Butorphanol nasal spray

What is Butorphanol Nasal Spray?

• Butorphanol nasal spray (Stadol NS) is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series.

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Butorphanol structure

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What are the uses of this medicine?

• Butorphanol nasal spray (Stadol NS) is a strong prescription pain medicine that contains an opioid ([[narcotic[[) that is used to manage pain when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.

How does this medicine work?

• Butorphanol is a partial opioid agonist at the mu opioid receptor and a full agonist at the kappa opioid receptor.
• The principal therapeutic action of butorphanol is analgesia.
• The precise mechanism of the analgesic action is unknown.
• However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• significant respiratory depression
• acute or severe bronchial asthma
• known or suspected gastrointestinal obstruction, including paralytic ileus
• hypersensitivity to butorphanol tartrate,the preservative benzethonium chloride

What drug interactions can this medicine cause?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Be sure to mention any of the following:

• antidepressants
• antihistamines
• barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, or secobarbital (Seconal)
• cyclobenzaprine (Amrix)
• dextromethorphan (found in many cough medications; in Nuedexta)
• erythromycin (E.E.S., Eryc, Erythrocin, others)
• medications for seizures
• lithium (Lithobid)
• medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, in Treximet), and zolmitriptan (Zomig)
• mirtazapine (Remeron)
• 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi)
• selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft)
• serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor)
• tricylic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• theophylline (Theochron, Uniphyl, others)
• trazodone (Oleptro)
• monoamine oxidase (MAO) inhibitors
• if you have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate)
• St. John's wort or tryptophan

Is this medicine FDA approved?

• It was patented in 1971 and approved for medical use in 1979.

How should this medicine be used?

Recommended dosage: Use for Pain:

• The usual recommended dose for initial nasal administration of Butorphanol Tartrate Nasal Spray 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.

Use in Balanced Anesthesia:

• The use of Butorphanol Tartrate Nasal Spray is not recommended because it has not been studied in induction or maintenance of anesthesia.

Labor:

• The use of Butorphanol Tartrate Nasal Spray is not recommended as it has not been studied in labor.

Elderly Patients and Patients with Renal or Hepatic Impairment:

• The initial dose sequence in elderly patients and patients with hepatic or renal impairment should be limited to 1 mg followed, if needed, by 1 mg in 90 to 120 minutes.

Administration:

• Butorphanol nasal spray comes as a solution (liquid) to spray in the nose.
• It is usually used as needed for pain but not more often than once every 3 to 4 hours.
• Butorphanol nasal spray should relieve your pain soon after you use it.
• If you are using a low starting dose of butorphanol nasal spray, your doctor may tell you that you may use a second dose if you still have pain 60 to 90 minutes after your first dose. Do not use this second dose unless your doctor tells you that you may.
• Do not stop using butorphanol nasal spray without talking to your doctor.
• If you suddenly stop using butorphanol nasal spray, you may experience withdrawal symptoms.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Butorphanol Tartrate Nasal Spray USP contains 2.5 mL of a 10 mg/mL solution of butorphanol tartrate

This medicine is available in fallowing brand namesː

• Stadol NS

What side effects can this medication cause?

The most common side effects of this medicine include:

• Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain.

Less common side effects may include:

• 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: Cough, dyspnea
• Skin and Appendages: sweating, pruritus
• Special Senses: blurred vision, ear pain, tinnitus, unpleasant taste

What special precautions should I follow?

• Butorphanol Tartrate Nasal Spray exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Butorphanol Tartrate Nasal Spray, and monitor all patients regularly for the development of these behaviors and conditions.
• Serious, life-threatening, or fatal respiratory depression may occur with use of Butorphanol Tartrate Nasal Spray. Monitor for respiratory depression, especially during initiation of Butorphanol Tartrate Nasal Spray or following a dose increase.
• Prolonged use of Butorphanol Tartrate Nasal Spray during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
• Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
• Butorphanol Tartrate Nasal Spray may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Butorphanol Tartrate Nasal Spray and know how they will react to the medication.
• Hypotension associated with syncope during the first hour of dosing with Butorphanol Tartrate Nasal Spray has been reported. Therefore, patients should be advised to avoid activities with potential risks.
• Butorphanol may produce respiratory depression, especially in patients receiving other CNS active agents, or patients suffering from CNS diseases or respiratory impairment.
• In patients with hepatic or renal impairment, the initial dose sequence of Butorphanol Tartrate Nasal Spray should be limited to 1 mg followed, if needed, by 1 mg in 90 to 120 minutes.
• Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Butorphanol Tartrate Nasal Spray securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
• Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose.
• Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop.
• Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Advise patients to seek medical attention if they experience a constellation of these symptoms.
• Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.
• Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed.
• Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated.
• Cardiac arrest or arrhythmias will require advanced life-support techniques.
• The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose.
• In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies of Butorphanol Tartrate Nasal Spray in pregnant women before 37 weeks of gestation.
• Butorphanol Tartrate Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the infant.

Can this medicine be used in children?

• Butorphanol Tartrate Nasal Spray is not recommended for use in patients below 18 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BUTORPHANOL TARTRATE

Inactive ingredients:

• BENZETHONIUM CHLORIDE
• HYDROCHLORIC ACID
• WATER
• SODIUM CHLORIDE
• SODIUM HYDROXIDE
• ANHYDROUS CITRIC ACID

Who manufactures and distributes this medicine?

Distr. by:

• West-Ward Pharmaceuticals Corp.
• Eatontown, NJ

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

• Dailymed label info on Butorphanol nasal spray
• FDA Butorphanol nasal spray

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