SHIRLEY,
N.Y., July 2, 2024 /PRNewswire/ -- American
Regent announces the launch and availability of Sodium Phosphates
Injection, USP, which is FDA-approved and therapeutically
equivalent to Sodium Phosphates.1 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 hypernatremia.
"An important part of our company's mission is to assist in
mitigating shortages and ensuring supply of critical medications
whenever possible. To that end, we are pleased to add Sodium
Phosphates Injection, USP to our robust line of products that are
formulated, filled, and finished at our US-based manufacturing
facilities," stated Joann Gioia,
Vice President and Chief Commercial Officer at American Regent,
Inc.
This product is available for immediate shipment. Customers
can order Sodium Phosphates Injection, USP through
their wholesaler/distributor, or by contacting our Customer Support
Group at 1-800-645-1706.
Sodium Phosphates Injection, USP is supplied as
follows:
NDC#
|
Strength
Pack
|
Supplied
as
|
Shelf
pack
|
0517-7305-25
|
15 mM P/5 mL (3 mM
P/mL) containing 20 mEq
Na+/5 mL (4 mEq/mL)
|
5
mL Single-dose, plastic
vial
|
25
|
0517-7315-25
|
45 mM P/15 mL (3 mM
P/mL) containing 60 mEq
Na+/15 mL (4 mEq/mL)
|
15 mL
Single-dose, plastic vial
|
25
|
0517-7350-25
|
150 mM P/50 mL (3 mM
P/mL) containing 200 mEq
Na+/50 mL (4 mEq/mL)
|
50
mL Single-dose, plastic
vial
|
25
|
See the following Important Safety Information, in addition to
the product's Full Prescribing Information.
For additional information, please visit www.americanregent.com
FOR ADDITIVE USE ONLY AFTER DILUTION IN I.V.
FLUIDS
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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Sodium phosphate is contraindicated
in diseases where high phosphorus or low calcium levels may be
encountered, and in patients with hypernatremia.
WARNINGS
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.
Solutions 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.
In patients with diminished renal function, administration of
solutions containing sodium ions may result in sodium
retention.
WARNING: 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 aluminum.
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.
PRECAUTIONS
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.
Use with caution in patients with renal impairment, cirrhosis,
cardiac failure, and other edematous or sodium-retaining
states.
Caution must be exercised in the administration of parenteral
fluids, especially those containing sodium ions, to patients
receiving corticosteroids or corticotropin.
Pregnancy: 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
needed.
Pediatric Use: The safety and effectiveness of
sodium phosphate has been established in pediatric patients
(neonates, infants, children, and adolescents).
Geriatric Use: 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 function.
ADVERSE REACTIONS
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.
OVERDOSAGE
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.
For additional safety information, please see Full
Prescribing Information.
You are encouraged to report Adverse Drug Events to American
Regent Inc. at 1-800-734-9236, or to the FDA by visiting
www.fda.gov/medwatch or by calling
1-800-FDA-1088.
You are encouraged to report adverse drug
events (ADEs) to American Regent:
T 1.800.734.9236;
E pv@americanregent.com;
F 1.610.650.0170
ADEs may also be reported to the
FDA:
1.800.FDA.1088
or www.fda.gov/medwatch
Medical Information:
T 1.888.354.4855
(9:00 am–5:00 pm Eastern Time, Monday–Friday)
www.americanregent.com/medical-affairs
For medical information outside of normal
business hours
that cannot wait until the next business day, please call
1.877.845.6371
About American Regent
American Regent,
Inc.®, a Daiichi Sankyo Group company, is an
industry-leading injectable manufacturer. For over 50 years,
American Regent has been developing, manufacturing, and supplying
quality generic and branded injectables for healthcare providers.
For more than 20 years, we have been a leader in IV iron
therapy.
American Regent is committed to US-based manufacturing. To that
end, over the last several years we have made significant
investments in expanding and modernizing our manufacturing
facilities in Ohio and
New York. This expansion will
nearly double our capacity and allow us to better serve our
customers now and in the future.
Speed counts. Flexibility matters. Reliability and quality are
paramount. Because patients should never have to wait for the
medications they need.
For more information, please visit www.americanregent.com.
About Daiichi Sankyo Group
Daiichi Sankyo is dedicated
to creating new modalities and innovative medicines by leveraging
our world-class science and technology for our purpose "to
contribute to the enrichment of quality of life around the world."
In addition to our current portfolio of medicines for cancer and
cardiovascular disease, Daiichi Sankyo is primarily focused on
developing novel therapies for people with cancer as well as other
diseases with high unmet medical needs. With more than 100 years of
scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 16,000 employees around the world draw upon
a rich legacy of innovation to realize our 2030 Vision to become an
"Innovative Global Healthcare Company Contributing to the
Sustainable Development of Society."
For more information, please visit: www.daiichisankyo.com.
All trademarks are the property of their respective owners.
Reference: 1. Orange book: Approved drug products with
therapeutic equivalence evaluations. US Food & Drug
Administration. Accessed April 12,
2024
.https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=018892#22110
View original content to download
multimedia:https://www.prnewswire.com/news-releases/american-regent-introduces-sodium-phosphates-injection-usp-fda-approved-and-ap-rated-302187998.html
SOURCE American Regent Inc