Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3588
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Duragesic (Patch, Extended Release)
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Special Precautions: DURAGESICcontains a high concentration of a potent
Schedule II opioid agonist, fentanyl. Schedule II opioid substances which
include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone
have the highest potential for abuse and associated risk of fatal overdose
due to respiratory depression. Fentanyl can be abused and is subject to criminal
diversion. Thehigh content of fentanyl in the patches (DURAGESIC) may be a particular target
for abuse and diversion. DURAGESIC patches
are intended for transdermal use (on intact skin) only. The DURAGESICpatch should not be used if the seal is broken, or the
patch is cut, damaged, or changed in any way. Using
a patch that is cut, damaged, or changed in any way can expose the patient
or caregiver to the contents of the patch, which can result in an overdose
of fentanyl that may be fatal. Each
DURAGESIC patch may be worn continuously for 72 hours. The
next patch should be applied to a different skin site after removal of the
previous transdermal system. If problems with adhesion
of the DURAGESIC patch occur, the edges of the patch may
be taped with first aid tape. If problems with adhesion persist, the patch
may be overlayed with a transparent adhesive film dressing (e.g., Bioclusive���or Tegaderm���). If the patch falls off before
72 hours, dispose of it by folding in half and flushing down the toilet.
A new patch may be applied to a different skin site. DURAGESIC is ONLY for use in
patients who are already tolerant to opioid therapy of comparable potency.
Use in non-opioid tolerant patients may lead to fatal respiratory depression.
Overestimating the DURAGESICdose when converting
patients from another opioid medication can result in fatal overdose with
the first dose. Due to the mean elimination half-life of 17 hours of DURAGESIC
, patients
who are thought to have had a serious adverse event, including overdose, will
require monitoring and treatment for at least 24 hours. The concomitant use of DURAGESIC with
all cytochrome P450 3A4 inhibitors (such
as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin,
nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin,
fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in
an increase in fentanyl plasma concentrations, which could increase or prolong
adverse drug effects and may cause potentially fatal respiratory depression.
Patients receiving DURAGESIC
and any CYP3A4 inhibitor should be carefully monitored
for an extended period of time and dosage adjustments should be made if warranted
(see BOX WARNING, CLINICAL
PHARMACOLOGY���Drug Interactions, WARNINGS,
and PRECAUTIONS for further information). Pediatric
patients converting to DURAGESIC with a 25 mcg/h patch should
be opioid-tolerant and receiving at least 60 mg of oral morphine or the equivalent
per day. The dose conversion schedule described in Table C, and method of
titration described below are recommended in opioid-tolerant pediatric patients
over 2 years of age with chronic pain (see PRECAUTIONS
- Pediatric Use). Respiratory depression is the chief hazard in elderly
or debilitated patients, usually following large initial doses in non-tolerant
patients, or when opioids are given in conjunction with other agents that
depress respiration. DURAGESICshould
be used with caution in elderly, cachectic, or debilitated patients as they
may have altered pharmacokinetics due to poor fat stores, muscle wasting,
or altered clearance .<br/>General Principles: DURAGESICis indicated for management of persistent , moderate to severe chronic pain that: DURAGESICshould ONLY be used in patients who are
already receiving opioid therapy, who have demonstrated opioid tolerance,
and who require a total daily dose at least equivalent to DURAGESIC25 mcg/h. Patients who
are considered opioid-tolerant are those who have been taking, for a week
or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone
daily, or at least 8 mg oral hydromorphone daily, or an equianalgesic dose
of another opioid. Because serious or life-threatening hypoventilation
could occur, DURAGESIC(fentanyl transdermal system) is contraindicated: Safety
of DURAGESIC has not been established in children under 2
years of age. DURAGESIC should be administered to children
only if they are opioid-tolerant and 2 years of age or older . Prescribers should individualize
treatment using a progressive plan of pain management such as outlined by
the World Health Organization, the Agency for Health Research and Quality,
the Federation of State Medical Boards Model Policy, or the American Pain
Society. With all opioids, the safety of patients
using the products is dependent on health care practitioners prescribing them
in strict conformity with their approved labeling with respect to patient
selection, dosing, and proper conditions for use. As
with all opioids, dosage should be individualized. The most important factor
to be considered in determining the appropriate dose is the extent of pre-existing
opioid-tolerance . Initial doses should be reduced in elderly or debilitated patients
. DURAGESIC (fentanyl
transdermal system) should be applied to intact, non-irritated, and non-irradiated
skin on a flat surface such as the chest, back, flank, or upper arm. In young
children and persons with cognitive impairment, adhesion should be monitored
and the upper back is the preferred location to minimizethe potential of
inappropriate patch removal. Hair at the application site should be clipped
(not shaved) prior to system application. If the site of DURAGESIC application
must be cleansed prior to application of the patch, do so with clear water.
Do not use soaps, oils, lotions, alcohol, or any other agents that might irritate
the skin or alter its characteristics. Allow the skin to dry completely prior
to patch application. DURAGESIC should
be applied immediately upon removal from the sealed package. Do not use if
the seal is broken. Do not alter the patch (e.g., cut) in any way prior to
application and do not use cut or damaged patches. Thetransdermal system should be pressed firmly in place with the palm of the
hand for 30 seconds, making sure the contact is complete, especially around
the edges. If the gel from the drug reservoir accidentally contacts the skin
of the patient or caregiver, the skin should be washed with copious amounts
of water. Do not use soap, alcohol, or other solvents to remove the gel because
they may enhance the drug's ability to penetrate the skin. DURAGESIC should be kept out of
the reach of children. Used patches should be folded so that the adhesive
side of the patch adheres to itself, then the patch should be flushed down
the toilet immediately upon removal. Patients should dispose of any patches
remaining from a prescription as soon as they are no longer needed. Unused
patches should be removed from their pouches, folded so that the adhesive
side of the patch adheres to itself, and flushed down the toilet.<br/>Dose Selection: Doses must be
individualized based upon the status of each patient and should be assessed
at regular intervals after DURAGESIC application. Reduced
doses of DURAGESIC are suggested for the elderly and other
groups discussed in PRECAUTIONS. DURAGESIC
is ONLY for use in patients who are already tolerant to
opioid therapy of comparable potency. Use in non-opioid tolerant patients
may lead to fatal respiratory depression. In selecting an initial DURAGESIC dose, attention
should be given to 1) the daily dose, potency, and characteristics of the
opioid the patient has been taking previously (e.g., whether it is a pure
agonist or mixed agonist-antagonist), 2) the reliability of the relative potency
estimates used to calculate the DURAGESIC dose needed (potency
estimates may vary with the route of administration), 3) the degree of opioid
tolerance and 4) the general condition and medical status of the patient.
