Butorphanol — uses, dosing, side effects & the brands that sell it · pharmaranks
Butorphanol: uses, dosing, side effects & brands
Butorphanol is an opioid agonist/antagonist sold in the U.S. under 3 brand and generic names, for pain. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
From the FDA label for Butorphanol Tartrate (application ANDA075499). Other butorphanol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see WARNINGS ]. Respiratory depression can occur at any time during opioid therapy,…
Butorphanol side effects
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, hypotension Digestive: Anorexia, constipation, dry mouth, nausea and/or vomiting, diarrhea. Nervous: Anxiety, confusion, dizziness, euphoria, floating feeling, insomnia, nervousness, paresthesia, somnolence, tremor…
Every butorphanol product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Butorphanol tartrate is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl)morphinan-3,14-diol[S-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt). The molecular formula is C 21 H 29 NO 2 •C 4 H 6 O 6 , which corresponds to a molecular weight of 477.55 g/mol and the following structural formula: Butorphanol tartrate is a white crystalline substance. The dose is expressed as the tartrate salt. One milligram of the salt is equivalent to 0.68 mg of the free base. The n-octanol/aqueous buffer partition coefficient of butorphanol is 180:1 at pH 7.5. Butorphanol tartrate nasal spray, USP is an aqueous solution of butorphanol tartrate for administration as a metered spray to the nasal mucosa. Each bottle of butorphanol tartrate nasal spray, USP contains 2.5 mL of a 10 mg/mL solution of butorphanol tartrate with sodium chloride, citric acid, and benzethonium chloride in purified water with sodium hydroxide and/or hydrochloric acid added to adjust the pH to 5. The pump reservoir must be fully primed [see PATIENT INSTRUCTIONS ] prior to initial use. After initial priming each metered spray delivers an average of 1 mg of butorphanol tartrate and the 2.5 mL bottle will deliver an average of 14 to 15 doses of butorphanol tartrate nasal spray, USP. If not used for 48 hours or longer, the unit must be reprimed…
What kind of drug is butorphanol?
The FDA classifies butorphanol as an opioid agonist/antagonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take butorphanol with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run butorphanol against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is butorphanol sold under?
We track 3 butorphanol-containing products in the U.S.: Stadol, Butorphanol Tartrate and Butorphanol Tartrate Preservative Free. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take butorphanol
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 ])
Across the brands we track, butorphanol is currently marketed as injectable, spray/inhaler, metered and spray/inhaler, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic butorphanol?
Yes. Our catalog lists 2 generic butorphanol products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.