sodium chloride and potassium chloride - Generic Medications

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: 20 mEq/ L Potassium Chloride in 0.45% Sodium Chloride Inj., USP Composition (g/L) Calculated Osmolarity (mOsmol/L) pH (range) Ionic Concentrations (mEq/L) NDC No. Size (mL) Sodium Chloride (NaCl) Potassium Chloride (KCl) Sodium (Na+) Potassium (K+) Chloride (Cl-) 0409-9257-39 1000 4.5 1.49 194 4.8 (3.5 to 6.5) 77 20 97 0990-9257-39 1000 4.5 1.49 194 4.8 (3.5 to 6.5) 77 20 97 The flexible 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. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.

Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See Table for summary of content and characteristics of these solutions. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid and/or electrolyte replenishers. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 0. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

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 *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. 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 The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

Each 100 mL of 20 mEq Potassium Chloride in 0.9% Sodium Chloride Injection (20 mEq K + /L) contains: Sodium Chloride USP 0.9 g Potassium Chloride USP 0.15 g; Water for Injection USP qs pH may be adjusted with Hydrochloric Acid NF pH: 5.6 (3.5–6.5) Calculated Osmolarity: 350 mOsmol/L Concentration of Electrolytes (mEq/L): Sodium 154 Potassium 20 Chloride 174 Potassium Chloride in 0.9% Sodium Chloride Injection is sterile, nonpyrogenic, hypertonic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44 Potassium Chloride USP KCl 74.55 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container .