sodium phosphate, monobasic, monohydrate and
sodium phosphate, dibasic, anhydrous injection, solution Hospira, Inc.
SODIUM PHOSPHATES Injection, USP
45 mM P in 15 mL
(3 mM P and 4 mEq
FOR ADDITIVE USE ONLY AFTER DILUTION
IN I.V. FLUIDS
Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL),
is a sterile, nonpyrogenic, concentrated solution containing a mixture of
monobasic sodium phosphate and dibasic sodium phosphate in water for injection.
solution is administered after dilution by the intravenous route as an electrolyte
replenisher. It must not be administered undiluted.
Each mL contains 276 mg of monobasic sodium
phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent
to 268 mg of dibasic sodium phosphate, heptahydrate).
mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately
3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM
PO4. It contains no bacteriostat, antimicrobial agent or added
buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 12 mOsmol/mL
The solution is intended as an alternative
to potassium phosphate to provide phosphorus for addition to large volume
infusion fluids for intravenous use.
It is provided
as a 15 mL partial fill single-dose vial; when lesser amounts are required,
the unused portion should be discarded with the entire unit.
Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4•
H2O, white, odorless crystals or granules freely soluble in water.
Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4,
colorless or white granular salt freely soluble in water.
semi-rigid container is fabricated from a specially formulated polyolefin.
It is a copolymer of ethylene and propylene. The safety of the plastic has
been confirmed by tests in animals according to USP biological standards for
plastic containers. The container requires no vapor barrier to maintain the
proper drug concentration.
Phosphorus in the form of organic and inorganic phosphate
has a variety of important biochemical functions in the body and is involved
in many significant metabolic and enzyme reactions in almost all organs and
tissues. It exerts a modifying influence on the steady state of calcium levels,
a buffering effect on acid-base equilibrium and a primary role in the renal
excretion of hydrogen ion.
Phosphorus is present in
plasma and other extracellular fluid, in cell membranes and intracellular
fluid, as well as in collagen and bone tissues. Phosphorus in the extracellular
fluid is primarily in inorganic form and plasma levels may vary somewhat with
age. The ratio of disodium phosphate and monosodium phosphate in the extracellular
fluid is 4 to 1 (80% to 20%) at the normal pH of 7.4. This buffer ratio varies
with the pH, but owing to its relatively low concentration, it contributes
little to the buffering capacity of the extracellular fluid.
present in large amounts in erythrocytes and other tissue cells, plays a significant
intracellular role in the synthesis of high energy organic phosphates. It
has been shown to be essential to maintain red cell glucose utilization, lactate
production, and the concentration of both erythrocyte adenosine triphosphate
(ATP) and 2,3 diphosphoglycerate (DPG), and must be deemed as important to
other tissue cells. Hypophosphatemia should be avoided during periods of total
parenteral nutrition, or other lengthy periods of intravenous infusions. It
has been suggested that patients receiving total parenteral nutrition receive
12 to 15 mM phosphorus per 250 g of dextrose. Serum phosphorus levels should
be regularly monitored and appropriate amounts of phosphorus should be added
to the infusions to maintain normal serum phosphorus levels. Intravenous infusion
of inorganic phosphorus may be accompanied by a decrease in the serum level
and urinary excretion of calcium. The normal level of serum phosphorus is
3.0 to 4.5 mg/100 mL in adults; 4.0 to 7.0 mg/100 mL in children.
infused phosphorus not taken up by the tissues is excreted almost entirely
in the urine. Plasma phosphorus is believed to be filterable by the renal
glomeruli, and the major portion of filtered phosphorus (greater than 80%)
is actively reabsorbed by the tubules. Many modifying influences tend to alter
the amount excreted in the urine.
Sodium is the principal
cation of extracellular fluid. It comprises more than 90% of the total cations
at its normal plasma concentration of approximately 142 mEq/liter. While the
sodium ion can diffuse across cell membranes, intracellular sodium is maintained
at a much lower concentration than extracellular sodium through the expenditure
of energy by the cell (so called “sodium cation pump”). Loss
of intracellular potassium ion is usually accompanied by an increase in intracellular
When serum sodium concentration is low,
the secretion of antidiuretic hormone (ADH) by the pituitary is inhibited,
thereby preventing water reabsorption by the distal renal tubules. On the
other hand, adrenal secretion of aldosterone increases renal tubular reabsorption
of sodium in an effort to re-establish normal serum sodium concentration.
