PREDNISONE tablet PREDNISONE- prednisone tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

JUBILANT CADISTA PHARMACEUTICALS INC.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Prednisone 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 Hypercalcemia associated with cancer Nonsuppurative thyroiditis 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

leaflet_short:

Prednisone Tablets, USP are available in the following strengths and package sizes: 2.5 mg - White, round tablets debossed with "C 782" on one side and scored on the other side.           Bottles of 30 tablets with Child Resistant Closure,   NDC 59746-782-30           Bottles of 100 tablets with Child Resistant Closure, NDC 59746-782-01 5 mg - White, round tablets debossed with "TL 172" on one side and scored on the other side.           Bottles of 100 tablets with Child Resistant Closure, NDC 59746-172-06           Bottles of 1000                                                          NDC 59746-172-10 10 mg - White, round tablets debossed with "TL 173" on one side and scored on the other side.           Bottles of 100 tablets with Child Resistant Closure, NDC 59746-173-06           Bottles of 500                                                            NDC 59746-173-09           Bottles of 1000                                                          NDC 59746-173-10 20 mg - Peach, round tablets debossed with "TL 175" on one side and scored on the other side.           Bottles of 100 tablets with Child Resistant Closure, NDC 59746-175-06           Bottles of 500                                                            NDC 59746-175-09           Bottles of 1000                                                          NDC 59746-175-10 50 mg - White, round tablets debossed with "C 783" on one side and scored on the other side.           Bottles of 100 tablets with Child Resistant Closure, NDC 59746-783-01            Store at 20° to 25° C (68° to 77° F) [See USP Room Temperature]. Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Revised 09/2021

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PREDNISONE- PREDNISONE TABLET
PREDNISONE - PREDNISONE TABLET
JUBILANT CADISTA PHARMACEUTICALS INC.
----------
PREDNISONE TABLETS, USP
RX ONLY
DESCRIPTION
Prednisone, USP is a glucocorticoid. Glucocorticoids are
adrenocortical steroids, both
naturally occurring and synthetic, which are readily absorbed from the
gastrointestinal
tract. Prednisone, USP is a white to practically white, odorless,
crystalline powder. It is
very slightly soluble in water; slightly soluble in alcohol, in
chloroform, in dioxane, and in
methanol.
The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione,
17,21-dihydroxy-
and its molecular weight is 358.43
The structural formula is represented below:
Prednisone Tablets, USP are available in 5 strengths: 2.5 mg, 5 mg, 10
mg, 20 mg, and
50 mg. In addition, each tablet contains the following inactive
Ingredients: Lactose
Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl
Sulfate and
Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains
FD & C yellow #
6, aluminum lake, HT 15-18%.
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
Prednisone 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
Hypercalcemia associated with cancer
Nonsuppurative thyroiditis
2. RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration (to tide th