Each patient should be maintained at the lowest dose providing acceptable
pain control.<br/>Initial DURAGESIC Dose Selection: Overestimating the DURAGESICdose when
converting patients from another opioid medication can result in fatal overdose
with the first dose. Due to the mean elimination half-life of 17 hours of
DURAGESIC,
patients who are thought to have had a serious adverse event, including overdose,
will require monitoring and treatment for at least 24 hours. There has been no systematic evaluation of DURAGESIC as
an initial opioid analgesic in the management of chronic pain, since most
patients in the clinical trials were converted to DURAGESIC from
other narcotics. The efficacy of DURAGESIC 12 mcg/h as an
initiating dose has not been determined. In addition, patients who are not
opioid-tolerant have experienced hypoventilation and death during useof DURAGESIC.
Therefore, DURAGESIC should be used only in patients who
are opioid-tolerant. To convert adult and
pediatric patients from oral or parenteral opioids to DURAGESIC,
use Table C: Alternatively,
for adult and pediatric patients taking opioids or doses not listed in Table C, use the following methodology: Alternatively, for adult and pediatric patients
taking opioids or doses not listed in Table C, use the conversion methodology
outlined above with Table D. The majority of patients are adequately maintained
with DURAGESIC administered every 72 hours. Some patients
may not achieve adequate analgesia using this dosing interval and may require
systems to be applied every 48 hours rather than every 72 hours. An increase
in the DURAGESIC dose should be evaluated before changing
dosing intervals in order to maintain patients on a 72-hour regimen. Dosing
intervals less than every 72 hours were not studied in children and adolescents
and are not recommended. Because of the increase
in serum fentanyl concentration over the first 24 hours following initial
system application, the initial evaluation of the maximum analgesic effect
of DURAGESIC cannot be made before 24 hours of wearing. The
initial DURAGESIC dose may be increased after 3 days . During the initial application
of DURAGESIC, patients should use short-acting analgesics
as needed until analgesic efficacy with DURAGESIC is attained.
Thereafter, some patients still may require periodic supplemental doses of
other short-acting analgesics for���breakthrough���pain.<br/>Dose Titration: The recommended initial DURAGESIC dose
based upon the daily oral morphine dose is conservative, and 50% of patients
are likely to require a dose increase after initial application of DURAGESIC.
The initial DURAGESIC dose may be increased after 3 days
based on the daily dose of supplemental opioid analgesics required by the
patient in the second or third day of the initial application. Physicians are advised that it may take up to 6 days after
increasing the dose of DURAGESIC for the patient to reach
equilibrium on the new dose . Therefore, patients
should wear a higher dose through two applications before any further increase
in dosage is made on the basis of the average daily use of a supplemental
analgesic. Appropriate dosage increments should
be based on the daily dose of supplementary opioids, using the ratio of 45
mg/24 hours of oral morphine to a 12.5 mcg/h increase in DURAGESIC dose.
DURAGESIC-12 delivers 12.5 mcg/h of fentanyl.<br/>Discontinuation of DURAGESIC: To convert patients to another opioid, remove DURAGESIC and
titrate the dose of the new analgesic based upon the patient's report
of pain until adequate analgesia has been attained. Upon system removal, 17
hours or more are required for a 50% decrease in serum fentanyl concentrations.
Opioid withdrawal symptoms (such as nausea, vomiting, diarrhea, anxiety, and
shivering) are possible in some patients after conversion or dose adjustment.
For patients requiring discontinuation of opioids, a gradual downward titration
is recommended since it is not known at what dose level the opioid may be
discontinued without producing the signs and symptoms of abrupt withdrawal. Tables
C, D, and E should
not be used to convert from DURAGESICto other
therapies. Because the conversion to DURAGESICis conservative,
use of Tables C, D,
and E for conversion to other analgesic
therapies can overestimate the dose of the new agent. Overdosage of the new
analgesic agent is possible.
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DURAGESIC (fentanyl transdermal system)
is a transdermal system providing continuous systemic delivery of fentanyl,
a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)
propanamide. The structural formula is: The molecular
weight of fentanyl base is 336.5, and the empirical formula is CHNO.
The n-octanol:water partition coefficient is 860:1. The pKa is 8.4.<br/>System Components and Structure: The amount of fentanyl released from each system
per hour is proportional to the surface area (25 mcg/h per 10 cm).
The composition per unit area of all system sizes is identical. Each system
also contains 0.1 mL of alcohol USP per 10 cm. DURAGESIC is a rectangular transparent
unit comprising a protective liner and four functional layers. Proceeding
from the outer surface toward the surface adhering to skin, these layers are: 1) a backing layer of polyester film; 2) a drug reservoir
of fentanyl and alcohol USP gelled with hydroxyethyl cellulose; 3) an ethylene-vinyl
acetate copolymer membrane that controls the rate of fentanyl delivery to
the skin surface; and 4) a fentanyl containing silicone adhesive. Before use,
a protective liner covering the adhesive layer is removed and discarded. The active component of the system is fentanyl. The remaining
components are pharmacologically inactive. Less than 0.2 mL of alcohol is
also released from the system during use.
