Potassium Chloride 20 MEQ/L in Lactated Ringer’s Solution with Dextrose 5 % Injectable Solution
Generic Name: DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE
Brand Name: Potassium Chloride in Lactated Ringers and Dextrose
- Substance Name(s):
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
- SODIUM LACTATE
- DEXTROSE MONOHYDRATE
WARNINGS
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is not for use for the treatment of lactic acidosis or severe metabolic acidosis.
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should not be administered simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation.
The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop.
Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Solutions containing dextrose should be used with caution, if at all, in patients with known allergy to corn or corn products.
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 fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema or acid-base imbalance.
The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injection.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.
Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be administered with particular caution, if at all, to patients with conditions predisposing to hyperkalemia (such as severe renal impairment or adrenocortical insufficiency, acute dehydration, or extensive tissue injury or burns), in patients with cardiac disease, and in patients treated with products that increase the risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine.
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be administered with particular caution, if at all, to patients with alkalosis or at risk for alkalosis.
Because lactate is metabolized to bicarbonate, administration may result in, or worsen, metabolic alkalosis.
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be administered with particular caution, if at all, to patients with severe renal impairment, hypervolemia, overhydration, or conditions that may cause sodium and/or potassium retention, fluid overload, or edema.
Potassium salts should never be administered by IV push.
DRUG INTERACTIONS
Drug Interactions Ceftriaxone – see CONTRAINDICATIONS Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids.
Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with drugs for which renal elimination is pH dependent.
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 such drugs.
Renal clearance of acidic drugs such as salicylates and barbiturates may be increased.
Renal clearance of alkaline drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine) and dextroamphetamine (dexamphetamine) sulfate, may be decreased.
Renal clearance of lithium may also be increased.
Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with lithium.
Because of its potassium content, administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be avoided in patients treated with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine.
Administration of potassium in patients treated with such medications can produce severe and potentially fatal hyperkalemia, particularly in patients with severe renal insufficiency.
Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.
OVERDOSAGE
Overdose An excessive volume or too high a rate of administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may lead to fluid and sodium overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired.
Excessive administration of lactate may lead to metabolic alkalosis.
Metabolic alkalosis may be accompanied by hypokalemia.
Excessive administration of potassium may lead to the development of hyperkalemia, especially in patients with severe renal impairment.
Excessive administration of calcium salts may lead to hypercalcemia.
Excessive administration of a dextrose-containing solution may lead to hyperglycemia, hyperosmolarity, osmotic diuresis, and dehydration.
When assessing overdose, any additives in the solution must also be considered.
The effects of overdose may require immediate medical attention and treatment.
DESCRIPTION
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration.
It contains no antimicrobial agents.
Composition, osmolarity, pH, ionic concentration and caloric content are shown below: Table 1.
Size (mL) Composition (g/L) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.Osmolarity (mOsmol/L) (calc.) The chemical structure for Dextrose Hydrous, USP is shown below: Dextrose Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Lactate, (C3H5NaO3) Potassium Chloride, USP (KCl) Calcium Chloride, USP (CaCl2-2H2O) Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP mEq Potassium added 20 mEq 1000 50 6 3.1 1.79 0.2 565 Table 2.
pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP Sodium Potassium Calcium Chloride Lactate mEq Potassium added 20 mEq 5.0 (3.5to6.5) 130 24 3 129 28 170 The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic).
VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle.
The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system.
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, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million.
However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
D-Glucose Monohydrate Structural Formula
HOW SUPPLIED
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in VIAFLEX Plus plastic containers is available as shown below: Code Size (mL) NDC Product Name 2B2224 1000 0338-0811-04 20 mEq/L Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat.
It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.
GERIATRIC USE
Geriatric Use Clinical studies of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, 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.
INDICATIONS AND USAGE
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP are indicated as a source of water, electrolytes, and calories or as alkalinizing agents.
PEDIATRIC USE
Pediatric Use Safety and effectiveness of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in pediatric patients have not been established by adequate and well-controlled studies.
However, the use of potassium chloride injection in pediatric patients to treat potassium deficiency states when oral replacement therapy is not feasible is referenced in the medical literature.
In newborns, the risk of hyperglycemia due to infusion of dextrose-containing solutions appears to be greater with lower birth weight.
In these patients, hyperglycemia and increased serum osmolarity have been associated with an increased risk of intraventricular cerebral hemorrhage.
Lactate-containing solutions should be administered with particular caution to neonates and infants less than 6 months of age.
PREGNANCY
Pregnancy Teratogenic Effects Pregnancy Category C.
Animal reproduction studies have not been conducted with Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP.
It is also not known whether Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be given to a pregnant woman only if clearly needed.
NUSRING MOTHERS
Nursing Mothers It is not known whether this drug is excreted in human milk.
Because many drugs are excreted 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.
DOSAGE AND ADMINISTRATION
As directed by a physician.
Dosage, rate, and duration of administration are to be individualized and dependent upon the indication for use, the patient’s age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations.
All injections in VIAFLEX Plus plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.
After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion.
Do not reconnect any partially used containers.
The infusion rate should not exceed the patient’s ability to utilize glucose in order to avoid hyperglycemia.
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 weight infants, because of the increased risk of hyperglycemia/hypoglycemia (See PRECAUTIONS, Pediatric Use).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not administer unless the solution is clear and the seal is intact.
When making additions to Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP, aseptic technique must be used.
Mix the solution thoroughly when additives have been introduced.
Do not store solutions containing additives.
Additives may be incompatible with Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP.
As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition, by checking for a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals.
Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is appropriate.
The instructions for use of the medication to be added and other relevant literature must be consulted.
Additives known or determined to be incompatible should not be used.