Drug Study
Drug Study
Generic Name: Therapeutic Binds with Injectio • Adjunct • Contraindicated in CNS: asthenia, Respiratory depression or death can occur even
fentaNYI citrate class: Opioid opioid n: 50 to general patients intolerant to drug. clouded sensorium, when transdermal drug has been used as
Brand Names: analgesics receptors in mcg/mL anesthetic Black Box Warning] Opioids con-fusion, recommended and has not been misused or
Abstral, Actiq, the CNS, should only be prescribed euphoria, sedation, abused. Drug should only be prescribed by health
Fentora Pharmacologic altering with benzodiazepines or somnolence, care providers knowledgeable in the use of potent
class: Opioid perception of other seizures, anxiety, opioids for management of long-term pain. Drug is
agonists and CNS depressants to depression, contraindicated for use in conditions in which the
emotional patients for whom alter. dizziness, hal- risk of life-threatening respiratory depression is
response to native treatment options lucinations, significantly increased. Transdermal patch is for
pain. are inadequate. I Black Box headache, hospital use only. a
Warning Transdermal form nervousness. CV; Black Box Warning Regularly monitor patients for
contraindicated in patients arrhythmias, chest development of opioid addiction, abuse, and
hypersensitive to ad- pain, HTN, hypoten- misuse. I Black Box Warning Serious, life-
hesives, those who are sion, DVT, PE. EENT: threatening or fatal respiratory depression can
opioid-naive, those who pharyngitis, dry occur. Monitor patient closely, especially within
need postoperative pain eyes, swelling, first 24 to 72 hours of drug initiation and after
management, and those strabismus, ptosis, dosage increase. O
with acute, mild, or epistaxis, nasal © Alert: If patient is taking opioids with sero-
intermittent pain that can discomfort, tonergic drugs, monitor for signs and symptoms of
be managed with rhinorrhea, nasal serotonin syndrome (agitation, hallu-cinations,
nonopioids. congestion, rapid HR, fever, excessive sweat-ing, shivering or
Don't use in patients with postnasal drip, shaking, muscle twitching or stiffness, trouble with
increased intracranial rhinitis (intranasal). coordination, nausea, vomiting, diarrhea),
pressure, head injury, Gl: con-stipation, especially when starting treatment or increasing
impaired con-sciousness, abdominal pain, dosage. Symptoms may occur within several hours
or coma. anorexia, diarrhea, of coadmin-istration but may also occur later,
Black Box Warning dyspepsia, dry especially after dosage increase. Discontinue the
Transmucosal forms mouth, ileus, opioid, serotonergic drug, or both if serotonin
contraindicated in those nausea, vomit-ing. syndrome is suspected.
who need acute or GU: urine retention. © Alert: Monitor patient for signs and symptoms
postoperative pain Musculoskeletal: of adrenal insufficiency (nausea, vomit-ing, loss of
management. I Black Box skeletal muscle appetite, fatigue, weakness, dizzi-ness, low BP).
Warning Nasal spray is rigidity (dose- Perform diagnostic testing if adrenal insufficiency
contraindicated in opioid- related). Res- is suspected. If adrenal insufficiency is confirmed,
nontolerant patients and in piratory: apnea, treat with corticosteroids and wean patient off
those who need acute or hypoventilation, opioids if ap-propriate. Discontinue corticosteroids
postoperative pain respiratory when clinically appropriate.
management. depression, © Alert: Don't stop drug abruptly; withdraw slowly
Black Box Warning] Drug dyspnea, cough, and individualize the gradual taper plan to prevent
may increase risks of opioid URI, brog-chitis. signs and symptoms of with-drawal, worsening
addiction, abuse, and Skin: diaphoresis, pain, and psychological distress in physically
misuse, which can lead to pruritus, erythema dependent patients. Refer to manufacturer's label
overdose and death. Risks at application site for specific tapering instructions.
