Peak Development for ...

Medication Administration

Vol. 16 Issue 9
September 2015

Analgesic Agents: Zohydro ER and Hysingla ER

The First Pure Hydrocodones
Peak Development Resources
P.O. Box 13267
Richmond, VA 23225
Phone: (804) 233-3707
Fax: (804) 233-3705
Email: editor@peakdev.com

Peak Development for Medication

Administration and Competency
Assessment Tool for Medication
Administration are components of
a site license for the Peak
Development Resources
Competency Assessment System
for Medication Administration
and may be reproduced for this
individual facility only. Sharing
of these components with any
other freestanding facility within
or outside the licensees corporate
entity is expressly prohibited.

The information contained in

Peak Development for Medication
Administration is intended only as
a guide for the practice of
licensed nursing personnel who
administer medications. Every
effort has been made to verify the
accuracy of the information
herein. Because of rapid changes
in the field of drug therapy, the
reader is advised to consult the
package insert, facility pharmacist
or patients physician for relevant
information. This is particularly
important for new or seldom used
drugs. Use of professional
judgment is required in all patient
care situations. It is the readers
responsibility to understand and
adhere to policies and procedures
set forth by the employing
institution. The editor and
publisher of this newsletter
disclaim any liability resulting
from use or misuse of
information contained herein.
Copyright 2015

After completion the learner should be able to:

1. Identify appropriate indications for use of
Zohydro ER and Hysingla ER.
2. Relate general characteristics of these drugs
to specific patient situations.
3. Apply nursing process considerations for
these drugs to specific patient situations.
Zohydro ER is an extended-release form of
the opioid analgesic, hydrocodone. It was
approved by the FDA in October 2013. Zohydro
ER is the first single-entity hydrocodone drug
approved for use in the US. Prior to this
approval, all hydrocodone products indicated for
pain relief in the US were manufactured in
combination with a non-opioid analgesic, most
commonly acetaminophen (such as Vicodin).
Zohydro ER is also the first extended-release
version of hydrocodone used in the US. In
November 2014, a second single-entity,
extended-release hydrocodone, Hysingla ER,
was approved.
A major concern with the approval of
Zohydro ER was how it might contribute to the
current epidemic of opioid abuse, overdose and
resultant deaths. Every day in the US, 44 people
die from the use of prescription opioid
analgesics, according to reports from the
Centers for Disease Control and Prevention
(CDC). The death rate of 5 to 5.4 per 100,000
population has remained fairly stable since
2009, but has more than tripled since 1999.
At the time of its initial approval, Zohydro ER
did not have abuse-deterrent technology. These
are properties that make the drug more difficult
to crush and/or mix with liquids, with the intent of
discouraging abuse by snorting or injection.
Hysingla ER was manufactured with abusedeterrent technology at the time of its approval.
Since then, the makers of Zohydro ER have
followed suit, and a new abuse-deterrent formula
was FDA-approved in January 2015. This new
formula became available in May 2015.

Indications
Zohydro ER and Hysingla ER are indicated
for the treatment of chronic pain that requires
daily, around-the-clock, long-term therapy. They
are used only when other treatments have not
been adequate or tolerated, and are not
indicated for intermittent (as-needed or prn) use.
Pharmacodynamics
Like other opioids, these drugs reduce pain
by binding to specific receptors in the brain and
spinal cord involved in the transmission of pain
impulses.
Pharmacokinetics
Absorption: Well-absorbed from the GI tract;
may be taken without regard to meals
Distribution: Extensively distributed throughout
body tissues; low protein binding
Metabolism: Metabolized in the liver, primarily
via the CYP3A4 enzymes
Elimination: Excreted via the kidneys
Major Interactions
Alcohol: Use of alcohol with extendedrelease forms of opioids, such as Zohydro ER
and Hysingla ER, may cause rapid release of
the opioid. This can raise serum drug levels to
dangerous, and possibly fatal, levels. As a CNS
depressant, alcohol use also increases the risk
of severe respiratory depression.
CNS depressants, such as sedatives,
hypnotics and other opioids: Increased risk of
severe respiratory depression.
Ketoconazole, erythromycin and ritonavir,
among others (CYP3A4 inhibitors): May
significantly increase opioid drug levels.
Rifampin, phenytoin and carbamazepine
(CYP3A4 inducers): Stopping these drugs during
use of Zohydro ER or Hysingla ER may cause
significant increase in opioid drug levels. Starting
these drugs during the opioid treatment may
cause a decrease in serum opioid levels, and
may precipitate withdrawal.

