HYDROCORTISONE- hydrocortisone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lineage Therapeutics Inc

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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) Acute rheumatic

Product summary:

Hydrocortisone Tablets, USP are available in the following strengths and package sizes: Hydrocortisone Tablets USP, 5 mg  are white, round, scored tablets, imprinted CP above score and 331 below score on one side, and the other side is plain.  They are supplied as follows:      Bottles of 50 Tablets          (NDC 54505-331-05) Hydrocortisone Tablets USP, 10 mg   are white, round, scored tablets, imprinted CP  above score and 332 below score on one side, and the other side is plain.  They are supplied as follows:      Bottles of 100 Tablets        (NDC 54505-332-10) Hydrocortisone Tablets USP, 20 mg  are white, round, scored tablets, imprinted CP above score and 333 below score on one side, and the other side is plain.  They are supplied as follows:      Bottles of 100 Tablets        (NDC 54505-333-10) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE- HYDROCORTISONE TABLET
LINEAGE THERAPEUTICS INC
----------
HYDROCORTISONE TABLETS, USP
LINEAGE THERAPEUTICS
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: lactose, pregelatinized
corn starch, microcrystalline cellulose, croscarmellose sodium, sodium
starch glycolate, and
magnesium stearate.
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 t