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Pharmacology: Fentanyl is an opioid analgesic. Fentanyl interacts
predominately with the opioid mu-receptor. These mu-binding sites are discretely
distributed in the human brain, spinal cord, and other tissues. In clinical
settings, fentanyl exerts its principal pharmacologic effects on the central
nervous system. In addition to analgesia,
alterations in mood, euphoria, dysphoria, and drowsiness commonly occur. Fentanyl
depresses the respiratory centers, depresses the cough reflex, and constricts
the pupils. Analgesic blood levels of fentanyl may cause nausea and vomiting
directly by stimulating the chemoreceptor trigger zone, but nausea and vomiting
are significantly more common in ambulatory than in recumbent patients, as
is postural syncope. Opioids increase the
tone and decrease the propulsive contractions of the smooth muscle of the
gastrointestinal tract. The resultant prolongation in gastrointestinal transit
time may be responsible for the constipating effect of fentanyl. Because opioids
may increase biliary tract pressure, some patients with biliary colic may
experience worsening rather than relief of pain. While
opioids generally increase the tone of urinary tract smooth muscle, the net
effect tends to be variable, in some cases producing urinary urgency, in others,
difficulty in urination. At therapeutic dosages, fentanyl usually does not
exert major effects on the cardiovascular system. However, some patients may
exhibit orthostatic hypotensionand fainting. Histamine
assays and skin wheal testing in clinical studies indicate that clinically
significant histamine release rarely occurs with fentanyl administration.
Clinical assays show no clinically significant histamine release in dosages
up to 50 mcg/kg.<br/>Pharmacokinetics: (see graph and tables) DURAGESIC (fentanyl
transdermal system) releases fentanyl from the reservoir at a nearly constant
amount per unit time. The concentration gradient existing between the saturated
solution of drug in the reservoir and the lower concentration in the skin
drives drug release. Fentanyl moves in the direction of the lower concentration
at a rate determined by the copolymer release membrane and the diffusion of
fentanyl through the skin layers. While the actual rate of fentanyl delivery
to the skin varies over the 72-hour application period, each system is labeled
with a nominal flux which represents the average amount of drug delivered
to the systemic circulation per hour across average skin. While there is variation in dose delivered among patients,
the nominal flux of the systems (12.5, 25, 50, 75, and 100 mcg of fentanyl
per hour) is sufficiently accurate as to allow individual titration of dosage
for a given patient. The small amount of alcohol which has been incorporated
into the system enhances the rate of drug flux through the rate-limiting copolymer
membrane and increases the permeability of the skin to fentanyl. Following DURAGESIC application, the skin
under the system absorbs fentanyl, and a depot of fentanyl concentrates in
the upper skin layers. Fentanyl then becomes available to the systemic circulation.
Serum fentanyl concentrations increase gradually following initial DURAGESIC application,
generally leveling off between 12 and 24 hours and remaining relatively constant,
with some fluctuation, for the remainder of the 72-hour application period.
Peak serum concentrations of fentanyl generally occurred between 24 and 72
hours after initial application (see Table A).
Serum fentanyl concentrations achieved are proportional to the DURAGESIC delivery
rate. With continuous use, serum fentanyl concentrations continue to rise
for the first few system applications. After several sequential 72-hour applications,
patients reach and maintain a steady state serum concentration that is determined
by individual variation in skin permeability and body clearance of fentanyl
(see graph and Table B). The
kinetics of fentanyl in normal subjects following application of a 100 mcg/hr
DURAGESIC patch were bioequivalent with or without a Bioclusiveoverlay
(polyurethane film dressing). After system
removal, serum fentanyl concentrations decline gradually, falling about 50%
in approximately 17 (range 13-22) hours. Continued absorption of fentanyl
from the skin accounts for a slower disappearance of the drug from the serum
than is seen after an IV infusion, where the apparent half-life is approximately
7 (range 3-12) hours. Fentanyl plasma protein binding capacity decreases
with increasing ionization of the drug. Alterations in pH may affect its distribution
between plasma and the central nervous system. Fentanyl accumulates in the
skeletal muscle and fat and is released slowly into the blood. The average
volume of distribution for fentanyl is 6 L/kg (range 3-8; N=8). Fentanyl is metabolized primarily via human cytochrome
P450 3A4 isoenzyme system. In humans, the drug appears to be metabolized primarily
by oxidative N-dealkylation to norfentanyl and other inactive metabolites
that do not contribute materially to the observed activity of the drug. Within
72 hours of IV fentanyl administration, approximately 75% of the dose is excreted
in urine, mostly as metabolites with less than 10% representing unchanged
drug. Approximately 9% of the dose is recovered in the feces, primarily as
metabolites. Mean values for unbound fractions of fentanyl in plasma are estimated
to be between 13 and 21%. Skin does not appear
to metabolize fentanyl delivered transdermally. This was determined in a human
keratinocyte cell assay and in clinical studies in which 92% of the dose
delivered from the system was accounted for as unchanged fentanyl that appeared
in the systemic circulation.<br/>Special Populations:<br/>Hepatic or Renal Disease: Insufficient information exists to make recommendations regarding
the use of DURAGESIC in patients with impaired renal or hepatic
function. Fentanyl is metabolized primarily via human cytochrome P450 3A4
isoenzyme system and mostly eliminated in urine. If the drug is used in these
patients, it should be used with caution because of the hepatic metabolism
and renal excretion of fentanyl.<br/>Pediatric Use: In 1.5 to 5 year old, non-opioid-tolerant pediatric patients,
the fentanyl plasma concentrations were approximately twice as high as that
of adult patients. In older pediatric patients, the pharmacokinetic parameters
were similar to that of adults. However, these findings have been taken into
consideration in determining the dosing recommendations for opioid-tolerant
pediatric patients (2 years of age and older). For pediatric dosing information,
refer to DOSAGE AND ADMINISTRATION section.<br/>Geriatric Use: Information from a pilot study of
the pharmacokinetics of IV fentanyl in geriatric patients (N=4) indicates
that the clearance of fentanyl may be greatly decreased in the population
above the age of 60. The relevance of these findings to DURAGESIC(fentanyl
transdermal system) is unknown at this time. Respiratory
depression is the chief hazard in elderly or debilitated patients, usually
following large initial doses in non-tolerant patients or when opioids are
given in conjunction with other agents that depress respiration. DURAGESIC should
be used with caution in elderly, cachectic or debilitated patients as they
may have altered pharmacokinetics due to poor fat stores, muscle wasting,
or altered clearance .<br/>Drug Interactions: The interaction between ritonavir, a CYP3A4 inhibitor,
and fentanyl was investigated in eleven healthy volunteers in a randomized
crossover study. Subjects received oral ritonavir or placebo for 3 days. The
ritonavir dose was 200 mg tid on Day 1 and 300 mg tid on Day 2 followed by
one morning dose of 300 mg on Day 3. On Day 2, fentanyl was given as a single
IV dose at 5 mcg/kg two hours after the afternoon dose of oral ritonavir or
placebo. Naloxone was administered to counteract the side effects of fentanyl.
