Country: United States
Language: English
Source: NLM (National Library of Medicine)
Fentanyl (UNII: UF599785JZ) (Fentanyl - UNII:UF599785JZ)
Lake Erie Medical DBA Quality Care Products LLC
Fentanyl
Fentanyl 25 ug
TRANSDERMAL
PRESCRIPTION DRUG
Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1) ], reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be o
Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. * This lowest dosage is designated as 12 mcg/h (however, the actual dosage is 12.5 mcg/h) to distinguish it from a 125 mcg/h dosage that could be prescribed by using multiple patches. Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
FENTANYL SYSTEM- FENTANYL PATCH Lake Erie Medical DBA Quality Care Products LLC ---------- Medication Guide Fentanyl (fen' ta 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 sever 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 oth Read the complete document
FENTANYL SYSTEM- FENTANYL PATCH LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FENTANYL TRANSDERMAL SYSTEM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FENTANYL TRANSDERMAL SYSTEM. FENTANYL TRANSDERMAL SYSTEM FOR TRANSDERMAL ADMINISTRATION, CII INITIAL U.S. APPROVAL: 1968 WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION, RISK OF INCREASED FENTANYL ABSORPTION WITH APPLICATION OF EXTERNAL HEAT; AND RISKS FROM CONCOMITANT USE OF BENZODIAZEPINES OR OTHER CNS DEPRESSANTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ FENTANYL TRANSDERMAL SYSTEM EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING, AND MONITOR REGULARLY FOR THESE BEHAVIORS OR CONDITIONS. (5.1) SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR. MONITOR CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.2) ACCIDENTAL EXPOSURE TO FENTANYL TRANSDERMAL SYSTEM, ESPECIALLY IN CHILDREN, CAN RESULT IN FATAL OVERDOSE OF FENTANYL. (5.3) PROLONGED USE OF FENTANYL TRANSDERMAL SYSTEM DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE AVAILABLE. (5.4) CONCOMITANT USE WITH CYP 3A4 INHIBITORS (OR DISCONTINUATION OF CYP 3A4 INDUCERS) CAN RESULT IN A FATAL OVERDOSE OF FENTANYL. (5.5) EXPOSURE OF THE FENTANYL TRANSDERMAL SYSTEM APPLICATION SITE AND SURROUNDING AREA TO DIRECT EXTERNAL HEAT SOURCES HAS RESULTED IN FATAL OVERDOSE OF FENTANYL. WARN PATIENTS TO AVOID EXPOSING THE FENTANYL TRANSDERMAL SYSTEM APPLICATION SITE AND SURROUNDI Read the complete document