BUTORPHANOL TARTRATE- butorphanol tartrate spray

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

BUTORPHANOL TARTRATE (UNII: 2L7I72RUHN) (Butorphanol - UNII:QV897JC36D)

Pieejams no:

Apotex Corp.

SNN (starptautisko nepatentēto nosaukumu):

BUTORPHANOL TARTRATE

Kompozīcija:

BUTORPHANOL TARTRATE 10 mg in 1 mL

Ievadīšanas:

NASAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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. Limitations of Use : Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS] reserve butorphanol tartrate nasal spray for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - Have not been tolerated or are not expected to be tolerated, - Have not provided adequate analgesia or are not expected to provide adequate analgesia Butorphanol tartrate nasal spray should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Butorphanol tartrate nasal spray is contraindicated in: - Patients with significant respiratory depression [see WARNINGS] - Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS] - Patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS] - Patients with hypersensitivity to butorphanol tartrate, the preservative benzethonium chloride, or any of the formulation excipients (e.g., anaphylaxis) [see WARNINGS]) Controlled Substance Butorphanol tartrate nasal spray contains butorphanol, a Schedule IV controlled substance.   Abuse Butorphanol tartrate nasal spray contains butorphanol tartrate, a substance with a high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see WARNINGS].   Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.   Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.   Misuse and abuse of butorphanol tartrate nasal spray increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of butorphanol tartrate nasal spray with alcohol and other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction.   All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of butorphanol tartrate nasal spray abuse include those with a history of prolonged use of any opioid, including products containing butorphanol tartrate, those with a history of drug or alcohol abuse, or those who use butorphanol tartrate nasal spray in combination with other abused drugs. “Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control.     Butorphanol tartrate nasal spray, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.   Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.   Risks Specific to Abuse of Butorphanol Tartrate Nasal Spray Abuse of butorphanol tartrate nasal spray poses a risk of overdose and death. The risk is increased with concurrent use of butorphanol tartrate nasal spray with alcohol and/or other CNS depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.   Dependence Both tolerance and physical dependence can develop during use of opioid therapy.   Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).   Physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.   Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use.   Do not abruptly discontinue butorphanol tartrate nasal spray in a patient physically dependent on opioids. Rapid tapering of butorphanol tartrate nasal spray in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.   When discontinuing butorphanol tartrate nasal spray, gradually taper the dosage using a patient-specific plan that considers the following: the dose of butorphanol tartrate nasal spray the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see DOSAGE AND ADMINISTRATION, and WARNINGS].   Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see  Pregnancy].

Produktu pārskats:

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, a bottle of nasal spray solution, and a patient instruction leaflet and medication guide. On average, one bottle will deliver 14 to 15 doses if no repriming is necessary. Butorphanol Tartrate Nasal Spray USP, 10 mg/mL NDC 60505-0813-1 - 10 mg per mL, 2.5 mL bottle Storage Conditions Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Store butorphanol tartrate nasal spray securely and dispose of properly [see PRECAUTIONS/ Information for Patients]. 1 IMITREX® is a registered trademark of Glaxo-Wellcome, Inc. PHARMACIST ASSEMBLY INSTRUCTIONS FOR BUTORPHANOL TARTRATE NASAL SPRAY, USP The pharmacist will assemble butorphanol tartrate nasal spray prior to dispensing to the patient, according to the following instructions: 1. Open the child-resistant plastic container and remove the spray pump and solution bottle. 2. Assemble butorphanol tartrate nasal spray by first unscrewing the white cap from the solution bottle and screwing the pump unit tightly onto the bottle. Make sure the clear cover is on the pump unit. 3. Return the butorphanol tartrate nasal spray bottle to the child-resistant plastic container for dispensing to the patient with patient instruction leaflet and medication guide. APOTEX INC. BUTORPHANOL TARTRATE NASAL SPRAY, USP 10 mg/mL Revised: January 2024

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE SPRAY
Apotex Corp.
----------
MEDICATION GUIDE
Butorphanol Tartrate (bue-TOR-fa-nol TAR-trate) Nasal Spray, USP 10
mg/mL
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. Store
butorphanol tartrate nasal spray away from children and in a safe
place to prevent stealing or
abuse. Selling or giving away butorphanol tartrate nasal spray is
against the law.
•
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

Produkta apraksts

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE SPRAY
APOTEX CORP.
----------
PRESCRIBING INFORMATION
RX ONLY
BUTORPHANOL TARTRATE NASAL SPRAY USP, 10 MG/ML CIV
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
BUTORPHANOL TARTRATE NASAL SPRAY
ADDICTION, ABUSE, AND MISUSE
BECAUSE THE USE OF 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 AND REASSESS ALL PATIENTS REGULARLY FOR THE DEVELOPMENT
OF
THESE BEHAVIORS AND CONDITIONS _[SEE WARNINGS]._
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF BUTORPHANOL TARTRATE NASAL SPRAY, ESPECIALLY DURING INITIATION
OR
FOLLOWING A DOSAGE INCREASE. TO REDUCE THE RISK OF RESPIRATORY
DEPRESSION, PROPER DOSING AND TITRATION OF BUTORPHANOL TARTRATE NASAL
SPRAY ARE ESSENTIAL _[SEE WARNINGS]._
ACCIDENTAL EXPOSURE
ACCIDENTAL EXPOSURE OF EVEN ONE DOSE OF BUTORPHANOL TARTRATE NASAL
SPRAY, ESPECIALLY IN CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF
BUTORPHANOL TARTRATE _[SEE WARNINGS]._
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF BUTORPHANOL TARTRATE NASAL SPRAY AND
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS FOR USE IN PATIENTS FOR WHOM
ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE _[SEE WARNINGS,_
_PRECAUTIONS; DRUG INTERACTIONS]._
NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS)
IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT
WOMAN, ADVISE THE PATIENT OF THE RISK OF NOWS, WHICH MAY BE LIFE-
THREATENING IF NOT RECOGNIZED AND TREATED. ENSURE THAT MANAGEMENT BY
NEONATOLOGY EXPERTS WILL BE AVAILABLE AT DELIVERY _[SEE WARNINGS]._
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS):
HEALT