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:

H.J. Harkins Company, Inc.

INN (International Name):

FENTANYL

Composition:

FENTANYL 25 ug in 1 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 - 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 use on an as needed basis (i.e., p

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 pouches which pose little risk of exposure to health care workers. Do not use a fentanyl transdermal system if the pouch seal is broken or the system is cut, damaged, or changed in any way. KEEP FENTANYL TRANSDERMAL SYSTEM OUT OF THE REACH OF CHILDREN AND PETS. Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). Apply immediately after removal from individually sealed pouch. Do not use if the pouch seal is broken. For transdermal use only. Bioclusive™ is a trademark of Ethicon, Inc. A schedule CII narcotic. DEA order form required. Manufactured by: Noven Pharmaceuticals, Inc. Miami, FL 33186 Manufactured for: Apotex Corp. Weston, FL 33326 Repacked by: H.J. Harkins Company, Inc. 513 Sandydale Drive Nipomo, CA 93444

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FENTANYL - FENTANYL PATCH, EXTENDED RELEASE
H.J. Harkins Company, Inc.
----------
MEDICATION GUIDE
FENTANYL TRANSDERMAL SYSTEM CII
Rx Only
IMPORTANT:
• Keep fentanyl transdermal system in a safe place away from
children and pets. Accidental use by a child
or pet is a medical emergency and may result in death. If a child or
pet accidentally uses fentanyl
transdermal system, get emergency help right away.
• Make sure you read the separate “Instructions for Applying a
Fentanyl Transdermal System.” Always
use a fentanyl transdermal system the right way. Fentanyl transdermal
system can cause serious breathing
problems and death, especially if it is used the wrong way.
• Fentanyl transdermal system is a federally controlled substance
(C-II) because it can be abused. Keep
fentanyl transdermal system in a safe place to prevent theft. Selling
or giving away fentanyl transdermal
system may harm others, and is against the law.
• Tell your doctor if you (or a family member) have ever abused or
been dependent on alcohol,
prescription medicines or street drugs.
Read the Medication Guide that comes with fentanyl transdermal system
before you start using it and
each time you get a new prescription. There may be new information.
This Medication Guide does not
take the place of talking to your healthcare provider about your
medical condition or your treatment.
Make sure you read and understand all the instructions for using
fentanyl transdermal system. Do not use
fentanyl transdermal system unless you understand everything. Talk to
your healthcare provider if you
have questions.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT
FENTANYL TRANSDERMAL SYSTEM?
Fentanyl transdermal system is a skin patch that contains fentanyl.
Fentanyl is a very strong opioid narcotic pain medicine that can cause
serious and life-threatening
breathing problems. Serious and life-threatening breathing problems
can happen because of an overdose
or if the dose you are using is too high for you. Call your doctor
right away or get emerg

Summary of Product characteristics

FENTANYL - FENTANYL PATCH, EXTENDED RELEASE
H.J. HARKINS COMPANY, INC.
----------
FENTANYL TRANSDERMAL SYSTEM
CII
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 SYSTEMS (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 [PR