INDICATIONS AND USAGE
Sodium Phosphates Injection, USP, 3 mM P/mL is indicated
as a source of phosphorus, for addition to large volume intravenous fluids,
to prevent or correct hypophosphatemia in patients with restricted or no oral
intake. It is also useful as an additive for preparing specific parenteral
fluid formulas when the needs of the patient cannot be met by standard electrolyte
or nutrient solutions.
The concomitant amount of sodium
(Na+ 4 mEq/mL) must be calculated into total electrolyte dose of
such prepared solutions.
Sodium phosphate is contraindicated in diseases where high
phosphorus or low calcium levels may be encountered, and in patients with
Sodium Phosphates Injection, USP, 3 mM P/mL must be diluted
and thoroughly mixed before use.
To avoid phosphorus
intoxication, infuse solutions containing sodium phosphate slowly. Infusing
high concentrations of phosphorus may result in a reduction of serum calcium
and symptoms of hypocalcemic tetany. Calcium levels should be monitored.
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 ions may result in sodium retention.
This product contains aluminum that may be toxic. Aluminum may reach toxic
levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature,
and they require large amounts of calcium and phosphate solutions, which contain
Research indicates that patients with impaired
kidney function, including premature neonates, who receive parenteral levels
of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels
associated with central nervous system and bone toxicity. Tissue loading may
occur at even lower rates of administration.
Do not administer unless solution is clear and seal is intact.
Discard unused portion.
Phosphorus replacement therapy
with sodium phosphate should be guided primarily by the serum phosphorus level
and the limits imposed by the accompanying sodium (Na+) ion.
with caution in patients with renal impairment, cirrhosis, cardiac failure
and other edematous or sodium-retaining states.
must be exercised in the administration of parenteral fluids, especially those
containing sodium ions, to patients receiving corticosteroids or corticotropin.
Pregnancy Category C:
Animal reproduction studies have not been conducted with
sodium phosphate. It is also not known whether sodium phosphate can cause
fetal harm when administered to a pregnant woman or can affect reproduction
capacity. Sodium phosphate should be given to a pregnant woman only if clearly
The safety and effectiveness of sodium phosphate has been
established in pediatric patients (neonates, infants, children and adolescents).
An evaluation of current literature revealed no clinical
experience identifying differences in response 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.
Sodium ions and phosphorus
are 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.
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
Adverse reactions involve the possibility of phosphorus intoxication.
Phosphorus intoxication results in a reduction of serum calcium and the symptoms
are those of hypocalcemic tetany. See WARNINGS.
In the event of overdosage, discontinue infusions containing
sodium phosphate immediately and institute corrective therapy to restore depressed
serum calcium and to reduce elevated serum sodium levels. See WARNINGS, PRECAUTIONS
and ADVERSE REACTIONS.
DOSAGE AND ADMINISTRATION
Sodium Phosphates Injection, USP, 3 mM P/mL is administered
intravenously only after dilutionand thorough mixing in a larger volume of fluid. The
dose and rate of administration are dependent upon the individual needs of
the patient. Serum sodium, phosphorus and calcium levels should be monitored
as a guide to dosage. Using aseptic technique, all or part of the contents
of one or more vials may be added to other intravenous fluids to provide any
desired number of millimoles (mM) of phosphorus.
patients on total parenteral nutrition, approximately 12 to 15 mM of phosphorus
(equivalent to 372 to 465 mg elemental phosphorus) per liter bottle of TPN
solution containing 250 g dextrose is usually adequate to maintain normal
serum phosphorus, though larger amounts may be required in hypermetabolic
states. The amount of sodium and phosphorus which accompanies the addition
of sodium phosphate also should be kept in mind, and if necessary, serum sodium
levels should be monitored.
The suggested dose of phosphorus
for infants receiving TPN is 1.5 to 2 mM P/kg/day.
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. See PRECAUTIONS.
Sodium Phosphates Injection, USP, 3 mM P/mL is supplied as
a 15 mL (45 mM P total) partial-fill single-dose container as follows: List
No. 7391, Plastic Vial.
Each container is partially
filled to provide air space needed for complete vacuum withdrawal of the contents
into the I.V. container.
Store at 20 to 25°C (68
to 77°F). [See USP Controlled Room Temperature.]