Children's Hospitals Today - Fall 2021 - 8

ADVERTISEMENT
ROUNDS / COMMENTARY
* In patients undergoing hemorrhoidectomy, a total of 266 mg (20 mL ) of
EXPAREL was diluted with 10 mL of saline, for a total of 30 mL, divided
into six 5 mL aliquots, injected by visualizing the anal sphincter as a
clock face and slowly infiltrating one aliquot to each of the even numbers
to produce a field block.
Local Analgesia via Infiltration Dosing in Pediatric Patients
The recommended dose of EXPAREL for single-dose infiltration in pediatric
patients, aged 6 to less than 17 years, is 4 mg/kg (up to a maximum of
266 mg), and is based upon two studies of pediatric patients undergoing
either spine surgery or cardiac surgery.
Regional Analgesia via Interscalene Brachial Plexus Nerve Block Dosing
in Adults
The recommended dose of EXPAREL for interscalene brachial plexus nerve
block in adults is 133 mg (10 mL), and is based upon one study of patients
undergoing either total shoulder arthroplasty or rotator cuff repair.
Compatibility Considerations
Admixing EXPAREL with drugs other than bupivacaine HCl prior to
administration is not recommended.
* Non-bupivacaine based local anesthetics, including lidocaine,
may cause an immediate release of bupivacaine from EXPAREL if
administered together locally. The administration of EXPAREL may
follow the administration of lidocaine after a delay of 20 minutes or
more.
* Bupivacaine HCl administered together with EXPAREL may impact the
pharmacokinetic and/or physicochemical properties of EXPAREL, and
this effect is concentration dependent. Therefore, bupivacaine HCl and
EXPAREL may be administered simultaneously in the same syringe,
and bupivacaine HCl may be injected immediately before EXPAREL as
long as the ratio of the milligram dose of bupivacaine HCl solution to
EXPAREL does not exceed 1:2.
The toxic effects of these drugs are additive and their administration
should be used with caution including monitoring for neurologic and
cardiovascular effects related to local anesthetic systemic toxicity.
* When a topical antiseptic such as povidone iodine (e.g., Betadine®
)
is applied, the site should be allowed to dry before EXPAREL is
administered into the surgical site. EXPAREL should not be allowed
to come into contact with antiseptics such as povidone iodine in
solution.
Studies conducted with EXPAREL demonstrated that the most common
implantable materials (polypropylene, PTFE, silicone, stainless steel, and
titanium) are not affected by the presence of EXPAREL any more than
they are by saline. None of the materials studied had an adverse effect
on EXPAREL.
Non-Interchangeability with Other Formulations of Bupivacaine
Different formulations of bupivacaine are not bioequivalent even if the
milligram dosage is the same. Therefore, it is not possible to convert
dosing from any other formulations of bupivacaine to EXPAREL and vice
versa.
Liposomal encapsulation or incorporation
in
a
lipid complex can
substantially affect a drug's functional properties relative to those of
the unencapsulated or nonlipid-associated drug. In addition, different
liposomal or lipid-complexed products with a common active ingredient
may vary from one another in the chemical composition and physical form
of the lipid component. Such differences may affect functional properties
of these drug products. Do not substitute.
CLINICAL PHARMACOLOGY
Pharmacokinetics
Administration of EXPAREL results in significant systemic plasma levels
of bupivacaine which can persist for 96 hours after local infiltration and
120 hours after interscalene brachial plexus nerve block. In general,
peripheral nerve blocks have shown systemic plasma levels of bupivacaine
for extended duration when compared to local infiltration. Systemic
plasma levels of bupivacaine following administration of EXPAREL are not
correlated with local efficacy.
PATIENT COUNSELING
Inform patients that use of local anesthetics may cause
methemoglobinemia, a serious condition that must be treated promptly.
Advise patients or caregivers to seek immediate medical attention if they or
someone in their care experience the following signs or symptoms: pale,
gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness
of breath; lightheadedness; or fatigue.
A
s children's hospitals, we are at
a pivotal point on our journey
Pacira Pharmaceuticals, Inc.
San Diego, CA 92121 USA
Patent Numbers:
6,132,766
5,891,467
to improve the quality of children's
health care and achieve better health
outcomes for all children. The events
of the past 20 months have brought
clarity and urgency to the work we
must do. Looking forward, we are
bolstered by what we have achieved
together in the last 25 years to prepare
us for this next step. We are ready.
Individually and collectively, our
hospitals and health systems have:
◼ Developed expertise in quality
improvement science.
5,766,627
8,182,835
Trademark of Pacira Pharmaceuticals, Inc.
For additional information call 1-855-RX-EXPAREL (1-855-793-9727)
Rx only
March 2021
◼ Improved data and analytic
tools to inform and augment
our efforts.
◼ Made progress we once thought
was impossible.
Re-imagining quality is important
8
work, and it will require more than a
simple shift in mindset. We must use
the data we have-not as a means for
competition, but as a way to understand
where there are gaps, monitor
improvement and measure outcomes.
Similarly, while we've made progress
in safety, we have work to do across
the domains of quality including timeliness,
effectiveness, efficiency, equity
and patient centeredness (STEEEP).
The focus of our work will also be
important. It's time to look beyond
the ways of the hospital and look at the
populations of children and patients
we can affect or influence in a powerful
way. How will we address opportunities
in behavioral health, care coordination
across the continuum from hospital to
home, and the overall health and wellbeing
of children in our communities?
This effort will require us to work
CHILDREN'S HOSPITALS TODAY Fall 2021
Moving forward faster
As executive leaders of our nation's children's
hospitals, we have an imperative to improve health
and health care outcomes for children.
BY KATY WELKIE
Photo: Kayla Bertucci, Children's Hospital New Orleans
Children's Hospitals Today - Fall 2021

Table of Contents for the Digital Edition of Children's Hospitals Today - Fall 2021
