HYDROCORTISONE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)

Tilgængelig fra:

Strides Pharma Inc.

INN (International Name):

Hydrocortisone

Sammensætning:

Hydrocortisone 5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske 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) - Acut

Produkt oversigt:

Hydrocortisone tablets, USP are available in the following strengths and package sizes: 5 mg White to off-white oval tablets debossed on one side with a bisect and other side with "P5". NDC 42543-140-50: Bottles of 50 tablets 10 mg White to off-white oval tablets debossed on one side with a bisect and other side with "P10". NDC 42543-141-01: Bottles of 100 tablets 20 mg White to off-white oval tablets debossed on one side with a bisect and other side with "P20". NDC 42543-142-01: Bottles of 100 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

HYDROCORTISONE- HYDROCORTISONE TABLET
STRIDES PHARMA INC.
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HYDROCORTISONE TABLETS, USP
5 MG, 10 MG AND 20 MG
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 tide th