Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
BUTORPHANOL TARTRATE (UNII: 2L7I72RUHN) (BUTORPHANOL - UNII:QV897JC36D)
Mylan Pharmaceuticals Inc.
BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE 10 mg in 1 mL
NASAL
PRESCRIPTION DRUG
Butorphanol tartrate nasal spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve butorphanol tartrate nasal spray for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) Butorphanol tartrate nasal spray is contraindicated in: Butorphanol tartrate nasal spray contains butorphanol, a Schedule IV controlled substance. Butorphanol tartrate nasal spray contains butorphanol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Butorphanol tartrate nasal spray can be abused and is subject to misuse, addiction, and criminal diversion (see WARNINGS). All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of
Butorphanol Tartrate Nasal Spray, USP is supplied in a child-resistant plastic container containing a 2.5 mL bottle of nasal spray solution (10 mg/mL) and a metered-dose spray pump with protective clip and dust cover (NDC 0378-9639-43; individual unit). A Medication Guide and Patient Instructions are enclosed. On average, one bottle will deliver 14 to 15 doses if no repriming is necessary. Store at 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide and Patient Instructions with each prescription. Store butorphanol tartrate nasal spray securely and dispose of properly (see PRECAUTIONS: Information for Patients/Caregivers). PHARMACIST ASSEMBLY INSTRUCTIONS FOR BUTORPHANOL TARTRATE NASAL SPRAY: The pharmacist will assemble butorphanol tartrate nasal spray prior to dispensing to the patient, according to the following instructions:
Abbreviated New Drug Application
Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE Butorphanol Tartrate Nasal Spray, USP (bue tor' fa nol tar' trate) CIV Butorphanol tartrate nasal spray is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. • An 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. Important information about butorphanol tartrate nasal spray: • Get emergency help or call 911 right away if you take too much butorphanol tartrate nasal spray (overdose). When you first start taking butorphanol tartrate nasal spray, 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 butorphanol tartrate nasal spray with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma and death. • Never give anyone else your butorphanol tartrate nasal spray. They could die from taking it. Selling or giving away butorphanol tartrate nasal spray is against the law. • Store butorphanol tartrate nasal spray securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take butorphanol tartrate nasal spray if you have: • Severe asthma, trouble breathing, or other lung problems. • A bowel blockage or have narrowing of the stomach or intestines. • Previously had an allergic reaction to butorphanol or the preservative benzethonium chloride. Before taking butorphanol tartrate nasal spray, tell your healthcare provider i Lees het volledige document
BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE SPRAY MYLAN PHARMACEUTICALS INC. ---------- WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE, AND MISUSE BUTORPHANOL TARTRATE NASAL SPRAY EXPOSES PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT’S RISK PRIOR TO PRESCRIBING BUTORPHANOL TARTRATE NASAL SPRAY, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS (SEE WARNINGS). OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS): 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 REMS FOR THESE PRODUCTS (SEE WARNINGS). UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES WITH APPROVED OPIOID ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS AVAILABLE TO HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO • • • • LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF BUTORPHANOL TARTRATE NASAL SPRAY. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF BUTORPHANOL TARTRATE NASAL SPRAY OR FOLLOWING A DOSE INCREASE (SEE WARNINGS). ACCIDENTAL EXPOSURE ACCIDENTAL EXPOSURE OF BUTORPHANOL, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF BUTORPHANOL (SEE WARNINGS). NEONATAL OPIOID WITHDRAWAL SYNDROME PROLONGED USE OF BUTORPHANOL TARTRATE NASAL SPRAY DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED, AND REQUIRES MANAGEMENT ACCORDING TO PROTOCOLS DEVELOPED BY NEONATOLOGY EXPERTS. IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE PATIENT Lees het volledige document