pentazocine / naloxone

• Risk factors: Personal or family history of substance or alcohol abuse | History of mental health conditions | Taking more of pentazocine/naloxone than prescribed or taking it for a long time

Taking pentazocine/naloxone can lead to abuse, misuse, or addiction, even if you take it at the recommended dose. This can cause serious problems, such as overdose and death. Because of this risk, the FDA has required pentazocine/naloxone and all opioids to be under a Risk Evaluation and Mitigation Strategy (REMS) program. This means your provider or pharmacist will talk to you about proper use, serious risks, and appropriate storage and disposal of this medication in order to keep you and your loved ones safe.

• Risk factors: Age 65 years or older | History of severe chronic obstructive pulmonary disease (COPD) | History of severe weakness or muscle loss (debilitation) | Drinking alcohol | Taking medications that affect your mental state | Taking high doses of pentazocine/naloxone

Pentazocine/naloxone can slow your breathing down to the point where it's life-threatening. This can cause symptoms, such as shortness of breath, slow and shallow breathing, and bluish-colored lips, fingers, or toes. If this change in your breathing isn't recognized and treated right away, it can lead to death. Pentazocine/naloxone is especially dangerous for children, who can experience slowed breathing and death even from one accidental dose of the medication. If you notice these symptoms, call 911 and get medical help right away.

Though slowed breathing can happen at any time while you're taking pentazocine/naloxone, the risk is the highest when you first start the medication or when your dose is raised. Your provider will monitor you closely for slowed breathing for the first few days after you start taking pentazocine/naloxone or after they prescribe a higher dose.

Drinking alcohol and taking medications that affect your mental state, such as benzodiazepines, sedatives, some muscle relaxants, and some mental health medications, can slow your breathing even further, which can lead to unconsciousness, coma, and death.

Your provider might prescribe naloxone (Narcan), which is a medication that can temporarily reverse the effects of pentazocine/naloxone. It's important that you and your caregiver know when and how to administer naloxone (Narcan).

• Risk factors: Long-term use during pregnancy

Taking pentazocine/naloxone for a long time during pregnancy can cause neonatal opioid withdrawal syndrome. This is a condition where your unborn baby becomes dependent on pentazocine/naloxone while in the womb because the medication is passed into their system through the placenta. Once your baby is born and they're no longer exposed to pentazocine/naloxone, they experience withdrawal symptoms, such as poor feeding or sucking, breathing problems, fever, high-pitched crying, or seizures. This can be life-threatening if it's not recognized and treated, and your baby will need special care after birth from experts in this area.

Pentazocine/naloxone can cause your body to produce less hormones. This is more likely to happen if you've been taking pentazocine/naloxone for more than one month. Let your provider know if you develop nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure, because these can be signs that your body isn't making enough hormones.

• Risk factors: Age 65 years or older | History of low blood volume | Taking other medications that lower blood pressure | Taking certain medications that alter your mental state

Pentazocine/naloxone can cause extremely low blood pressure, including a drop in blood pressure when you stand from a sitting or lying down position. This can lead to dizziness and fainting. To avoid falling, get up slowly if you've been sitting or lying down. This drop in blood pressure is more likely to happen when you first start pentazocine/naloxone or when your dose is raised. If dizziness or lightheadedness doesn't go away, talk to your healthcare provider.

Pentazocine/naloxone can cause hallucinations, confusion, or it can make you feel lost. This usually goes away within a few hours. Let your provider know if you experience any of these symptoms because they'll need to monitor you very closely.

• Risk factors: History of seizures

If you have a condition that causes seizures, pentazocine/naloxone can make you have seizures more often. It can also raise your risk of seizures in certain situations even if you haven't had a seizure in the past. Before you start taking pentazocine/naloxone, let your healthcare provider know if you have a history of seizures.

• Risk factors: Taking medications that can raise serotonin levels in your body

Taking opioids like pentazocine/naloxone with medications that can raise the serotonin levels in your body can cause a rare, but life-threatening condition called serotonin syndrome. This is because of very high levels of serotonin in your blood, which can cause a racing heart, unstable blood pressure, high fever, sudden changes in thought, mood, and movement, and hallucinations. If you experience any of these symptoms, seek medical help right away.

Examples of medications that can raise your serotonin levels include sertraline (Zoloft), fluoxetine (Prozac), bupropion (Wellbutrin), duloxetine (Cymbalta), and amitriptyline. Let your provider know if you are taking or planning to take any of these medications before starting pentazocine/naloxone.