HYDROCORTISONE- hydrocortisone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocortisone tablets, USP are indicated in the following conditions. - 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

Product summary:

Hydrocortisone Tablets, USP 5 mg are white, scored, round tablets debossed “3578” on one side and debossed “V” on the reverse side; and are supplied as follows: Unit dose packages of 30 (5 x 6) NDC 68084-789-25 Hydrocortisone Tablets, USP 10 mg are white, scored, round tablets debossed “3579” on one side and debossed “V” on the reverse side; and are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-469-01 Hydrocortisone Tablets, USP 20 mg are white, scored, round tablets debossed “3580” on one side and debossed “V” on the reverse side; and are supplied as follows: Unit dose packages of 30 (5 x 6) NDC 68084-930-25 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE- HYDROCORTISONE TABLET
AMERICAN HEALTH PACKAGING
----------
HYDROCORTISONE TABLETS, USP
8246901/0517
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 215°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,
magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate,
sodium starch glycolate.
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, USP 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
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. RHEUMATIC DISORDERS
As adjunctive therapy f