Drugs with anticholinergic effects (including

antihistamines, atropine and ipratropium): Increased risk of
urinary retention, severe constipation and paralytic ileus.
Adverse Effects/Toxicity
A black-box warning is required regarding the risk of
addiction/abuse, neonatal withdrawal syndrome, respiratory
depression, accidental ingestion and alcohol use. Also
included is the risk of fatal overdose if drugs that inhibit or
induce certain CYP enzymes are started or stopped. Other
adverse effects include dizziness, sedation, fatigue,
constipation, nausea, vomiting, urinary retention, headache,
and hypotension, especially orthostatic.
Precautions/Contraindications
Use with caution in the elderly and patients with chronic
respiratory disease, head injury, renal or hepatic impairment,
and history of seizures or addiction/abuse. These drugs are
contraindicated for use in patients with significant respiratory
depression, severe asthma or paralytic ileus.
Nursing Process
Assessment
Determine baseline status: To monitor effectiveness of
therapy, a pain assessment is done prior to administration of
the medication. A thorough pain assessment should include
documentation of the following:
Description of pain quality and time of onset/how long it lasts
Location of pain and whether it radiates to other locations
Intensity/Severity: use the facilitys approved pain scale,
such as a rating from 0 - 10
Factors that intensify or alleviate the pain; also assess for
factors such as anxiety, fear and anger
Vital signs; take prior to administration of pain medication
Response to pain medication and other treatment
Identify risk factors: Before starting the medication, a
thorough medication history should be taken of all prescription
and over-the-counter drugs, as well as supplements. Extreme
caution should be used in administering extended-release
hydrocodone to patients with conditions listed in the
precautions section of this newsletter. These patients require
more frequent assessment.
Age-specific considerations: FDA pregnancy category C.
Not recommended for use in breastfeeding women, as higher
opioid dosages over a prolonged period of time may cause
sedation and other effects in the infant. Safety and
effectiveness have not been determined in children under age
18. Geriatric patients may have an increased risk for adverse
effects, such as sedation and confusion. A lower starting
dosage may be required.

Planning and Analysis

The therapeutic goal of treatment with Zohydro ER and
Hysingla ER is relief of pain, while minimizing adverse effects.
Intervention
Medication administration: Both drugs are available in oral
forms only. Zohydro ER is provided in capsules ranging in
strength from 10 to 50 mg, taken every 12 hours. Hysingla ER
is available in tablet form, ranging from 20 to 120 mg, taken
once every 24 hours. The tablets and capsules should always
be swallowed whole, to prevent excessive amounts of drug
release and overdose. These drugs should not be stopped
suddenly, as physical withdrawal may occur in some cases.
Dosage should be gradually reduced prior to discontinuation.
Observe for therapeutic effects: Peak plasma drug
concentrations occur 5 hours after administration of Zohydro
ER, and 630 hours after Hysingla ER. A stable plasma level
is usually achieved within 3 days for both drugs, and it may
take several days for pain relief to occur. The frequency of
assessment for pain relief is individualized, based on factors
such as patient condition, risk factors, age, and how long the
drug has been taken. An immediate-release opioid may be
required for ongoing or breakthrough pain, until the dosage of
Zohydro ER or Hysingla ER is adequately titrated.
Observe for adverse effects: Assess for respiratory
depression and other adverse effects. If excessive sedation or
respirations <10/min occur, hold the dose and notify physician.
The greatest risk for adverse effects is usually within the first 3
days of therapy, as serum drug levels increase and stabilize.
Monitoring should be more frequent during this period. Monitor
the patient for hypotension and dizziness, use fall precautions,
and have the patient change positions slowly until drug effects
are known. Also assess bowel and bladder function to detect
constipation, hypoactive bowel sounds or urinary retention.
Patient/Family teaching:
Take the drug exactly as directed and swallow it whole
do not crush or chew, as this could cause an overdose.
Do not take alcohol in any form (beverage, cold medicine)
Do not drive or operate dangerous equipment until you
know how the medication will affect you.
Do not stop taking the drug without talking with the doctor.
Seek immediate medical help if you experience shortness
of breath, difficulty breathing, palpitations or faintness.
Evaluation
While meeting the therapeutic goal for pain management
with long-acting hydrocodone, it is important for the nurse to
continuously assess for individual therapeutic response and
adverse effects. Through careful planning and
implementation, the nurse can promote safe and effective
pain control.

Peak Development for Medication Administration

Analgesic Agents: Zohydro ER and Hysingla ER

Page 2

Peak Development for ...

Medication Administration
Competency Assessment Tool

Vol. 16 Issue 9
September 2015

Analgesic Agents: Zohydro ER and Hysingla ER

The First Pure Hydrocodones
NAME:

DATE:

UNIT:

