Butorphanol Tartrate 10 mg/mL
Butorphanol Tartrate · SPRAY · Bryant Ranch Prepack
Butorphanol Tartrate is a spray containing butorphanol tartrate at 10 mg/mL, taken nasal. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Butorphanol Tartrate
- Generic Name
- Butorphanol Tartrate
- NDC Code (Product)
72162-2099- Manufacturer
- Bryant Ranch Prepack
- Strength
- 10 mg/mL
- Dosage Form
- SPRAY
- Route
- NASAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA075499
- Marketing Start
- 12/04/2002
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Butorphanol tartrate nasal spray should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see WARNINGS ]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of butorphanol tartrate nasal spray for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into account the…
Warnings
WARNINGS Addiction, Abuse, and Misuse Butorphanol tartrate nasal spray contains butorphanol, a Schedule IV controlled substance. As an opioid, butorphanol tartrate nasal spray exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed butorphanol tartrate nasal spray. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing butorphanol tartrate nasal spray, and reassess all patients receiving butorphanol tartrate nasal spray for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as butorphanol tartrate nasal spray, but use in such patients necessitates intensive counseling about the risks and…
Contraindications
CONTRAINDICATIONS 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 ])
Adverse Reactions
ADVERSE REACTIONS Clinical Trial Experience A total of 788 patients were studied in premarketing clinical trials of butorphanol tartrate nasal spray. In nearly all cases the type and incidence of side effects with butorphanol 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 intranasal butorphanol, except acute studies in normal subjects. 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 with Butorphanol Tartrate Nasal Spray were somnolence (49%), dizziness (23%), nausea and/or vomiting (8%). In long-term trials with butorphanol tartrate nasal spray 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, pain. Cardiovascular: Hypertension,…
Frequently Asked Questions
What is Butorphanol Tartrate used for?
Butorphanol Tartrate contains Butorphanol Tartrate. It is a spray taken nasal. Consult your doctor for specific uses.
Is Butorphanol Tartrate a controlled substance?
Yes, Butorphanol Tartrate is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Butorphanol Tartrate?
The generic name for Butorphanol Tartrate is Butorphanol Tartrate. There are no other listed brand versions of Butorphanol Tartrate.
What is the NDC code for Butorphanol Tartrate 10 mg/mL?
The NDC (National Drug Code) for Butorphanol Tartrate 10 mg/mL is 72162-2099, listed by Bryant Ranch Prepack.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)