Dextrose - B. Braun Medical Inc. | B. Braun US Pharmaceutical Manufacturing LLC

• Dextrose Injection (70%) is not for direct intravenous infusion. Prior to administration, Dextrose Injection (70%) must be diluted with other compatible intravenous fluids and used as a PN admixture.
• Visually inspect the PN solution to ensure precipitates or cloudiness have not formed during the mixing or addition of additives. Discard container if precipitates or cloudiness are observed.
• Administer the PN admixture containing Dextrose Injection (70%) via intravenous infusion into a central or peripheral vein. The choice of a peripheral or central venous route should depend on the osmolarity of the final infusate. Infuse PN admixtures with osmolarity of 900 mOsmol/L or greater through a central catheter to avoid venous irritation [see Warnings and Precautions (5.5)].
• If admixed or infused with lipid emulsion, do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer.
• Use of a final filter is recommended during administration of parenteral solutions, where possible.
• Discard the unused portion.

To Open

• Do not remove from overwrap until ready to use. Inspect overwrap.
  Do not use if overwrap has been damaged. (Figure 1)

• Do not use unless solution is clear and closure is intact.

• Tear overwrap starting from the tear notches. (Figure 2)

• Inspect the container for minute leaks by squeezing inner bag firmly. If leaks are found, discard the bag as sterility may be impaired.

• Because additives may be incompatible, evaluate all additions for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If it is deemed advisable to introduce additives, use aseptic technique and mix thoroughly.

• 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 [see Warnings and Precautions (5.2)].

Preparation for Admixing

1. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). (Figure 3)

2. Hang bag on suitable fixture (Figure 4)

3. Do not use/penetrate blocked port (see Figure 5, left upper corner).

4. Remove aluminum foil of set port at the bottom of container.

5. Attach suitable transfer device or compounding set (Figure 5). Refer to complete directions accompanying device.

6. Once container closure has been penetrated, withdrawal of content should be completed within 4 hours.

• To reduce the risk of air embolism, adhere to the following preparation instructions for Dextrose Injections (70%):
  • Use a non-vented infusion set or close the vent on a vented set
  • Use a dedicated line without any connections (do not connect flexible containers in series).
  • Do not pressurize the flexible container to increase flow rates
  • If using a pumping device, turn off pump before the container is empty.
• Inspect the final PN admixture containing Dextrose Injections (70%) to ensure that:
  • precipitates have not formed during mixing or addition of additives and inspect again before administration.
  • emulsion has not separated, if lipids have been added. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion.
  • Discard the PN admixture if any precipitates are observed or emulsion has separated.

Dextrose Injection (70%) is a part of the parenteral nutrition (PN) regimen which also includes amino acids, electrolytes, and possibly lipid emulsion. Protein, caloric, fluid and electrolyte requirements all need to be taken into consideration when determining individual patient dosage needs.

Individualize the dosage of Dextrose Injection based on the patient’s clinical condition (ability to adequately metabolize dextrose), body weight, nutritional and fluid requirements, as well as additional calories given orally or enterally to the patient. Vitamins and trace elements and other components (including amino acids, electrolytes, and lipid emulsion) can be added to the PN solution to meet nutrient needs and prevent deficiencies and complications from developing.

The administration rate should be governed, especially during the first few days of therapy, based on the patient’s tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of blood glucose levels.

In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria.

Consider gradual decrease in flow rate in the last hour of infusion to reduce the risk of hypoglycemia [see Warnings and Precautions (5.3)].

Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypoglycemia. Closely monitor blood glucose concentration during treatment with Dextrose Injection (70%) to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

Pulmonary vascular precipitates causing pulmonary vascular emboli (including some fatalities) and respiratory distress have been reported in patients receiving parenteral nutrition.

Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates; however, precipitates have also been reported even in the absence of phosphate salt in the solution. Precipitation following passage through an in-line filter and suspected in vivo precipitate formation has also been reported.

Visually inspect the prepared PN admixture containing Dextrose Injection (70%), the infusion set, and catheter for precipitates, prior to administration as well as periodically during the administration. If signs of respiratory distress or pulmonary embolism occur, stop the PN infusion and initiate a medical evaluation.

The use of Dextrose Injection (70%) in patients with impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death.

Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration, and electrolyte losses [see Warnings and Precautions (5.11) , Use in Specific Populations (8.4)]. Patients with underlying CNS disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state.

Monitor blood glucose levels and treat hyperglycemia to maintain levels within normal limits while administering the PN admixture containing Dextrose Injection (70%). Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection (70%) administration.

Hypersensitivity reactions, including anaphylaxis, have been reported with dextrose [see Adverse Reactions (6)]. Stop administration of the PN admixture containing Dextrose Injection (70%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

Dextrose Injection (70%) is for admixture with amino acids or dilution with other compatible intravenous fluids. It is not for direct intravenous infusion. Administer solutions with an osmolarity of ≥ 900 mOsm/L through a central vein. The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis [see Dosage and Administration (2.1) ]. If thrombophlebitis develops, remove the catheter as soon as possible.

Dextrose Injection (70%) may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. The risk of hospital-acquired hyponatremia is increased in younger pediatric patients, geriatric patients, patients treated with diuretics, and patients with cardiac or pulmonary failure or with the syndrome of inappropriate antidiuretic hormone (SIADH) (e.g., postoperative patients, patients concomitantly treated with arginine vasopressin analogs or certain antiepileptic, psychotropic, and cytotoxic drugs)  [see Drug Interactions (7.1), Use in Specific Populations (8.4) ].

Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema. To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-based balance, and signs of neurologic complications.

Avoid Dextrose Injection (70%) in patients with or at risk for hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations, chloride concentrations, fluid status, acid-base balance, and neurologic status [see Warnings and Precautions (5.11)].

