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KCL in D5W

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KCL in D5W

WARNINGS

The administration of intravenous solutions can cause fluid and/or solute overload 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. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Solutions containing 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.

In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention.

Composition – Each 100 mL contains: Concentration of Electrolytes (mEq/liter) Calories per liter Calculated Osmolarity mOsmol/liter pH
Solution Hydrous Dextrose USP Potassium Chloride USP
Potassium Chloride
0.15% Potassium Chloride in 5% Dextrose Injection USP (20 mEq K+/liter 5 g 0.15 g 20 20 170 295 4.3 (3.5-6.5)
0.30% Potassium Chloride in 5% Dextrose Injection USP (40 mEq K+/liter 5 g 0.3 g 40 40 170 330 4.3 (3.5-6.5)
Water for Injection USP qs
©2004 B. Braun Medical Inc.

PRECAUTIONS

General

These solutions should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.

Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.

Additional essential electrolytes, minerals, and vitamins should be supplied as needed.

Care should be exercised in administering solutions containing potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.

Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels.

Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly when accompanied by renal disease.

Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.

To minimize the risk of possible incompatibilities arising from mixing any of these solutions with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

Do not use plastic container in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

These solutions are intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

Laboratory Tests

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in these or alternative solutions.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Potassium Chloride in 5% Dextrose Injections USP (potassium chloride in 5% dextrose injection) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy: Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with Potassium Chloride in 5% Dextrose Injections USP. It is also not known whether Potassium Chloride in 5% Dextrose Injections USP (potassium chloride in 5% dextrose injection) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in 5% Dextrose Injections USP should be given to a pregnant woman only if clearly needed.

Labor and Delivery

The effects Potassium Chloride in Dextrose Injections USP on the duration of labor or delivery, on the possibility that forceps delivery or other intervention or resuscitation of the newborn will be necessary, and on the later growth, development, and functional maturation of the child are unknown.

As reported in the literature, potassium containing solutions have been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.

Nursing Mothers

It is not know whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Potassium Chloride in 5% Dextrose Injections USP are administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Potassium Chloride in 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.

For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended.

Dextrose is safe and effective for the stated indications in pediatric patients (see INDICATIONS AND USAGE). As reported in the literature, the dosage selection 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. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants

In neonates or in very small infants even small volumes of fluid may affect fluid and electrolyte balance. Care must be exercised in treatment of neonates, especially pre-term neonates, whose renal function may be immature and whose ability to excrete fluid and solute loads may be limited. Fluid intake, urine output, and serum electrolytes should be monitored closely.

See WARNINGS and DOSAGE AND ADMINISTRATION.

Geriatric Use

Geriatric Use: Clinical studies of Potassium Chloride in 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 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.

These drugs are known to be substantially excreted by the kidney, and the risk of toxic reactions to these drugs may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

See WARNINGS.

Last reviewed on RxList: 12/3/2008
This monograph has been modified to include the generic and brand name in many instances.

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