POTASSIUM PHOSPHATES- monobasic potassium phosphate and dibasic potassium phosphate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR), POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)

Available from:

CMP PHARMA, INC.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

POTASSIUM PHOSPHATES INJECTION is indicated as a source of phosphorus in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated. POTASSIUM PHOSPHATES INJECTION is indicated as a source of phosphorus for parenteral nutrition in adults weighing at least 45 kg and pediatric patients 12 years of age and older weighing at least 40 kg when oral or enteral nutrition is not possible, insufficient or contraindicated. Limitations of Use Safety has not been established for parenteral nutrition in adults weighing less than 45 kg or pediatric patients less than 12 years of age or weighing less than 40 kg due to the risk of aluminum toxicity [see Warnings and Precautions (5.5), Use in Specific Population (8.4) ]. POTASSIUM PHOSPHATES INJECTION is contraindicated in patients with: - hyperkalemia [see Warnings and Precautions (5.3) ] - hyperphosphatemia [see Warnings and Precautions (5.4) ] -

Product summary:

POTASSIUM PHOSPHATES INJECTION, USP: phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 71 mEq/15 mL (4.7 mEq/mL) as a clear and colorless solution supplied in a 15 mL single-dose glass vial (NDC 46287-024-15) in a ten count carton (NDC 46287-024-10). Store at 2°C to 8°C (36°F to 46°F). Do not freeze. For storage of admixed solution see Dosage and Administration 2.2, 2.4 .

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM PHOSPHATES- MONOBASIC POTASSIUM PHOSPHATE AND DIBASIC
POTASSIUM
PHOSPHATE INJECTION
CMP PHARMA, INC.
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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: (1)
in intravenous fluids to correct hypophosphatemia in adults and
pediatric patients 12 years of age and older when oral
or enteral replacement is not possible, insufficient or
contraindicated. (1.1)
for parenteral nutrition in adults weighing at least 45 kg and
pediatric patients 12 years of age and older weighing at least
40 kg when oral or enteral nutrition is not possible, insufficient or
contraindicated. (1.2)
Limitations of Use: Safety has not been established for parenteral
nutrition in adults weighing less than 45 kg or
pediatric patients less than 12 years of age or weighing less than 40
kg due to the risk of aluminum toxicity. (1.2, 5.5,
8.4)
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 4.7 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: (2)
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 phosphate.
(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 info