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 is a narcotic analgesic (pain medicine) that is sprayed into the nose. It is used to relieve moderate or severe pain. It is also used to relieve pain that occurs after an operation.

Narcotic analgesics act in the central nervous system (CNS) to relieve pain. Some of their side effects are also caused by actions in the CNS.

If a narcotic is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal side effects when you stop taking the medicine.

This medicine is available only with your doctor's or dentist'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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of butorphanol in children with use in other age groups.

Older adults

Elderly people are especially sensitive to the effects of butorphanol. This may increase the chance of side effects, especially dizziness, during treatment. Studies in older adults show that butorphanol stays in the body for a longer time than it does in younger adults. Your doctor will consider this when deciding on your dose.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

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
• Codeine
• Dihydrocodeine
• Fentanyl
• Fospropofol
• Hydrocodone
• Hydromorphone
• Levorphanol
• Meperidine
• Methadone
• Morphine
• Morphine Sulfate Liposome
• Oxycodone
• Oxymorphone
• Propoxyphene
• Sufentanil
• Tapentadol

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:

• CNS disease affecting breathing or
• Emphysema, asthma, or other chronic lung disease or
• Head injury Some of the side effects of butorphanol can be dangerous if you have any of these conditions

• Drug dependence, especially narcotic abuse, or history of, or
• Emotional problems The chance of side effects may be increased; also, withdrawal symptoms may occur if a narcotic you are dependent on is replaced by butorphanol

• Heart disease or
• Kidney disease or
• Liver disease The chance of side effects may be increased

Proper Use of This Medicine:

You will be given an instruction sheet with your prescription for butorphanol that explains how to use the pump spray unit. If you have any questions about using the unit, ask your health care professional.

To use:

• Use this medicine only as directed by your medical doctor or dentist. Do not use more of it, do not use it more often, and do not use it for a longer time than your medical doctor or dentist told you. This is especially important for elderly patients, who may be more sensitive to the effects of butorphanol. If too much is used, the medicine may become habit-forming (causing mental or physical dependence) or lead to medical problems because of an overdose.
• Remove the protective cover and clip. Before you use each new bottle of butorphanol, the spray pump needs to be started. To do this, point the sprayer away from you and other people or pets. Pump the spray unit firmly about 7 or 8 times. A fine, wide spray should come out by the seventh or eighth time you pump the unit. If the unit is not used for 48 hours or longer, the spray pump should be started again by pumping it 1 or 2 times only.
• Before each use, blow your nose gently.
• For a 1-mg dose, insert the spray tip into one nostril. Close off the other nostril by pressing the side of your nose with your index finger. Tilt your head slightly forward and spray one time. Sniff gently with your mouth closed.
• Remove the spray tip from your nostril. Tilt your head back and sniff gently.
• For a 2-mg dose, repeat these steps using the other nostril.
• Replace the protective cover and clip after each use.

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:
  • For pain:
    • Adults 1 mg (one spray in one nostril). If pain is not relieved within sixty to ninety minutes, another spray (1 mg) in one nostril may be used. This dosing procedure may be repeated in three to four hours as needed. However, if pain is severe, a 2-mg dose (one spray in each nostril) may be used every three to four hours, but it is important to remain lying down if drowsiness or dizziness occurs.
    • Children and teenagers 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.

Precautions While Using This Medicine:

Butorphanol will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicines, including other narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. 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 are not alert and clearheaded.

Dizziness, lightheadedness, or fainting may occur, especially in the first hour after use or when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine.

Butorphanol may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you have been using this medicine regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are using before stopping completely, in order to lessen the chance of withdrawal side effects.

If you think you or someone else may have used an overdose, get emergency help at once. Using an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or death. Signs of overdose include convulsions (seizures), confusion, severe nervousness or restlessness, severe dizziness, severe drowsiness, slow or troubled breathing, and severe weakness.

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.

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

Cold, clammy skin

confusion

convulsions (seizures)

dizziness (severe)

drowsiness (severe)

nervousness, restlessness, or weakness (severe)

small pupils

slow heartbeat

slow or troubled breathing

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Difficulty in breathing

fever

nosebleeds

ringing or buzzing in ears

runny nose

sinus congestion

sneezing

sore throat

Less common or rare

Blurred vision

congestion in chest

cough

difficulty in urinating

difficult or painful breathing

ear pain

fainting

hallucinations

itching

sinus congestion with pain

skin rash or hives

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

Confusion

constipation

dizziness

drowsiness

dry mouth

flushing

headache

irritation inside nose

loss of appetite

nasal congestion

nausea or vomiting

sweating or clammy feeling

trouble in sleeping

unpleasant taste

weakness (severe)

Less common or rare

Anxious feeling

behavior changes

burning, crawling, or prickling feeling on skin

false sense of well-being

feeling hot

floating feeling

nervousness, sometimes with restlessness

pounding heartbeat

stomach pain

strange dreams

trembling

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Anxious feeling

diarrhea

nervousness and restlessness

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.