Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Potassium Chloride Injection in Viaflex Plus plastic containers is available as follows: 10 mEq/100 mL NDC 0338-0709-48 10 mEq/50 mL NDC 0338-0705-41 20 mEq/100 mL NDC 0338-0705-48 20 mEq/50 mL NDC 0338-0703-41 40 mEq/100 mL NDC 0338-0703-48 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that this product be stored at room temperature (25°C).; PRINCIPAL DISPLAY PANEL Container Label Container Label LOT EXP NDC 0338-0705-41 Highly Concentrated (200 mEq/L) Potassium Chloride Potassium Chloride Injection 10 mEq per 50 mL 50 mL STERILE SINGLE DOSE CONTAINER EACH 50 mL CONTAINS 746 mg g POTASSIUM CHLORIDE pH 5 (4 TO 8) POTASSIUM 200 mEq/L CHLORIDE 200 mEq/L HYPERTONIC 400 mOsmol/L (CALC) DOSAGE: SEE PRESCRIBING INFORMATION USE ONLY WITH A CALIBRATED INFUSION DEVICE USE CENTRAL ROUTE WHENEVER POSSIBLE DO NOT ADD SUPPLEMENTARY MEDICATION STORE IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (77°F or 25°C) UNTIL READY TO USE Rx ONLY 0725004354 BAXTER Logo USA 2B0821 Barcode FPO (01)00303380705412 Container Label Container Label LOT EXP NDC 0338-0703-41 Highly Concentrated (400 mEq/L) Potassium Chloride Potassium Chloride Injection 20 mEq per 50 mL 50 mL STERILE SINGLE DOSE CONTAINER EACH 50 mL CONTAINS 1.49 g POTASSIUM CHLORIDE pH 5 (4 TO 8) POTASSIUM 400 mEq/L CHLORIDE 400 mEq/L HYPERTONIC 799 mOsmol/L (CALC) DOSAGE: SEE PRESCRIBING INFORMATION USE ONLY WITH A CALIBRATED INFUSION DEVICE USE CENTRAL ROUTE WHENEVER POSSIBLE DO NOT ADD SUPPLEMENTARY MEDICATION STORE IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (77°F or 25°C) UNTIL READY TO USE Rx ONLY 0725004355 BAXTER Logo USA 2B0822 Barcode FPO (01)00303380703418 Container Label Container Label LOT EXP NDC 0338-0703-48 Highly Concentrated (400 mEq/L) Potassium Chloride Potassium Chloride Injection 40 mEq per 100 mL 400 mEq/L 100 mL STERILE SINGLE DOSE CONTAINER EACH 100 mL CONTAINS 2.98 g POTASSIUM CHLORIDE pH 5 (4 TO 8) POTASSIUM 400 mEq/L CHLORIDE 400 mEq/L HYPERTONIC 799 mOsmol/L (CALC) DOSAGE: SEE PRESCRIBING INFORMATION USE ONLY WITH A CALIBRATED INFUSION DEVICE USE CENTRAL ROUTE WHENEVER POSSIBLE DO NOT ADD SUPPLEMENTARY MEDICATION STORE IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (77°F or 25°C) UNTIL READY TO USE Rx ONLY 0725004356 BAXTER Logo USA 2B0824 Barcode FPO (01)00303380703487 Container Label Container Label LOT EXP NDC 0338-0709-48 Highly Concentrated (100 mEq/L) Potassium Chloride Potassium Chloride Injection 10 mEq per 100 mL 100 mEq/L 100 mL STERILE SINGLE DOSE CONTAINER EACH 100 mL CONTAINS 746 mg POTASSIUM CHLORIDE pH 5 (4 TO 8) POTASSIUM 100 mEq/L CHLORIDE 100 mEq/L HYPERTONIC 200 mOsmol/L (CALC) DOSAGE: SEE PRESCRIBING INFORMATION USE ONLY WITH A CALIBRATED INFUSION DEVICE USE CENTRAL ROUTE WHENEVER POSSIBLE DO NOT ADD SUPPLEMENTARY MEDICATION STORE IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (77°F or 25°C) UNTIL READY TO USE Rx ONLY 0725004357 BAXTER Logo USA 2B0826 Barcode FPO (01)00303380709489 Container Label Container Label LOT EXP NDC 0338-0705-48 Highly Concentrated (200 mEq/L) Potassium Chloride Potassium Chloride Injection 20 mEq per 100 mL 200 mEq/L 100 mL STERILE SINGLE DOSE CONTAINER EACH 100 mL CONTAINS 1.49 g POTASSIUM CHLORIDE pH 5 (4 TO 8) POTASSIUM 200 mEq/L CHLORIDE 200 mEq/L HYPERTONIC 400 mOsmol/L (CALC) DOSAGE: SEE PRESCRIBING INFORMATION USE ONLY WITH A CALIBRATED INFUSION DEVICE USE CENTRAL ROUTE WHENEVER POSSIBLE DO NOT ADD SUPPLEMENTARY MEDICATION STORE IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (77°F or 25°C) UNTIL READY TO USE Rx ONLY 0725004358 BAXTER Logo USA 2B0827 Barcode FPO (01)00303380705481 Potassium Chloride Injection Representative Container Label NDC 0338-0705-41 Potassium Chloride Injection Representative Container Label NDC 0338-0703-41 Potassium Chloride Injection Representative Container Label NDC 0338-0703-48 Potassium Chloride Injection Representative Container Label NDC 0338-0709-48 Potassium Chloride Injection Representative Container Label NDC 0338-0705-48
- HOW SUPPLIED Potassium Chloride Injection in Viaflex Plus plastic containers is available as follows: 10 mEq/100 mL NDC 0338-0709-48 10 mEq/50 mL NDC 0338-0705-41 20 mEq/100 mL NDC 0338-0705-48 20 mEq/50 mL NDC 0338-0703-41 40 mEq/100 mL NDC 0338-0703-48 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that this product be stored at room temperature (25°C).
