Prescription Drugs

CLINICAL PHARMACOLOGY Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP has value as a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

Potassium Chloride in 5% Dextrose and Sodium Chloride (potassium chloride in 5% dextrose and sodium chloride injection) Injection, USP in Plastic Container Viaflex® Plus Container DESCRIPTION Potassium Chloride in 5% Dextrose and Sodium Chloride (potassium chloride in 5% dextrose and sodium chloride injection) Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Table 1 Size (mL) Composition(g/L) *Osmolarity (mOsmol/L) (calc.) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) **Dextrose Hydrous, USP Sodium Chloride, USP (NaCl) Potassium Chloride, USP (KCl) Sodium Potassium Chloride Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP mEq Potassium 10 mEq 1000 50 2 0.75 341 4.5 (3.5 to 6.5) 34 10 44 170 20 mEq 1000 50 2 1.5 361 4.5 34 20 54 170 10 mEq 500 (3.5 to 6.5) 30 mEq 1000 50 2 2.24 381 4.5 (3.5 to 6.5) 34 30 64 170 40 mEq 1000 50 2 3 401 4.5 (3.5 to 6.5) 34 40 74 170 Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection, USP mEq Potassium 20 mEq 1000 50 3.3 1.5 405 4.5 56 20 76 170 10 mEq 500 (3.5 to 6.5) 30 mEq 1000 50 3.3 2.24 425 4.5 (3.5 to 6.5) 56 30 86 170 40 mEq 1000 50 3.3 3 446 4.5 (3.5 to 6.5) 56 40 96 170 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP mEq Potassium 10 mEq 1000 50 4.5 0.75 426 4.5 (3.5 to 6.5) 77 10 87 170 20 mEq 1000 50 4.5 1.5 447 4.5 77 20 97 170 10 mEq 500 (3.5 to 6.5) 30 mEq 1000 50 4.5 2.24 466 4.5 (3.5 to 6.5) 77 30 107 170 40 mEq 1000 50 4.5 3 487 4.5 (3.5 to 6.5) 77 40 117 170 Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP mEq Potassium 20 mEq 1000 50 9 1.5 601 4.5 (3.5 to 6.5) 154 20 174 170 40 mEq 1000 50 9 3 641 4.5 (3.5 to 6.5) 154 40 194 170 *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions ( ≥ 600 mOsmol/L) may cause vein damage. D-Glucose monohydrate The Viaflex® Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146®Plastic). Viaflex®Plus on the container indicates the presence of a drug additive in a drug vehicle. The Viaflex®Plus plastic container system utilizes the same container as the Viaflex®plastic container system. 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 tests for plastic containers as well as by tissue culture toxicity studies.

INDICATIONS Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP is indicated as a source of water, electrolytes 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. Use of a final filter is recommended during administration of all parenteral solutions, where possible. All injections in Viaflex® Plus 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 Potassium Chloride in 5% Dextrose and Sodium Chloride (potassium chloride in 5% dextrose and sodium chloride injection) Injection, USP in Viaflex®Plus plastic container is available as follows: Code Size (mL) NDC Product Name 2B1604 1000 0338-0661-04 10 mEq/L Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP 2B1614 1000 0338-0663-04 20 mEq/L Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP 2B1613 500 0338-0663-03 2B1624 1000 0338-0665-04 30 mEq/L Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP 2B1634 1000 0338-0667-04 40 mEq/L Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP 2B1474 1000 0338-0603-04 20 mEq/L Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection, USP 2B1473 500 0338-0603-03 2B1484 1000 0338-0605-04 30 mEq/L Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection, USP 2B1494 1000 0338-0607-04 40 mEq/L Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection, USP 2B1644 1000 0338-0669-04 10 mEq/L Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 2B1654 1000 0338-0671-04 20 mEq/L Potassium Chloride in 5% Dextrose and 2B1653 500 0338-0671-03 0.45% Sodium Chloride Injection, USP 2B1664 1000 0338-0673-04 30 mEq/L Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 2B1674 1000 0338-0675-04 40 mEq/L Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 2B2434 1000 0338-0803-04 20 mEq/L Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP 2B2454 1000 0338-0807-04 40 mEq/L Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C);brief exposure up to 40°C does not adversely affect the product. Directions for Use of Viaflex® Plus 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 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. Rev.November 2001. FDA revision date: 8/31/2005

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

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

SIDE EFFECTS Reactions which may occur because of the solution 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 Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention. Potassium Chloride in 5% Dextrose and Sodium Chloride (potassium chloride in 5% dextrose and sodium chloride injection) Injection, USP should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present. Injections containing carbohydrates with low electrolyte concentration should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis. The container label for these injections bears the statement: Do not administer simultaneously with blood. The intravenous administration of Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection. In patients with diminished renal function, administration of Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP may result in sodium or potassium retention. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage. Potassium salts should never be administered by IV push. 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. Caution must be exercised in the administration of Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin. Potassium Chloride in 5% Dextrose and Sodium Chloride (potassium chloride in 5% dextrose and sodium chloride injection) 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 Potassium Chloride in 5% Dextrose and Sodium Chloride (potassium chloride in 5% dextrose and sodium chloride injection) Injection, USP. It is also not known whether Potassium Chloride in 5% Dextrose and Sodium Chloride (potassium chloride in 5% dextrose and sodium chloride injection) Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed. Pediatric Use Safety and effectiveness of Potassium Chloride in 5% Dextrose and Sodium Chloride (potassium chloride in 5% dextrose and sodium chloride injection) Injection, USP in pediatric patients have not been established by adequate and well-controlled studies. However, the use of potassium chloride injection in pediatric patients to treat potassium deficiency states when oral replacement therapy is not feasible is referenced in the medical literature. Dextrose is safe and effective for the stated indications in pediatric patients (see INDICATIONS AND DOSAGE). As reported in the literature, the dosage selection and constant infusion rate of intravenous 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 is prescribed to pediatric patients, particularly neonates and low birth weight infants. Carcinogenesis, mutagenesis, impairment of fertility Studies with Potassium Chloride in 5% Dextrose and Sodium Chloride (potassium chloride in 5% dextrose and sodium chloride injection) Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP is administered to a nursing mother. For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended. Do not administer unless solution is clear and seal is intact.