The results suggested that ritonavir might decrease the clearance of fentanyl
by 67%, resulting in a 174% (range 52%-420%) increase in fentanyl AUC.
Coadministration of ritonavir in patients receiving DURAGESIC has
not been studied; however, an increase in fentanyl AUC is expected . Fentanyl is metabolized mainly via the
human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore, potential
interactions may occur when DURAGESIC is given concurrently
with agents that affect CYP3A4 activity. Coadminstration with agents that
induce CYP3A4 activity may reduce the efficacy of DURAGESIC.
The concomitant use of transdermal fentanyl with all CYP3A4 inhibitors (such
as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin,
nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin,
fluconazole, fosamprenavir, grapefruit juice, and verapamil) may also result
in an increase in fentanyl plasma concentrations, which could increase or
prolong adverse drug effects and may cause potentially fatal respiratory depression.
Patients receiving DURAGESIC and
any CYP3A4 inhibitor should be carefully monitored for an extended period
of time and dosage adjustments should be made if warranted (seeBOX WARNING, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION for further
information).
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Because serious
or life-threatening hypoventilation could occur, DURAGESIC (fentanyl
transdermal system) is contraindicated: DURAGESIC(fentanyl transdermal system) is contraindicated in patients
who have or are suspected of having paralytic ileus. DURAGESIC(fentanyl transdermal system) is contraindicated
in patients with known hypersensitivity to fentanyl or any components of this
product.
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DURAGESIC (fentanyl transdermal system)
is supplied in cartons containing 5 individually packaged systems. See
chart for information regarding individual systems.<br/>Safety and Handling: DURAGESIC is supplied in sealed
transdermal systems which pose little risk of exposure to health care workers.
If the gel from the drug reservoir accidentally contacts the skin, the area
should be washed with copious amounts of water. Do not use soap, alcohol,
or other solvents to remove the gel because they may enhance the drug's
ability to penetrate the skin. Do not use a DURAGESIC patch
if the seal is broken or the patch is cut, damaged, or changed in any way.
Using a patch that is cut, damaged, or changed
in any way can expose the patient or caregiver to the contents of the patch,
which can result in an overdose of fentanyl that may be fatal. KEEP DURAGESICOUT OF THE REACH OF CHILDREN
AND PETS. Do not store above 77��F
(25��C). Apply immediately after removal from individually sealed package.
Do not use if the seal is broken. For transdermal
use only . Bioclusiveis a
trademark of Ethicon, Inc.Tegadermis a trademark of 3M A schedule CII narcotic. DEA order form required. Manufactured by:ALZA CorporationMountain View, CA 94043 Manufactured for::Janssen, division of Ortho-McNeil-Janssen Pharmaceuticals,
Inc.Titusville, NJ 08560 10459501 February
2008
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DURAGESICcontains a high concentration of a potent Schedule II opioid
agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone,
methadone, morphine, oxycodone, and oxymorphone have the highest potential
for abuse and associated risk of fatal overdose due to respiratory depression.
Fentanyl can be abused and is subject to criminal diversion. The high content
of fentanyl in the patches (DURAGESIC) may be a particular target for abuse and diversion. DURAGESIC is indicated
for management of persistent
, moderate to severe chronic
pain that: DURAGESICshould ONLY be used in patients who are already
receiving opioid therapy, who have demonstrated opioid tolerance, and who
require a total daily dose at least equivalent to DURAGESIC25 mcg/h. Patients who are
considered opioid-tolerant are those who have been taking, for a week or longer,
at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily,
or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another
opioid. Because
serious or life-threatening hypoventilation could occur, DURAGESIC (fentanyl
transdermal system) is contraindicated: (See CONTRAINDICATIONS for
further information.) Since
the peak fentanyl levels occur between 24 and 72 hours of treatment, prescribers
should be aware that serious or life threatening hypoventilation may occur,
even in opioid-tolerant patients, during the initial application period. The concomitant
use of DURAGESIC with
all cytochrome P450 3A4 inhibitors (such
as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin,
nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin,
fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in
an increase in fentanyl plasma concentrations, which could increase or prolong
adverse drug effects and may cause potentially fatal respiratory depression.
Patients receiving DURAGESIC
and any CYP3A4 inhibitor should be carefully monitored
for an extended period of time and dosage adjustments should be made if warranted
(see CLINICAL PHARMACOLOGY���Drug Interactions,
WARNINGS, PRECAUTIONS and
DOSAGE AND ADMINISTRATION and for further
information). The
safety of DURAGESIC has not been established in children
under 2 years of age. DURAGESIC should be administered to
children only if they are opioid-tolerant and 2 years of age or older . DURAGESIC is ONLY for use in patients
who are already tolerant to opioid therapy of comparable potency. Use in non-opioid
tolerant patients may lead to fatal respiratory depression. Overestimating the DURAGESICdose when converting patients
from another opioid medication can result in fatal overdose with the first
dose. Due to the mean elimination half-life of 17 hours of DURAGESIC
, patients who
are thought to have had a serious adverse event, including overdose, will
require monitoring and treatment for at least 24 hours. DURAGESICcan be abused in a manner similar to other
opioid agonists, legal or illicit. This risk should be considered when administering,
prescribing, or dispensing DURAGESICin
situations where the healthcare professional is concerned about increased
risk of misuse, abuse, or diversion. Persons at increased risk for opioid abuse include those
with a personal or family history of substance abuse (including drug or alcohol
abuse or addiction) or mental illness (e.g., major depression). Patients should
be assessed for their clinical risks for opioid abuse or addiction prior to
being prescribed opioids. All patients receiving opioids should be routinely
monitored for signs of misuse, abuse, and addiction. Patients at increased
risk of opioid abuse may still be appropriately treated with modified-release
opioid formulations; however, these patients will require intensive monitoring
for signs of misuse, abuse, or addiction. DURAGESIC patches
are intended for transdermal use (on intact skin) only. Do not use
a DURAGESIC patch if the seal is broken or the patch is
cut, damaged or changed in any way. Using a
patch that is cut, damaged, or changed in any way can expose the patient or
caregiver to the contents of the patch, which can result in an overdose of
fentanyl that may be fatal. Avoid exposing the DURAGESIC application
site and surrounding area to direct external heat sources, such as heating
pads or electric blankets, heat or tanning lamps, saunas, hot tubs, and heated
water beds, while wearing the system. Avoid taking hot baths or sunbathing.
