Ultiva is an opioid medication that is used to treat or prevent pain during and after surgery or other medical procedures.

Ultiva may also be used for purposes not listed in this medication guide.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. `

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

Ultiva is injected into a vein by a healthcare provider.

Ultiva is usually given through an infusion connected to pump that will release the correct dose of the medication to provide continuous pain relief during and after your surgery.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely.

You may be given other pain medications to use after your Ultiva treatment is discontinued. Keep using these medicines for as long as your doctor has prescribed.

You should not be treated with Ultiva if you are allergic to it.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• a head injury, brain tumor, or seizure;

• problems with your gallbladder or pancreas;

• alcoholism or drug addiction;

• if you have recently used alcohol, sedatives, tranquilizers, or other opioid medications; or

• if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Receiving Ultiva during late pregnancy may cause side effects in the newborn baby, including severe drowsiness and breathing problems. Your baby's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

In a medical setting you are not likely to miss a dose.

A Ultiva overdose can be fatal. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

In a medical setting an overdose would be treated quickly.

Do not drink alcohol for at least 24 hours after your surgery. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how Ultiva will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Your caregivers will watch for any side effects you have, such as:

• shallow breathing, breathing that stops during sleep;

• fast or slow heart rate;

• stiff muscles;

• low blood pressure (severe weakness, feeling light-headed); or

• serotonin syndrome--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects of Ultiva may include:

• slow breathing;

• slow heart rate;

• muscle stiffness; or

• low blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many other drugs can be dangerous when used with opioid medicine. Tell your doctor if you also use:

• other opioid medicines;

• a benzodiazepine sedative like Valium, Klonopin, or Xanax;

• sleep medicine, muscle relaxers, or other drugs that make you drowsy; or

• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

This list is not complete. Many drugs may affect Ultiva, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.