INTRAVENOUS SOLUTIONS with POTASSIUM CHLORIDEPotassium Chloride
in 0.9% Sodium Chloride Injection, USP
POTASSIUM CHLORIDE IN SODIUM CHLORIDE
sodium chloride and
potassium chloride injection, solution HOSPIRA, INC.
INTRAVENOUS SOLUTIONS with POTASSIUM CHLORIDE Potassium Chloride
in 0.9% Sodium Chloride Injection, USP
Flexible Plastic Container
Intravenous solutions with potassium chloride (I.V. solutions
with KCl) are sterile and nonpyrogenic solutions in water for injection. They
are for administration by intravenous infusion only.
Table for summary of content and characteristics of these solutions.
solutions contain no bacteriostat, antimicrobial agent or added buffer and
each is intended only for use as a single-dose injection. When smaller doses
are required the unused portion should be discarded.
solutions are parenteral fluid and/or electrolyte replenishers.
Chloride, USP is chemically designated KCl, a white granular powder freely
soluble in water.
Sodium Chloride, USP is chemically
designated NaCl, a white crystalline powder freely soluble in water.
for Injection, USP is chemically designated H20.
flexible plastic container is fabricated from a specially formulated polyvinylchloride.
Water can permeate from inside the container into the overwrap but not in
amounts sufficient to affect the solution significantly. Solutions inside
the plastic container also can leach out certain of its chemical components
in very small amounts before the expiration period is attained. However, the
safety of the plastic has been confirmed by tests in animals according to
USP biological standards for plastic containers.
When administered intravenously, these solutions provide
a source of water and potassium chloride with 0.9% sodium chloride.
solutions containing potassium chloride are particularly intended to provide
needed potassium cation (K+). Potassium is the chief cation of
body cells (160 mEq/liter of intracellular water). It is found in low concentration
in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult).
Potassium plays an important role in electrolyte balance. Normally about 80
to 90% of the potassium intake is excreted in the urine; the remainder in
the stools and to a small extent, in the perspiration. The kidney does not
conserve potassium well so that during fasting or in patients on a potassium-free
diet, potassium loss from the body continues resulting in potassium depletion.
A deficiency of either potassium or chloride will lead to a deficit of the
Sodium chloride in water dissociates to provide
sodium (Na+) and chloride (Cl⁻) ions. Sodium (Na+)
is the principal cation of the extracellular fluid and plays a large part
in the therapy of fluid and electrolyte disturbances. Chloride (Cl⁻)
has an integral role in buffering action when oxygen and carbon dioxide exchange
occurs in the red blood cells. The distribution and excretion of sodium (Na+)
and chloride (Cl⁻) are largely under the control of the kidney which
maintains a balance between intake and output.
is an essential constituent of all body tissues and accounts for approximately
70% of total body weight. Average normal adult daily requirement ranges from
two to three liters (1.0 to 1.5 liters each for insensible water loss
by perspiration and urine production).
is maintained by various regulatory mechanisms. Water distribution depends
primarily on the concentration of electrolytes in the body compartments and
sodium (Na+) plays a major role in maintaining physiologic equilibrium.
INDICATIONS AND USAGE
These solutions are indicated in patients requiring parenteral
administration of potassium chloride and sodium chloride.
Solutions containing potassium chloride are contraindicated
in diseases where high potassium levels may be encountered.
Solutions which contain 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.
avoid potassium intoxication, do not infuse these solutions rapidly. In patients
with severe renal insufficiency or adrenal insufficiency, administration of
potassium chloride may cause potassium intoxication.
containing sodium ions should be used with great care, if at all, in patients
with congestive heart failure, severe renal insufficiency and in clinical
states in which there exists edema with sodium retention.
patients with diminished renal function, administration of solutions containing
sodium or potassium ions may result in sodium or potassium retention.
intravenous administration of these solutions can cause fluid and/or solute
overloading 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 of administered
parenteral solutions. The risk of solute overload causing congested states
with peripheral and pulmonary edema is directly proportional to the electrolyte
concentrations of such solutions.
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.
must be exercised in the administration of parenteral fluids, especially those
containing sodium ions, to patients receiving corticosteroids or corticotropin.
