PREDNISOLONE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

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

Product summary:

Prednisolone Syrup, USP 5mg/5 mL is a clear, colorless to pale, straw-yellow dye-free liquid with a cherry aroma containing 5 mg of Prednisolone in each 5mL (teaspoonful) and is supplied in 120 mL bottles ( NDC 54868-4748-0 ). 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 54868-4749-0 ) and 480 mL bottles (NDC 54868-4749-1 ). 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISOLONE - PREDNISOLONE SYRUP
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
PREDNISOLONE SYRUP, USP 5MG/5 ML
Prednisolone syrup 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 11β,
17,21-Trihydroxypregna-1,4-diene-3,20-dione
(anhydrous). Its molecular weight is 360.45. The molecular formula is
C
H O and the structural
formula is:
Prednisolone Syrup, USP 5mg/5 mL contains 5 mg of prednisolone in each
5 mL. Benzoic acid, 0.1% is
added as a preservative. It also contains not more than 0.4% alcohol,
citric acid, edetate disodium,
flavors, glycerin, glycyrrhizin (ammoniated), propylene glycol,
purified water, saccharin sodium, and
sorbitol.
PREDNISOLONE SYRUP, USP 15MG/5 ML
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)-.
21
28
5
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 (hydrocortison