Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Dextrose Injection, USP (50%) is supplied as a clear, colorless solution in single-dose containers as follows: Unit of Sale and Product Description Strength (Concentration) NDC Bundle of 10 50 mL Ansyr ® II Plastic Syringe with syringe and barrel detached 50% (25 g/50 mL) (0.5 g/mL) 0409-7517-16 Tray of 25 50 mL Single-Dose Fliptop Vials 50% (25 g/50 mL) (0.5 g/mL) 0409-6648-02 Storage and Handling Minimize exposure of Dextrose Injection (50%) to heat. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1027-9.0 Logo; PRINCIPAL DISPLAY PANEL - 50 mL Syringe Label - 0409-7517-66 50% DEXTROSE 50 mL Single-dose Rx only NDC 0409-7517-66 50% DEXTROSE Injection, USP 25 g/50 mL (0.5 g/mL) For intravenous use. Usual dosage: See insert. Sterile, nonpyrogenic. 2.53 mOsmol/mL (calc.). pH 4.2 (3.2 to 6.5) Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL-7117 LOT ##-###-AA EXP DMMMYYYY Principal Display Panel - 50 mL Syringe Label - 0409-7517-66; PRINCIPAL DISPLAY PANEL - 50 mL Syringe Carton - 0409-7517-66 50 mL NDC 0409-7517-66 50% DEXTROSE Injection, USP 25 g/50 mL (0.5 g/mL) Ansyr ® II Unit of Use Syringe Rx only LOT #####AA EXP DMMMYYYY Hospira ◀ PRESS AND PULL TO OPEN ▶ Principal Display Panel - 50 mL Syringe Carton - 0409-7517-66; PRINCIPAL DISPLAY PANEL - 50 mL Syringe Label - 0409-4902-64 50% DEXTROSE 50 mL Single-dose Rx only NDC 0409-4902-64 50% DEXTROSE Inj., USP 25 g/50 mL (0.5 g/mL) For intravenous use. Usual dosage: See insert. Sterile, nonpyrogenic. 2.53 mOsmol/mL (calc.) pH 4.2 (3.2 to 6.5) Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL–7116 LOT ##–###–AA EXP DMMMYYYY Principal Display Panel - 50 mL Syringe Label - 0409-4902-64; PRINCIPAL DISPLAY PANEL - 50 mL Syringe Carton - 0409-4902-64 50 mL NDC 0409-4902-64 50% DEXTROSE Injection, USP 25 g/50 mL (0.5 g/mL) LIFESHIELD ® Glass ABBOJECT ® Unit of Use Syringe with male luer lock adapter and 18-Gauge protected needle Rx only Hospira LOT #####AA EXP DMMMYYYY ◀ PRESS AND PULL TO OPEN Principal Display Panel - 50 mL Syringe Carton - 0409-4902-64; PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 0409-6648-16 50 mL Single-dose 50% Dextrose Injection, USP 25 grams/50 mL (0.5 g/mL) Distributed by Hospira, Inc. Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 0409-6648-16; PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 0409-6648-02 50 mL Single-dose Fliptop Vial Rx only NDC 0409-6648-02 Contains 25 of NDC 0409-6648-16 50% Dextrose Injection, USP 25 grams/50 mL (0.5 g/mL) Hospira Principal Display Panel - 50 mL Vial Tray - 0409-6648-02; PRINCIPAL DISPLAY PANEL - 50 mL Syringe Label - 0409-0505-15 50 mL Single-Dose Syringe Rx only NDC 0409-0505-15 50% DEXTROSE Inj., USP 25 g/50 mL (0.5 g/mL) For intravenous use. Recommended Dosage: See Prescribing Information. Sterile, nonpyrogenic. 2.53 mOsmol/mL (calc.) pH 3.2 to 6.5 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 50 mL Syringe Label - 0409-0505-15; PRINCIPAL DISPLAY PANEL - 50 mL Vial Carton - 0409-0505-15 PRESS AND PULL TO OPEN 50 mL NDC 0409-0505-15 Rx only 50% DEXTROSE Injection, USP 25 g/50 mL (0.5 g/mL) For intravenous use with male luer lock adapter Glass Abboject ® Single-Dose Syringe Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Carton - 0409-0505-15
- 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Dextrose Injection, USP (50%) is supplied as a clear, colorless solution in single-dose containers as follows: Unit of Sale and Product Description Strength (Concentration) NDC Bundle of 10 50 mL Ansyr ® II Plastic Syringe with syringe and barrel detached 50% (25 g/50 mL) (0.5 g/mL) 0409-7517-16 Tray of 25 50 mL Single-Dose Fliptop Vials 50% (25 g/50 mL) (0.5 g/mL) 0409-6648-02 Storage and Handling Minimize exposure of Dextrose Injection (50%) to heat. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1027-9.0 Logo
