Butorphanol Tartrate Spray
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Questions & Answers
Side Effects & Adverse Reactions
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 spray 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 section below.)
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Butorphanol Tartrate Nasal Spray USP is indicated for the management of pain when the use of an opioid analgesic is appropriate.
History
There is currently no drug history available for this drug.
Other Information
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 C21H29NO2•C4H6O6, which corresponds to a molecular weight of 477.55 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 5.0. The pump reservoir must be fully primed (see PATIENT INSTRUCTIONS) prior to initial use. After initial priming each metered spray delivers an average of 1.0 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 (see PATIENT INSTRUCTIONS). With intermittent use requiring repriming before each dose, the 2.5 mL bottle will deliver an average of 8 to 10 doses of Butorphanol Tartrate Nasal Spray USP depending on how much repriming is necessary.
Sources
Butorphanol Tartrate Spray Manufacturers
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Roxane Laboratories, Inc
![Butorphanol Tartrate Spray, Metered [Roxane Laboratories, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Butorphanol Tartrate Spray | Energetix Corp
Take 30 drops orally twice daily or as directed by a healthcare professional.
Consult a physician for use in children under 12 years of age.
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A-s Medication Solutions Llc
Butorphanol Tartrate Spray | A-s Medication Solutions Llc
Factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, the use of other drugs, type of anesthesia to be used, and surgical procedure involved. Use in the elderly, in patients with hepatic or renal disease, or in labor requires extra caution (see PRECAUTIONS section and Individualization of Dosage in CLINICAL PHARMACOLOGYsection). The following doses are for patients who do not have impaired hepatic or renal function and who are not on CNS active agents.
Use for PainThe usual recommended dose for initial nasal administration is 1 mg (1 spray in one nostril). Adherence to this dose reduces the incidence of drowsiness and dizziness. If adequate pain relief is not achieved within 60 to 90 minutes, an additional 1 mg dose may be given.
The initial dose sequence outlined above may be repeated in 3 to 4 hours as required after the second dose of the sequence.
Depending on the severity of the pain, an initial dose of 2 mg (1 spray in each nostril) may be used in patients who will be able to remain recumbent in the event drowsiness or dizziness occurs. In such patients single additional 2 mg doses should not be given for 3 to 4 hours.
Use in Balanced AnesthesiaThe use of butorphanol tartrate nasal spray is not recommended because it has not been studied in induction or maintenance of anesthesia.
LaborThe use of butorphanol tartrate nasal spray is not recommended as it has not been studied in labor.
Safety and HandlingButorphanol tartrate nasal spray is an open delivery system with increased risk of exposure to health care workers.
In the priming process, a certain amount of butorphanol may be aerosolized; therefore, the pump sprayer should be aimed away from the patient or other people or animals.
The disposal of Schedule IV controlled substances must be consistent with State and Federal Regulations. The unit should be disposed of by unscrewing the cap, rinsing the bottle, and placing the parts in a waste container.
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Mylan Pharmaceuticals Inc.
Butorphanol Tartrate Spray | Mylan Pharmaceuticals Inc.
Factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and surgical procedure involved. Use in the elderly and in patients with hepatic or renal disease requires extra caution (see PRECAUTIONS and CLINICAL PHARMACOLOGY: Individualization of Dosage). The following doses are for patients who do not have impaired hepatic or renal function and who are not on CNS active agents.
Use for PainThe usual recommended dose for initial nasal administration of butorphanol tartrate nasal solution is 1 mg (1 spray in one nostril). Adherence to this dose reduces the incidence of drowsiness and dizziness. If adequate pain relief is not achieved within 60 to 90 minutes, an additional 1 mg dose may be given.
The initial dose sequence outlined above may be repeated in 3 to 4 hours as required after the second dose of the sequence.
Depending on the severity of the pain, an initial dose of 2 mg (1 spray in each nostril) may be used in patients who will be able to remain recumbent in the event drowsiness or dizziness occurs. In such patients, single additional 2 mg doses should not be given for 3 to 4 hours.
Use in Balanced AnesthesiaThe use of butorphanol tartrate nasal solution is not recommended because it has not been studied in induction or maintenance of anesthesia.
LaborThe use of butorphanol tartrate nasal solution is not recommended as it has not been studied in labor.
Safety and HandlingButorphanol tartrate nasal solution is an open delivery system with increased risk of exposure to health care workers.
In the priming process, a certain amount of butorphanol may be aerosolized; therefore, the pump sprayer should be aimed away from the patient or other people or animals.
The disposal of Schedule IV controlled substances must be consistent with State and Federal Regulations. The unit should be disposed of by unscrewing the cap, rinsing the bottle, and placing the parts in a waste container.
![Butorphanol Tartrate Spray, Metered [A-s Medication Solutions Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1b22bb27-177a-49a7-a4bc-8e25bcbae32a&name=5988-0.jpg)
![Butorphanol Tartrate Spray [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9c069ce5-ea67-4f42-afe4-30b01b4ce24d&name=069add61-a692-413c-8ac1-96662aca0cbb-10.jpg)
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