CORTISONE ACETATE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Hikma Pharmaceuticals USA Inc.

INN (Kansainvälinen yleisnimi):

CORTISONE ACETATE

Koostumus:

CORTISONE ACETATE 25 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

- 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 exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Acute rheumatic carditis Systemic dermat

Tuoteyhteenveto:

Cortisone Acetate Tablets USP 25 mg: White, Round, Scored Tablet; Imprinted "West-ward 202." Store at 20-25°C (68-77°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: West-ward Pharmaceutical Corp. Eatontown, N.J. 07724 Revised July 2009

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

CORTISONE ACETATE- CORTISONE ACETATE TABLET
HIKMA PHARMACEUTICALS USA INC.
----------
CORTISONE ACETATE TABLETS, USP
Rev. 07/09
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 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_
23
30
6
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