POTASSIUM PHOSPHATES- potassium phosphate, monobasic potassium phosphate, dibasic injection, solution, concentrate

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Potassium Phosphate, Monobasic (UNII: 4J9FJ0HL51) (Potassium Cation - UNII:295O53K152, Phosphate Ion - UNII:NK08V8K8HR), Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Potassium Cation - UNII:295O53K152, Phosphate Ion - UNII:NK08V8K8HR)

Mevcut itibaren:

Fresenius Kabi USA, LLC

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Potassium Phosphates Injection is indicated as a source of phosphorus: - in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. - for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. Potassium Phosphates Injection is contraindicated in patients with: - hyperkalemia [see Warning and Precautions (5.3)] - severe renal impairment (eGFR less than 30 mL/min/1.73m2 ) or end stage renal disease [see Warning and Precautions (5.3)] - hyperphosphatemia [see Warning and Precautions (5.4)] - hypercalcemia or significant hypocalcemia [see Warning and Precautions (5.4)] Risk Summary Administration of the recommended dose of Potassium Phosphates Injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Potassium Phosphates Inj

Ürün özeti:

Potassium Phosphates Injection, USP is a clear and colorless solution supplied as phosphorus 3 mmol/mL and potassium 4.4 mEq/mL as shown: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Pharmacy Bulk Package vial: Discard within 4 hours of initial entry [see Dosage and Administration (2.3)]. For storage of admixed solution see Dosage and Administration 2.1, 2.3.

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

POTASSIUM PHOSPHATES- POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM
PHOSPHATE, DIBASIC INJECTION, SOLUTION, CONCENTRATE
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM PHOSPHATES
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
POTASSIUM
PHOSPHATES INJECTION.
POTASSIUM PHOSPHATES INJECTION, FOR INTRAVENOUS USE.
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
Potassium Phosphates Injection is a phosphorus replacement product
indicated as a source of
phosphorus:
in intravenous fluids to correct hypophosphatemia in adults and
pediatric patients when oral or enteral
replacement is not possible, insufficient or contraindicated. (1)
for parenteral nutrition in adults and pediatric patients when oral or
enteral nutrition is not possible,
insufficient or contraindicated. (1)
DOSAGE AND ADMINISTRATION
Administer intravenously only after dilution or admixing in a larger
volume of fluid. (2.1)
Potassium Phosphates Injection provides phosphorus 3 mmol/mL
(potassium 4.4 mEq/mL). (2.2, 2.4)
Monitor serum phosphorus, potassium, calcium, and magnesium
concentrations. (2.2, 2.4)
See full prescribing information for instructions on preparation and
administration. (2.1, 2.3)
Recommended Dosage for Correction of Hypophosphatemia in Intravenous
Fluids
POTASSIUM PHOSPHATES INJECTION is only for administration to a patient
with a serum potassium
concentration less than 4 mEq/dL; otherwise, use an alternative source
of phosphorus. (2.1)
The dosage is dependent upon the individual needs of the patient, and
the contribution of phosphorus
and potassium from other sources. (2.2)
See full prescribing information for recommendations on initial or
single dosing, repeated dosing,
concentration and infusion rate. (2.1, 2.2)
Recommended Dosage for Administration in Parenteral Nutrition
Individualize the dosage based upon the patient's clinical condition,
nutritional requirements, and the
contribution of oral or enteral phosphoru