PREDNISONE tablet PREDNISONE solution PREDNISONE INTENSOL solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

PREDNISONE

Composition:

PREDNISONE 1 mg

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) Acute rheumatic carditis Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Acute exacerbations of multiple sclerosis Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement Systemic fungal infections and known hypersensitivity to components.

Product summary:

PredniSONE Tablets, USP 1 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 092” debossed on the other side. NDC 0054-8739-25: 10x10 Unit-Dose NDC 0054-4741-25: Bottle of 100 Tablets NDC 0054-4741-31: Bottle of 1,000 Tablets 2.5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 339” debossed on the other side. NDC 0054-8740-25: 10x10 Unit-Dose NDC 0054-4742-25: Bottle of 100 Tablets 5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 612” debossed on the other side. NDC 0054-8724-25: 10x10 Unit-Dose NDC 0054-4728-25: Bottle of 100 Tablets NDC 0054-4728-31: Bottle of 1,000 Tablets 10 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 899” debossed on the other side. NDC 0054-0017-20: 10x10 Unit-Dose NDC 0054-0017-25: Bottle of 100 Tablets NDC 0054-0017-29: Bottle of 500 Tablets 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 0054-0018-20: 10x10 Unit-Dose NDC 0054-0018-25: Bottle of 100 Tablets NDC 0054-0018-29: Bottle of 500 Tablets 50 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 343” debossed on the other side. NDC 0054-0019-20: 10x10 Unit-Dose NDC 0054-0019-25: Bottle of 100 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF. PROTECT FROM MOISTURE. PredniSONE Oral Solution USP, 5 mg per 5 mL Clear, colorless, slightly viscous solution. NDC 0054-3722-50: Bottle of 120 mL NDC 0054-3722-63: Bottle of 500 mL 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. PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL Clear, colorless, slightly viscous solution. NDC 0054-3721-44: Bottle of 30 mL with calibrated oral syringe (graduations of 0.25 mL [1.25 mg] to 1 mL [5 mg] on the syringe) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense only in the bottle and only with the calibrated oral syringe provided. Discard opened bottle after 90 days. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000278/04 Revised February 2024

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNISONE- PREDNISONE TABLET
PREDNISONE- PREDNISONE SOLUTION
PREDNISONE INTENSOL- PREDNISONE INTENSOL SOLUTION, CONCENTRATE
HIKMA PHARMACEUTICALS USA INC.
----------
PREDNISONE TABLETS, USP
PREDNISONE ORAL SOLUTION, USP
PREDNISONE _INTENSOL_™ ORAL SOLUTION (CONCENTRATE)
RX ONLY
DESCRIPTION
Prednisone 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 partially white, crystalline
powder. It is very slightly
soluble in water; slightly soluble in alcohol, chloroform, dioxane,
and methanol.
The chemical name for prednisone is
17,21-dihydroxypregna-1,4-dienne-3,11,20-trione.
The structural formula is represented below:
Each tablet, for oral administration, contains 1, 2.5, 5, 10, 20, or
50 mg of prednisone.
PredniSONE Oral Solution contains 5 mg prednisone per 5 mL, and
PredniSONE
_Intensol_
Oral Solution (Concentrate) contains 5 mg prednisone per mL.
_Inactive Ingredients:_
PredniSONE Tablets, USP contain 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 contains alcohol 5% and the following
inactive
ingredients: anhydrous citric acid, edetate disodium, fructose,
hydrochloric acid, maltol,
peppermint oil, polysorbate 80, propylene glycol, saccharin sodium,
sodium benzoate,
C
H
O M.W. 358.44
21
26
5
_TM_
vanilla flavor and purified water.
PredniSONE _Intensol™_ Oral Solution (Concentrate) contains alcohol
30% and the
following inactive ingredients: anhydrous citric acid, poloxamer 188,
propylene glycol
and purified water.
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