Potassium replacement therapy should be guided primarily
by serial electrocardiograms. Plasma potassium levels are not necessarily
indicative of tissue potassium levels.
plasma concentrations of potassium may cause death through cardiac depression,
arrhythmias or arrest.
should be used with caution in the presence of cardiac disease, particularly
in digitalized patients or in the presence of renal disease.
should be exercised to insure that the needle (or catheter) is well within
the lumen of the vein and that extravasation does not occur.
not administer unless solution is clear and container is undamaged. Discard
Category C: Animal reproduction studies have not been conducted
with potassium chloride or sodium chloride. It is also not known whether potassium
chloride or sodium chloride can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. Potassium chloride or sodium chloride
should be given to a pregnant woman only if clearly needed.
The safety and effectiveness in the pediatric population
are based on the similarity of the clinical conditions of the pediatric and
adult populations. In neonates or very small infants the volume of fluid may
affect fluid and electrolyte balance.
Reactions which may occur because of the solutions or technique
of administration include febrile response, infection at the site of injection,
venous thrombosis or phlebitis extending from the site of injection, extravasation
If an adverse reaction does occur,
discontinue the infusion, evaluate the patient, institute appropriate therapeutic
countermeasures and save the remainder of the fluid for examination if deemed
Nausea, vomiting, abdominal pain and diarrhea
have been reported with potassium therapy. The signs and symptoms of potassium
intoxication include paresthesias of the extremities, flaccid paralysis, listlessness,
mental confusion, weakness and heaviness of the legs, hypotension, cardiac
arrhythmias, heart block, electrocardiographic abnormalities such as disappearance
of P waves, spreading and slurring of the QRS complex with development of
a biphasic curve and cardiac arrest.
solutions are intrinsically irritating to tissues. Therefore, extreme care
should be taken to avoid perivascular infiltration. Local tissue necrosis
and subsequent sloughing may result if extravasation occurs. Chemical phlebitis
and venospasm have also been reported.
infiltration occur, I.V. administration at that site should be discontinued
at once. Local infiltration of the affected area with procaine hydrochloride,
1%, to which hyaluronidase may be added, will often reduce venospasm and dilute
the potassium remaining in the tissues locally. Local application of heat
may also be helpful.
In the event of potassium overdosage, discontinue the infusion
immediately and institute intensive corrective therapy to reduce serum potassium
levels. (See WARNINGS and PRECAUTIONS.)
DOSAGE AND ADMINISTRATION
These solutions should be administered only by intravenous
infusion and as directed by the physician. The dose and rate of injection
are dependent upon the age, weight and clinical condition of the patient.
If the serum potassium level is greater than 2.5 mEq/liter, potassium should
be given at a rate not to exceed 10 mEq/hour in a concentration less than
30 mEq/liter. Somewhat faster rates and greater concentrations (usually up
to 40 mEq/liter) of potassium may be indicated in patients with more severe
potassium deficiency. The total 24-hour dose should not generally exceed 200 mEq
Additives may be incompatible. Consult with pharmacist, if
available. When introducing additives, use aseptic technique, mix thoroughly
and do not store.
Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. (See PRECAUTIONS.)
INSTRUCTIONS FOR USE
outer wrap at notch and remove solution container. If supplemental medication
is desired, follow directions below before preparing for administration. 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.
To Add Medication
Prepare additive port.
Using aseptic technique and an additive delivery needle of
appropriate length, puncture resealable additive port at target area, inner
diaphragm and inject. Withdraw needle after injecting medication.
The additive port may be protected by covering with an additive
Mix container contents thoroughly.
Preparation for Administration
(Use aseptic technique)
Close flow control clamp of administration set.
Remove cover from outlet port at bottom of container.
Insert piercing pin of administration set into port with
a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton.
Suspend container from hanger.
Squeeze and release drip chamber to establish proper fluid
level in chamber.
Open flow control clamp and clear air from set. Close clamp.
Attach set to venipuncture device. If device is not indwelling,
prime and make venipuncture.
Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container
in series connections.
Intravenous solutions with potassium chloride (I.V. solution
with KCl) are supplied in single-dose flexible plastic containers. See Table:
4.8 (3.5 to 6.5)
4.8 (3.5 to 6.5)
Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat. Protect from freezing. It is recommended that the product
be stored at room temperature (25°C); however, brief exposure up to 40°C
does not adversely affect the product.