PREDNISOLONE SODIUM PHOSPHATE ODT- prednisolone sodium phosphate tablet, orally disintegrating PREDNISOLONE SODIUM PHOSPHATE ta

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

Available from:

Prasco Laboratories

INN (International Name):

PREDNISOLONE SODIUM PHOSPHATE

Composition:

PREDNISOLONE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prednisolone Sodium Phosphate Orally Disintegrating Tablets are indicated in the treatment of the following diseases or conditions: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: - Atopic dermatitis - Drug hypersensitivity reactions - Seasonal or perennial allergic rhinitis - Serum sickness - Bullous dermatitis herpetiformis - Contact dermatitis - Exfoliative erythroderma - Mycosis fungoides - Pemphigus - Severe erythema multiforme (Stevens-Johnson syndrome) - Congenital adrenal hyperplasia - Hypercalcemia of malignancy - Nonsuppurative thyroiditis - Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable. During acute episodes in: - Crohn's Disease - Ulcerative colitis - Acquired (autoimmune) hemolytic anemia - Diamond-Blackfan anemia - Idiopathic thrombocytopenic purpura in

Product summary:

Prednisolone Sodium Phosphate Orally Disintegrating Tablets 13.4 mg prednisolone sodium phosphate (equivalent to 10 mg prednisolone base) is a white, flat faced, beveled tablet, debossed with ORA on one side and 10 on the other. Supplied as: Prednisolone Sodium Phosphate Orally Disintegrating Tablets 20.2 mg prednisolone sodium phosphate (equivalent to 15 mg prednisolone base) is a white, flat faced, beveled tablet, debossed with ORA on one side and 15 on the other. Supplied as: Prednisolone Sodium Phosphate Orally Disintegrating Tablets 40.3 mg prednisolone sodium phosphate (equivalent to 30 mg prednisolone base) is a white, flat faced, beveled tablets, debossed with ORA on one side and 30 on the other. Supplied as: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP controlled Room Temperature]. Protect from moisture. Do not break or use partial Prednisolone Sodium Phosphate Orally Disintegrating Tablets. Keep out of the reach of children.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PREDNISOLONE SODIUM PHOSPHATE ODT- PREDNISOLONE SODIUM
PHOSPHATE TABLET, ORALLY DISINTEGRATING
PREDNISOLONE SODIUM PHOSPHATE - PREDNISOLONE SODIUM
PHOSPHATE TABLET, ORALLY DISINTEGRATING
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREDNISOLONE SODIUM
PHOSPHATE ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR PREDNISOLONE SODIUM PHOSPHATE ORALLY DISINTEGRATING
TABLETS.
PREDNISOLONE SODIUM PHOSPHATE ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1955
INDICATIONS AND USAGE
Prednisolone Sodium Phosphate Orally Disintegrating Tablets are a
corticosteroid indicated
as an anti-inflammatory or immunosuppressive agent for certain
allergic, dermatologic,
gastrointestinal, hematologic, ophthalmologic, nervous system, renal,
respiratory, rheumatologic,
specific infectious diseases or conditions and organ transplantation
(1)
for the treatment of certain endocrine conditions (1)
for palliation of certain neoplastic conditions (1)
DOSAGE AND ADMINISTRATION
Individualize dosing based on disease severity and patient response:
Initial Dose: 10 mg to 60 mg of prednisolone (as 13.4 mg to 80.6 mg of
prednisolone sodium
phosphate) (2)
Maintenance Dose: Use lowest dosage that will maintain an adequate
clinical response (2)
Discontinuation: Withdraw gradually if discontinuing long-term or
high-dose therapy (2)
Take with food to avoid gastrointestinal (GI) irritation (2)
DO NOT BREAK OR USE PARTIAL PREDNISOLONE SODIUM PHOSPHATE ORALLY
DISINTEGRATING TABLETS. USE AN APPROPRIATE FORMULATION OF PREDNISOLONE
IF
INDICATED DOSE CANNOT BE OBTAINED USING PREDNISOLONE SODIUM PHOSPHATE
ORALLY
DISINTEGRATING TABLETS. (2)
DOSAGE FORMS AND STRENGTHS
Orally Disintegrating Tablets:
10 mg Tablets (as 13.4 mg prednisolone sodium phosphate) (3)
15 mg Tablets (as 20.2 mg prednisolone sodium phosphate) (3)
30 mg Tablets (as 40.3 mg prednisolone sodium phosphate) (3)
CONTRAINDICATIONS
Hypersensitivity to prednisolone or a