DELTASONE- prednisone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sonoma Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prednisone tablets and solutions 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; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 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

Product summary:

PredniSONE Tablets USP 20 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 760” debossed on the other side. NDC 69668-220-20 Bottles of 20 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DELTASONE- PREDNISONE TABLET
SONOMA PHARMACEUTICALS, INC.
----------
DELTASONE TABLETS USP
RX ONLY
DESCRIPTION
Prednisone Tablets USP are available for oral administration
containing either 1 mg, 2.5 mg, 5 mg, 10
mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the
following inactive ingredients: lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinized starch, sodium starch
glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only).
Prednisone Oral Solution USP is formulated for oral administration
containing 5 mg per 5 mL of
prednisone USP and alcohol 5%. The oral solution contains the
following inactive ingredients:
anhydrous citric acid, edetate disodium, fructose, hydrochloric acid,
maltol, peppermint oil,
polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate,
vanilla flavor and purified water.
Prednisone _Intensol™_ Oral Solution (Concentrate) is formulated for
oral administration containing 5 mg
per mL of prednisone USP and alcohol 30%. In addition, the oral
solution contains the following
inactive ingredients: anhydrous citric acid, poloxamer 188, propylene
glycol and purified water.
Prednisone tablets contain prednisone which is a glucocorticoid.
Glucocorticoids are adrenocortical
steroids, both naturally occurring and synthetic, which are readily
absorbed from the gastrointestinal
tract. The chemical name for prednisone is
17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The
structural formula is represented below:
C
H
O
M.W. 358.44
C
H
O
M.W. 358.44
Prednisone is a white to partially white, crystalline powder. It is
very slightly soluble in water; slightly
soluble in alcohol, chloroform, dioxane, and methanol.
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
are primarily used for their potent anti-inflammatory effects in
disorders of many organ systems.
Glucocorticoids cause pro