FDA label ebfef58c-ce2c-4bb1-b117-71be6938375b

What is the most important information I should know about butorphanol tartrate nasal solution? Your doctor has prescribed butorphanol tartrate nasal solution to treat your pain. The medication in butorphanol tartrate nasal solution belongs to a group of medicines that is known to cause dependence and abuse. Butorphanol tartrate nasal solution causes these effects only in a small number of patients. However, because it can have these effects, it is VERY IMPORTANT that you not use butorphanol tartrate nasal solution more often or in larger doses than your doctor has instructed. Also, it is important to have regular checkups with your doctor to ensure that you’re using butorphanol tartrate nasal solution correctly. The longer you use butorphanol tartrate nasal solution, the greater your risk of getting dependent on it. Because butorphanol tartrate nasal solution may make you feel sleepy or dizzy, do not drive or operate dangerous machinery, e.g., automobiles, until you can no longer feel the effects of the drug. Also, do not drink alcohol while using butorphanol tartrate nasal solution because it may worsen any side effects.

KEEP OUT OF THE REACH OF CHILDREN.

USUAL DOSE: ONE Spray. Spray ONLY ONCE into ONLY ONE nostril. DO NOT spray into both nostrils unless directed by your doctor. DO NOT repeat sooner than directed by your doctor.

WARNINGS Patients Dependent on Narcotics Because of its opioid antagonist properties, butorphanol is not recommended for use in patients dependent on narcotics. Such patients should have an adequate period of withdrawal from opioid drugs prior to beginning butorphanol therapy. In patients taking opioid analgesics chronically, butorphanol has precipitated withdrawal symptoms such as anxiety, agitation, mood changes, hallucinations, dysphoria, weakness, and diarrhea. Because of the difficulty in assessing opioid tolerance in patients who have recently received repeated doses of narcotic analgesic medication, caution should be used in the administration of butorphanol to such patients. Drug Abuse and Dependence Drug Abuse Butorphanol tartrate, by all routes of administration, has been associated with episodes of abuse. Of the cases received, there were more reports of abuse with the nasal solution formulation than with the injectable formulation. Physical Dependence, Tolerance, and Withdrawal Prolonged, continuous use of butorphanol tartrate may result in physical dependence or tolerance (a decrease in response to a given dose). Abrupt cessation of use by patients with physical dependence may result in symptoms of withdrawal. Note: Proper patient selection, dose and prescribing limitations, appropriate directions for use, and frequent monitoring are important to minimize the risk of abuse and physical dependence. (See DRUG ABUSE AND DEPENDENCE .)

ADVERSE REACTIONS Clinical Trial Experience A total of 2446 patients were studied in premarketing clinical trials of butorphanol. Approximately half received butorphanol tartrate injection with the remainder receiving butorphanol tartrate nasal solution. In nearly all cases, the type and incidence of side effects with butorphanol by any route were those commonly observed with opioid analgesics. The adverse experiences described below are based on data from short-term and long-term clinical trials in patients receiving butorphanol by any route. There has been no attempt to correct for placebo effect or to subtract the frequencies reported by placebo-treated patients in controlled trials. The most frequently reported adverse experiences across all clinical trials were somnolence (43%), dizziness (19%), nausea and/or vomiting (13%). In long-term trials with butorphanol tartrate nasal solution only, nasal congestion (13%) and insomnia (11%) were frequently reported. The following adverse experiences were reported at a frequency of 1% or greater in clinical trials and were considered to be probably related to the use of butorphanol. Body as a Whole: asthenia/lethargy, headache, sensation of heat. Cardiovascular: vasodilation, palpitations. Digestive: anorexia, constipation, dry mouth, nausea and/or vomiting, stomach pain. Nervous: anxiety, confusion, dizziness, euphoria, floating feeling, insomnia, nervousness, paresthesia, somnolence, tremor. Respiratory: bronchitis, cough, dyspnea, epistaxis, nasal congestion, nasal irritation, pharyngitis, rhinitis, sinus congestion, sinusitis, upper respiratory infection. Skin and Appendages: sweating/clammy, pruritus. Special Senses: blurred vision, ear pain, tinnitus, unpleasant taste. The following adverse experiences were reported with a frequency of less than 1% in clinical trials and were considered to be probably related to the use of butorphanol. Cardiovascular: hypotension, syncope. Nervous: abnormal dreams, agitation, dysphoria, hallucinations, hostility, withdrawal symptoms. Skin and Appendages: rash/hives. Urogenital: impaired urination. The following infrequent additional adverse experiences were reported in a frequency of less than 1% of the patients studied in short-term butorphanol tartrate nasal solution trials and under circumstances where the association between these events and butorphanol administration is unknown. They are being listed as alerting information for the physician. Body as a Whole: edema. Cardiovascular: chest pain, hypertension, tachycardia. Nervous: depression. Respiratory: shallow breathing. Postmarketing Experience Postmarketing experience with butorphanol tartrate nasal solution has shown an adverse event profile similar to that seen during the premarketing evaluation of butorphanol by all routes of administration. Adverse experiences that were associated with the use of butorphanol tartrate nasal solution and that are not listed above have been chosen for inclusion below because of their seriousness, frequency of reporting, or probable relationship to butorphanol. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These adverse experiences include apnea, convulsion, delusion, drug dependence, excessive drug effect associated with transient difficulty speaking and/or executing purposeful movements, overdose, and vertigo. Reports of butorphanol overdose with a fatal outcome have usually but not always been associated with ingestion of multiple drugs.