prednisolone- Prednisolone syrup

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

KV Pharmaceuticals

INN (Међународно име):

Prednisolone

Фармацеутски облик:

SYRUP

Састав:

5 mg in 5 mL

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

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 58177-912- 03). Dispense in tight, light-resistant and child-resistant container as defined in USP/NF. Store at controlled room temperature 15°C to 30°C (59°F to 86°F). Do not refrigerate. Manufactured by KV Pharmaceutical Company for ETHEX Corporation St. Louis, MO  63043

Карактеристике производа

PREDNISOLONE- PREDNISOLONE SYRUP
KV PHARMACEUTICALS
----------
RX ONLY
DESCRIPTION
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.
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
Prednisolone syrup is indicated in the following conditions:
1. ENDOCRINE DISORDERS
21
28
5
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-