There is a potential for temperature-dependent increases in fentanyl released
from the system resulting in possible overdose and death. Patients wearing
DURAGESIC systems who develop fever or increased core body
temperature due to strenuous exertion should be monitored for opioid side
effects and the DURAGESIC dose should be adjusted if necessary.
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General: DURAGESIC (fentanyl transdermal
system) should not be used to initiate opioid therapy in patients who are
not opioid-tolerant. Children converting to DURAGESIC should
be opioid-tolerant and 2 years of age or older . Patients, family members, and caregivers should be instructed
to keep patches (new and used) out of the reach of children and others for
whom DURAGESIC was not prescribed. A considerable amount
of active fentanyl remains in DURAGESIC even after use as
directed. Accidental or deliberate application or ingestion by a child or
adolescent will cause respiratory depression that could result in death.<br/>Cardiac Disease: Fentanyl may produce bradycardia. Fentanyl should
be administered with caution to patients with bradyarrhythmias.<br/>Hepatic or Renal Disease: Insufficient information exists to make recommendations
regarding the use of DURAGESIC in patients with impaired
renal or hepatic function. If the drug is used in these patients, it should
be used with caution because of the hepatic metabolism and renal excretion
of fentanyl.<br/>Use in Pancreatic/Biliary Tract Disease: DURAGESIC may cause spasm of the
sphincter of Oddi and should be used with caution in patients with biliary
tract disease, including acute pancreatitis. Opioids like DURAGESIC may
cause increases in the serum amylase concentration.<br/>Tolerance: Tolerance is a state of adaptation in which exposure
to a drug induces changes that result in a diminution of one or more of the
drug's effects over time. Tolerance may occur to both the desired and
undesired effects of drugs, and may develop at different rates for different
effects.<br/>Physical Dependence: Physical dependence is a state of adaptation that
is manifested by an opioid specific withdrawal syndrome that can be produced
by abrupt cessation, rapid dose reduction, decreasing blood level of the drug,
and/or administration of an antagonist. The opioid abstinence or withdrawal
syndrome is characterized by some or all of the following: restlessness, lacrimation,
rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis,
irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia,
nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory
rate, or heart rate. In general, opioids should not be abruptly discontinued
.<br/>Ambulatory Patients: Strong opioid analgesics impair the mental or physical
abilities required for the performance of potentially dangerous tasks, such
as driving a car or operating machinery. Patients who have been given DURAGESIC should
not drive or operate dangerous machinery unless they are tolerant to the effects
of the drug.<br/>Information for Patients: Patients and their caregivers should be provided
with a Medication Guide each time DURAGESIC is dispensed
because new information may be available. Patients
receiving DURAGESIC patches should be given the following
instructions by the physician:<br/>Drug Interactions:<br/>Agents Affecting Cytochrome P450 3A4
Isoenzyme System: Fentanyl is metabolized mainly via the human cytochrome
P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur
when DURAGESIC is given concurrently with agents that affect
CYP3A4 activity. Coadminstration with agents that induce CYP3A4 activity may
reduce the efficacy of DURAGESIC. The concomitant use of
transdermal fentanyl with all CYP3A4 inhibitors such as ritonavir, ketoconazole,
itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone,
amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir,
grapefruit juice, and verapamil) may result in an increase in fentanyl plasma
concentrations, which could increase or prolong adverse drug effects and may
cause fatal respiratory depression. Patients receiving DURAGESIC
and any CYP3A4 inhibitor should be carefully monitored
for an extended period of time, and dosage adjustments should be made if warranted
(see BOX WARNING, CLINICAL PHARMACOLOGY���Drug Interactions , WARNINGS, and DOSAGE AND ADMINISTRATION for further
information).<br/>Central Nervous System Depressants: The concomitant use of DURAGESIC (fentanyl
transdermal system) with other central nervous system depressants, including
but not limited to other opioids, sedatives, hypnotics, tranquilizers (e.g.,
benzodiazepines), general anesthetics, phenothiazines, skeletal muscle relaxants,
and alcohol, may cause respiratory depression, hypotension, and profound sedation,
or potentially result in coma or death. When such combined therapy is contemplated,
the dose of one or both agents should be significantly reduced.<br/>MAO Inhibitors: DURAGESIC is not recommended
for use in patients who have received MAOI within 14 days because severe and
unpredictable potentiation by MAO inhibitors has been reported with opioid
analgesics.<br/>Carcinogenesis, Mutagenesis, and Impairment of Fertility: Studies in animals to evaluate the carcinogenic
potential of fentanyl HCl have not been conducted. There was no evidence of
mutagenicity in the Ames Salmonella mutagenicity assay, the primary rat hepatocyte
unscheduled DNA synthesis assay, the BALB/c 3T3 transformation test, and the
human lymphocyte and CHO chromosomal aberration in-vitro assays. The potential effects of fentanyl on male and female fertility
were examined in the rat model via two separate experiments. In the male fertility
study, male rats were treated with fentanyl (0, 0.025, 0.1 or 0.4 mg/kg/day)
via continuous intravenous infusion for 28 days prior to mating; female rats
were not treated. In the female fertility study, female rats were treated
with fentanyl (0, 0.025, 0.1 or 0.4 mg/kg/day) via continuous intravenous
infusion for 14 days prior to mating until day 16 of pregnancy; male rats
were not treated. Analysis of fertility parameters in both studies indicated
that an intravenous dose of fentanyl up to 0.4 mg/kg/day to either the male
or the female alone produced no effects on fertility (this dose is approximately
1.6 times the daily human dose administered by a 100 mcg/hr patch on a mg/mbasis).
