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. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. Dextrose Injection, USP (5%) is a clear, sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after admixture with a single-dose powdered or liquid (up to 10 mL) drug vial [see Dosage and Administration (2.1) ] . Partial-fill containers, designed to facilitate admixture, are available in 50 mL, 100 mL, and 250 mL sizes. See Table 1 for the content and characteristics of this solution. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is supplied as single-dose containers. The pH is 4.3 (range is 3.2 to 6.5). Table 1. Contents and Characteristics of 5% Dextrose Injections, USP Strength Fill Volume Amount of Dextrose Hydrous per Container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous per Container mOsmol per Liter 5% Dextrose Injection, USP (50 mg/mL) 50 mL 2.5 grams 8.5 253 100 mL 5 grams 17 253 250 mL 12.5 grams 42.5 253 Dextrose is derived from corn. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. structural formula dextrose

Dextrose Injection (5%) is indicated as a source of water and calories in adult and pediatric patients and may also be used as a diluent for reconstitution of a powder or liquid drug product. Dextrose Injection (5%) is indicated as a source of water and calories in adult and pediatric patients and may also be used as a diluent for reconstitution of a powder or liquid drug product. ( 1 )

• Only for intravenous infusion. ( 2.1 ) • Infusion rate depends on the age, weight, clinical, and metabolic conditions of the patient and concomitant therapy. See full prescribing information for more information on preparation, administration, and dosing considerations. ( 2.1 , 2.2 , 2.3 ) 2.1 Important Administration Instructions Dextrose Injection (5%) 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. • To avoid venous irritation, consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater [see Warnings and Precautions (5.4) ] . • Do not administer Dextrose Injection (5%) simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. • Use of a final filter is recommended during administration of parenteral solutions, where possible. • Discard the unused portion. • Do not use the Dextrose Injection (5%) ADD-Vantage TM diluent containers with chemotherapy agents. 2.2 Important Preparation Information Visually inspect the Dextrose Injection (5%) for particulate matter and discoloration. Do not administer Dextrose Injection (5%) if the solution is cloudy, there are precipitates, and the container is damaged. To reduce the risk of air embolism, adhere to the following preparation instructions for Dextrose Injection (5%): • 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 to administer Dextrose Injection (5%), turn off the pump before the container is empty. To Open : • Peel overwrap at corner and remove solution container. o Use unit within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date. • 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. To Assemble Vial and Flexible Diluent Container : 1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Once the breakaway cap has been removed, do not access the vial with the syringe. b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.) 2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.) 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately. To Reconstitute the Drug : 1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.) 3. Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 4. Mix container contents thoroughly and use within the specified time. 5. Look through the bottom of the vial to verify that the stopper has been removed and complete mixing has occurred. (SEE FIGURE 7.) If the rubber stopper is not removed from the vial, and the medication is not released on the first attempt, the inner cap may be manipulated back into the rubber stopper without removing the drug vial from the diluent container. Repeat steps 3 through 5. Preparation for Administration: 1. Confirm the activation and admixture of vial contents. 2. Check for leaks by squeezing the container firmly. If leaks are found, discard the unit because sterility may be compromised. 3. Close the flow control clamp of the administration set. 4. Remove the cover from the outlet port at the bottom of the container. 5. Insert the piercing pin of the administration set into the port with a twisting motion until the pin is firmly seated. Note: See full directions on the administration set carton. 6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend the container from the hanger. 7. Squeeze and release the drip chamber to establish the proper fluid level in the chamber. 8. Open the flow control clamp and clear air from set. Close clamp. 9. Attach the set to the venipuncture device. If the device is not indwelling, prime and make venipuncture. 10. Regulate the rate of administration with the flow control clamp. Do not use the flexible container in series connections. Fig.1 and Fig. 2 Fig. 3 Fig 4 Fig 5 Fig 6 and Fig 7 2.3 Dosage Considerations 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%) administration rate should be based on the patient’s tolerance of dextrose, especially for preterm neonates 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) ] .

Dextrose Injection (5%) is contraindicated in patients with: • Clinically significant hyperglycemia [see Warnings and Precautions (5.2) ] . • Known hypersensitivity to dextrose [see Warnings and Precautions (5.3) ] . • Clinically significant hyperglycemia. ( 4 ) • Known hypersensitivity to dextrose. ( 4 )

The following clinically significant adverse reactions are also described elsewhere in the labeling: • Neonatal Hypoglycemia [see Warnings and Precautions (5.1) ] • Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.2) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] • Phlebitis and Thrombosis [see Warnings and Precautions (5.4) ] • Hyponatremia [see Warnings and Precautions (5.5) ] • Electrolyte Imbalance, Fluid Overload and Hypervolemia [see Warnings and Precautions (5.6) ] • Refeeding Syndrome [see Warnings and Precautions (5.7) ] The following adverse reactions associated with the use of Dextrose Injection (5%) 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 possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Administration site conditions: blister, erythema, extravasation, pain, phlebitis, vein damage, thrombosis Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritus, 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 (5%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions ( 5.1 , 5.2 , 5.5 , 5.6 )] . Monitor patients’ blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance. Concomitant administration of Dextrose Injection (5%) 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%) 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) ].