BUTORPHANOL TARTRATE spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

BUTORPHANOL TARTRATE

Composition:

BUTORPHANOL TARTRATE 10 mg in 1 mL

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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): 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: Butorphanol Tartrate Nasal Spray contains butorphanol, a Schedule IV controlled substance. Butorphanol Tartrate Nasal Spray contains butorphanol, a substance with 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, 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. 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] .

Product summary:

Butorphanol Tartrate Nasal Spray, USP is supplied in a child-resistant vial 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 0054-3090-36: 2.5 mL Bottle. Store at 20° to 25°C (68° to 77°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. 1 IMITREX® is a registered trademark of Glaxo-Wellcome, Inc. Store Butorphanol Tartrate Nasal Spray securely and dispose of properly [see PRECAUTIONS: Information for Patients] .

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE SPRAY, METERED
Hikma Pharmaceuticals USA Inc.
----------
MEDICATION GUIDE
Butorphanol Tartrate Nasal Spray, USP (bue tor’ fa nol tar’ trate)
CIV
Rx only
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.
Befo

Summary of Product characteristics

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE SPRAY, METERED
HIKMA PHARMACEUTICALS USA INC.
----------
BUTORPHANOL TARTRATE NASAL SPRAY, USP CIV
RX ONLY
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 DOSE 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 _[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)
HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO COMPLETE A REMS-
COMPLIANT EDUCATION PROGRAM AND TO COUNSEL PATI