Label: POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE- dextrose monohydrate, sodium chloride, sodium lactate, potassium chloride, calcium chloride injection, solution

Hypersensitivity Reactions

Hypersensitivity and infusion reactions have been reported with Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP (see ADVERSE REACTIONS). Stop the infusion immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Electrolyte Imbalances

Fluid Overload

Depending on the volume and rate of infusion, the intravenous administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP can cause electrolyte disturbances such as overhydration and congested states, including pulmonary congestion and edema. Avoid Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP 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.

Hyperglycemia and Hyperosmolar Hyperglycemic State

Administration of solutions containing dextrose and lactate in patients with impaired glucose tolerance or diabetes mellitus may worsen hyperglycemia (see PRECAUTIONS, Pediatric Use). Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death.

Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses.

Patients with underlying central nervous system disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state.

Monitor blood glucose concentrations and treat hyperglycemia to maintain concentrations within normal limits while administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP. Insulin may be administered or adjusted to maintain optimal blood glucose concentrations.

Hyperkalemia

Potassium-containing solutions, including Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may increase the risk of hyperkalemia.

Patients at increased risk of developing hyperkalemia include those:

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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.

•

Treated concurrently or recently with agents or products that cause or increase the risk of hyperkalemia (see PRECAUTIONS).

Avoid use of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in patients with, or at risk for, hyperkalemia. If use cannot be avoided, monitor serum potassium concentrations.

To avoid life threatening hyperkalemia, do not administer Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP as an intravenous push (i.e., intravenous injection manually with a syringe connected to the intravenous access) without a quantitative infusion device.

Alkalosis

Because lactate is metabolized to bicarbonate, administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may result in, or worsen, metabolic alkalosis. Avoid Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in patients with alkalosis or at risk for alkalosis.

Hyponatremia

Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may cause hyponatremia. Glucose intravenous infusions are usually isotonic solutions. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization. Monitoring of serum sodium is particularly important for hypotonic fluids.

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.

The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of hypotonic Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP.

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 diuretics, certain antiepileptic and psychotropic medications). See PRECAUTIONS, Drug Interactions and Pediatric Use.

Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular, premenopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.

Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.

Patients with Renal Impairment

Administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in patients with or at risk of severe renal impairment, may result in hyperkalemia and/or fluid overload (see WARNINGS). Avoid Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.

Patients with Hepatic Impairment

In patients with severe hepatic impairment, lactate metabolism may be impaired and Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may not produce alkalization. Consider when monitoring serum lactate levels.

Hypercalcemia

Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP contains calcium salts and may cause hypercalcemia. Avoid administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in patients with hypercalcemia or conditions predisposing to hypercalcemia; and in patients with calcium renal calculi or history of such calculi.

Vein Thrombosis

Use a peripheral vein if the final dextrose concentration is 5% or less and the osmolality is approximately less than 900 mOsm/L. Consider central vein administration of hypertonic solutions with osmolarity of 900 mOsmol or more to avoid venous irritation, including phlebitis. Monitoring of Serum Lactate Levels

Administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may result in an iatrogenic increase in serum lactate levels and interfere with interpretation of serum lactate levels in patients with severe metabolic acidosis including lactic acidosis.

Drug Interactions

Ceftriaxone

For information on interaction with ceftriaxone – see CONTRAINDICATIONS

Other Products that Cause Hyperkalemia

Administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated concurrently or recently with products that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia.

Avoid use of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients receiving such products (e.g., potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine). If use cannot be avoided, monitor serum potassium concentrations.

Other Products that Affect Fluid and/or Electrolyte Balance

Administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. Avoid use of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.

Other Drugs that Increase the Risk of Hyponatremia

Administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.

Avoid use of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. 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.

Lithium

Renal sodium and lithium clearance may be increased during administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP. Avoid use of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in patients receiving lithium. If use cannot be avoided, monitor serum lithium concentrations during concomitant use.

Digoxin

Administration of calcium may increase the effects of digitalis and lead to serious or fatal cardiac arrhythmia. In patients treated with digoxin, consider reducing the volume, and/or rate of administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP.

Other Drugs that Increase the Risk of Hypercalcemia

Avoid Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.

Drugs with pH Dependent Renal Elimination

Due to the alkalinizing action of lactate (formation of bicarbonate), Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may interfere with the elimination of drugs with pH dependent renal elimination. Renal clearance of acidic drugs may be increased. Renal clearance of alkaline drugs may be decreased.

Pregnancy

There are no adequate, well-controlled studies with Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP can cause fetal harm when administered to a pregnant woman. Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery

Intrapartum maternal intravenous infusion of glucose-containing solutions may produce maternal hyperglycemia with subsequent fetal hyperglycemia and fetal metabolic acidosis as well as rebound hypoglycemia in the neonate. Fetal hyperglycemia can result in increased fetal insulin levels which may result in neonatal hypoglycemia following delivery. Consider the potential risks and benefits for each specific patient before administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP.

Nursing Mothers

It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is administered to a nursing mother.

Pediatric Use

The use of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in pediatric patients is based on clinical practice (see DOSAGE AND ADMINISTRATION).

Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo-or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may result in increased serum osmolality and risk of intracerebral hemorrhage.

Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

Administration of a lactate-containing intravenous solution to infants should take into account that the liver and kidneys are still maturing during the first year of life, which also affects the biotransformation and renal excretion of lactate.

Geriatric Use

Geriatric patients are at increased risk of developing electrolyte imbalances. Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP 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. Therefore, 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. Consider monitoring renal function in elderly patients.

Post-Marketing Adverse Reactions

The following adverse reactions associated with the use of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP were identified in clinical trials or postmarketing reports. Because postmarketing 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.

Hypersensitivity and infusion reactions: angioedema, chest pain, chest discomfort, decreased heart rate, tachycardia, blood pressure decreased, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesias, oral hypoesthesia, dyspepsia, nausea, anxiety, pyrexia and headache.

General Disorders and Administration Site Conditions: phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning, infusion site anesthesia (numbness)

Metabolism and Nutrition Disorders: hyperkalemia, hypervolemia, hyponatremia

Nervous System Disorders: hyponatremic encephalopathy.

To Open

Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. 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

1.

Suspend container from eyelet support.

2.

Remove protector from outlet port at bottom of container.

3.

Attach administration set. Refer to complete directions accompanying set.

To Add Medication