Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ)
Par Pharmaceutical Inc.
FENTANYL
FENTANYL 25 ug in 1 h
TRANSDERMAL
PRESCRIPTION DRUG
Fentanyl transdermal system is contraindicated in the following patients and situations: Clinical Considerations Fetal/neonatal adverse reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly [see Warnings Precautions (5.4)]. Teratogenic Effects Pregnancy C: There are no adequate and well-controlled studies in pregnant women. Fentanyl transdermal system should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The potential effects of fentanyl on embryo-fetal development were studied in the rat, mouse, and rabbit models. Published literature reports that administration of fentanyl (0, 10, 100, or 500 mcg/kg/day) to pregnant female Sprague-Dawley
Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Fentanyl Transdermal System-25 10 2.5 49884-761-78 Fentanyl Transdermal System-50 20 5 49884-762-78 Fentanyl Transdermal System-75 30 7.5 49884-763-78 Fentanyl Transdermal System-100 40 10 49884-764-78 Store in original unopened pouch. Do not store above 77°F (25°C).
Abbreviated New Drug Application
FENTANYL- FENTANYL PATCH Par Pharmaceutical Inc. ---------- MEDICATION GUIDE Fentanyl Transdermal System, CII Rx only Fentanyl Transdermal System, CII Rx only 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 medication 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. 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 medical problems. Proper disposal of fentanyl transdermal system after use and for unused patches when no longer needed: Fold the sticky sides of the patch together and flush down the toilet. Do not put patches in a trash can. • Get emergency help right away if you use too much Прочитајте комплетан документ
FENTANYL- FENTANYL PATCH PAR PHARMACEUTICAL INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION FENTANYL TRANSDERMAL SYSTEM, CII THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FENTANYL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FENTANYL. FENTANYL (FENTANYL) PATCH FOR TRANSDERMAL USE. INITIAL U.S. APPROVAL: 1968 WARNING: ADDICTION, ABUSE, AND MISUSE: LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION, AND EXPOSURE TO HEAT _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • • • • RECENT MAJOR CHANGES Boxed Warning 4/2014 Indications and Usage ( 1) 4/2014 Dosage and Administration ( 2) 4/2014 Warnings and Precautions ( 5) 4/2014 INDICATIONS AND USAGE • • • DOSAGE AND ADMINISTRATION • • • FENTANYL TRANSDERMAL SYSTEM EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT’S RISK BEFORE PRESCRIBING, AND MONITOR REGULARLY FOR DEVELOPMENT OF 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 OF 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) INITIATION OF CYP 3A4 INHIBITORS (OR DISCONTINUATION OF CYP 3A4 INDUCERS) CAN RESULT IN A FATAL OVERDOSE OF FENTANYL FROM FENTANYL TRANSDERMAL SYSTEM. (5.10) AVOID EXPOSING THE FENTANYL TRANSDERMAL SYSTEM APPLICATION SITE AND SURROUNDING AREA TO DIRECT EXTERNAL HEAT SOURCES. TEMPERATURE DEPENDE Прочитајте комплетан документ