- PRINCIPAL DISPLAY PANEL - 50 mL Syringe Label - 0409-7517-66 50% DEXTROSE 50 mL Single-dose Rx only NDC 0409-7517-66 50% DEXTROSE Injection, USP 25 g/50 mL (0.5 g/mL) For intravenous use. Usual dosage: See insert. Sterile, nonpyrogenic. 2.53 mOsmol/mL (calc.). pH 4.2 (3.2 to 6.5) Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL-7117 LOT ##-###-AA EXP DMMMYYYY Principal Display Panel - 50 mL Syringe Label - 0409-7517-66
- PRINCIPAL DISPLAY PANEL - 50 mL Syringe Carton - 0409-7517-66 50 mL NDC 0409-7517-66 50% DEXTROSE Injection, USP 25 g/50 mL (0.5 g/mL) Ansyr ® II Unit of Use Syringe Rx only LOT #####AA EXP DMMMYYYY Hospira ◀ PRESS AND PULL TO OPEN ▶ Principal Display Panel - 50 mL Syringe Carton - 0409-7517-66
- PRINCIPAL DISPLAY PANEL - 50 mL Syringe Label - 0409-4902-64 50% DEXTROSE 50 mL Single-dose Rx only NDC 0409-4902-64 50% DEXTROSE Inj., USP 25 g/50 mL (0.5 g/mL) For intravenous use. Usual dosage: See insert. Sterile, nonpyrogenic. 2.53 mOsmol/mL (calc.) pH 4.2 (3.2 to 6.5) Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL–7116 LOT ##–###–AA EXP DMMMYYYY Principal Display Panel - 50 mL Syringe Label - 0409-4902-64
- PRINCIPAL DISPLAY PANEL - 50 mL Syringe Carton - 0409-4902-64 50 mL NDC 0409-4902-64 50% DEXTROSE Injection, USP 25 g/50 mL (0.5 g/mL) LIFESHIELD ® Glass ABBOJECT ® Unit of Use Syringe with male luer lock adapter and 18-Gauge protected needle Rx only Hospira LOT #####AA EXP DMMMYYYY ◀ PRESS AND PULL TO OPEN Principal Display Panel - 50 mL Syringe Carton - 0409-4902-64
- PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 0409-6648-16 50 mL Single-dose 50% Dextrose Injection, USP 25 grams/50 mL (0.5 g/mL) Distributed by Hospira, Inc. Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 0409-6648-16
- PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 0409-6648-02 50 mL Single-dose Fliptop Vial Rx only NDC 0409-6648-02 Contains 25 of NDC 0409-6648-16 50% Dextrose Injection, USP 25 grams/50 mL (0.5 g/mL) Hospira Principal Display Panel - 50 mL Vial Tray - 0409-6648-02
- PRINCIPAL DISPLAY PANEL - 50 mL Syringe Label - 0409-0505-15 50 mL Single-Dose Syringe Rx only NDC 0409-0505-15 50% DEXTROSE Inj., USP 25 g/50 mL (0.5 g/mL) For intravenous use. Recommended Dosage: See Prescribing Information. Sterile, nonpyrogenic. 2.53 mOsmol/mL (calc.) pH 3.2 to 6.5 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 50 mL Syringe Label - 0409-0505-15
- PRINCIPAL DISPLAY PANEL - 50 mL Vial Carton - 0409-0505-15 PRESS AND PULL TO OPEN 50 mL NDC 0409-0505-15 Rx only 50% DEXTROSE Injection, USP 25 g/50 mL (0.5 g/mL) For intravenous use with male luer lock adapter Glass Abboject ® Single-Dose Syringe Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Carton - 0409-0505-15
Overview
Dextrose, USP is chemically designated C 6 H 12 O 6 • H 2 O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following structural formula: Water for Injection, USP is chemically designated H 2 O. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. Dextrose Injection, USP (50%) is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection. Each milliliter (mL) of fluid contains 0.5 grams of dextrose, hydrous which delivers 3.4 kcal/gram (0.85 kcal/mL). The solution has an osmolarity of 2.53 mOsmol/mL (calculation) and the pH range is 3.2 to 6.5. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The Dextrose Injection (50%) vial contains no more than 600 mcg/L of aluminum. The solution contains no bacteriostatic, antimicrobial agent or added buffer (except for pH adjustment) and is supplied as single-dose containers. Dextrose is derived from corn. Chemical Structure
