Oliceridine is an opioid medicine that is used to treat severe pain when other treatments have not provided relief.

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

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Using oliceridine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Oliceridine is given around the clock (continuous) using an infusion pump attached to a catheter placed into a vein. A healthcare provider can teach you how to properly use the infusion pump by yourself.

Never use oliceridine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of oliceridine.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Tell your caregivers if you feel any burning, pain, or swelling around your port needle.

If you have used opioid medicine regularly and are opioid-dependent, you should not stop using oliceridine suddenly, or you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Usual Adult Dose for Pain:

Initial dose: 1.5 mg intravenously
Supplemental dose: 0.75 mg intravenously every hour as needed, starting 1 hour after initial dose
Maximum single dose: 3 mg
Maximum daily dose: 27 mg

Patient Controlled Analgesia (PCA):
Recommended demand dose: 0.35 mg with a 6-minute lock out; may consider a demand dose of 0.5 mg
Maximum dose: 27 mg per day


Comments:
-Use the lowest effective dose for the shortest duration consistent with treatment goals.
-Individualize dose based on pain severity, patient response and prior analgesic experience, and addiction, abuse, and misuse risk.
-Use beyond 48 hours has not been studied in trials.
-Onset of analgesia is expected within 2 to 5 minutes of initial dose.
-An initial 1 mg dose of this drug is approximately equipotent to 5 mg morphine; as patients differ in their response to opioids, use this comparison only as a guide.

Use: Management of acute pain severe enough to require an intravenous opioid analgesic and for whom other treatments are inadequate.
Because of the risk of addiction, abuse, and misuse, even at recommended doses, reserve use for those in whom alternative treatments (e.g. non-opioid analgesics or opioid combination products):
-Have not been tolerated or toleration is not expected
-Have not provided adequate analgesia or adequate analgesia is not expected

You should not use oliceridine if you are allergic to it, or if you have:

• severe asthma or breathing problems; or

• a stomach or bowel obstruction (including paralytic ileus).

In some people, oliceridine breaks down very slowly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death. Tell your doctor if you've ever been told you are a "poor metabolizer."

Tell your doctor if you have ever had:

• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;

• liver disease;

• low blood pressure;

• long QT syndrome (in you or a family member);

• drug or alcohol addiction;

• depression, mental illness;

• problems with your gallbladder or pancreas; or

• a head injury, brain tumor, or seizure.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

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

Since oliceridine is used for pain, you are not likely to miss a dose. The infusion pump will control how much and how often you use this medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, limp muscles, cold or clammy skin, pinpoint pupils, slow heartbeats, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Avoid driving or hazardous activity until you know how oliceridine 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 give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Oliceridine may cause serious side effects. Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;

• a slow heart rate or weak pulse;

• a light-headed feeling, like you might pass out;

• severe constipation;

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;

• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

• low oxygen in your blood--confusion, feeling restless or short of breath, blue-colored lips or skin.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or 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 oliceridine may include:

• nausea, vomiting, constipation;

• headache, dizziness;

• itching; or

• low oxygen in your blood.

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.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other opioids--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

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