Peak Development for ...

Medication Administration

Vol. 16 Issue 4
April 2015

Antimicrobial Agents: Fidaxomicin (Dificid)

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
fidaxomicin.
2. Relate general characteristics of fidaxomicin
to specific patient situations.
3. Apply nursing process considerations for
fidaxomicin to specific patient situations.
Clostridium Difficile Infection
C. diff infection (CDI), also called C. diffassociated disease (CDAD), is a potentially
serious intestinal illness caused by infection
with Clostridium difficile (C. diff). It is a grampositive, anaerobic bacillus that forms spores,
making it hardy and resistant to destruction by
cleaning agents or other substances. C. diff
bacteria produce exotoxins that can cause
serious illness or death.
An estimated 3% of healthy persons carry
this organism as normal bowel flora. In most
cases, the other normal bacteria in the bowel
keep the C. diff controlled. Illness with CDI may
result when the balance of normal bowel
bacteria becomes upset, allowing the C. diff
bacteria to multiply. It may also occur when
someone who is either colonized or has an
active infection with C. diff passes the bacteria
on to another person. C. diff is spread by
contact, via the fecal-oral route, from touching
the person or articles contaminated with the
persons stool. In healthcare facilities, these
organisms are commonly carried from one
patient to another on the hands of healthcare
providers, or on contaminated equipment, such
as stethoscopes.
Recent use of antibiotics is the most
common risk factor associated with CDI,
accounting for approximately 90% of cases.
Antibiotic use may reduce levels of some
beneficial bacteria, allowing C. diff bacteria to
multiply and reach pathogenic levels. Risk
increases with the use of broad-spectrum
antibiotics, multiple antibiotics, and prolonged

use of antibiotics. Symptoms of CDI include

watery diarrhea, fever, anorexia, nausea, lower
abdominal pain, and malaise. In most cases,
there is no blood apparent in the stools. The
disease may progress to life-threatening
complications, including pseudomembranous
colitis, paralytic ileus, bowel perforation, toxic
megacolon, sepsis, and septic shock.
Vancomycin and metronidazole have been
the primary drugs used to treat Clostridium
infection. In 2011, fidaxomicin (Dificid) became
the first drug specifically developed and
approved to treat only CDI. Compared to
vancomycin, fidaxomicin had a lower relapse
rate in studies.
Indications
Fidaxomicin is indicated for the treatment of
C. diff - associated diarrhea in adults.
Pharmacodynamics
Fidaxomicin is a narrow-spectrum antibiotic
in the macrolide class. It is bactericidal, acting
by inhibiting RNA synthesis in the cell.
Pharmacokinetics
Absorption: Very low oral bioavailability, as it
remains within the GI tract after oral
administration and has minimal systemic
absorption; not affected by food
Distribution: Remains local, therefore minimal
distribution to body tissues and fluids; unknown
whether it is excreted in breast milk
Metabolism: Hydrolyzed in the GI tract to a
less active metabolite
Elimination: Excreted primarily by fecal route
Major Interactions
Cyclosporine: Concurrent use may increase
serum levels of fidaxomicin and decrease its
concentration in the GI tract, but no dosage
adjustment is necessary.
Adverse Effects/Toxicity
Adverse effects associated with fidaxomicin
include nausea/vomiting, abdominal pain, GI

bleeding, anemia and neutropenia. Hypersensitivity reactions,

including rash, itching, difficulty breathing, and swelling of the
face, mouth and throat, have also been reported.
Precautions/Contraindications
Fidaxomicin should not be used for systemic infections,
since it remains primarily within the GI tract. To prevent the
development of drug-resistant bacteria, it should be used only
for treatment of confirmed or strongly suspected C. diff
infection. The drug should be used with caution in patients with
previous allergic reaction to other macrolide antibiotics, such
as erythromycin and azithromycin. It should be discontinued
and an alternative drug used if severe hypersensitivity reaction
occurs.
Nursing Process
Assessment
Determine baseline status: As with any patient taking
antimicrobial medication, a complete assessment of the
presenting condition should be performed as a baseline for
measurement of antibiotic effectiveness. This includes
temperature, pulse, respiration, and blood pressure, as well as
any signs or symptoms related to the infection. With CDI, a
thorough GI assessment should be performed, including
presence of diarrhea or other stool abnormality, abdominal
pain, tenderness, distention or rigidity, bowel sounds, anorexia
and nausea/vomiting. The frequency, amount, color, and
consistency of stools should be assessed and documented.
The patients fluid status should be assessed, noting any signs
of dehydration, such as dry mucous membranes, headache,
fatigue, decreased urine output or concentrated urine.
The patient should be monitored carefully for signs of
worsening condition, including fever, tachycardia, hypotension,
abdominal distention, or sudden cessation of diarrhea, which
may signal paralytic ileus or toxic megacolon. If life-threatening
colitis develops, surgical removal of the colon with ileostomy
may be required.
Identify risk factors: Assess for factors that increase the
risk of CDI, including antibiotic use within the past 2-3 months,
the presence of chronic illnesses, advanced age, lengthy
hospitalization, decreased immune function, invasive GI
procedures, and use of proton pump inhibitors, such as
omeprazole, that decrease gastric acidity. Any history of
allergic drug reactions, especially to macrolides, should also
be assessed.
Age-specific considerations: FDA pregnancy risk category
B. The drug should be used cautiously in breastfeeding
mothers, although the low oral bioavailability of this drug is
thought to cause little risk to the nursing infant. Safety and
efficacy in the pediatric population have not been established.

