PREDNISOLONE SODIUM PHOSPHATE- prednisolone tablet, orally disintegrating

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Mylan Pharmaceuticals Inc.

INN (Међународно име):

PREDNISOLONE SODIUM PHOSPHATE

Састав:

PREDNISOLONE 21-PHOSPHATE 10 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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: During acute episodes in: For the treatment of: To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: During an exacerbation or as maintenance therapy in selected cases of: Prednisolone sodium phosphate orally disintegrating tablets are contraindicated in patients who are hypersensitive to corticosteroids such as prednisolone or any components of this product. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy. Based on findings from human and animal studies, corticosteroids

Резиме производа:

Prednisolone Sodium Phosphate Orally Disintegrating Tablets are available containing 13.4 mg, 20.2 mg or 40.3 mg of prednisolone sodium phosphate, USP equivalent to 10 mg, 15 mg or 30 mg of prednisolone. The 10 mg tablets are white to off-white, speckled, round, unscored tablets debossed with P10 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4710-22 bottles of 48 tablets The 15 mg tablets are white to off-white, speckled, round, unscored tablets debossed with P15 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4715-22 bottles of 48 tablets The 30 mg tablets are white to off-white, speckled, round, unscored tablets debossed with P30 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4730-22 bottles of 48 tablets Store at 20° to 25°C (68° to 77°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. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE TABLET, ORALLY
DISINTEGRATING
MYLAN PHARMACEUTICALS INC.
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity (5.10) 3/2020
INDICATIONS AND USAGE
Prednisolone sodium phosphate orally disintegrating tablets are a
corticosteroid indicated
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DOSAGE AND ADMINISTRATION
Individualize dosing based on disease severity and patient response:
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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:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
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)
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