Butorphanol Tartrate Nasal spray, solution

What is this medicine?

BUTORPHANOL (byoo TOR fa nole) is a pain reliever. It is used to treat moderate to severe pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• brain tumor
• drug abuse or addiction
• head injury
• heart disease
• if you frequently drink alcohol-containing drinks
• kidney disease
• liver disease
• lung or breathing disease, like asthma
• an allergic reaction to butorphanol, opioid analgesics, benzethonium chloride, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

The medicine is only for use in the nose. Follow the directions on the prescription label. Make sure that you are using your inhaler correctly. Ask you doctor or health care provider if you have any questions.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

What if I miss a dose?

This does not apply. Use the medicine as needed for pain.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• buprenorphine
• nalbuphine
• pentazocine

This medicine may also interact with the following medications:

• alcohol
• antihistamines for allergy, cough and cold
• barbiturates, like phenobarbital
• medicines for depression, anxiety, or psychotic disturbances
• medicines for pain like tramadol and propoxyphene
• medicines for sleep
• other medicines used in the nose like oxymetazoline, phenylephrine, sumatriptan, xylometazoline

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• anxiety, nervousness, agitation
• breathing problems
• changes in vision
• confusion
• feeling faint or lightheaded, falls
• irregular or pounding heartbeat
• ringing in the ears

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• difficulty sleeping at night
• dizziness
• drowsiness
• dry mouth
• nausea, vomiting
• stuffy nose, sinus congestion

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect them from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and is against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Throw away any unused medicine after the expiration date.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.