HYDROCORTISONE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

American Health Packaging

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Hydrocortisone tablets are indicated in the following conditions. - 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 - Non suppurative thyroiditis - Hypercalcemia associated with cancer 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 During an exacerbation or as maintenance therapy in selected cases of: - Systemic lupus erythematosus - Systemic dermatomyositis (polymyositis

Produktsammanfattning:

Hydrocortisone tablets, USP are available in the following strengths and package sizes: 10 mg White to off-white oval tablets debossed on one side with a bisect and other side with "P10". Unit dose packages of 100 (10 x 10) NDC 60687-511-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

HYDROCORTISONE- HYDROCORTISONE TABLET
AMERICAN HEALTH PACKAGING
----------
HYDROCORTISONE TABLETS, USP
8451101/0819
RX ONLY
DESCRIPTION
Hydrocortisone tablets, USP contain hydrocortisone which is a
glucocorticoid.
Glucocorticoids are adrenocortical steroids, both naturally occurring
and synthetic,
which are readily absorbed from the gastrointestinal tract.
Hydrocortisone USP is white
to practically white, odorless, crystalline powder with a melting
point of about 215º C. It
is very slightly soluble in water and in ether; sparingly soluble in
acetone and in alcohol;
slightly soluble in chloroform.
The chemical name for hydrocortisone is pregn-4-ene-3,
20-dione,11,17,21-trihydroxy-,
(11β)-. Its molecular weight is 362.46 and the structural formula is
as outlined below.
Hydrocortisone tablets, USP are available for oral administration in
three strengths: each
tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone.
Inactive ingredients:
colloidal silicon dioxide, lactose monohydrate, magnesium stearate and
microcrystalline
cellulose.
ACTIONS
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-
retaining properties, are used as replacement therapy in
adrenocortical deficiency
states. Their synthetic analogs are primarily 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
Hydrocortisone tablets are 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
Non suppurative thyroiditis
Hypercalcemia associated with cancer
2. RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration (to