Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE SODIUM CHLORIDE AND POTASSIUM CHLORIDE ICU MEDICAL INC. FDA Approved 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 Tables 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, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: 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 O. 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 in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the 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

Drug Facts

Composition & Profile

Strengths
5 % 0.225 % 0.45 % 0.9 %
Quantities
1000 count 1000 ml 100 ml 500 ml
Treats Conditions
Indications And Usage These Solutions Are Indicated In Patients Requiring Parenteral Administration Of Potassium Chloride With Minimal Carbohydrate Calories And Sodium Chloride

Identifiers & Packaging

Container Type BOTTLE
UNII
660YQ98I10 451W47IQ8X LX22YL083G
Packaging

HOW SUPPLIED Intravenous solutions with potassium chloride (I.V. solution with KCl) are supplied in single-dose flexible plastic containers. See Tables: TABLE 1 Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Inj., USP COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na+) Potassium (K+) Chloride (Cl–) Approximate kcal/L NDC NO. 20 mEq 1000 50 2.25 1.49 370 4.2 (3.5 to 6.5) 38.5 20 58.5 170 0409-7901-09 1 20 mEq 1000 50 2.25 1.49 370 4.2 (3.5 to 6.5) 38.5 20 58.5 170 0990-7901-09 1 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. TABLE 2 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Inj., USP COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na+) Potassium (K+) Chloride (Cl–) Approximate kcal/L NDC NO. 10 mEq 1000 50 4.5 0.745 426 4.2 (3.5 to 6.5) 77 10 87 170 0409-7993-09 2 10 mEq 1000 50 4.5 0.745 426 4.2 (3.5 to 6.5) 77 10 87 170 0990-7993-09 1,2 10 mEq 500 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 0409-7902-03 2 10 mEq 500 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 0990-7902-03 1,2 20 mEq 1000 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 0409-7902-09 1,2 20 mEq 1000 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 0990-7902-09 1,2 30 mEq 1000 50 4.5 2.24 467 4.2 (3.5 to 6.5) 77 30 107 170 0409-7903-09 1 30 mEq 1000 50 4.5 2.24 467 4.2 (3.5 to 6.5) 77 30 107 170 0990-7903-09 1 40 mEq 1000 50 4.5 2.98 487 4.2 (3.5 to 6.5) 77 40 117 170 0409-7904-09 1,2 40 mEq 1000 50 4.5 2.98 487 4.2 (3.5 to 6.5) 77 40 117 170 0990-7904-09 1,2 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. TABLE 3 Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Inj., USP COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na+) Potassium (K+) Chloride (Cl–) Approximate kcal/L NDC NO. 20 mEq 1000 50 9 1.49 600 4.2 (3.5 to 6.5) 154 20 174 170 0409-7107-09 2 20 mEq 1000 50 9 1.49 600 4.2 (3.5 to 6.5) 154 20 174 170 0990-7107-09 1,2 40 mEq 1000 50 9 2.98 640 4.2 (3.5 to 6.5) 154 40 194 170 0409-7109-09 2 40 mEq 1000 50 9 2.98 640 4.2 (3.5 to 6.5) 154 40 194 170 0990-7109-09 1,2 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. May contain HCl for pH adjustment. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: December, 2020 1 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 2 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA IFU0000280; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000044 20 mEq POTASSIUM 1000 mL NDC 0990-7107-09 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.9% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 149 mg; SODIUM CHLORIDE 900 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 20 mEq; SODIUM 154 mEq; CHLORIDE 174 mEq. 600 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx only 3 v CONTAINS DEHP IMP0000044 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000044; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000045 40 mEq POTASSIUM 1000 mL NDC 0990-7109-09 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.9% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 298 mg; SODIUM CHLORIDE 900 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 40 mEq; SODIUM 154 mEq; CHLORIDE 194 mEq. 640 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP IMP0000045 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000045; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4420 30 mEq POTASSIUM 1000 mL NDC 0990-7903-09 30 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 224 mg; SODIUM CHLORIDE 450 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 30 mEq; SODIUM 77 mEq; CHLORIDE 107 mEq. 467 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP IM-4420 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4420; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4421 40 mEq POTASSIUM 1000 mL NDC 0990-7904-09 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 298 mg; SODIUM CHLORIDE 450 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 40 mEq; SODIUM 77 mEq; CHLORIDE 117 mEq. 487 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP IM-4421 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4421; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000057 10 mEq POTASSIUM 1000 mL NDC 0990-7993-09 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 74.5 mg; SODIUM CHLORIDE 450 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 10 mEq; SODIUM 77 mEq; CHLORIDE 87 mEq. 426 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP IMP0000057 ICU Medical, Inc. Lake Forest, Illinois, 60045 USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000057; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4418 20 mEq POTASSIUM 1000 mL NDC 0990-7901-09 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.225% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 149 mg; SODIUM CHLORIDE 225 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 20 mEq; SODIUM 38.5 mEq; CHLORIDE 58.5 mEq. 370 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. ©HOSPIRA 2004 IM-0057 (4/04) PRINTED IN USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA Rx ONLY 3 v CONTAINS DEHP IM-4418 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4418; PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - IM-4447 10 mEq POTASSIUM 500 mL NDC 0990-7902-03 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Inj., USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 149 mg; SODIUM CHLORIDE 450 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 20 mEq; SODIUM 77 mEq; CHLORIDE 97 mEq. 447 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP ICU Medical, Inc., Lake Forest, Illinois, 60045, USA IM-4447 icumedical PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - IM-4447; PRINCIPAL DISPLAY PANEL - Overwrap TO OPEN TEAR AT NOTCH 2 HDPE DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 PRINCIPAL DISPLAY PANEL - Overwrap

Package Descriptions
  • HOW SUPPLIED Intravenous solutions with potassium chloride (I.V. solution with KCl) are supplied in single-dose flexible plastic containers. See Tables: TABLE 1 Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Inj., USP COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na+) Potassium (K+) Chloride (Cl–) Approximate kcal/L NDC NO. 20 mEq 1000 50 2.25 1.49 370 4.2 (3.5 to 6.5) 38.5 20 58.5 170 0409-7901-09 1 20 mEq 1000 50 2.25 1.49 370 4.2 (3.5 to 6.5) 38.5 20 58.5 170 0990-7901-09 1 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. TABLE 2 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Inj., USP COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na+) Potassium (K+) Chloride (Cl–) Approximate kcal/L NDC NO. 10 mEq 1000 50 4.5 0.745 426 4.2 (3.5 to 6.5) 77 10 87 170 0409-7993-09 2 10 mEq 1000 50 4.5 0.745 426 4.2 (3.5 to 6.5) 77 10 87 170 0990-7993-09 1,2 10 mEq 500 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 0409-7902-03 2 10 mEq 500 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 0990-7902-03 1,2 20 mEq 1000 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 0409-7902-09 1,2 20 mEq 1000 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 0990-7902-09 1,2 30 mEq 1000 50 4.5 2.24 467 4.2 (3.5 to 6.5) 77 30 107 170 0409-7903-09 1 30 mEq 1000 50 4.5 2.24 467 4.2 (3.5 to 6.5) 77 30 107 170 0990-7903-09 1 40 mEq 1000 50 4.5 2.98 487 4.2 (3.5 to 6.5) 77 40 117 170 0409-7904-09 1,2 40 mEq 1000 50 4.5 2.98 487 4.2 (3.5 to 6.5) 77 40 117 170 0990-7904-09 1,2 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. TABLE 3 Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Inj., USP COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na+) Potassium (K+) Chloride (Cl–) Approximate kcal/L NDC NO. 20 mEq 1000 50 9 1.49 600 4.2 (3.5 to 6.5) 154 20 174 170 0409-7107-09 2 20 mEq 1000 50 9 1.49 600 4.2 (3.5 to 6.5) 154 20 174 170 0990-7107-09 1,2 40 mEq 1000 50 9 2.98 640 4.2 (3.5 to 6.5) 154 40 194 170 0409-7109-09 2 40 mEq 1000 50 9 2.98 640 4.2 (3.5 to 6.5) 154 40 194 170 0990-7109-09 1,2 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. May contain HCl for pH adjustment. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: December, 2020 1 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 2 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA IFU0000280
  • PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000044 20 mEq POTASSIUM 1000 mL NDC 0990-7107-09 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.9% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 149 mg; SODIUM CHLORIDE 900 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 20 mEq; SODIUM 154 mEq; CHLORIDE 174 mEq. 600 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx only 3 v CONTAINS DEHP IMP0000044 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000044
  • PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000045 40 mEq POTASSIUM 1000 mL NDC 0990-7109-09 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.9% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 298 mg; SODIUM CHLORIDE 900 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 40 mEq; SODIUM 154 mEq; CHLORIDE 194 mEq. 640 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP IMP0000045 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000045
  • PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4420 30 mEq POTASSIUM 1000 mL NDC 0990-7903-09 30 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 224 mg; SODIUM CHLORIDE 450 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 30 mEq; SODIUM 77 mEq; CHLORIDE 107 mEq. 467 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP IM-4420 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4420
  • PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4421 40 mEq POTASSIUM 1000 mL NDC 0990-7904-09 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 298 mg; SODIUM CHLORIDE 450 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 40 mEq; SODIUM 77 mEq; CHLORIDE 117 mEq. 487 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP IM-4421 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4421
  • PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000057 10 mEq POTASSIUM 1000 mL NDC 0990-7993-09 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 74.5 mg; SODIUM CHLORIDE 450 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 10 mEq; SODIUM 77 mEq; CHLORIDE 87 mEq. 426 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP IMP0000057 ICU Medical, Inc. Lake Forest, Illinois, 60045 USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IMP0000057
  • PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4418 20 mEq POTASSIUM 1000 mL NDC 0990-7901-09 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.225% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 149 mg; SODIUM CHLORIDE 225 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 20 mEq; SODIUM 38.5 mEq; CHLORIDE 58.5 mEq. 370 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. ©HOSPIRA 2004 IM-0057 (4/04) PRINTED IN USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA Rx ONLY 3 v CONTAINS DEHP IM-4418 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - IM-4418
  • PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - IM-4447 10 mEq POTASSIUM 500 mL NDC 0990-7902-03 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Inj., USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 149 mg; SODIUM CHLORIDE 450 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION. MAY CONTAIN HCl FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL (NOT INCLUDING IONS FOR pH ADJUSTMENT): POTASSIUM 20 mEq; SODIUM 77 mEq; CHLORIDE 97 mEq. 447 mOsmol/LITER (CALC.) pH 4.2 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP ICU Medical, Inc., Lake Forest, Illinois, 60045, USA IM-4447 icumedical PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - IM-4447
  • PRINCIPAL DISPLAY PANEL - Overwrap TO OPEN TEAR AT NOTCH 2 HDPE DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 PRINCIPAL DISPLAY PANEL - Overwrap

Overview

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 Tables 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, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: 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 O. 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 in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the 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

Indications & Usage

These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.

Dosage & Administration

These solutions should be administered only by intravenous infusion and as directed by the physician. The dose and rate of injection are dependent upon the age, weight and clinical condition of the patient. If the serum potassium level is greater than 2.5 mEq/liter, potassium should be given at a rate not to exceed 10 mEq/hour in a concentration less than 30 mEq/liter. Somewhat faster rates and greater concentrations (usually up to 40 mEq/liter) of potassium may be indicated in patients with more severe potassium deficiency. The total 24-hour dose should not generally exceed 200 mEq of potassium. As reported in the literature, the dosage 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. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

Warnings & Precautions
WARNINGS Solutions which contain potassium ions 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. To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with severe renal insufficiency or adrenal insufficiency, administration of potassium chloride may cause potassium intoxication. Solutions containing sodium ions 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. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. 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 dilutional states is inversely proportional to the electrolyte concentration of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Contraindications

Solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered.

Adverse Reactions

Reactions which may occur because of the solutions or 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. Nausea, vomiting, abdominal pain and diarrhea have been reported with potassium therapy. The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest. Potassium-containing solutions are intrinsically irritating to tissues. Therefore, extreme care should be taken to avoid perivascular infiltration. Local tissue necrosis and subsequent sloughing may result if extravasation occurs. Chemical phlebitis and venospasm have also been reported. Should perivascular infiltration occur, I.V. administration at that site should be discontinued at once. Local infiltration of the affected area with procaine hydrochloride, 1%, to which hyaluronidase may be added, will often reduce venospasm and dilute the potassium remaining in the tissues locally. Local application of heat may also be helpful.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .


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