In a separate study, a single daily bolus dose of fentanyl was shown to impair
fertility in rats when given in intravenous doses of 0.3 times the human dose
for a period of 12 days.<br/>Pregnancy���Pregnancy Category C: No epidemiological studies of congenital anomalies
in infants born to women treated with fentanyl during pregnancy have been
reported. The potential effects of fentanyl
on embryo-fetal development were studied in the rat, mouse, and rabbit models.
Published literature reports that administration of fentanyl (0, 10, 100,
or 500��g/kg/day) to pregnant female Sprague-Dawley rats from day 7
to 21 via implanted microosmotic minipumps did not produce any evidence of
teratogenicity (the high dose is approximately 2 times the daily human dose
administered by a 100 mcg/hr patch on a mg/mbasis). In contrast,
the intravenous administration of fentanyl (0, 0.01, or 0.03 mg/kg) to bred
female rats from gestation day 6 to 18 suggested evidence of embryotoxicity
and a slight increase in mean delivery time in the 0.03 mg/kg/day group. There
was no clear evidence of teratogenicity noted. Pregnant
female New Zealand White rabbits were treated with fentanyl (0, 0.025, 0.1,
0.4 mg/kg) via intravenous infusion from day 6 to day 18 of pregnancy. Fentanyl
produced a slight decrease in the body weight of the live fetuses at the high
dose, which may be attributed to maternal toxicity. Under the conditions of
the assay, there was no evidence for fentanyl induced adverse effects on embryo-fetal
development at doses up to 0.4 mg/kg (approximately 3 times the daily human
dose administered by a 100 mcg/hr patch on a mg/mbasis). There are no adequate and well-controlled studies in pregnant
women. DURAGESIC should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.<br/>Nonteratogenic Effects: Chronic maternal treatment with fentanyl during
pregnancy has been associated with transient respiratory depression, behavioral
changes, or seizures characteristic of neonatal abstinence syndrome in newborn
infants. Symptoms of neonatal respiratory or neurological depression were
no more frequent than expected in most studiesof infants born to women treated
acutely during labor with intravenous or epidural fentanyl. Transient neonatal
muscular rigidity has been observed in infants whose mothers were treated
with intravenous fentanyl. The potential
effects of fentanyl on prenatal and postnatal development were examined in
the rat model. Female Wistar rats were treated with 0, 0.025, 0.1, or 0.4 mg/kg/day
fentanyl via intravenous infusion from day 6 of pregnancy through 3 weeks
of lactation. Fentanyl treatment (0.4 mg/kg/day) significantly decreased body
weight in male and female pups and also decreased survival in pups at day
4. Both the mid-dose and high-dose of fentanyl animals demonstrated alterations
in some physical landmarks of development (delayed incisor eruption and eye
opening) and transient behavioral development (decreased locomotor activity
at day 28 which recovered by day 50). The mid-dose and the high-dose are 0.4
and 1.6 times the daily human dose administered by a 100 mcg/hr patch on a
mg/mbasis.<br/>Labor and Delivery: Fentanyl readily passes across the placenta to the
fetus; therefore, DURAGESIC is not recommended for analgesia
during labor and delivery.<br/>Nursing Mothers: Fentanyl is excreted in human milk; therefore, DURAGESIC is
not recommended for use in nursing women because of the possibility of effects
in their infants.<br/>Pediatric Use: The safety of DURAGESIC was evaluated
in three open-label trials in 291 pediatric patients with chronic pain,
2 years of age through 18 years of age. Starting doses of 25 mcg/h and higher
were used by 181 patients who had been on prior daily opioid doses of at least
45 mg/day of oral morphine or an equianalgesic dose of another opioid. Initiation
of DURAGESIC therapy in pediatric patients taking less than
60 mg/day of oral morphine or an equianalgesic dose of another opioid has
not been evaluated in controlled clinical trials. Approximately 90% of the
total daily opioid requirement (DURAGESIC plus rescue medication)
was provided by DURAGESIC. DURAGESIC was
not studied in children under 2 years of age. DURAGESIC should
be administered to children only if they are opioid-tolerant and 2 years of
age or older (see DOSAGE AND
ADMINISTRATION and BOX WARNING). To
guard against accidental ingestion by children, use caution when choosing
the application site for DURAGESIC and
monitor adhesion of the system closely.<br/>Geriatric Use: Information from a pilot study of the pharmacokinetics
of IV fentanyl in geriatric patients (N=4) indicates that the clearance of
fentanyl may be greatly decreased in the population above the age of 60. The
relevance of these findings to DURAGESIC; (fentanyl transdermal
system) is unknown at this time. Respiratory depression
is the chief hazard in elderly or debilitated patients, usually following
large initial doses in non-tolerant patients, or when opioids are given in
conjunction with other agents that depress respiration. DURAGESIC should be used with caution in elderly,
cachectic, or debilitated patients as they may have altered pharmacokinetics
due to poor fat stores, muscle wasting, or altered clearance .
|
| dailymed-instance:overdosag... |
Clinical Presentation: The manifestations of fentanyl overdosage are an
extension of its pharmacologic actions with the most serious significant effect
being hypoventilation.<br/>Treatment: For the management of hypoventilation, immediate
countermeasures include removing the DURAGESIC (fentanyl
transdermal system) system and physically or verbally stimulating the patient.
These actions can be followed by administration of a specific narcotic antagonist
such as naloxone. The duration of hypoventilation following an overdose may
be longer than the effects of the narcotic antagonist's action (the half-life
of naloxone ranges from 30 to 81 minutes). The interval between IV antagonist
doses should be carefully chosen because of the possibility of re-narcotization
after system removal; repeated administration of naloxone may be necessary.