increase in patients with a (transdermal). © Alert: When tapering opioids, monitor patient
personal or family history Ocher physical closely for signs and symptoms of opioid
of substance abuse or dependence. withdrawal (restlessness, lacrimation, rhin-orrhea,
mental illness. yawning, perspiration, chills, myal-gia, mydriasis,
Assess risks before drug is irritability, anxiety, insomnia, backache, joint pain,
prescribed. I weakness, abdominal cramps, anorexia, nausea,
• Transdermal form is vomiting, diarrhea, increased BP or HR, increased
contraindicated in patients respiratory rate). Such symptoms may indicate a
with acute or severe need to taper more slowly. Also watch for suicidal
bronchial asthma, known thoughts, use of other substances, and mood
or suspected paralytic changes.
ileus, and GI obstruction. O Alert: Monitor patient for signs and symptoms of
Black Box Warning Refer to decreased sex hormone levels (low libido, erectile
manufacturer's instructions dysfunction, amenorrhea, in-fertility). If signs and
for REMS requirements. I symptoms occur, evaluate patient and obtain
© Alert: Drug may lead to laboratory testing.
rare but serious decrease • For better analgesic effect, give drug before
in adrenal gland cortisol patient has intense pain.
production. • Alert: High doses can produce muscle rigidity,
Alert: Drug may cause which can be reversed with neuromuscular
decreased sex hormone blockers; however, patient must be artificially
levels with long-term use. ventilated.
• Fentora contraindicated © Alert: Avoid use in patients at risk for increased
in patients with mucositis ICP.
more severe than grade 1. • Monitor circulatory and respiratory status and
*• Use with caution in urinary function carefully. Drug may cause
patients with brain tu- respiratory depression, hypotension, urine
mors, COPD, decreased retention, nausea, vomiting, ileus, or altered level
respiratory reserve, of consciousness, no matter how it's given.
potentially compromised • Periodically monitor postoperative vital signs and
respirations, hepatic or bladder function. Because drug decreases both
renal disease, or cardiac rate and depth of respira-tions, monitoring of
bradyarrhythmias. arterial oxygen saturation (Saoz) may help assess
• Use with caution in respiratory de-pression. Immediately report
elderly or debilitated respiratory rate below 12 breaths/minute,
patients. decreased respiratory volume, or decreased Sao,.
• Opioids can cause sleep- • Drug may cause constipation. Assess bowel
related breathing function and need for stool softeners and
disorders, including central stimulant laxatives.
sleep apnea (CSA) and Black Box Warning Fentanyl is an opioid agonist
sleep-related hypoxemia. and schedule Il controlled substance with potential
Opioid use increases risk of for abuse. Be alert for signs of misuse, abuse, or
CSA in a dose-dependent diversion. O Transdermal form
fashion. In patients who Black Box Warning Transdermal drug levels peak
present with CSA, consider between 24 and 72 hours after initial application
decreasing opioid dosage and dose increases. Monitor patients for life-
using best practices for threatening hypoventilation, especially during
opioid taper. these times.
Dialyzable drug: Unknown. • Fentanyl patches should be used only in patients
A Overdose S&S: CNS age 2 or older who are opioid tolerant, who have
depression, respiratory chronic moderate to severe pain poorly controlled
depression, apnea, flaccid by other drugs, and who need a total daily opioid
skeletal mus-cos, dose at least equivalent to the 25-mcg/hour
bradycardia, hypotension, fentanyl patch.
circulatory • When converting patient from another opi-oid,
collapse. determine the initial fentanyl dosage with great
care; overestimating the dosage could be
PREGNANCY-LACTATION- dangerous or fatal.
REPRODUCTION • Identify all daily drugs, particularly
• There are no well- CYP3A4 inhibitors, which may increase fentanyl
controlled studies in levels.
pregnant women. Use • Monitor patients closely, and provide immediate
during pregnancy only if care for evidence of overdose, such as slow or
potential benefit justifies shallow breathing, a slow heart-beat, severe
potential risk to sleepiness, cold and clammy skin, trouble walking
the fetus. and talking, and feeling faint, dizzy, or confused.
