Prescription Drugs

CLINICAL PHARMACOLOGY Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP has value asa source of water and calories. It is capable of inducing diuresis depending on the clinical condition of the patient

Dextrose (dextrose (hydrous dextrose)) Injection, Solution DESCRIPTION Dextrose (hydrous dextrose) Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, and caloric content are shown in Table 1. Table 1 Size (mL) *Dextrose Hydrous, USP (g/L) Osmolarity (mOsmol/L) (calc.) pH Caloric Content (kcal/L) 5% Dextrose Injection, USP 25 Quad pack 50 Single pack Quad pack 50 252 4.0 (3.2 to 6.5) 170 Multi pack 100 Single pack Quad pack Multi pack 150 250 500 1000 10% Dextrose Injection, USP 250 500 1000 100 505 4.0 (3.2 to 6.5) 340 The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e. g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological test for plastic containers as well as by tissue culture toxicity studies.

INDICATIONS Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP is indicated as a source of water and calories. DOSAGE AND ADMINISTRATION As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment. Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives. HOW SUPPLIED Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP in VIAFLEX plastic container is available as follows: Code Size ( mL) NDC Product Name 2B0080 25 Quad pack 0338-0017-10 5% Dextrose Injection, USP 2B0086 50 Single pack 0338-0017-41 2B0081 Quad pack 0338-0017-11 5% Dextrose Injection, USP 2B0088 Multi pack 0338-0017-31 2B0087 100 Single pack 0338-0017-48 2B0082 Quad pack 0338-0017-18 2B0089 Multi pack 0338-0017-38 2B0061 150 0338-0017-01 5% Dextrose Injection, USP 2B0062 250 0338-0017-02 2B0063 500 0338-0017-03 2B0064 1000 0338-0017-04 2B0162 250 0338-0023-02 2B0163 500 0338-0023-03 10% Dextrose Injection, USP 2B0164 1000 0338-0023-04 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25deg;C/ 77deg;F); brief exposure up to 40deg;C/ 104deg;F does not adversely affect the product. Directions For Use Of Viaflex Plastic Container Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. To Open Tear overwrap down side at slit and remove solution 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. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow “ To Add Medication” directions below. Preparation for Administration Suspend container from eyelet support. Remove plastic protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set. To Add Medication Warning: Additives may be incompatible. To add medication before solution administration Prepare medication site. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. To add medication during solution administration Close clamp on the set. Prepare medication site. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Remove container from IV pole and/or turn to an upright position. Evacuate both ports by squeezing them while container is in the upright position. Mix solution and medication thoroughly. Return container to in-use position and continue administration. Baxter Healthcare Corporation, Deerfield, IL 60015 USA. FDA revision date: n/a

PATIENT INFORMATION No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

OVERDOSE No information provided. CONTRAINDICATIONS Solutions containing dextrose (hydrous dextrose (hydrous dextrose) ) may be contraindicated in patients with known allergy to corn or corn products.

SIDE EFFECTS Reactions which may occur because of the injection or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. DRUG INTERACTIONS No information provided.

WARNINGS Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. Excessive administration of dextrose (hydrous dextrose (hydrous dextrose) ) injections may result in significant hypokalemia. In very low birth weight infants, excessive or rapid administration of dextrose (hydrous dextrose (hydrous dextrose) ) injection may result in increased serum osmolality and possible intracerebral hemorrhage. PRECAUTIONS Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus. Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Dextrose Injection, USP. It is also not known whether Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP should be given to a pregnant woman only if clearly needed. Pediatric Use Dextrose (hydrous dextrose (hydrous dextrose) ) is safe and effective for the stated indications in pediatric patients (see INDICATIONS AND USAGE). As reported in the literature, the dosage selection and constant infusion rate of intravenous dextrose (hydrous dextrose (hydrous dextrose) ) must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose (hydrous dextrose (hydrous dextrose) ) is prescribed to pediatric patients, particularly neonates and low birth weight infants. Geriatric Use Clinical studies of Dextrose (hydrous dextrose (hydrous dextrose) ) Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy. Do not administer unless solution is clear and seal is intact.