HYDROCORTISONE- hydrocortisone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 3.   Collagen Diseases During an exacerbation or as maintenance therapy in selected

Product summary:

Hydrocortisone Tablets USP, 20 mg: White, Round Scored Tablets; Debossed "West-ward 254" on one side and Scored on the other side. Bottles of 30 Tablets             NDC 0143-1254-01       Store at 20° to 25 o C (68° to 77 o 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE- HYDROCORTISONE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
HYDROCORTISONE TABLETS
Hydrocortisone Tablets, USP
Rev. 10/16
R
Only
DESCRIPTION
Hydrocortisone is a glucocorticoid. Glucocorticoids are adrenocortical
steroids, both naturally
occurring and synthetic, which are readily absorbed from the
gastrointestinal tract.
Hydrocortisone, USP is a 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 molecular weight is
362.46. It is designated chemically
as pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. The molecular
formula is C
H
O
and the
structural formula is:
Each tablet for oral administration contains 5 mg, 10 mg, or 20 mg of
hydrocortisone.
Inactive ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide,
Magnesium Stearate,
Microcrystalline Cellulose, and 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
x
21
30
5
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. _Rheumatic Disorders_
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode