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Butorphanol (Nasal route)

Pronunciation:

bue-TOR-fa-nol

Brand Names:

  • Stadol NS

Dosage Forms:

  • Spray

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

Opioid Agonist/Antagonist

Chemical—

Opioid

Uses of This Medicine:

Butorphanol nasal spray is used to relieve pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Butorphanol acts on the central nervous system (CNS) to relieve pain.

When butorphanol is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of butorphanol nasal spray in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butorphanol nasal spray in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving butorphanol nasal spray.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Alphaprodine
  • Carbinoxamine
  • Codeine
  • Dihydrocodeine
  • Fentanyl
  • Fospropofol
  • Hydrocodone
  • Hydromorphone
  • Levorphanol
  • Meclizine
  • Meperidine
  • Methadone
  • Morphine
  • Morphine Sulfate Liposome
  • Oxycodone
  • Oxymorphone
  • Propoxyphene
  • Sufentanil
  • Suvorexant
  • Tapentadol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Perampanel

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, history of or
  • Breathing problems (e.g., chronic obstructive pulmonary disease [COPD], cor pulmonale, hypoxia) or
  • CNS diseases or
  • Drug dependence, especially narcotic abuse or dependence, or history of—Use with caution. May increase risk for more serious side effects.
  • Brain tumor or
  • Head injuries or
  • Increased pressure in the head—Some of the side effects of butorphanol nasal spray can cause serious problems in people who have these medical problems.
  • Heart attack or
  • Heart or blood vessel problems or
  • Hypertension (high blood pressure) or
  • Hypotension (low blood pressure) or
  • Respiratory depression (hypoventilation or slow breathing)—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.

If you are using the nasal spray for the first time, you will need to prime the spray. To do this, you should release eight test sprays into the air away from the face, or pump the bottle until some of the medicine sprays out. Now it is ready to use. Prime the spray if it has not been used for more than 48 hours or longer. Shake the medicine well before each use.

Before using this medicine, gently blow your nose to clear the nostrils.

After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For nasal dosage form (spray):
    • For pain:
      • Adults—1 milligram (mg) or 1 spray in one nostril. A second spray may be taken 60 to 90 minutes after the first dose if needed. This may be repeated every 3 to 4 hours as needed.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

For pregnant women: Do not use this medicine during labor and delivery of your child.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
Bloody nose
body aches or pain
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chills
cough
cough producing mucus
difficult or labored breathing
difficulty with breathing
ear congestion
fast, irregular, pounding, or racing heartbeat or pulse
feeling faint, dizzy, or lightheaded
feeling of warmth or heat
fever
flushing or redness of the skin, especially on the face and neck
headache
loss of voice
runny nose
shakiness in the legs, arms, hands, or feet
shortness of breath
sneezing
sore throat
stuffy nose
sweating
tightness in the chest
trembling or shaking of the hands or feet
unusual tiredness or weakness
wheezing
Rare
Blurred vision
chest pain
confusion
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fainting
shallow breathing
Incidence not known
Bluish lips or skin
convulsion
not breathing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
Change in consciousness
extremely shallow or slow breathing
loss of consciousness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Nausea
sleepiness or unusual drowsiness
sleeplessness
trouble sleeping
unable to sleep
vomiting
Less common
Bad or unusual or unpleasant (after) taste
continuing ringing or buzzing or other unexplained noise in the ears
difficulty having a bowel movement (stool)
dry mouth
ear pain
false or unusual sense of well-being
fear or nervousness
floating feeling
hearing loss
lack or loss of strength
loss of appetite
pain or tenderness around the eyes and cheekbones
sneezing
stomach pain
tender, swollen glands in the neck
trouble with swallowing
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
voice changes
weight loss
Incidence not known
Dizziness or lightheadedness
false beliefs that cannot be changed by facts
feeling of constant movement of self or surroundings
sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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