Patients who receive parenteral nutrition (PN), including admixtures containing Dextrose Injection (70%), are at high risk of infections because the nutritional components of PN can support microbial growth; patients on long-term parenteral nutrition may have additional risk factors for infection (e.g., immunosuppression related to malnutrition, other conditions, or concomitant drug use); and they receive the parenteral nutrition through intravenous catheters.

To decrease the risk of infectious complications, ensure aseptic technique are used for catheter placement, catheter maintenance, and the preparation and administration of PN containing Dextrose Injection (70%). Monitor for signs and symptoms of infections, including fever and chills, as well as laboratory test results that might indicate infection (including leukocytosis and hyperglycemia) and perform frequent checks of the intravenous catheter insertion site for edema, redness, and discharge.

Administering PN, including admixtures containing Dextrose Injection (70%), to severely undernourished patients may result in refeeding syndrome, which is characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, closely monitor severely undernourished patients and slowly increase nutrient intake.

Risk of Parenteral Nutrition Associated Liver Disease

Parenteral nutrition-associated liver disease (PNALD), also referred to as intestinal failure-associated liver disease (IFALD), can present as cholestasis or hepatic steatosis, and may progress to steatohepatitis with fibrosis and cirrhosis (possibly leading to chronic hepatic failure). The etiology of PNALD is multifactorial; however, intravenously administered phytosterols (plant sterols) contained in plant-derived lipid formulations have been associated with development of PNALD.

Other Hepatobiliary Disorders

Hepatobiliary disorders including cholecystitis and cholelithiasis have developed in some parenteral nutrition-treated patients without preexisting liver disease.

Monitor liver tests when administering PN admixtures containing Dextrose Injection (70%). Patients developing signs of hepatobiliary disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.

Dextrose Injection (70%) contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Preterm neonates are particularly at risk because their kidneys are immature, and they require large amounts of concomitant calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including preterm neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system (CNS) and bone toxicity. Tissue loading may occur at even lower rates of administration.

Exposure to aluminum from Dextrose Injection (70%) when administered at the maximum recommended dosage is not more than 0.5 mcg/kg/day [see Description (11)].

When prescribing Dextrose Injection (70%) for use in PN solutions containing other small volume parenteral products, limit the total daily patient exposure to aluminum in the PN admixture to no more than 5 mcg/kg/day [see Use in Specific Populations (8.4) ].

Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions.

Depending on the volume and infusion rate, Dextrose Injection (70%) can cause fluid overload, including pulmonary edema.

Avoid Dextrose Injection (70%) in patients at risk for fluid and/or solute overload. If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations, and acid-base balance, especially during prolonged use. Additional monitoring is recommended for patients with water and electrolyte disturbances that could be aggravated by increased glucose, insulin administration and/or free water load.

Dextrose Injection (70%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions (5.1, 5.3 , 5.6 , 5.7 )]. Monitor patients’ blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance.

Concomitant administration of  Dextrose Injection (70%)  with drugs associated with hyponatremia may increase the risk of developing hyponatremia. Drugs associated with hyponatremia include diuretics and those that cause SIADH (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), arginine vasopressin analogs, certain antiepileptic, psychotropic, and cytotoxic drugs).

Avoid use of Dextrose Injection (70%) in patients receiving drugs associated with hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.6)].

Risk Summary

Appropriate administration of Dextrose Injection (70%) during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. However, maternal hyperglycemia secondary to infusion of glucose-containing products at the time of delivery has been associated with adverse neonatal outcomes such as neonatal hypoglycemia. Malnutrition in pregnant women is associated with adverse maternal and fetal outcomes (see Clinical Considerations). Animal reproduction studies have not been conducted with injectable dextrose solutions.

The 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

Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake.

Risk Summary

There are no data on the effects of Dextrose Injection (70%) on levels of glucose in human milk, on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dextrose Injection (70%) and any potential adverse effects on the breastfed infant from Dextrose Injection (70%) or from the underlying maternal condition.

Dextrose Injection (70%) is indicated in pediatric patients as a source of calories and fluid replenishment when mixed with amino acids or other compatible intravenous fluids for patients requiring parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypo- or hyperglycemia. Therefore, they need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

Dextrose Injection (70%) can cause imbalances in fluid and electrolytes in pediatric patients and requires close monitoring of volume status and plasma electrolyte concentrations, particularly in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Pediatric patients are at increased risk for developing hyponatremic encephalopathy [see Warnings and Precautions (5.6)].

In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage.

Pediatric patients may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.9) ].

Dextrose Injection (70%) contains aluminum that may be associated with central nervous system and bone toxicity. Preterm infants and pediatric patients up to 2 years of age receiving prolonged parenteral nutrition treatment with Dextrose Injection (70%) may be at higher risk for aluminum toxicity due to multiple factors, including immature renal function [see Warnings and Precautions (5.10) ].

Dextrose Injection (70%) has not been studied in sufficient number of patients aged 65 and over to determine whether they respond differently from younger subjects. Geriatric patients are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.6)]. Other reported clinical experience has not identified differences in responses between the geriatric and younger patients. In general, the infusion rate for geriatric patients should start slow and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload.

Dextrose is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (70%) may be greater in patients with impaired renal function. Because geriatric patients are more likely to have impaired renal function, care should be taken in selection of infusion rate and patients should be closely monitored during Dextrose Injection (70%) treatment.

Dextrose  provides a source of carbohydrate calories and is used to supplement nutrition by providing glucose parenterally.

The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose have not been fully characterized.

Dextrose is oxidized to carbon dioxide and water.

Studies with dextrose to evaluate its carcinogenic potential, mutagenic potential, or effects on fertility have not been performed.