DEXTROSE - Baxter Healthcare Corporation | Bieffe Medital SA

• Dextrose Injection (5% and 10%) is intended for intravenous use.

• Use a peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L.
• Consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater to avoid venous irritation [see Warnings and Precautions (5.4)].
• Avoid administering Dextrose Injection (5% and 10%) simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. If there is only a single IV access, flush the line thoroughly with normal saline before and after blood product administration.
• Use of a final filter is recommended during administration of parenteral solutions, where possible.
• It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.
• Use promptly; do not store solutions containing additives.
• Discard the unused portion.
• To determine if chemotherapy agents are compatible with Dextrose solutions, consult the specific chemotherapy agent prescribing information to determine if Dextrose is the appropriate diluent.

Visually inspect the Dextrose Injection (5% and 10%) for particulate matter and discoloration. Do not administer Dextrose Injection (5% and 10%) if the solution is cloudy, there are precipitates, or the container is damaged.

To reduce the risk of air embolism, adhere to the following preparation instructions for Dextrose Injection (5% and 10%):

• 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).
• The use of pressure infusion is not recommended as a method to increase flow rates. However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion.
• If using a pumping device to administer Dextrose Injection (5% and 10%), turn off the pump before the container is empty.

To Open

• Do not remove from overpouch until ready to use.
• Tear overwrap down side at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks.
• Visually inspect the container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Evaluate the following:
  • oIf the outlet port protector is damaged, detached, or not present, discard container.
  • oCheck to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals.
  • oCheck for minute leaks by squeezing the inner bag firmly. If leaks are found, discard container.

Preparation for Administration

1. 1.Suspend container from eyelet support.
2. 2.Remove protector from outlet port at bottom of container.
3. 3.Attach administration set. Refer to complete directions accompanying set.

To Add Medication

• Additives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible.
• Consult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique.
• When introducing additives, consult the instructions for use of the medication to be added and other relevant literature.
• Before adding a substance or medication, verify that it is soluble and/or stable in Dextrose Injection and that the pH range of Dextrose Injection is appropriate.

To Add Medication Before Solution Administration

1. 1.Prepare medication site.
2. 2.Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
3. 3.Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
4. 4.After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals.

To Add Medication During Solution Administration

1. 1.Close clamp on the set.
2. 2.Prepare medication site.
3. 3.Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
4. 4.Remove container from IV pole and/or turn to an upright position.
5. 5.Evacuate both ports by squeezing them while container is in the upright position.
6. 6.Mix solution and medication thoroughly.
7. 7.After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals, do not use.
8. 8.Return container to in-use position and continue administration.

The choice of dextrose concentration, rate, and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy.

Dextrose Injection (5% and 10%) patients’ tolerance of dextrose, especially for premature infants with low birth weight.

Increase the infusion rate gradually as needed; frequently monitor blood glucose concentrations to avoid hyperglycemia [see Warnings and Precautions (5.2 ), Use in Specific Populations (8.4)].

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 (5% and 10%) to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

The use of Dextrose Injection (5% and 10%) 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 (5.6),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 Dextrose Injection (5% and 10%). Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection (5% and 10%) administration.

Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (5% and 10%) administration [see Adverse Reactions (6)]. Stop administration immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

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 (5% and 10%) 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)].

Avoid Dextrose Injection (5% and 10%) in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations, chloride concentrations, fluid status, acid-base balance, and neurologic status [see Warnings and Precautions (5.6)].

Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (5% and 10%).

Depending on the administered volume and infusion rate, Dextrose Injection (5% and 10%) can cause fluid overload, including pulmonary edema.

Avoid Dextrose Injection (5% and 10%) in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, 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.

Refeeding severely undernourished patients may result in refeeding syndrome, 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, monitor severely undernourished patients and slowly increase nutrient intake.

Dextrose Injection (5% and 10%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)]. Monitor patient’s blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance.

Concomitant administration of Dextrose Injection (5% and 10%) 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 (5% and 10%) in patients receiving drugs associated with hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5)].

Risk Summary

Dextrose Injection (5% and 10%) has been used for decades during labor and delivery. Although there are a few case reports that describe adverse effects of dextrose use in other stages of pregnancy, exposure during pregnancy in general is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with dextrose.

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.

Risk Summary

Dextrose Injection (5% and 10%) has been used for decades and is not expected to cause harm to a breastfed infant. There are no data on the effects of Dextrose Injection (5% and 10%) 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 (5% and 10%) and any potential adverse effects on the breastfed infant from Dextrose Injection (5% and 10%) or from the underlying maternal condition.

Dextrose Injection (5% and 10%) is indicated in pediatric patients as a source of water and calories, and may also be used as a diluent for reconstitution of a powder or liquid drug product.

Neonates, especially premature infants 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 (5% and 10%) 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(5.5, 5.6)].

In very low birth weight infants, excessive or rapid administration of Dextrose Injection (5% and 10%) may result in increased serum osmolality and risk of intracerebral hemorrhage.

Dextrose Injection (5% and 10%) has not been studied insufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Geriatric patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.5)]. Other reported clinical experience has not identified differences in responses between the geriatric and younger adult patients. In general, the infusion rate for geriatric patients should start low and be titrated up cautiously, reflecting their greater risk for electrolyte abnormalities and fluid overload.

Dextrose Injection (5% and 10%) is known to be substantially excreted by the kidney, and the risk of adverse reactions to Dextrose Injection (5% and 10%) 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 (5% and 10%) 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 the drug’s carcinogenic potential, mutagenic potential, or effects on fertility have not been performed.