Indications & Usage
Dextrose (50%) Injection is indicated for the treatment of insulin-induced hypoglycemia (e.g., hyperinsulinemia, insulin shock) in adults and pediatric patients 2 years of age and older. Dextrose Injection (50%) is indicated for the treatment of insulin-induced hypoglycemia (e.g., hyperinsulinemia, insulin shock) in adults and pediatric patients 2 years of age and older. ( 1 )
Dosage & Administration
• Only for intravenous infusion. Do not administer subcutaneously or intramuscularly. ( 2.1 ) • Adults and Pediatric Patients 12 Years of Age and Older o Administer into a central vein or large peripheral vein. o Recommended dosage is 10 to 25 grams (20 to 50 mL) administered once. Repeated doses may be administered as clinically appropriate. ( 2.2 ) • Pediatric Patients 2 to 11 Years of Age o Administer into a central vein. o Appropriate dosage depends on the age, weight, clinical and metabolic conditions of the patient, and concomitant therapy. ( 2.2 ) • Maximum rate of dextrose administration without producing hyperglycemia is 0.5 g/kg of body weight/hour. ( 2.2 ) • See full prescribing information for more information on preparation and administration instructions. ( 2.1 , 2.2 ) 2.1 Important Preparation and Administration Instructions • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use Dextrose Injection (50%) if the solution is cloudy or the seal has been broken. • Obtain a blood glucose level prior to administering Dextrose Injection (50%). However, in an emergency, administer Dextrose Injection (50%) promptly without awaiting blood glucose test results. • Do not administer Dextrose Injection (50%) simultaneously with blood through the same infusion set because pseudoagglutination of red blood cells may occur. • Administer Dextrose Injection (50%) intravenously. Do not administer Dextrose Injection (50%) subcutaneously or intramuscularly. • Discard the unused portion. 2.2 Recommended Dosage and Administration Adults and Pediatric Patients 12 Years of Age and Older When possible, administer Dextrose Injection (50%) into a central vein or large peripheral vein because Dextrose Injection (50%) has an osmolarity greater than 900 mOsm/L and can cause venous irritation. The recommended dosage of Dextrose Injection (50%) is 10 to 25 grams (20 to 50 mL) of Dextrose Injection (50%), administered once via intravenous infusion. Repeated doses may be administered as clinically appropriate. Slowly infuse Dextrose Injection (50%) to reduce the risk of developing hyperglycemia and to minimize venous irritation [see Warnings and Precautions (5.1 , 5.3) ] . The maximum rate at which Dextrose Injection (50%) can be infused without producing hyperglycemia is 0.5 g/kg of body weight/hour. Pediatric Patients 2 to 11 Years of Age Administer Dextrose Injection (50%) into a central vein. Avoid administration of Dextrose Injection (50%) into a peripheral vein because Dextrose Injection (50%) has an osmolarity greater than 900 mOsm/L and can cause venous irritation [ Warnings and Precautions (5.3) ] . If central venous access cannot be obtained, consider using an alternative commercially available dextrose product with a lower concentration. The appropriate dosage of Dextrose Injection (50%) depends on the age, weight, clinical and metabolic conditions of the patient, and concomitant therapy. Slowly infuse Dextrose Injection (50%) to reduce the risk of developing hyperglycemia and to minimize venous irritation [see Warnings and Precautions (5.1 , 5.3 )] . The maximum rate at which Dextrose Injection (50%) can be infused without producing hyperglycemia is 0.5 g/kg of body weight/hour.