Reversal of the narcotic effect may result in acute onset of pain and the
release of catecholamines. Always ensure a
patent airway is established and maintained, administer oxygen and assist
or control respiration as indicated and use an oropharyngeal airway or endotracheal
tube if necessary. Adequate body temperature and fluid intake should be maintained. If severe or persistent hypotension occurs, the possibility
of hypovolemia should be considered and managed with appropriate parenteral
fluid therapy.
|
| dailymed-instance:genericMe... |
fentanyl
|
| dailymed-instance:fullName |
Duragesic (Patch, Extended Release)
|
| dailymed-instance:adverseRe... |
In post-marketing experience,
deaths from hypoventilation due to inappropriate use of DURAGESIC(fentanyl transdermal system)
have been reported (see BOX WARNING and
CONTRAINDICATIONS).<br/>Pre-Marketing Clinical Trial Experience: Although DURAGESIC use in post-operative
or acute pain and in patients who are not opioid-tolerant is CONTRAINDICATED,
the safety of DURAGESIC was originally evaluated in 357 post-operative
adult patients for 1 to 3 days and 153 cancer patients for a total of
510 patients. The duration of DURAGESIC use varied in cancer
patients; 56% of patients used DURAGESIC for over 30 days,
28% continued treatment for more than 4 months, and 10% used DURAGESIC for
more than 1 year. Hypoventilation was the
most serious adverse reaction observed in 13 (4%) post-operative patients
and in 3 (2%) of the cancer patients. Hypotension and hypertension were observed
in 11 (3%) and 4 (1%) of the opioid-naive patients. Various
adverse events were reported; a causal relationship to DURAGESIC was
not always determined. The frequencies presented here reflect the actual frequency
of each adverse effect in patients who received DURAGESIC.
There has been no attempt to correct for a placebo effect, concomitant use
of other opioids, or to subtract the frequencies reported by placebo-treated
patients in controlled trials. Adverse reactions
reported in 153 cancer patients at a frequency of 1% or greater are presented
in Table 1; similar reactions were seen in
the 357 post-operative patients. In the pediatric
population, the safety of DURAGESIC has been evaluated in
291 patients with chronic pain 2-18 years of age. The duration of DURAGESIC use
varied; 20% of pediatric patients were treated for���15 days; 46% for
16-30 days; 16% for 31-60 days; and 17% for at least 61 days. Twenty-five
patients were treated with DURAGESIC for at least 4 months
and 9 patients for more than 9 months. There
was no apparent pediatric-specific risk associated with DURAGESIC use
in children as young as 2 years old when used as directed. The most common adverse events were fever (35%), vomiting
(33%), and nausea (24%). Adverse events reported
in pediatric patients at a rate of���1% are presented in Table
1. The following adverse effects have been reported
in less than 1% of the 510 adult post-operative and cancer patients studied: Cardiovascular: bradycardia Digestive: abdominal
distention Nervous:
aphasia, hypertonia, vertigo, stupor, hypotonia, depersonalization,
hostility Respiratory:
stertorous breathing, asthma, respiratory disorder Skin and Appendages, General:
exfoliative dermatitis, pustules Special Senses: amblyopia Urogenital: bladder pain, oliguria, urinary frequency<br/>Post-Marketing Experience - Adults: The following adverse reactions have been reported
in association with the use of DURAGESIC and not reported
in the pre-marketing adverse reactions section above: Body as a Whole: edema Cardiovascular: tachycardia Metabolic and Nutritional :
weight loss Special
Senses: blurred vision Urogenital: decreased libido, anorgasmia, ejaculatory
difficulty
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| dailymed-instance:warning |
DURAGESIC
patches are intended for transdermal use (on intact skin)
only. Do not use a DURAGESIC patch if the seal
is broken or the patch is cut, damaged or changed in any way. Using
a patch that is cut, damaged, or changed in any way can expose the patient
or caregiver to the contents of the patch, which can result in an overdose
of fentanyl that may be fatal. The safety of DURAGESIC
(fentanyl transdermal system) has not been established
in children under 2 years of age. DURAGESIC should be administered
to children only if they are opioid-tolerant and 2 years of age or older (see
PRECAUTIONS - Pediatric Use). DURAGESIC
is ONLY for use in patients who are already tolerant to
opioid therapy of comparable potency. Use in non-opioid tolerant patients
may lead to fatal respiratory depression. Overestimating
the DURAGESICdose when
converting patients from another opioid medication can result in fatal overdose
with the first dose. The mean elimination half-life of DURAGESICis 17 hours. Therefore, patients
who have experienced serious adverse events, including overdose, will require
monitoring for at least 24 hours after DURAGESIC removal
since serum fentanyl concentrations decline gradually and reach an approximate
50% reduction in serum concentrations 17 hours after system removal. DURAGESIC should be prescribed only by persons
knowledgeable in the continuous administration of potent opioids, in the management
of patients receiving potent opioids for treatment of pain, and in the detection
and management of hypoventilation including the use of opioid antagonists. All patients and their caregivers
should be advised to avoid exposing the DURAGESICapplication site and surrounding area to direct
external heat sources, such as heating pads or electric blankets, heat or
tanning lamps, saunas, hot tubs, and heated water beds, etc., while wearing
the system. Patients should be advised against taking hot baths or sunbathing.
There is a potential for temperature-dependent increases in fentanyl released
from the system resulting in possible overdose and death. Based
on a pharmacokinetic model, serum fentanyl concentrations could theoretically
increase by approximately one-third for patients with a body temperature of
40��C (104��F) due to temperature-dependent increases in fentanyl
released from the system and increased skin permeability. Patients
wearing DURAGESIC systems who develop fever or increased
core body temperature due to strenuous exertion should be monitored for opioid
side effects and the DURAGESIC dose should be adjusted if
necessary. Death and other serious
medical problems have occurred when people were accidentally exposed to DURAGESIC.
Examples of accidental exposure include transfer of a DURAGESIC patch
from an adult's body to a child while hugging, accidental sitting on
a patch and possible accidental exposure of a caregiver's skin to the
medication in the patch whilethe caregiver was applying or removing the patch. Placing DURAGESIC in the mouth, chewing it,
swallowing it, or using it in ways other than indicated may cause choking
or overdose that could result in death.<br/>Misuse, Abuse and Diversion of Opioids: Fentanyl is an opioid agonist of the morphine-type.