Black Box Warning • Give patients detailed instructions for using
Prolonged maternal use of fentanyl patches correctly and safely.
opioids during pregnancy • Make dosage adjustments gradually in patient
can cause neonatal using the transdermal system. Reaching steady-
withdrawal syndrome, state level of a new dosage may take up to 6 days;
which may be life- delay dosage adjustment until after at least two
threatening and requires applications.
management by • Monitor patient who develops adverse reactions
neonatology experts. to the transdermal system for at least 12 hours
Advise patient of the risk of after removal. Drug level drops gradually; it may
neonatal withdrawal take as long as 17 hours to decline by 50%.
syndrome. O • Most patients experience good control of pain
• Drug appears in human for 3 days while wearing the transdermal system,
milk. Refer to individual but a few may need a new application after 48
manufacturer's instructions hours.
for use in breastfeeding • Because the drug level rises for the first
women. • 24 hours after application, analgesic effect can't
be evaluated on the first day. Make sure patient
has adequate supplemental analgesic to prevent
breakthrough pain. • When reducing opioid
therapy or switching to a different analgesic,
withdraw the transdermal system gradually.
Because the drug level drops gradually after
removal, give half the equianalgesic dose of the
new analgesic 12 to 18 hours after removal.
4 Alert: Transdermal patches must be stored, used,
and disposed of properly to prevent poisonings or
other harm, especially to children and pets. A
patch that has been worn for 3 days may still
contain enough fentanyl to cause harm, or even kill
a child or pet.
Patches should only be handled by patient or
patient's caregivers.
Intranasal and transmucosal forms
Black Box Warning Intranasal and transmu-cosal
forms are used only to manage breakthrough
cancer pain in patients who are already receiving
and tolerating opioids. I Black Box Warning
Intranasal and transmu-cosal forms aren't
bioequivalent and can't be substituted on a
microgram-per-microgram basis. I
• Look alike- sound alike: Don't confuse fentanyl
with alfentanil.
PATIENT TEACHING
Black Box Warning Caution patient or caregiver of
patient taking an opioid with a benzo-diazepine,
CNS depressant, or alcohol to seek immediate
medical attention for dizziness, light-headedness,
extreme sleepiness, slowed or difficult breathing,
or unresponsiveness.
Black Box Warning Advise patient that drug
increases risk of opioid addiction, abuse, and
misuse, which can lead to overdose and death.
Teach patient proper use of drug. I
• When drug is used for pain control, instruct
patient to request drug before pain becomes
intense.
© Alert: Encourage patient to report all
medications being taken, including prescription
and OTC medications and supplements.
© Alert: Caution patient to immediately re port
signs and symptoms of serotonin sym drome,
adrenal insufficiency, and decreased sex hormone
levels to health care provider.
© Alert: Counsel patient not to discontinue opioids
without first discussing need for a gradual tapering
regimen with prescriber.
• Teach patients that naloxone is prescribed in
conjunction with the opioid when begin ning and
renewing treatment as a preventive measure to
reduce opioid overdose and death.
. Tell home care patient to avoid drinking alcohol
or taking other CNS-type drugs, unless specifically
prescribed by practitioner, because additive effects
can occur.
• Teach patient about proper application of
transdermal patch. Tell patient to clip hair at
application site but not to use a razor, which nay
irritate skin. Wash area with clear wa-her, if
needed, but not with soaps, oils, lotions, alcohol,
or other substances that may irritate skin or
prevent adhesion. Dry area completely before
application.
• Tell patient to remove transdermal system from
package just before applying, hold in place for 30
seconds, and be sure the edges of patch stick to
skin.
© Alert: Teach patient not to alter the transdermal
patch (such as by cutting it) before applying.
• Advise parent or caregiver to place transdermal
patch on the upper back for child or patient who's
cognitively impaired, to reduce chance the patch
will be removed and placed in the mouth.
• Teach patient to dispose of the transdermal
patch by folding it so the adhesive side adheres to
itself and then flushing it down the toilet.
• Tell patient that, if another patch is needed after
48 to 72 hours, to apply it to a different skin site.
• Tell patient that pain relief with the patch may
not occur for several hours after the patch is
applied. Oral, immediate-release opioids may be
needed for initial pain relief.