Directions: Place the letter of the one best answer in the space provided.
_____1. Zohydro ER is indicated for:
A. daily, 24-hour treatment of pain
B. acute and chronic pain, lasting days to months
C. intermittent use, taken as needed for pain
D. all of the above
_____2. A major difference between Zohydro ER and Hysingla ER is that:
A. Hysingla ER is a long-acting, single-entity hydrocodone; Zohydro ER is not
B. Zohydro ER has abuse-deterrent technology, while Hysingla ER does not
C. Hysgingla ER is taken once daily, while Zohydro ER is taken every 12 hours
D. Zohydro ER contains acetaminophen; Hysingla ER does not
_____3. There is little to no risk of respiratory depression when long-acting hydrocodone is
administered by the oral route.
A. True
B. False
_____4. A patient who began taking Zohydro ER two days ago states that he feels light-headed
and dizzy when the nurse helps him get out of bed and walk to the bathroom. Which
adverse effect of Zohydro ER is he most likely experiencing?
A. urinary retention
B. physical drug dependence
C. headache
D. orthostatic hypotension
_____5. The use of Zohydro ER is contraindicated for which of the following patients:
A. Mr. N, who has severe asthma
B. Mrs. D, who has a history of substance abuse
C. Mr. Y, who is 82 years old
D. Mrs. V, who is currently taking erythromycin

_____6. A patient who is taking Zohydro ER has become unable to swallow, and a feeding tube has
been inserted. The appropriate nursing action in this situation is to:
A. administer the previously-ordered prn opioid whenever the patient has pain
B. open the Zohydro ER capsule and mix the beads with water to put down the tube
C. call the prescriber to request a different pain medication
D. call the prescriber to obtain orders for the IV form of Zohydro ER
_____7. When starting Hysingla ER, the greatest risk of adverse effects occurs within the first:
A. two hours
B. three days
C. two weeks
D. month
_____8. Other opioid pain medications should never be administered to a patient currently taking
Zohydro ER or Hysingla ER.
A. True
B. False
_____9. When administering Zohydro ER or Hysingla ER, increased frequency of assessment and
monitoring is required for patients with:
A. emphysema
B. renal impairment
C. a history of seizures
D. all of the above
_____10. A patient taking Zohydro ER makes all of the following statements. Which one carries the
greatest risk of harm to the patient:
A. After I take it in the morning, I dont eat breakfast. Ill eat something around noon.
B. Theyre big pills, but I make sure to swallow them whole.
C. Im able to drive without any problems.
D. I occasionally have a martini or two in the evening.

Competency Assessment Tool

Analgesic Agents: Zohydro ER and Hysingla ER

Page 2

Peak Development for ...

Medication Administration

Month: September 2015

Issue: Analgesic Agents: Zohydro ER
and Hysingla ER

Group Tracking Log

Employee Name

Unit

Test Date

Score

Peak Development Resources

Contact Hour Application for Medication
Administration

Additional Information:
Phone: (804) 233-3707
Fax:
(804) 233-3705
Email: editor@peakdev.com

PLEASE COMPLETE EACH SECTION LEGIBLY. INCOMPLETE APPLICATIONS CANNOT BE PROCESSED.

1. Issue:
Month:

Analgesic Agents: Zohydro ER and Hysingla ER

September 2015
Contact Hours Awarded Through: September 2017

2. Facility Information
(provide information about the subscribing facility):
Facility Name: ________________________________
Address: ___________________________________
___________________________________
City: _________________ State: _____ Zip: _______
3. Applicant Information
(provide information about yourself)
Name: ___________________________________
Address: _________________________________
City: ________________ State: _____ Zip: ______
Daytime Phone Number:___________________
Nursing License #: ________________________
Licensing State: __________________________
Previous Peak Development Contact Hours: Yes

No

4. Test Answers: Darken the appropriate circle

below to answer each test question.

6. PAYMENT INFORMATION:
APPLICATIONS MUST INCLUDE PAYMENT
Cost: $10 per test nonrefundable
Check Payment method - Provide all information
_______ Check Payable to Peak Development Resources
($40.00 service fee for returned checks)
_______ Credit Card (circle one):
VISA
MASTERCARD
Credit Card Number: ____________________________
Credit Card Expiration Date: ___________
Print Name on Card: ____________________________
Authorized Signature: ___________________________
Billing Address for credit card:
Address: _______________ _____________________
____________________________________
State: ________ Zip: __________
7. EVALUATION
A. How long, in minutes, did it take you to complete
this educational packet? _______minutes.
B.

Please rate each of the following categories by

circling the number that best reflects your
experience with this self-study packet:
1=Strongly agree
2=Agree
3=Disagree
4=Strongly disagree

1.

2.

3.

4.

5.

1. I met the stated course objectives.

6.

2. Subject matter was accurate.

7.

3. Content reflected current information.

8.

9.

4. This self-study packet was an effective

way for me to learn.
5. Reading level and content were
10.
0
0
0
0
appropriate for me.
6.
Test reflected the stated course
5. Contact Hour Information:
objectives.
One contact hour is awarded for each test grade of 70%
7. Completing this self-study packet was
or higher from an issue of Peak Development for
an effective use of my time.
Medication Administration. The applicant must be an
employee of a subscribing institution. The application fee 8. This packet met my educational
needs.
is nonrefundable, regardless of test grade.

8. Mail completed application and payment to:

Peak Development Resources, LLC

P.O. Box 13267
Richmond, VA 23225