HYDROCORTISONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

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 rheumat

Product summary:

Hydrocortisone Tablets, USP 5 mg are white, round tablets bisected, debossed “CP” score “331” on one side and plain on the other side. They are available as follows: Bottles of 50:                          NDC 0115-1696-06 Hydrocortisone Tablets, USP 10 mg are white, round tablets bisected, debossed “CP” score “332” on one side and plain on the other side. They are available as follows: Bottles of 100:                        NDC 0115-1697-01 Hydrocortisone Tablets, USP 20 mg are white, round tablets bisected, debossed “CP” score “333” on one side and plain on the other side. They are available as follows: Bottles of 100:                        NDC 0115-1700-01 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
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
HYDROCORTISONE TABLETS, USP
5 MG, 10 MG AND 20 MG
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
or practically white, 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 362.5 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, USP.
INACTIVE INGREDIENTS: Anhydrous lactose, pregelatinized 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 DISORD