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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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)

Available from:

Amneal Pharmaceuticals Private Limited

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 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)]. - Hyperphosphatemia [see Warning and Precautions (5.4)]. - Hypercalcemia or significant hypocalcemia [see Warning and Precautions (5.4)] .  - Severe renal impairment (eGFR less than 30 mL/min/1.73 m2 ) or end stage renal disease [see Warning and Precautions (5.3)] . 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 injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Phosphorus is an essential mineral element. Parenteral supplementation with potassium phosphates should be considered if a pregnant woman’s requirements cannot be fulfilled by oral or enteral intake. Risk Summary Phosphorus and potassium are present in human milk. Administration of the recommended dose of potassium phosphates injection is not expected to cause harm to a breastfed infant. There is no information on the effects of potassium phosphates on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for potassium phosphates injection and any potential adverse effects on the breastfed child from potassium phosphates injection or from underlying maternal condition. Safety and effectiveness of potassium phosphates injection have been established in pediatric patients as a source of phosphorus: - in intravenous fluids to correct hypophosphatemia when oral or enteral replacement is not possible, insufficient, or contraindicated. - for parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated. Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with potassium phosphates injection may be at higher risk of aluminum toxicity [see Warnings and Precautions (5.6)] . In general, dose selection of potassium phosphates injection for an elderly patient should be cautious, starting at the low end of the dosing range because of the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. It may be useful to monitor renal function during treatment [see Use in Specific Populations (8.6)] . Potassium and phosphorus are known to be substantially excreted by the kidney and the risk of adverse reactions to potassium phosphates injection may be greater in patients with impaired renal function [see Warnings and Precautions (5.3, 5.4, 5.5)] . Potassium phosphates injection is contraindicated due to the risk of hyperkalemia in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2 ) or end stage renal disease [see Contraindications (4)] . In patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 ), start at the low end of the dosage range and monitor serum potassium, phosphorus, calcium and magnesium concentrations [see Dosage and Administration (2.2, 2.4)].

Product summary:

Potassium Phosphates Injection, USP is a sterile clear, colorless solution supplied as phosphorus 3 mmol/mL and potassium 4.4 mEq/mL as shown: Product Code Unit of Sale Strength Each 1693 NDC 80830-1693-5 Carton containing 25 units Phosphorus 15 mmol/5 mL and Potassium 22 mEq/5 mL NDC 80830-1693-1 10 mL single-dose, polypropylene vial NDC 80830-1693-3 Carton containing 5 units 1691 NDC 80830-1691-5 Carton containing 25 units Phosphorus 45 mmol/15 mL and Potassium 66 mEq/15 mL NDC 80830-1691-1 20 mL single-dose, polypropylene vial NDC 80830-1691-2 Carton containing 10 units 1692 NDC 80830-1692-5 Carton containing 25 units Phosphorus 150 mmol/50 mL and Potassium 220 mEq/50 mL NDC 80830-1692-1 50 mL fill Pharmacy Bulk Package, polypropylene vial NDC 80830-1692-2 Carton containing 10 units 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM PHOSPHATES- POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM
PHOSPHATE, DIBASIC INJECTION, SOLUTION, CONCENTRATE
AMNEAL PHARMACEUTICALS PRIVATE LIMITED
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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 ente