- PRINCIPAL DISPLAY PANEL Container Label Container Label LOT EXP NDC 0338-0705-41 Highly Concentrated (200 mEq/L) Potassium Chloride Potassium Chloride Injection 10 mEq per 50 mL 50 mL STERILE SINGLE DOSE CONTAINER EACH 50 mL CONTAINS 746 mg g POTASSIUM CHLORIDE pH 5 (4 TO 8) POTASSIUM 200 mEq/L CHLORIDE 200 mEq/L HYPERTONIC 400 mOsmol/L (CALC) DOSAGE: SEE PRESCRIBING INFORMATION USE ONLY WITH A CALIBRATED INFUSION DEVICE USE CENTRAL ROUTE WHENEVER POSSIBLE DO NOT ADD SUPPLEMENTARY MEDICATION STORE IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (77°F or 25°C) UNTIL READY TO USE Rx ONLY 0725004354 BAXTER Logo USA 2B0821 Barcode FPO (01)00303380705412 Container Label Container Label LOT EXP NDC 0338-0703-41 Highly Concentrated (400 mEq/L) Potassium Chloride Potassium Chloride Injection 20 mEq per 50 mL 50 mL STERILE SINGLE DOSE CONTAINER EACH 50 mL CONTAINS 1.49 g POTASSIUM CHLORIDE pH 5 (4 TO 8) POTASSIUM 400 mEq/L CHLORIDE 400 mEq/L HYPERTONIC 799 mOsmol/L (CALC) DOSAGE: SEE PRESCRIBING INFORMATION USE ONLY WITH A CALIBRATED INFUSION DEVICE USE CENTRAL ROUTE WHENEVER POSSIBLE DO NOT ADD SUPPLEMENTARY MEDICATION STORE IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (77°F or 25°C) UNTIL READY TO USE Rx ONLY 0725004355 BAXTER Logo USA 2B0822 Barcode FPO (01)00303380703418 Container Label Container Label LOT EXP NDC 0338-0703-48 Highly Concentrated (400 mEq/L) Potassium Chloride Potassium Chloride Injection 40 mEq per 100 mL 400 mEq/L 100 mL STERILE SINGLE DOSE CONTAINER EACH 100 mL CONTAINS 2.98 g POTASSIUM CHLORIDE pH 5 (4 TO 8) POTASSIUM 400 mEq/L CHLORIDE 400 mEq/L HYPERTONIC 799 mOsmol/L (CALC) DOSAGE: SEE PRESCRIBING INFORMATION USE ONLY WITH A CALIBRATED INFUSION DEVICE USE CENTRAL ROUTE WHENEVER POSSIBLE DO NOT ADD SUPPLEMENTARY MEDICATION STORE IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (77°F or 25°C) UNTIL READY TO USE Rx ONLY 0725004356 BAXTER Logo USA 2B0824 Barcode FPO (01)00303380703487 Container Label Container Label LOT EXP NDC 0338-0709-48 Highly Concentrated (100 mEq/L) Potassium Chloride Potassium Chloride Injection 10 mEq per 100 mL 100 mEq/L 100 mL STERILE SINGLE DOSE CONTAINER EACH 100 mL CONTAINS 746 mg POTASSIUM CHLORIDE pH 5 (4 TO 8) POTASSIUM 100 mEq/L CHLORIDE 100 mEq/L HYPERTONIC 200 mOsmol/L (CALC) DOSAGE: SEE PRESCRIBING INFORMATION USE ONLY WITH A CALIBRATED INFUSION DEVICE USE CENTRAL ROUTE WHENEVER POSSIBLE DO NOT ADD SUPPLEMENTARY MEDICATION STORE IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (77°F or 25°C) UNTIL READY TO USE Rx ONLY 0725004357 BAXTER Logo USA 2B0826 Barcode FPO (01)00303380709489 Container Label Container Label LOT EXP NDC 0338-0705-48 Highly Concentrated (200 mEq/L) Potassium Chloride Potassium Chloride Injection 20 mEq per 100 mL 200 mEq/L 100 mL STERILE SINGLE DOSE CONTAINER EACH 100 mL CONTAINS 1.49 g POTASSIUM CHLORIDE pH 5 (4 TO 8) POTASSIUM 200 mEq/L CHLORIDE 200 mEq/L HYPERTONIC 400 mOsmol/L (CALC) DOSAGE: SEE PRESCRIBING INFORMATION USE ONLY WITH A