Sodium glycerophosphate

Glycophos is indicated as a source of phosphorus in adults and pediatric patients 12 years and older as part of parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. Glycophos is a phosphorus replacement product indicated as a source of phosphorus in adults and pediatric patients 12 years and older as part of parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Sodium glycerophosphate, an organic phosphate salt, functions as a source of phosphorus. Phosphorus in the form of organic and inorganic phosphate has a variety of biochemical functions in all organs and tissues, including critical roles in nucleic acid structure, energy storage and transfer, cell signaling, cell membrane composition and structure, acid-base balance, mineral homeostasis, and bone mineralization.

Important Administration Information Glycophos is not for direct intravenous infusion. Glycophos must be diluted and used as a PN admixture. Check serum phosphorus and calcium concentrations and normalize calcium concentration prior to administration. Important Preparation Instructions Calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium-phosphate precipitates. The sodium amount is 2 mEq/mL (46 mg/mL) and should be factored into the total sodium dose calculation for the prepared PN admixture. See full prescribing information for instructions on preparation and administration. Recommended Dosage Glycophos provides phosphorus 1 mmol/mL (sodium 2 mEq/mL).

Glycophos is contraindicated in patients with: Hyperphosphatemia. Hypernatremia. Hypercalcemia or hypocalcemia. eGFR less than 30 mL/min/1.73 m 2 or patients receiving dialysis treatment. History of a hypersensitivity reaction to sodium glycerophosphate or any of the inactive ingredients. Reactions have included anaphylaxis. Hyperphosphatemia. Hypernatremia. Hypercalcemia or hypocalcemia eGFR less than 30 mL/min/1.73 m 2 and patients receiving dialysis treatment history of a hypersensitivity reaction to sodium glycerophosphate or any of the inactive ingredients

Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. Hyperphosphatemia and Hypocalcemia: Monitor serum phosphorus and calcium concentrations during and following infusion. Risk of Sodium Retention: Closely monitor patients with congestive heart failure, renal impairment, cirrhosis, and other conditions with risk for edema and/or sodium retention. Consider all sources of sodium, including concomitant use of sodium-retaining drugs, and adjust dose as needed. Hypersensitivity Reactions: Monitor for signs or symptoms and discontinue infusion if reactions occur. Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants. Hypomagnesemia: Reported in patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment.

The following clinically significant adverse reactions are described elsewhere in the labeling: Pulmonary Embolism Due to Pulmonary Vascular Precipitates. Hyperphosphatemia and Hypocalcemia. Risk of Sodium Retention. Hypersensitivity Reactions. Aluminum Toxicity. Hypomagnesemia. Vein Damage and Thrombosis. The following adverse reactions associated with use of intravenous Glycophos ( Table 1 ) were identified in clinical studies or postmarketing reports. Given that some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure.

Drugs with Effects on Sodium Retention Concomitant use of Glycophos with sodium-retaining drugs (e.g., corticosteroids, corticotropin or non-steroidal anti-inflammatory agents) may lead to edema due to fluid retention. Monitor patients for swelling and weight gain. If edema occurs, consider modifying the Glycophos dosage or discontinue the concomitant sodium-retaining drug.

Store at 20°C to 25°C (68°F to 77°F). Pharmacy Bulk Package vial: Use within 4 hours after initial container closure penetration when stored at room temperature 20°C to 25°C (68°F to 77°F). Store the PN admixture containing Glycophos under refrigeration at 2°C to 8°C (36°F to 46°F), for no longer than 24 hours.