PREDNISONE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

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Download Ciri produk (SPC)
19-09-2023

Bahan aktif:

PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT)

Boleh didapati daripada:

PD-Rx Pharmaceuticals, Inc.

INN (Nama Antarabangsa):

PREDNISONE

Komposisi:

PREDNISONE 20 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 Duri

Ringkasan produk:

Prednisone Tablets, USP are available in the following strengths and package sizes: 20 mg - Peach, round tablets debossed with "TL 175" on one side and scored on the other side. NDC 43063-703-05 Bottle of 5 Tablets NDC 43063-703-06 Bottle of 6 Tablets NDC 43063-703-09 Bottle of 9 Tablets NDC 43063-703-10 Bottle of 10 Tablets NDC 43063-703-12 Bottle of 12 Tablets NDC 43063-703-14 Bottle of 14 Tablets NDC 43063-703-15 Bottle of 15 Tablets NDC 43063-703-18 Bottle of 18 Tablets NDC 43063-703-20 Bottle of 20 Tablets NDC 43063-703-21 Bottle of 21 Tablets NDC 43063-703-25 Bottle of 25 Tablets NDC 43063-703-30 Bottle of 30 Tablets Store at 20° to 25° C (68° to 77° F) [See USP Room Temperature]. Revised 09/2021

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

                                PREDNISONE- PREDNISONE TABLET
PD-RX 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 the
patient over an acute
episode or exacer
                                
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