DEXTROSE

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

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 )

Only for intravenous infusion. Do not administer subcutaneous or intramuscularly. ( 2.1 ) Adults and Pediatric Patients 12 years of Age and Older Administer into a central vein or large peripheral vein. Recommended dosage is 10to 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 Administer into a central vein 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 o.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.

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 )

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.

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) ] .