resistant containers as defined in the USP/NF. Store at controlled room temperature 15°C to 30°C (59°F to 86°F). Do Not Refrigerate. Manufactured by KV Pharmaceutical Co. for ETHEX Corporation St. Louis, MO  63044 P3127-2 08/06

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISOLONE - PREDNISOLONE SYRUP
ETHEX CORPORATION
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PREDNISOLONE SYRUP, USP
15 MG/5 ML
DESCRIPTION
PREDNISOLONE SYRUP, 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 Pregna-
1,4-diene-3,20-dione,11,17,21- trihydroxy-,(11β)-.
PREDNISOLONE SYRUP, USP 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, ethyl maltol, flavors,
glycerin, ammoniated glycyrrhizin, propylene glycol, purified water,
sodium saccharin, sucrose, FD&C
blue #1 and 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.
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 SYRUP 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