CORTISONE ACETATE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ)

Dostupné s:

Hikma Pharmaceuticals USA Inc.

INN (Mezinárodní Name):

CORTISONE ACETATE

Složení:

CORTISONE ACETATE 25 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 rheumatic carditis Systemic dermatomyosit

Přehled produktů:

Cortisone Acetate Tablets, USP 25 mg: White, Round, Scored Tablet; Imprinted “West-ward 202.” Bottles of 100 tablets.                                                    NDC 0143-9700-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: HIKMA Pharmaceuticals P.O. Box 182400 Amman 11118 – Jordan Distributed by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 USA Revised July 2016

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CORTISONE ACETATE- CORTISONE ACETATE TABLET
HIKMA PHARMACEUTICALS USA INC.
----------
CORTISONE ACETATE TABLETS, USP
CORTISONE ACETATE TABLETS, USP
Rev. 07/16
Rx Only
DESCRIPTION:
Glucocorticoids are adrenocortical steroids, both naturally occurring
and synthetic, which are readily
absorbed from the gastrointestinal tract.
Cortisone acetate is a white or practically white, odorless,
crystalline powder. It is stable in air. It is
insoluble in water. The molecular weight is 402.49. It is designated
chemically as 21-(acetyloxy)-17-
hydroxypregn-4-ene-3,11,20-trione. The molecular formula is C
H O and the structural formula is:
Cortisone Acetate Tablets, USP contain 25 mg of cortisone acetate in
each tablet.
Inactive ingredients are Anhydrous Lactose, Colloidal Silicon Dioxide,
Magnesium Stearate,
Microcrystalline Cellulose, Sodium Lauryl Sulfate, and Sodium Starch
Glycolate.
CLINICAL PHARMACOLOGY:
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-retaining
properties, are used as replacement therapy in adrenocortical
deficiency states. They are also used for
their potent anti-inflammatory effects in disorders of many organ
systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify the body’s
immune responses to diverse stimuli.
INDICATIONS AND USAGE:
_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
23
30
6
exacerbation) in:
Psoriatic arthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis
(selected cases may require low-dose
maintenance therapy) Ankylosing spondylitis
Acute