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 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.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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 sleep

• muscle relaxants

• narcotic medicines (opiates) for pain

• other medicines used in the nose like oxymetazoline, phenylephrine, sumatriptan, xylometazoline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

This medicine may be used to treat migraines. If you take migraine medicines for 10 or more days a month, your migraines may get worse. Keep a diary of headache days and medicine use. Contact your healthcare professional if your migraine attacks occur more frequently.

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

• headache

• loss of appetite

• nausea, vomiting

• stuffy nose, sinus congestion

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages. Do not use the medicine after the expiration date. Follow the directions in the MedGuide.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Butorphanol Tartrate Solution for injection

What is this medicine?

BUTORPHANOL (byoo TOR fa nole) is a pain reliever. It is used to treat moderate to severe pain. It is also used to prevent pain before surgery and during child birth.

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, benzethonium chloride, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle or a vein. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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 sleep

• muscle relaxants

• narcotic medicines (opiates) for pain

• tramadol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

This medicine may be used to treat migraines. If you take migraine medicines for 10 or more days a month, your migraines may get worse. Keep a diary of headache days and medicine use. Contact your healthcare professional if your migraine attacks occur more frequently.

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

• headache

• loss of appetite

• nausea, vomiting

• pain, redness, or irritation at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label. Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.