DEXTROSE

Dextrose, USP is chemically designated D-glucose monohydrate, (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water, with 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 (25%) is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for intravenous injection. Each milliliter (mL) of fluid contains 0.25 grams of dextrose, hydrous, which delivers 3.4 kcal/gram (0.85 kcal/mL). The solution has an osmolarity of 1.39 mOsmol/mL (calculation) and the pH range is 3.2 to 6.5. May contain hydrochloric acid and sodium hydroxide for pH adjustment. The solution contains no bacteriostatic, antimicrobial agent or added buffer (except for pH adjustment) and is supplied in a single-dose Ansyr™ Plastic Syringe. Dextrose is derived from corn. structural formula dextrose, usp

Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients from birth up to 2 years of age. Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients younger than 2 years old. ( 1 )

Only for intravenous infusion. Do not administer subcutaneously or intramuscularly. ( 2.1 ) The recommended initial dose is 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg). If clinically indicated, additional single doses of 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg) may be administered. ( 2.2 ) Infusion rate depends on the age, weight, and clinical and metabolic conditions of the patient and concomitant therapy. ( 2.2 ) See full prescribing information for more information on preparation, administration instructions, and dosing considerations. ( 2.1 , 2.2 ) 2.1 Important Preparation and Administration Instructions Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration. Do not use Dextrose Injection (25%) if the solution is cloudy or the seal has been broken. Obtain blood glucose level prior to administering Dextrose Injection (25%). However, in cases of emergency, administer Dextrose Injection (25%) promptly without awaiting blood glucose test results. Administer Dextrose Injection (25%) via slow intravenous injection into a central vein to reduce the risk of developing hyperglycemia and to minimize venous irritation [see Warnings and Precautions (5.1 , 5.3 ) ] . Do not administer Dextrose Injection (25%) simultaneously with blood through the same infusion set because pseudoagglutination of red blood cells may occur. Administer Dextrose Injection (25%) intravenously. Do not administer Dextrose Injection (25%) subcutaneously or intramuscularly. Discard the unused portion. 2.2 Recommended Dosage The recommended initial dose of Dextrose Injection (25%) is 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg). If clinically indicated, additional single doses of Dextrose Injection (25%) 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg) may be administered. Select the appropriate infusion rate based on the age, weight, and clinical and metabolic conditions of the patient.

Dextrose Injection (25%) is contraindicated in patients with: Intracranial or intraspinal hemorrhage because Dextrose Injection (25%) 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. Known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ]. Intracranial or intraspinal hemorrhage. ( 4 ) Severe dehydration. ( 4 ) Hypersensitivity to dextrose. ( 4 )

The following clinically significant adverse reactions are also described elsewhere in the labeling: Hyperglycemia and Hyperosmolar Hyperglycemic State [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.

7.1 Drugs with Effects on Glycemic Control and Electrolyte Balance Dextrose Injection (25%) 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 (25%) 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 (25%) 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) ] .