PREDNISONE- prednisone tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

Prednisone (UNII: VB0R961HZT) (Prednisone - UNII:VB0R961HZT)

Dostępny od:

JUBILANT CADISTA PHARMACEUTICALS INC.

INN (International Nazwa):

Prednisone

Skład:

Prednisone 1 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Prednisone 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 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 cases of: Systemic lupus erythematosus Sys

Podsumowanie produktu:

Prednisone Tablets, USP are available in the following strengths and package sizes: 1 mg (White, round tablets debossed with "TL 171" on one side and scored on the other side.) Bottles of 100               NDC 59746-171-06 Bottles of 1000             NDC 59746-171-10 Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised 01/2018

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

PREDNISONE - PREDNISONE TABLET
JUBILANT CADISTA PHARMACEUTICALS INC.
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PREDNISONE TABLETS, USP RX ONLY
DESCRIPTION
Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical
steroids, both naturally occurring
and synthetic, which are readily absorbed from the gastrointestinal
tract. The molecular formula for
prednisone is C
H O . Chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione
and has the
following structural formula:
Molecular weight: 358.44
Prednisone is a white to practically white, odorless, crystalline
powder. It melts at about 230°C with
some decomposition. Prednisone is very slightly soluble in water;
slightly soluble in alcohol, in
chloroform, in dioxane, and in methanol.
Each tablet, for oral administration, contains 1 mg of prednisone.
Inactive Ingredients: Lactose, Magnesium Stearate, Pregelatinized
Starch, Sodium Lauryl Sulfate and
Sodium Starch Glycolate.
CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-retaining
properties, are used as replacement therapy in adrenocortical
deficiency states. Their synthetic analogs,
such as prednisone, 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
Prednisone 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
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
21
26
5
_2. Rheumatic Disorders_
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode or
exacerbation) in:
Psoriatic arthritis
Rheumatoid art