FENTANYL patch, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Dispensing Solutions Inc.

INN (International ime):

FENTANYL

Sastav:

FENTANYL 25 ug in 1 h

Administracija rute:

TRANSDERMAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems: They are supplied by Dispensing Solutions Inc. as follows: Fentanyl transdermal systems are supplied in sealed blister packages which pose little risk of exposure to health care workers. If the drug matrix accidentally contacts the skin, the area should be washed with copious amounts of water. Do not use soap, alcohol, or other solvents because they may enhance the drug’s ability to penetrate the skin. Do not use a fentanyl transdermal system if the 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 at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Apply immediately after removal from individually sealed blister package. Do not use if the seal is broken. For transdermal use only. A SCHEDULE CII NARCOTIC. DEA ORDER FORM REQUIRED. Bioclusive™ is a trademark of Ethicon, Inc. Dilaudid® is a registered trademark of Abbott Laboratories. Dolophine® is a registered trademark of Roxane Laboratories, Inc. Levo-Dromoran® is a registered trademark of Valeant Pharmaceuticals International. Numorphan® is a registered trademark of Endo Pharmaceuticals. Demerol® is a registered trademark of Sanofi-Aventis U.S. Manufactured By: Aveva Drug Delivery Systems A Nitto Denko Company Miramar, FL 33025 Distributed By: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 And Relabeled By: Dispensing Solutions Inc. 3000 West Warner Ave Santa Ana, CA 92704 United States

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

FENTANYL - FENTANYL PATCH, EXTENDED RELEASE
Dispensing Solutions 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

Svojstava lijeka

FENTANYL - FENTANYL PATCH, EXTENDED RELEASE
DISPENSING SOLUTIONS 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 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 FO