FENTANYL- fentanyl patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ)

Available from:

St. Marys Medical Park Pharmacy

INN (International Name):

FENTANYL

Composition:

FENTANYL 25 ug in 1 h

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: - requires continuous, around-the-clock opioid administration for an extended period of time, and - cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids Fentanyl transdermal system 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 fentanyl transdermal system 25 mcg/hr (see DOSAGE AND ADMINISTRATION). 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, fentanyl transdermal system is contraindicated for

Product summary:

HOW SUPPLIED Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FENTANYL- FENTANYL PATCH
St. Marys Medical Park Pharmacy
----------
FENTANYL- fentanyl patch, extended release
Apotex Corp.
----------
Medication Guide
Fentanyl Transdermal System, Cll
(fen' ta nil)
Fentanyl transdermal system is:
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain severe
enough to require daily around-the-clock, long-term treatment with an
opioid, in people who are already
regularly using opioid pain medicine, when other pain treatments such
as non-opioid pain medicines or
immediate-release opioid medicines do not treat your pain well enough
or you cannot tolerate them.
A long-acting (extended-release) opioid pain medicine that can put you
at risk for overdose and death.
Even if you take your dose correctly as prescribed you are at risk for
opioid addiction, abuse, and misuse
that can lead to death.
Not for use to treat pain that is not around-the-clock.
Important information about fentanyl transdermal system:
Get emergency help right away if you use too much fentanyl transdermal
system (overdose). When you
first start taking fentanyl transdermal system, when your dose is
changed, or if you take too much
(overdose), serious or life threatening breathing problems that can
lead to death may occur.
Taking fentanyl transdermal system with other opioid medicines,
benzodiazepines, alcohol, or other
central nervous system depressants (including street drugs) may cause
severe drowsiness, decreased
awareness, breathing difficulties, with slow or shallow breathing,
coma, and death.
Never give anyone else your fentanyl transdermal system. They could
die from using it. Store fentanyl
transdermal system away from children and in a safe place to prevent
stealing or abuse. Selling or giving
away fentanyl transdermal system is against the law.
If the patch accidentally sticks to a family member while in close
contact, take the patch off, wash the
area with water, and get emergency help right away because an
accidental exposure to fentanyl
transdermal system can lea

Summary of Product characteristics

FENTANYL- FENTANYL PATCH
ST. MARYS MEDICAL PARK PHARMACY
----------
FENTANYL
Full Prescribing Information
FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
BOXED WARNING
Fentanyl transdermal system contains 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 (fentanyl
transdermal system) may be a
particular target for abuse and diversion.
Fentanyl transdermal system is indicated for management of persistent,
moderate to severe chronic
pain that:
requires continuous, around-the-clock opioid administration for an
extended period of time, and
cannot be managed by other means such as non-steroidal analgesics,
opioid combination products,
or immediate-release opioids
Fentanyl transdermal system 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 fentanyl transdermal system 25 mcg/hr. 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,
fentanyl transdermal system is
contraindicated:
in patients who are not opioid-tolerant
in the management of acute pain or in patients who require opioid
analgesia for a short period of
time
in the management of post-operative pain, including use after
out-patient or day surgeries (e.g.,
tonsillectomies)
in the management of mild pain
in the management of intermittent pain [e.g., use on an as needed
basis (prn)]
(See CONTRAINDICATIONS for further information.)
Since