Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
FENTANYL (UNII: UF599785JZ) (Fentanyl - UNII:UF599785JZ)
Apotex Corp.
FENTANYL
FENTANYL 12 ug in 1 h
TRANSDERMAL
PRESCRIPTION DRUG
Fentanyl transdermal system is indicated for the management of severe and persistent pain that requires an extended treatment with a daily opioid analgesic 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, which can occur at any dosage or duration, 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 ot
Fentanyl transdermal system is supplied in cartons containing 5 individual child-resistant packaged systems. See chart for information regarding individual systems. * This lowest strength is designated as 12 mcg/hour (however, the actual strength is 12.5 mcg/hour) to distinguish it from 125 mcg/hour strength that could be prescribed by using multiple transdermal systems. Store in original unopened blister. Store up to 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). Store fentanyl transdermal system securely and dispose of properly [see Patient Counseling Information (17) ]
Abbreviated New Drug Application
FENTANYL- FENTANYL PATCH, EXTENDED RELEASE Apotex Corp. ---------- MEDICATION GUIDE Fentanyl Transdermal System, Cll (fen' ta nil) Fentanyl transdermal system is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent that requires an extended treatment period with a daily opioid pain medicine, 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 to be used on an “as needed” basis. Important information about fentanyl transdermal system: • Get emergency help or call 911 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. • Taking fentanyl transdermal system with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) may cause severe 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 taking it. Selling or giving away fentanyl transdermal system is against the law. • Store fentanyl transdermal system, securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. • If the patch accidentally sticks to a family member while in close contact, take the Կարդացեք ամբողջական փաստաթուղթը
FENTANYL- FENTANYL PATCH, EXTENDED RELEASE APOTEX CORP. ---------- 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, CII INITIAL U.S. APPROVAL: 1968 WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL TRANSDERMAL SYSTEM _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) TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF ADDICTION, ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A RISK EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.6) 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. (5.5) CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4 INDUCERS) CAN RESULT IN A FATAL OVERDOSE OF FENTANYL. (5.7) 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 SURROUNDING AREA TO DIRECT EXTERNAL HEAT SOURCES. (5.8) CONCOMITANT USE Կարդացեք ամբողջական փաստաթուղթը