HYDROCORTISONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

STAT RX USA LLC

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 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 or osteoarthritis   Epicondylitis - Collagen Diseases   During an exacerbation or as maintenance therapy in selected cases of:   Systemic lupus erythematosus

Product summary:

Hydrocortisone Tablets USP 20 mg: White, round, scored tablets; imprinted "West-ward 254". Bottles of 100 tablets. Unit Dose Boxes of 100 tablets. 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 2003

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE - HYDROCORTISONE TABLET
STAT RX USA LLC
----------
Rev. 07/03
RX ONLY
DESCRIPTION
Glucocorticoids are adrenocortical steroids, both naturally occurring
and synthetic, which are readily
absorbed from the gastrointestinal tract.
Hydrocortisone is a white to practically white, odorless, crystalline
powder, very slightly soluble in
water. The molecular weight is 362.47. It is designated chemically as
11B, 17,21-trihydroxy-pregn-4-
ene-3,20-dione. The molecular formula is C
H O and the structural formula is:
Hydrocortisone is believed to be the principal hormone secreted by the
adrenal cortex.
Each tablet for oral administration contains 20 mg of hydrocortisone.
Inactive Ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide,
Magnesium Stearate,
Microcrystalline Cellulose, 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 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 arthri