Black Box Warning Inform patient that heat from
fever or environment, such as from heating pads,
electric blankets, heat lamps, hot tubs, or water
beds, may increase transdermal delivery and cause
toxicity requiring dosage adjustment. Instruct
patient to notify prescriber if fever occurs or if
patient will be spending time in a hot climate: I
© Alert: Instruct patient that if an MRI is re-quired,
to inform the facility that patient is wearing a
transdermal patch.
• Teach patient proper administration of
transmucosal forms.
° Advise patient that transmucosal lozenge
contains 2 g sugar per unit.
• Teach patient proper administration of the nasal
spray, and explain that a fine mist isn't always felt
and to rely on the audible click and advancement
of the dose counter.
Generic Therapeutic class: Binds with Adules: 5 to 15 Moderate • Drug should be CNS: clouded Use care when prescribing and
Name: Opioid analgesics opioid mg immediate- to severe prescribed only by health sensorium, dizziness, administering oxycodone
oxyCODONE receptors in release form" or pain care professionals euphoria, light- concentrated oral solution, to avoid
Pharmacologic the ONS, oral solution PO knowledgeable in the use headedness, physical dosing er-tors due to confusion
class: Opioids altering every 4 to 6 of potent opioids for the dependence, seda-tion, between milligram and milliliter and
Brand perception of hours. Titrate management of chronic somnolence, headache, among other oxycodone solutions
Names: and dosage based on pain. asthenia, fever, with different concentrations, which
Xtampza ER emotional response. For Black Box Warning abnormal dreams, could result in accidental overdose
control of se- Opioids should only be confusion. CV: brady- and death.
vere, chronic prescribed with cardia, hypotension, Take care to ensure the proper dose is
pain, give on a benzodiazepines or other edema, flushing, HIN, communicated and dispensed. I Black
regularly CNS depressants to tachycardia. EENT: Box Warning Serious, life-threatening
scheduled basis patients for whom blurred vision, pharyn- or fatal respiratory depression can
every 4 to 6 alternative treatment gitis, rhinitis, sinusitis. occur. Monitor patient closely,
hours. options are inadequate. Gl constipation, nau- especially within first 24 to 72 hours of
Moderate to Alert: Patients are at sea, vomiting, ileus, starting drug and after a dosage
severe pain in increased risk for diarrhea, anorexia, gas- increase. I Black Box Warning
patients not oversedation and tritis. GU: urine Routinely monitor all patients on
currently respiratory depression if retention. Hematologic: opioids for signs and symptoms of
receiving opioids, they snore or have a anemia; decreased Hb misuse, abuse, and addiction. O Black
who need a history of slep apnea, level, platelet count, Box Warning Accidental ingestion of
continuous, haven't used opioids RBC count. Hepatic: even one dose of drug, especially by
around-the clock recently or are first time increased ALT level. children, can be fatal. "
analgesic for an opioid users, have Metabolic: © Alert: Carefully monitor vital signs,
extended period increased opioid dosage hypochloremia, pain level, respiratory status, and
of time requirements or opioid hyponatremia, sedation level in all patients receiving
habituation, have Te- hyperglycemia. opioids, especially those receiving IV
Adults: 10 mg ceived general anesthesia Musculoskeletal: weak- drugs, even when given
extended-release for longer lengths of time ness, arthralgia, back postoperatively.
tablets or 9 mg or received other pain, tremor. Respi- © Reassess patient's level of pain at
extended-release sedating drugs, have ratory: respiratory least 15 and 30 minutes after
capsules PO preexisting pulmonary or depression, cough, administration.
every cardiac disease, or have dysp-nea. Skin: ° For full analgesic effect, give drug
12 hours. May thoracic or other surgical diaphoresis, pruritus. before patient has intense pain.
increase dose incisions carefully. • Keep opioid antagonist (naloxone)
every 1 to that may impair and resuscitation equipment available.
