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(butorphanol tartrate) Nasal Spray USP
Butorphanol tartrate is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl)morphinan-3,14-diol D-(-)-tartrate (1:1) salt. The molecular formula is C21H29NO2 •C4H6O6, which corresponds to a molecular weight of 477.6 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 USP with benzethonium chloride, citric acid (anhydrous), purified water, sodium chloride and sodium hydroxide. 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.
What are the possible side effects of butorphanol (Stadol)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have any of these serious side effects:
- pounding, or uneven heartbeats;
- shallow breathing, slow heartbeat;
- cold, clammy skin;
- problems with urination;
- confusion, feeling like you are floating;
- feeling like you might pass out; or
- dangerously high blood pressure (severe headache, blurred vision, ringing in your...
Last reviewed on RxList: 10/31/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Stadol Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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