Warnings & Precautions
• Hyperglycemia or Hyperosmolar Syndrome : Monitor blood and urine glucose; administer insulin as needed. ( 5.1 ) • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion immediately if reaction occurs. ( 5.2 ) • Phlebitis and Thrombosis : Remove catheter as soon as possible if thrombophlebitis develops. ( 2.1 , 5.3 ) • Electrolyte Imbalance and Fluid Overload : Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration. ( 5.4 ) • Hyponatremia : Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. ( 5.5 ) • Potential Aluminum Toxicity for Patients with Immature or Impaired Renal Function : Prolonged administration of Dextrose Injection (50%) may lead to toxic levels of aluminum in pediatric patients with immature renal function or renal impairment, and in adults with renal impairment. ( 5.6 ) 5.1 Hyperglycemia and Hyperosmolar Hyperglycemic State Significant hyperglycemia and hyperosmolar hyperglycemic state may result from too rapid administration of Dextrose Injection (50%). Symptoms of hyperosmolar hyperglycemic state include mental confusion and loss of consciousness . To minimize these risks, slowly infuse Dextrose Injection (50%) and monitor blood and urine glucose during treatment with Dextrose Injection (50%). If Dextrose Injection (50%) is abruptly discontinued, patients should receive 5% or 10% dextrose injection to avoid rebound hypoglycemia. 5.2 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (50%) administration [see Adverse Reactions (6) ] . Stop administration of Dextrose Injection (50%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated. 5.3 Phlebitis and Thrombosis Dextrose Injection (50%) is hypertonic (has an osmolarity greater than 900 mOsm/L) and may cause phlebitis and thrombosis at the site of injection. If thrombophlebitis occurs, remove the catheter as soon as possible. Administer Dextrose Injection (50%) via slow intravenous infusion into a central vein (when possible) to reduce the risk of phlebitis and thrombosis. Ensure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis occurs, stop administration of Dextrose Injection (50%) and initiate corrective measures. Avoid administration of Dextrose Injection (50%) into a peripheral vein in pediatric patients 2 to 11 years old. If central venous access cannot be obtained in these pediatric patients, consider using an alternative commercially available dextrose product with a lower concentration. Do not administer Dextrose Injection (50%) subcutaneously or intramuscularly. 5.4 Electrolyte Imbalance and Fluid Overload Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (50%). Depending on the administered volume and the infusion rate, administration of Dextrose Injection (50%) can cause fluid overload including pulmonary edema. Avoid Dextrose Injection (50%) 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. 5.5 Hyponatremia Dextrose Injection (50%) 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 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) and Use in Specific Populations (8.4) ] . Avoid Dextrose Injection (50%) 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 (5.4) ] . 5.6 Potential Aluminum Toxicity for Patients with Immature or Impaired Renal Function Dextrose Injection (50%) contains up to 600 mcg/L of aluminum. Prolonged administration of Dextrose Injection (50%) may lead to toxic levels of aluminum in pediatric patients with immature renal function. Due to the potential for excessive aluminum exposure, Dextrose Injection (50%) is not approved for pediatric patients younger than 2 years of age. Parenteral aluminum exposure greater than 4 to 5 mcg/kg/day has been associated with central nervous system and bone toxicity in this age group. Prolonged administration of Dextrose Injection (50%) may also lead to toxic levels of aluminum in adults and pediatric patients with renal impairment.
Contraindications
Dextrose Injection (50%) is contraindicated in patients with: • Intracranial or intraspinal hemorrhage because Dextrose Injection (50%) can worsen cerebral edema by causing a fluid shift across the blood-brain barrier. • Severe dehydration because of the potential to worsen the patient’s hyperosmolar state. • Alcohol withdrawal because of the potential to precipitate Wernicke encephalopathy (WE) or cardiomyopathy in thiamine-deficient patients. • Known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ] . • Intracranial or intraspinal hemorrhage. ( 4 ) • Severe dehydration. ( 4 ) • Alcohol withdrawal. ( 4 ) • Known hypersensitivity to dextrose. ( 4 )
Adverse Reactions
The following clinically significant adverse reactions are also described elsewhere in the labeling: • Hyperglycemia and Hyperosmolar Syndrome [see Warnings and Precautions (5.1) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] • Phlebitis and Thrombosis [see Warnings and Precautions (5.3) ] • Electrolyte Imbalance and Fluid Overload [see Warnings and Precautions (5.4) ] • Hyponatremia [see Warnings and Precautions (5.5) ] The following adverse reactions associated with the use of Dextrose Injection were identified in clinical trials or postmarketing reports. Because 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 drug exposure. Administration site conditions: blister, extravasation, phlebitis, erythema, pain, vein damage, thrombosis Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritis, pyrexia, rash Cardiovascular disorders: cyanosis, volume overload The most common adverse reactions are hyperglycemia, hypersensitivity reactions, hyponatremia, infection (both systemic and at the injection site), vein thrombosis, phlebitis, and electrolyte imbalance. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Effects on Glycemic Control and Electrolyte Balance: Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance. Avoid use of Dextrose Injection in patients receiving drugs associated with hyponatremia. ( 7.1 ) 7.1 Drugs with Effects on Glycemic Control and Electrolyte Balance Dextrose Injection (50%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions (5.1 , 5.4 , 5.5) ] . Monitor patients’ blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance. Concomitant administration of Dextrose Injection (50%) 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 (50%) 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) ] .
Storage & Handling
Storage and Handling Minimize exposure of Dextrose Injection (50%) to heat. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1027-9.0 Logo
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