Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)
Mylan Pharmaceuticals Inc.
PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE 21-PHOSPHATE 10 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE TABLET, ORALLY DISINTEGRATING MYLAN PHARMACEUTICALS INC. ---------- 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 • • • DOSAGE AND ADMINISTRATION Individualize dosing based on disease severity and patient response: • • • • 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: • • • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • • • 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 Preberite celoten dokument