prednisolone- Prednisolone solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Prednisolone (UNII: 9PHQ9Y1OLM) (Prednisolone - UNII:9PHQ9Y1OLM)

Tilgjengelig fra:

Pharmaceutical Associates, Inc.

INN (International Name):

Prednisolone

Legemiddelform:

SOLUTION

Sammensetning:

15 mg in 5 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

PrednisoLONE Syrup (PrednisoLONE Oral Solution USP) is indicated in the following conditions: - 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 - 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 - Collagen Diseases During an exacer

Produkt oppsummering:

PrednisoLONE Syrup (PrednisoLONE Oral Solution USP) is a berry-flavored, red liquid containing 15 mg of prednisolone in each 5 mL (teaspoonful) and is supplied in 8 fl oz bottles (NDC 0121- 0687-08), 16 fl oz bottles (NDC 0121- 0687-16) and 5 mL unit dose cups packaged in trays of 10 (NDC 0121-0687-05). 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. Dose/Volume Chart 15 mg prednisolone = 1 teaspoon 10 mg prednisolone = 2/3 teaspoon 7.5 mg prednisolone = 1/2 teaspoon 5 mg prednisolone = 1/3 teaspoon Store at controlled room temperature, 20°-25°C (68°-77° F). [See USP] DO NOT REFRIGERATE. R11/06 Pharmaceutical Associates, Inc. Greenville, SC  29605

Preparatomtale

PREDNISOLONE- PREDNISOLONE SOLUTION
PHARMACEUTICAL ASSOCIATES, INC.
----------
RX ONLY
DESCRIPTION
PrednisoLONE Syrup (PrednisoLONE Oral Solution USP) contains
prednisolone which is a
glucocorticoid. Glucocorticoids are adreno-cortical 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-,(11,β)-. Its
molecular weight is 360.45. The molecular formula is C
H O , and the structural formula is:
PREDNISOLONE SYRUP (PREDNISOLONE ORAL SOLUTION USP) contains 15 mg of
prednisolone in each
5 mL. Sodium benzoate, 0.1% is added as a preservative. It also
contains alcohol 5% (v/v), artificial
berry flavor, citric acid anhydrous, edetate disodium, FD&C Blue No.
1, FD&C Red No. 40, glycerin,
propylene glycol, purified water, sodium saccharin, and sucrose.
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 (PrednisoLONE Oral Solution USP) 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 hyp