Medication Guide

Butorphanol Tartrate Nasal Spray 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.

•

An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about Butorphanol Tartrate Nasal Spray:

•

Get emergency help or call 911 right away if you take too much Butorphanol Tartrate Nasal Spray (overdose). When you first start taking Butorphanol Tartrate Nasal Spray, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.

•

Taking Butorphanol Tartrate Nasal Spray with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma and death.

•

Never give anyone else your Butorphanol Tartrate Nasal Spray. They could die from taking it. Selling or giving away Butorphanol Tartrate Nasal Spray is against the law.

•

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.

Do not take Butorphanol Tartrate Nasal Spray if you have:

•

Severe asthma, trouble breathing, or other lung problems.

•

A bowel blockage or have narrowing of the stomach or intestines.

•

Previously had an allergic reaction to butorphanol or the preservative benzethonium chloride.

Tell your healthcare provider if you are:

•

Noticing your pain getting worse. If your pain gets worse after you take Butorphanol Tartrate Nasal Spray, do not take more of Butorphanol Tartrate Nasal Spray without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking Butorphanol Tartrate Nasal Spray.

•

Pregnant or planning to become pregnant. Use of Butorphanol Tartrate Nasal Spray for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

•

Breastfeeding. Butorphanol passes into breast milk and may harm your baby.

•

Living in a household where there are small children or someone who has abused street or prescription drugs.

•

Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Butorphanol Tartrate Nasal Spray with certain other medicines can cause serious side effects that could lead to death.

When taking Butorphanol Tartrate Nasal Spray:

•

Do not change your dose. Take Butorphanol Tartrate Nasal Spray exactly as prescribed by your healthcare provider. See the detailed Patient Instructions for information about how to take Butorphanol Tartrate Nasal Spray. Use the lowest dose possible for the shortest time needed.

•

For acute (short-term) pain, you may only need to take Butorphanol Tartrate Nasal Spray for a few days. You may have some Butorphanol Tartrate Nasal Spray left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused Butorphanol Tartrate Nasal Spray.

•

Take your prescribed dose as instructed by your healthcare provider. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.

•

Call your healthcare provider if the dose you are taking does not control your pain.

•

If you have been taking Butorphanol Tartrate Nasal Spray regularly, do not stop taking Butorphanol Tartrate Nasal Spray without talking to your healthcare provider.

•

After you stop taking Butorphanol Tartrate Nasal Spray, dispose of unused Butorphanol Tartrate Nasal Spray by unscrewing the cap, rinsing the bottle, and placing the parts in a waste container. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking Butorphanol Tartrate Nasal Spray DO NOT:

•

Drive or operate heavy machinery, until you know how Butorphanol Tartrate Nasal Spray affects you. Butorphanol Tartrate Nasal Spray can make you sleepy, dizzy, or lightheaded.

•

Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Butorphanol Tartrate Nasal Spray may cause you to overdose and die.

The possible side effects of Butorphanol Tartrate Nasal Spray:

•

Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:

•

Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of Butorphanol Tartrate Nasal Spray. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922

For more information, please call 1-800-962-8364.