2 days until breathing. Monitor © Alert: If patient is taking opioids
desired pain patients with sero-tomergic drugs, watch for
control is © Alert: Drug may lead to signs and symptoms of serotonin
achieved. rare but serious decrease syndrome (agitation, hal-lucinations,
For pediatric in adrenal gland cortisol rapid HR, fever, excessive sweat-ing,
dosing, refer to production. shivering or shaking, muscle twitching
manufacturer's © Alert: Drug may cause or stiffness, trouble with coordination,
recommendation decreased sex hormone nau-sea, vomiting, diarrhea),
s. levels with long-term use. especially at start of treatment or with
Adiust-a-dose: • Contraindicated in dosage increases. Signs and symptoms
For elderly or patients hypersensitive to may occur within several hours of
debilitated drufraindicated in known coadministration but may also occur
patients and or suspected par. alytic later, especially after dosage increase.
those with ileus, significant Discontinue opioid, serotonergic drug,
hepatic or renal respiratory depression, or both if serotonin syndrome is
impairment, or if and acute or severe suspected.
patient is bronchial asthma. © Alert: Monitor patient for signs and
receiving CNS • Use with caution in symptoms of adrenal insufficiency
depressants, elderly and debilitated (nausea, vomit-ing, loss of appetite,
decrease initial patients and in those fatigue, weakness, dizzi-ness, low BP).
starting dose by with head injury, Perform diagnostic testing if adrenal
one-third to one- increased ICP, seizures, insufficiency is suspected. If adrenal
half. asthma, COPD, prostatic insufficiency is confirmed, treat with
hyperplasia, severe corticosteroids and wean patient off
hepatic or renal dis-ease, opioids if ap-propriate. Discontinue
acute abdominal corticosteroids when clinically
conditions, urethral appropriate.
stricture, • Alert: Monitor patient for signs and
hypothyroidism, Addison symptoms of decreased sex hormone
disease, and arrhythmias. levels (low libido, erectile dysfunction,
Black Box Warning amenorrhea, in-fertility). If signs and
Serious, life-threatening, symptoms occur, evaluate patient and
or fatal respiratory obtain lab testing.
depression may occur • Patients taking extended-release
with use of extended- form around-the-clock may need to
release oxy. codone. take immediate-release form for
Monitor patient for worsening of pain or prevention of
respiratory de-pression, incident pain (e.g., breakthrough
especially during pain).
initiation of therapy and • Single-drug oxycodone solution or
after a dosage increase. tablets are especially useful for
Instruct patient to patients who shouldn't take aspirin or
swallow extended- acetaminophen.
release oxy. codone • Monitor circulatory and respiratory
tablets whole; crushing, status closely, especially within the
dissolving, or chewing the first 24 to 72 hours of initiation of
tablets can cause rapid therapy. Withhold dose and notify
release and absorption of prescriber if respirations are shallow
a potentially fatal dose of or if respiratory rate falls below 12
oxycodone. breaths/minute.
Black Box Warning] • Monitor patient's bladder and bowel
Accidental ingestion of pat-terns. Patient may need a
even one dose of drug, stimulant laxative because drug has a
especially by children, constipating effect.
can result in a fatal • Extended-release formula isn't
oxycodone overdose. I intended for as-needed use or for
Black Box Warning immediate postoperative pain. Drug is
Patients must be indicated only for postoperative use if
screened for increased patient was receiving it before surgery
risk of opioid abuse or if pain is expected to persist for an
(personal or family extended time.
history of substance © Alert: Drug is potentially addictive,
abuse or mental illness) even at recommended doses, and if
before being prescribed drug is misused.
opioids. Chewing, crushing, snorting, or
Black Box Warning injecting it can lead to overdose and
Oxycodone extended- death.
release tablets are • OxyContin has been formulated to
indicated for the manage prevent immediate access to full-dose
ment of moderate to oxycodone by cutting, chewing, or
severe pain, when a con- breaking the tablet.
tinuous, around-the-clock Attempts to dissolve tablets will result
opioid analgesic is in a gummy substance that can't be
needed for an extended drawn up into a syringe or injected.
period of time. © Alert: Don't stop drug abruptly;
They aren't intended for withdraw slowly and individualize
use as as-needed gradual taper plan to prevent signs
analgesics. a and symptoms of withdrawal,
Dialyzable drug: worsening of pain, and psychological
Unknown. distress in physically dependent
A Overdose S&S: CNS patients. Refer to manufacturer's label
depression, respiratory for specific tapering instructions.