Such drugs are sought by drug abusers and people with addiction disorders
and are subject to criminal diversion. Fentanyl
can be abused in a manner similar to other opioids, legal or illicit. This
should be considered when prescribing or dispensing DURAGESIC in
situations where the physician or pharmacist is concerned about an increased
risk of misuse, abuse, or diversion. DURAGESIC has
been reported as being abused by other methods and routes of administration.
These practices will result in uncontrolled delivery of the opioid and pose
a significant risk to the abuser that could result in overdose and death . Concerns about abuse,
addiction, and diversion should not prevent the proper management of pain.
However, all patients treated with opioids require careful monitoring for
signs of abuse and addiction, since use of opioid analgesic products carries
the risk of addiction even under appropriate medical use. Healthcare professionals should contact their state professional
licensing board or state controlled substances authority for information on
how to prevent and detect abuse or diversion of this product.<br/>Hypoventilation (Respiratory Depression): Serious or life-threatening hypoventilation may
occur at any time during the use of DURAGESIC especially
during the initial 24-72 hours following initiation of therapy and following
increases in dose. Because significant amounts
of fentanyl are absorbed from the skin for 17 hours or more after the patch
is removed, hypoventilation may persist beyond the removal of DURAGESIC.
Consequently, patients with hypoventilation should be carefully observed for
degree of sedation and their respiratory rate monitored until respiration
has stabilized. The use of concomitant CNS
active drugs requires special patient care and observation. Respiratory depression is the chief hazard of opioid agonists,
including fentanyl the active ingredient in DURAGESIC. Respiratory
depression is more likely to occur in elderly or debilitated patients, usually
following large initial doses in non-tolerant patients, or when opioids are
given in conjunction with other drugs that depress respiration. Respiratory depression from opioids is manifested by a reduced
urge to breathe and a decreased rate of respiration, often associated with
the���sighing���pattern of breathing (deep breaths separated by
abnormally long pauses). Carbon dioxide retention from opioid-induced respiratory
depression can exacerbate the sedating effects of opioids. This makes overdoses
involving drugs with sedative properties and opioids especially dangerous. DURAGESIC should be used with extreme caution
in patients with significant chronic obstructive pulmonary disease or cor
pulmonale, and in patients having a substantially decreased respiratory reserve,
hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients,
even usual therapeutic doses of DURAGESIC may decrease respiratory
drive to the point of apnea. In these patients, alternativenon-opioid analgesics
should be considered, and opioids should be employed only under careful medical
supervision at the lowest effective dose.<br/>Chronic Pulmonary Disease: Because potent opioids can cause serious or life-threatening
hypoventilation, DURAGESIC should be administered with caution
to patients with pre-existing medical conditions predisposing them to hypoventilation.
In such patients, normal analgesic doses of opioids may further decrease respiratory
drive to the point of respiratory failure.<br/>Head Injuries and Increased Intracranial Pressure: DURAGESIC should not be used in
patients who may be particularly susceptible to the intracranial effects of
COretention such as those with evidence of increased intracranial
pressure, impaired consciousness, or coma. Opioids may obscure the clinical
course of patients with head injury. DURAGESIC should be
used with caution in patients with brain tumors.<br/>Interactions with other CNS Depressants: The concomitant use of DURAGESIC (fentanyl
transdermal system) with other central nervous system depressants, including
but not limited to other opioids, sedatives, hypnotics, tranquilizers (e.g.,
benzodiazepines), general anesthetics, phenothiazines, skeletal muscle relaxants,
and alcohol, may cause respiratory depression, hypotension, and profound sedation
or potentially result in coma. When such combined therapy is contemplated,
the dose of one or both agents should be significantly reduced.<br/>Interactions with Alcohol and Drugs of Abuse: Fentanyl may be expected to have additive CNS depressant
effects when used in conjunction with alcohol, other opioids, or illicit drugs
that cause central nervous system depression.<br/>Interactions with CYP3A4 Inhibitors: The concomitant use of transdermal fentanyl with
all CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin,
clarithromycin, nelfinavir, and nefazadone, amiodarone, amprenavir, aprepitant,
diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and
verapamil) may also result in an increase in fentanyl plasma concentrations,
which could increase or prolong adverse drug effects and may cause potentially
fatal respiratory depression. Patients receiving DURAGESIC
and any CYP3A4 inhibitor should be carefully monitored
for an extended period of time, and dosage adjustments should be made if warranted
(seeBOX WARNING,
CLINICAL PHARMACOLOGY���Drug Interactions,
PRECAUTIONS, and DOSAGE AND ADMINISTRATION for further information)..
|
| dailymed-instance:indicatio... |
DURAGESIC is indicated for management
of persistent, moderate to severe
chronic pain that: DURAGESIC should ONLY be used in
patients who are already receiving opioid therapy, who have demonstrated opioid
tolerance, and who require a total daily dose at least equivalent to DURAGESIC'
25 mcg/h . Patients who are considered opioid-tolerant are those who have
been taking, for a week or longer, at least 60 mg of morphine daily, or at
least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone
daily, or an equianalgesic dose of another opioid. Because
serious or life-threatening hypoventilation could result, DURAGESIC is
contraindicated for use on an as needed basis (i.e., prn), for the management
of post-operative or acute pain, or in patients who are not opioid-tolerant
or who require opioid analgesia for a short period of time . An evaluation of the appropriateness and adequacy of treating
with immediate-release opioids is advisable prior to initiating therapy with
any modified-release opioid. Prescribers should individualize treatment in
every case, initiating therapy at the appropriate point along a progression
from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs
and acetaminophen, to opioids, in a plan of pain management such as outlined
by the World Health Organization, the Agency for Health Research and Quality,
the Federation of State Medical Boards Model Policy, or the American Pain
Society. Patients should be assessed for their
clinical risks for opioid abuse or addiction prior to being prescribed opioids.
Patients receiving opioids should be routinely monitored for signs of misuse,
abuse, and addiction. Persons at increased risk for opioid abuse include those
with a personal or family history of substance abuse (including drug or alcohol
abuse or addiction) or mental illness (e.g., major depression). Patients at
increased risk may still be appropriately treated with modified-release opioid
formulations; however these patients will require intensive monitoring for
signs of misuse, abuse, or addiction.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Duragesic
|