buprenorphine / naloxone

• Risk factors: History of alcohol use disorder | History of substance use disorder

Suboxone is a schedule III controlled substance. It contains the opioid buprenorphine, which has a risk of misuse and dependence. Misusing the medication can raise the risk of addiction. It can also raise the risk of other serious side effects, such as dangerously slow breathing and overdose.

Take Suboxone film (buprenorphine / naloxone) exactly as prescribed. Don't change your dose or how often you take it without talking to your prescriber first.

• Risk factors: Age 65 years or older | Chronic obstructive pulmonary disease (COPD) or other breathing problems | Other medical conditions that cause or raise the risk for slow breathing | Taking sedatives, opioids, or other medications that can slow breathing at the same time | Drinking alcohol

Suboxone contains buprenorphine, which can cause dangerously slow breathing. This can be life-threatening. Your risk is higher if you take other medications that can slow your breathing. This includes benzodiazepines and other opioids. The risk is also higher if you drink alcohol with Suboxone film (buprenorphine / naloxone).

Your prescriber might recommend that you have naloxone (Narcan). It can quickly reverse an opioid overdose, including slowed breathing. Make sure you and your loved ones know how to use naloxone. Give naloxone and call 911 right away if you have trouble breathing, your lips turn blue, or you can't be woken up.

• Risk factors: History of opioid use disorder | Previous opioid overdose | Taking opioids while taking Suboxone film (buprenorphine / naloxone) | Taking sedatives or other medications that can cause slowed breathing | Drinking alcohol | Accidental exposure in children

People being treated for opioid use disorder are at risk of having a relapse. This means they might start using opioids again, which can raise their risk of an opioid overdose. In addition, even one dose of an opioid medication like Suboxone film (buprenorphine / naloxone) can be dangerous for a child who takes it by accident.

An opioid overdose can be life-threatening. Signs of an opioid overdose include very slow breathing, a slow heartbeat, extreme sleepiness, cold or clammy skin, or not waking up. Call 911 right away if you think someone has overdosed.

Your prescriber might recommend carrying naloxone (Narcan), a medication that can reverse an opioid overdose. Make sure you and your loved ones know when and how to use it in case an accidental overdose happens. Store Suboxone film (buprenorphine / naloxone) out of the reach of children, pets, and visitors.

• Risk factors: Age 65 years and older | Taking other medications that make you less alert or slow your body down | Drinking alcohol

Suboxone film (buprenorphine / naloxone) can make you very sleepy. It can also make it harder to think clearly, react quickly, and focus. Alcohol can make these effects worse. Medications that make you sleepy, like benzodiazepines, sedatives, and muscle relaxants, can also make the effects worse.

Don't drive or do anything that requires you to be alert until you know how Suboxone film (buprenorphine / naloxone) affects you. Avoid drinking alcohol or taking medications that make you sleepy unless your prescriber says it's safe. Tell your care team right away if you feel very sleepy while taking Suboxone film (buprenorphine / naloxone).

• Risk factors: Taking Suboxone film (buprenorphine / naloxone) during pregnancy

Taking Suboxone film (buprenorphine / naloxone) during pregnancy can cause your unborn baby to become physically dependent on the medication. This happens because opioids can pass from your bloodstream to your baby during pregnancy.

After birth, your baby can have withdrawal symptoms. These can include high-pitched crying, poor feeding, shaking, irritability, unusual sleep patterns, or seizures. This is called neonatal opioid withdrawal syndrome (NOWS). It can be serious if it's not spotted and treated in time.

Tell your healthcare team if you took Suboxone film (buprenorphine / naloxone) during pregnancy. Also tell them if your newborn has signs of withdrawal.

• Risk factors: Taking Suboxone film (buprenorphine / naloxone) for longer than 1 month

Opioid-containing medications like Suboxone film (buprenorphine / naloxone) might lower your adrenal hormone levels. This is more likely to happen if you take it for longer than 1 month. Tell your prescriber right away if you have symptoms of low adrenal hormones. These can include nausea, vomiting, loss of appetite, tiredness, dizziness, or weakness. If this happens, your prescriber might work with you to stop Suboxone film (buprenorphine / naloxone). Then, they might treat you with a corticosteroid medication.

• Risk factors: Long-term use of Suboxone film (buprenorphine / naloxone) or other opioids | Stopping or lowering the dose of Suboxone film (buprenorphine / naloxone) suddenly | Taking Suboxone film (buprenorphine / naloxone) too soon after using another opioid | Liver damage

Taking Suboxone film (buprenorphine / naloxone) for a long time can cause physical dependence. This means your body gets used to the medication. When this happens, stopping it suddenly or lowering the dose too fast can cause withdrawal. Symptoms can include anxiety, restlessness, irritability, cravings, a runny nose, sweating, chills, and body aches.

Because Suboxone contains naloxone, withdrawal can also happen if you take it too soon after using another opioid. It can also happen if Suboxone film (buprenorphine / naloxone) is misused by injection.

Take Suboxone film (buprenorphine / naloxone) exactly as prescribed. Don't stop taking it or lower your dose without talking to your prescriber. If you need to stop treatment, your prescriber will slowly lower your dose to help prevent withdrawal symptoms.

• Risk factors: History of liver damage | Hepatitis B or C infection | Taking other medications that can cause liver damage | Injection drug use

Tell your prescriber if you have liver problems before starting Suboxone film (buprenorphine / naloxone). This medication isn't recommended for people with moderate or severe liver problems. Liver problems can cause the naloxone component to build up in your body. This might trigger withdrawal symptoms when you first start treatment. Your prescriber can help decide whether this medication is right for you.

Also, some people who've taken buprenorphine medications have developed liver problems. These can range from mild to severe and life-threatening. Your prescriber will check your liver with blood tests before you start Suboxone film (buprenorphine / naloxone). They might also check from time to time during treatment. This helps your prescriber find problems early.

Some people who take buprenorphine medications that dissolve in the mouth have had dental problems. These problems can include cavities, tooth infections, damaged teeth, and even tooth loss. Some people needed dental treatments, such as fillings, root canals, or tooth removal.

Help protect your teeth by getting regular dental checkups. Practice good oral hygiene, and brush your teeth and floss every day. After the Suboxone film (buprenorphine / naloxone) dissolves under your tongue, swish water around your mouth and swallow it. Wait at least 1 hour after you take the medication brushing your teeth.

• Risk factors: Low heart rate | Heart rhythm problems, such as atrial fibrillation (AFib) | Heart failure | Low potassium | Low magnesium | Taking digoxin

Suboxone film (buprenorphine / naloxone) can cause QT prolongation. This is when the heart takes longer than usual to reset between beats. In rare cases, this can lead to a serious heart rhythm problem.

Before starting Suboxone film (buprenorphine / naloxone), tell your prescriber about your medical history. Your risk of QT prolongation might be higher if you have certain heart problems or abnormal electrolyte levels. Your prescriber can check your risk and make sure Suboxone film (buprenorphine / naloxone) is safe for you.

Call your prescriber right away if you have signs of an irregular heartbeat. This can include a pounding or racing heart, trouble breathing, feeling faint or lightheaded, or chest pain.

Suboxone film (buprenorphine / naloxone) can cause your blood pressure to drop when you stand. This is called orthostatic hypotension. The sudden drop in blood pressure can make you feel dizzy or faint.

To avoid falling, stand up slowly while holding onto something stable. Be sure to sit back down if you feel dizzy and wait until you feel better. Talk to a healthcare professional if any dizziness or lightheadedness doesn't go away.