CALIBRATED INFUSION DEVICE USE CENTRAL ROUTE WHENEVER POSSIBLE DO NOT ADD SUPPLEMENTARY MEDICATION STORE IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (77°F or 25°C) UNTIL READY TO USE Rx ONLY 0725004358 BAXTER Logo USA 2B0827 Barcode FPO (01)00303380705481 Potassium Chloride Injection Representative Container Label NDC 0338-0705-41 Potassium Chloride Injection Representative Container Label NDC 0338-0703-41 Potassium Chloride Injection Representative Container Label NDC 0338-0703-48 Potassium Chloride Injection Representative Container Label NDC 0338-0709-48 Potassium Chloride Injection Representative Container Label NDC 0338-0705-48
Overview
This Potassium Chloride Injection, is a sterile, nonpyrogenic, highly concentrated, ready-to-use, solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. Potassium Chloride Injection mEq Potassium/Container Composition (g/L) Potassium Chloride, USP (KCl) Osmolarity Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Potassium Chloride 10 mEq/100 mL 7.46 200 5.0 (4.0 to 8.0) 100 100 10 mEq/50 mL 20 mEq/100 mL 14.9 400 5.0 (4.0 to 8.0) 200 200 20 mEq/50 mL 40 mEq/100 mL 29.8 799 5.0 (4.0 to 8.0) 400 400 This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in 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. 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 may leach out certain of its chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
Indications & Usage
Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.
Dosage & Administration
The dose and rate of administration are dependent upon the specific condition of each patient. Administer intravenously only with a calibrated infusion device at a slow, controlled rate. Highest concentrations (400 mEq/L) should be exclusively administered via central intravenous route. Whenever possible, administration via a central route is recommended for all concentrations of Potassium Chloride Injection for thorough dilution by the blood stream and decreasing the risk of extravasation and to avoid pain and phlebitis associated with peripheral infusion (see WARNINGS ). Correct placement of the catheter should be verified before administration. Recommended administration rates should not usually exceed 10 mEq per hour or 200 mEq for a 24 hour period if the serum potassium level is greater than 2.5 mEq per liter. In urgent cases where the serum potassium level is less than 2.0 mEq per liter or where severe hypokalemia is a threat, (serum potassium level less than 2.0 mEq per liter and electrocardiographic changes and/or muscle paralysis) rates up to 40 mEq per hour or 400 mEq over a 24 hour period can be administered very carefully when guided by continuous monitoring of the EKG and frequent serum K + determinations to avoid hyperkalemia and cardiac arrest. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Use of a final filter is recommended during administration of all parenteral solutions where possible. Do not add supplementary medication.
