Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ)
Lake Erie Medical DBA Quality Care Products LLC
FENTANYL
FENTANYL 50 ug in 1 h
TRANSDERMAL
PRESCRIPTION DRUG
Fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. Patients considered opioid-tolerant are those who are taking 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 for a week or longer. Fentanyl transdermal system is contraindicated in the following patients and situations due to the risk of fatal respiratory depression: - in patients who are not opioid‑tolerant [see Warnings and Precautions (5.2)]. - in the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of tim
Fentanyl Transdermal System is supplied in cartons containing 4 individually packaged systems. See chart for information regarding individual systems. Fentanyl Transdermal System Dose (mcg/hr) System Size (cm2 ) Fentanyl Content (mg) NDC Number Fentanyl transdermal system-25 7.8 2.75 0406-9025-76 Fentanyl transdermal system-50 15.6 5.50 0406-9050-76 Fentanyl transdermal system-75 23.4 8.25 0406-9075-76 Fentanyl transdermal system-100 31.2 11.0 0406-9000-76 Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F).
Abbreviated New Drug Application
FENTANYL TRANSDERMAL SYSTEM- FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE Lake Erie Medical DBA Quality Care Products LLC ---------- Medication Guide Fentanyl Transdermal System, CII (fĕn´ tә-nĭl) 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 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 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 syste Baca dokumen lengkap
FENTANYL TRANSDERMAL SYSTEM- FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE 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: ABUSE POTENTIAL, RESPIRATORY DEPRESSION AND DEATH, ACCIDENTAL EXPOSURE, CYTOCHROME P450 3A4 INTERACTION, AND EXPOSURE TO HEAT SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. CONTAINS A HIGH CONCENTRATION OF FENTANYL, A SCHEDULE II CONTROLLED SUBSTANCE, WHICH IS SUBJECT TO MISUSE, ABUSE, ADDICTION, AND CRIMINAL DIVERSION. (9) FATAL RESPIRATORY DEPRESSION COULD OCCUR IN PATIENTS WHO ARE NOT OPIOID TOLERANT AND IN PATIENTS THAT ARE OPIOID TOLERANT EVEN IF FENTANYL TRANSDERMAL SYSTEM IS NOT MISUSED OR ABUSED. (5) ACCIDENTAL EXPOSURE OF FENTANYL TRANSDERMAL SYSTEM, ESPECIALLY IN CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF FENTANYL. (5) CYP 3A4 INHIBITORS CAN RESULT IN A FATAL OVERDOSE OF FENTANYL FROM FENTANYL TRANSDERMAL SYSTEM. (5) AVOID EXPOSING THE FENTANYL TRANSDERMAL SYSTEM APPLICATION SITE AND SURROUNDING AREA TO DIRECT EXTERNAL HEAT SOURCES. TEMPERATURE DEPENDENT INCREASES IN FENTANYL RELEASE FROM THE SYSTEM MAY RESULT IN OVERDOSE AND DEATH. (5) RECENT MAJOR CHANGES Boxed Warning 7/2012 Indications and Usage (1) 7/2012 Dosage and Administration (2) 7/2012 Contraindications (4) 7/2012 Warnings and Precautions (5) 7/2012 INDICATIONS AND USAGE Fentanyl transdermal system contains fentanyl, a full opioid agonist. Fentanyl transdermal system is indicated for the management of persistent, moderate to severe chronic pain in OPIOID TOLERANT patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. (1) Fentanyl transdermal system is NOT intended for use as an as-needed analgesic. ( Baca dokumen lengkap