FENTANYL - fentanyl patch, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

FENTANYL

Composition:

FENTANYL 25 ug in 72 h

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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. 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/h (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 o

Product summary:

Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Fentanyl transdermal system 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 fentanyl transdermal system 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 FENTANYL TRANSDERMAL SYSTEM OUT OF THE REACH OF CHILDREN AND PETS. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.] Apply immediately after removal from individually sealed package. Do not use if the seal is broken. For transdermal use only. A SCHEDULE CII NARCOTIC. DEA ORDER FORM REQUIRED. Manufactured by: Watson Laboratories, Inc Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Revised: August 2008

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FENTANYL - FENTANYL PATCH, EXTENDED RELEASE
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
FENTANYL (Fen-te-nil) Transdermal System, CII
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 lead to death or other serious medic

Summary of Product characteristics

FENTANYL - FENTANYL PATCH, EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
FENTANYL TRANSDERMAL SYSTEM C-II
REVISED: AUGUST 2008
RX ONLY
FULL PRESCRIBING INFORMATION
FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
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/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,
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 NE