Warnings & Precautions
WARNINGS Hyperkalemia THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. TO AVOID POTASSIUM INTOXICATION, DO NOT INFUSE THESE SOLUTIONS RAPIDLY. Potassium Chloride Injection should be administered with extreme caution, if at all, to patients with conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with: • severe renal impairment, • acute dehydration, • extensive tissue injury or burns, • certain cardiac disorders such as congestive heart failure or AV block, • potassium-aggravated skeletal muscle channelopathies (e.g., hyperkalemic periodic paralysis, paramyotonia congenita, and potassium-aggravated myotonia/paramyotonia). Potassium Chloride Injection should be administered with caution to patients who are at risk of experiencing hyperosmolality, acidosis, or undergo correction of alkalosis (conditions associated with a shift of potassium from intracellular to extracellular space) and patients treated concurrently or recently with agents or products that can cause hyperkalemia (see PRECAUTIONS , Drug Interactions ). If used in high-risk patients, especially close monitoring and careful dose selection and adjustment is required. PATIENTS REQUIRING HIGHLY CONCENTRATED SOLUTIONS SHOULD BE KEPT ON CONTINUOUS CARDIAC MONITORING AND UNDERGO FREQUENT TESTING FOR SERUM POTASSIUM AND ACID-BASE BALANCE, ESPECIALLY IF THEY RECEIVE DIGITALIS. Administration of concentrated potassium solutions can cause cardiac conduction disorders (including complete heart block) and other cardiac arrhythmias at any time during infusion. Continuous cardiac monitoring is performed to aid in the detection of cardiac arrhythmias due to a sudden increase in serum potassium concentration (e.g., when potassium infusion is started), or transient or sustained hyperkalemia (see ADVERSE REACTIONS and OVERDOSAGE ). Frequently, mild or moderate hyperkalemia is asymptomatic and may be manifested only by increased serum potassium concentrations and, possibly, characteristic EKG changes. However, fatal arrhythmias can develop at any time during hyperkalemia. Serum potassium levels are not necessarily indicative of tissue potassium levels. Tissue Damage and Thrombophlebitis When infusing concentrated potassium solutions, including Potassium Chloride Injection, care must be taken to prevent paravenous administration or extravasation because such solutions may be associated with tissue damage, which may be severe and include vascular, nerve, and tendon damage, leading to surgical intervention, including amputation. Secondary complications including pulmonary embolism from thrombophlebitis have been reported as a consequence of tissue damage from potassium chloride. Administer intravenously only with a calibrated infusion device at a slow, controlled rate. (see DOSAGE AND ADMINISTRATION ) . Highest concentrations (400 mEq per L) should be exclusively administered via central intravenous route. Whenever possible, administration via a central route is recommended for all concentrations of Potassium Chloride Injection for thorough dilution by the blood stream and decreasing the risk of extravasation and to avoid pain and phlebitis associated with peripheral infusion. Correct placement of the catheter should be verified before administration. Hyponatremia Monitoring of serum sodium is particularly important for hypotonic fluids. Potassium Chloride Injection has an osmolarity of 200 to 799 mOsmol/L (see DESCRIPTION ). Potassium Chloride Injection may cause hyponatremia. The risk for hyponatremia is increased, in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia and in patients treated with medications that increase the risk of hyponatremia (such as certain diuretic, antiepileptic and psychotropic medications) (see PRECAUTIONS, Drug Interactions ). Acute hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. Avoid Potassium Chloride Injection in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. High volume infusion must be used with close monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopression release (including SIADH), due to the risk of hospital-acquired hyponatremia. Fluid Overload Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, the intravenous administration of Potassium Chloride Injection can cause electrolyte disturbances such as overhydration/hypervolemia and congested states including central (e.g., pulmonary edema) and peripheral edema. Avoid Potassium Chloride Injection in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations and acid base balance as needed and especially during prolonged use. Hyperchloremia In patients with or at risk of hyperchloremia, Potassium Chloride Injection may exacerbate or result in hyperchloremia. Monitor plasma chloride levels and renal function in such patients.
Contraindications
Potassium Chloride Injection is contraindicated in patients with: • hyperkalemia • known hypersensitivity to Potassium Chloride Injection
Adverse Reactions
The following adverse reactions associated with the use of Potassium Chloride Injection were identified in postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Immune system disorders: Hypersensitivity, as manifested by rash and angioedema Metabolism and nutrition disorders: Hyperkalemia, hyponatremia Cardiac disorders: Cardiac arrest*, asystole*, ventricular fibrillation*, bradycardia *as a manifestation of rapid intravenous administration and/or of hyperkalemia Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea General disorders and administration site conditions: Chest pain, infusion site thrombosis, infusion site phlebitis, infusion site erythema, infusion site swelling, infusion site pain, infusion site irritation, and/or a burning sensation. Nervous System Disorders: Hyponatremic encephalopathy The following adverse reactions were reported in association with extravasation: Skin necrosis, skin ulcer, soft tissue necrosis, muscle necrosis, nerve injury, tendon injury, and vascular injury.
Drug Interactions
Other Products that Cause Hyperkalemia Administration of Potassium Chloride Injection in patients treated concurrently or recently with other products that can cause hyperkalemia or increase the risk of hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, cyclosporine and tacrolimus) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia (see WARNINGS ). Avoid use of Potassium Chloride injection in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations. Other Drugs that Increase the Risk of Hyponatremia Administration of Potassium Chloride Injection in patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia (see WARNINGS ). Avoid use of Potassium Chloride Injection in patients receiving drugs that may increase the risk of hyponatremia, such as diuretics and antiepileptics. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.
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