There are no known drug issues specific to the geriatric

population.
Planning and Analysis
The goal of treatment with fidaxomicin is that the patient
becomes infection-free, with no adverse effects resulting from
drug therapy.
Intervention
Medication administration: Fidaxomicin is administered
orally, in tablet form, 200 mg twice daily for 10 days. It may be
taken with or without food. Anti-diarrheal drugs should not be
used in patients with CDI, as this prolongs exposure of the gut
to the C. diff toxins and increases the risk of toxic megacolon.
Also, opioids should be avoided or used with great caution,
since they may reduce peristalsis and increase the risk of
paralytic ileus or toxic megacolon.
Observe for therapeutic effects: Symptoms such as
diarrhea, abdominal pain and anorexia should improve, usually
within several days. By the end of therapy, all symptoms of
CDI should have resolved.
Observe for adverse effects: If nausea/vomiting occur,
administer the drug with food. Hold the dose and notify the
physician if GI bleeding, hypersensitivity reaction or alterations
in CBC occur.
Patient/Family teaching: Patient and family teaching should
focus on appropriate medication administration and monitoring
and include the following:
The drug may be taken with or without food. If GI upset
occurs, take with food.
Take the full course of antibiotic as directed, even if you feel
better. Not finishing the medication may result in return of
symptoms and/or development of drug-resistant bacteria.
Do not take any over-the-counter medicines to decrease
diarrhea, as this slows the elimination of toxins and
increases the risk of complications.
Contact the doctor if symptoms become worse rather than
better.
Contact the doctor if you have bloody stool, vomiting of dark,
coffee-ground material, faintness, pale skin, severe
abdominal pain, or signs of infection, such as new onset of
fever, chills, cough, shortness of breath, or body aches.
Discontinue medication and report to the doctor if itching,
rash, hives, or other signs of hypersensitivity occur.
Evaluation
Through careful monitoring and therapeutic administration of
fidaxomicin, the expected outcomes of eliminating infection
and early detection of any adverse effects can be safely
promoted.

Peak Development for Medication Administration

Antimicrobial Agents: Fidaxomicin (Dificid)

Page 2

Peak Development for ...

Medication Administration
Competency Assessment Tool

Vol. 16 Issue 4
April 2015

Antimicrobial Agents: Fidaxomicin (Dificid)

NAME:

DATE:

UNIT:

Directions: Place the letter of the one best answer in the space provided.
_____1. The most common risk factor for C. diff infection (CDI) is:
A. recent use of antibiotics
B. advanced age
C. prolonged hospitalization
D. use of proton pump inhibitors
_____2. Common symptoms of CDI include all of the following EXCEPT:
A. bloody diarrhea
B. fever
C. abdominal pain
D. nausea
_____3. Fidaxomicin is a member of which of the following class of antibiotics:
A. lincosamides
B. ketolides
C. macrolides
D. aminoglycosides
_____4. Studies have shown that fidaxomicin has which of the following advantages over
vancomycin in treatment of CDI:
A. symptoms resolve more quickly with fidaxomicin
B. fidaxomicin only has to be taken for 5 days
C. the risk of relapse is decreased with fidaxomicin
D. none of the above both drugs are equal in these characteristics
_____5. Fidaxomicin is indicated for use in either local GI or systemic C. diff infections.
A. True
B. False

_____6. Known characteristics of fidaxomicin include which of the following:

A. drug metabolites are excreted in breast milk
B. the drug remains primarily in the GI tract
C. metabolism of the drug occurs in the liver
D. all of the above
_____7. A patient who is allergic to which of the following medications may be more likely to have
an allergic reaction to fidaxomicin:
A. telavancin
B. clindamycin
C. gentamicin
D. azithromycin
_____8. Anti-diarrheal drugs are commonly administered along with fidaxomicin to relieve the
severe diarrhea associated with CDI.
A. True
B. False
_____9. Patient teaching regarding use of fidaxomicin should include taking the drug:
A. on an empty stomach in the morning
B. after meals
C. with meals
D. either with or without food
_____10. During treatment with fidaxomicin, the patient should be assessed for all of the following
EXCEPT:
A. neutropenia
B. anemia
C. fluid volume overload
D. GI bleeding

Competency Assessment Tool

Antimicrobial Agents: Fidaxomicin (Dificid)

Page 2

Month: April 2015

Issue:
Antimicrobial Agents:
Fidaxomicin (Dificid)

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