PREDNISONE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

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Download Ciri produk (SPC)
21-07-2010

Bahan aktif:

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

Boleh didapati daripada:

STAT RX USA LLC

INN (Nama Antarabangsa):

PREDNISONE

Komposisi:

PREDNISONE 10 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Prednisone tablets are indicated in the following conditions: 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. 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. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupu

Ringkasan produk:

Prednisone Tablets USP, 5 mg: White, round tablets, scored on one side and “West-ward 475” debossed on the other side. Each tablet contains 5 mg of prednisone for oral administration. Blister Pack of 21 tablets NDC# 45802-733 -21 Blister Pack of 48 tablets NDC# 45802-733 -67 Prednisone Tablets USP, 10 mg: White, round tablets, scored on one side and “West-ward 473” debossed on the other side. Each tablet contains 10 mg of prednisone for oral administration. Blister Pack of 21 tablets NDC# 45802-303 -21 Blister Pack of 48 tablets NDC# 45802-303 -67 Store at 20-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Manufactured by: West-ward Pharmaceutical Corporation Eatontown, NJ 07724 DISTRIBUTED BY PERRIGO® ALLEGAN, MI 49010 PREDNISONE TABLETS Revised 09/07 0P800 RC J4

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

                                PREDNISONE - PREDNISONE TABLET
STAT RX USA LLC
----------
PREDNISONE TABLETS
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 C21H26O5. Chemically, it is 17,21-dihydroxypregna-1,
4-diene-3,11, 20-trione and has
the following structural formula:
PREDNISONE DP 10MG STRUCTURE IMAGE
Prednisone is a white to practically white, odorless, crystalline
powder and has a molecular weight of
358.44. It melts at about 230°C with some decomposition. Prednisone
is very slightly soluble in water,
slightly soluble in alcohol, chloroform, dioxane, and methanol.
Each tablet, for oral administration, contains 5 mg or 10 mg of
prednisone.
Inactive ingredients:
5 MG: anhydrous lactose, colloidal silicon dioxide, magnesium
stearate, microcrystalline cellulose,
sodium starch glycolate, and talc.
10 MG: anhydrous lactose, colloidal silicon dioxide, magnesium
stearate, microcrystalline cellulose,
sodium starch glycolate, and talc.
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, such as prednisone, cause profound and varied
metabolic effects. In addition, they
modify the body’s immune response to diverse stimuli.
INDICATIONS AND USAGE
Prednisone tablets are indicated in the following conditions:
_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, hypercalce
                                
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