depression, apnea, © Alert: When tapering opioids,
flaccid skeletal muscles, monitor patients closely for signs and
bradycardia, symptoms of opioid withdrawal
hypotension, circulatory (restlessness, lacrima-tion, rhinorrhea,
collapse, cardiac arrest, yawning, perspiration, chills, myalgia,
respiratory ar. mydriasis, irritability, anxiety, in-
rest, death, somnia, backache, joint pain,
weakness, abdominal cramps,
PREGNANCY-LACTATION- anorexia, nausea, vomiting, diarrhea;
REPRODUCTION increased BP or HR and increased
© Alert: Carefully weigh respiratory rate), which may indicate a
risks and benefts of using need to taper more slowly. Also
drug during pregnancy. monitor patients for suicidal thoughts,
Black Box Warning use of other substances, or changes in
Prolonged use of mood.
extended-release • Look alike-sound alike: Don't confuse
oxycodone during oxy-codone with hydrocodone,
pregnancy can result in Oxycontin, or oxymorphone. Don't
neonatal opioid confuse Oxycontin with MS Contin or
withdrawal syndrome, oxybutynin, or Roxicodone with
which may be life- Roxanol.
threatening if not
recognized and treated PATIENT TEACHING
and requires Black Box Warning Caution patient or
management according caregiver of patient taking an opioid
to protocols developed with a benzo-diazepine, CNS
By neonatology experts. depressant, or alcohol to seek
If prolonged use is immediate medical attention if patient
required, advise patient experiences dizziness, light-
of risks and ensure headedness, extreme sleepiness,
appropriate treatment is slowed or difficult breathing, or
available. unresponsiveness. I
• There are no adequate Black Box Warning Advise patient that
studies in pregnant drug increases risk of opioid addiction,
women. Use only if abuse, and misuse, which can lead to
potential benefit justifies overdose and death. Teach patient
potential risks to the proper use of drug. I
fetus. • Instruct patient to take drug before
• Drug isn't pain is intense.
recommended for use .• Explain assessment and monitoring
during or immediately process to patient and family. Instruct
before labor as uterine them to immediately report difficulty
contractions may be breathing or other signs or symptoms
adversely affected. of a potential ad. verse opioid-related
• Naloxone should be reaction.
available to reverse Tell patient to take drug with milk or
opioid-induced after
respiratory depression in eating.
the Black Box Warning Instruct patient or
neonate. care. giver to keep drug out of the
• Drug appears in human reach of chil dren because accidental
milk. Breastfeeding isn't ingestion can result in a fatal
recommended. oxycodone overdose. Advise patient or
• Long-term opioid use caregiver that if accidental inges. tion
may cause secondary occurs, to seek emergency medical
hypogonadism, which help immediately.|
may lead to sexual Black Box Warning Tell patient to
dysfunction or infertility. swallow extended-release tablets
whole. I © Alert: Encourage patient to
report all medications being taken,
including prescription and OTC
medications and supplements.
© Alert: Caution patient to
immediately report symptoms of
serotonin syndrome, adrenal
insufficiency, and decreased sex
hormone levels.
• Caution ambulatory patient about
getting out of bed or walking. Warn
outpatient to avoid driving and other
hazardous activities that require
mental alertness until drug's CNS
effects are known.
• Advise patient to avoid alcohol use
during
therapy.
• Tell patient not to stop drug
abruptly.
• Inform patient that urine drug
testing and review of state
prescription drug monitoring program
will be done periodically.
• Teach patient that naloxone is
prescribed in conjunction with the
opioid when treatment begins or is
renewed as a preventive measure to
reduce opioid overdose and death.
© Alert: Counsel patient not to
discontinue opioids without first
discussing with prescriber the need for
a gradual tapering regimen.
Name of Patient: Marlin Ponce
Age: 19 years old
Chief Complaint: sustained a single stab wound to the left chest in the mid axillary line, just below the level of the nipple