FENTANYL patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

FENTANYL

Composition:

FENTANYL 1.28 mg in 1 [USP'U]

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., prn

Product summary:

Fentanyl transdermal system is supplied in cartons containing individually packaged systems.  Fentanyl Transdermal 12 mcg/hr Fentanyl Transdermal 25 mcg/hr Fentanyl Transdermal 50 mcg/hr Fentanyl Transdermal 75 mcg/hr Fentanyl Transdermal 100 mcg/hr Fentanyl transdermal systems are supplied in sealed pouches which pose little risk of exposure to healthcare workers. Do not use a fentanyl transdermal system if the pouch seal is broken or the patch 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 at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Apply immediately after removal from individually sealed pouch. Do not use if the pouch seal is broken. For transdermal use only. A schedule CII narcotic. DEA order form required. BIOCLUSIVE® is a registered trademark of Systagenix Wound Management, Inc. Askina® Derm is a registered trademark of BBraun Melsungen AG DILAUDID® is a registered trademark of Purdue Pharmaceutical Products L.P. DOLOPHINE® is a registered trademark of Roxane Laboratories, Inc. LEVO-DROMORAN® is a registered trademark of Valeant Pharmaceuticals NUMORPHAN® is a registered trademark of Endo Pharmaceuticals, Inc. DEMEROL® is a registered trademark of Sanofi-Synthelabo Inc. of Sanofi-Aventis U.S. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED DECEMBER 2009 FTS:R17 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FENTANYL - FENTANYL PATCH
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
FENTANYL TRANSDERMAL SYSTEM
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 emergency medical help if
you:
�

Summary of Product characteristics

FENTANYL - FENTANYL PATCH
PHYSICIANS TOTAL CARE, INC.
----------
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/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 POSTOPERATIVE 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 THE PEAK FENTANYL CONCENTRA