Prescription Drugs

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

Potassium Chloride in Sodium Chloride Injection, USP in Plastic Container (potassium chloride in sodium chloride injection) VIAFLEX Plus Container DESCRIPTION Potassium Chloride in Sodium Chloride Injection, USP is a sterile, nonpyrogenic, solution for fluid and electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1. Table 1 Size (mL) Composition (g/L) *Osmolarity (mOsmol/L) (Calc.) pH Ionic Concentration (mEq/L) Sodium Chloride, USP (NaCl) Potassium Chloride, USP (KCl) Sodium Potassium Chloride 20 mEq/L Potassium Chloride in 0.45% Sodium Chloride Injection, USP 1000 4.5 1.5 194 5.5 (3.5 to 6.5) 77 20 97 20 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP 1000 9 1.5 348 5.5 (3.5 to 6.5) 154 20 174 40 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP 1000 9 3 388 5.5 (3.5 to 6.5) 154 40 194 *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions ( > 600 mOsmol/L) may cause vein damage. 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 Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 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 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 Sodium Chloride Injection, USP in VIAFLEX Plus Plastic Container is available as follows: Code Size (mL) NDC Product Name 2B1357 1000 0338-0704-34 20 mEq/L Potassium Chloride in 0.45% Sodium Chloride Injection, USP 2B1764 1000 0338-0691-04 20 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP 2B1984 1000 0338-0695-04 40 mEq/L Potassium Chloride in 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 (25o C/77o F); brief exposure up to 40o C (104o F) 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. For Product Information 1-800-933-0303. Rev. March 2005. FDA Rev date: 5/1/2005

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

OVERDOSE No information provided. CONTRAINDICATIONS None known

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 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 Sodium Chloride 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. The intravenous administration of Potassium Chloride in 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 Sodium Chloride Injection, USP may result in sodium or potassium retention. 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 Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin. Pregnancy: Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with Potassium Chloride in Sodium Chloride Injection, USP. It is also not known whether Potassium Chloride in Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed. Carcinogenesis, mutagenesis, impairment of fertility Studies with Potassium Chloride in Sodium Chloride 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 Sodium Chloride Injection, USP is administered to a nursing mother. Pediatric Use Safety and effectiveness of Potassium Chloride in Sodium Chloride 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. For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended. Geriatric Use Clinical studies of Potassium Chloride in Sodium Chloride 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 other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Do not administer unless solution is clear and seal is intact.