Potassium Chloride
Potassium Chloride Prescribing Information
Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.
When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.
The dose and rate of administration are dependent upon the specific condition of each patient.
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
If used in high-risk patients, especially close monitoring and careful dose selection and adjustment is required.
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
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.
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.
Monitoring of serum sodium is particularly important for hypotonic fluids. Potassium Chloride Injection has an osmolarity of 200 to 799 mOsmol/L (see
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
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.
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.
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.
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
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.
Potassium Chloride Injection is contraindicated in patients with:
- hyperkalemia
- known hypersensitivity to Potassium Chloride Injection
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.
*as a manifestation of rapid intravenous administration and/or of hyperkalemia
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.
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
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
If used in high-risk patients, especially close monitoring and careful dose selection and adjustment is required.
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
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.
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.
Monitoring of serum sodium is particularly important for hypotonic fluids. Potassium Chloride Injection has an osmolarity of 200 to 799 mOsmol/L (see
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
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.
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.
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.
This Potassium Chloride Injection, is a sterile, nonpyrogenic, highly concentrated, readyto-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.
* Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage. | |||||
| Potassium Chloride Injection mEq Potassium/ Container | Composition (g/L) Potassium Chloride, USP (KCl) | Osmolarity* (mOsmol/L) (calc) | pH | Ionic Concentration (mEq/L)
| |
Potassium | Chloride | ||||
| 10 mEq/100 mL | 7.45 | 200 | 5.8 (4.0 to 8.0) | 100 | 100 |
| 10 mEq/50 mL 20 mEq/100 mL | 14.9 | 400 | 5.8 (4.0 to 8.0) | 200 | 200 |
| 20 mEq/50 mL 40 mEq/100 mL | 29.8 | 799 | 5.8 (4.0 to 8.0) | 400 | 400 |