Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR), POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)
CMP PHARMA, INC.
INTRAVENOUS
PRESCRIPTION DRUG
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) ] -
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 .
New Drug Application
POTASSIUM PHOSPHATES- MONOBASIC POTASSIUM PHOSPHATE AND DIBASIC POTASSIUM PHOSPHATE INJECTION CMP PHARMA, INC. ---------- 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 Przeczytaj cały dokument