benzhydrocodone / acetaminophen

• Risk factors: Taking more than the prescribed dose | Long-term use | History of substance abuse | History of mental health conditions

Even at recommended doses, Apadaz (benzhydrocodone / acetaminophen) can cause addiction, abuse, or misuse. Using Apadaz (benzhydrocodone / acetaminophen) for reasons other than prescribed (misuse) or at higher doses than prescribed can lead to overdose and death.

Risk Evaluation and Mitigation Strategy (REMS) is a safety program that the FDA requires for medications with serious safety risks, like Apadaz (benzhydrocodone / acetaminophen). This is to make sure the medication does more benefit rather than harm. Apadaz (benzhydrocodone / acetaminophen) has a REMS, which means your provider or pharmacist will talk to you about safe use, serious side effects, and how to store and throw away the medication correctly.

• Risk factors: Age 65 or greater | Children | High dose | History of lung problems | Weight loss or weakness from illness | Taking other painkillers, benzodiazepines, or sedatives | Early in treatment | Switching from a different opioid

Apadaz (benzhydrocodone / acetaminophen) can cause life-threatening irregular or slow breathing, even at recommended doses. Your risk is higher when you first start taking it, take higher doses of Apadaz (benzhydrocodone / acetaminophen), if you're 65 years or older, have certain medical problems, or are taking medications that can cause similar side effects. Don't drink alcohol while taking Apadaz (benzhydrocodone / acetaminophen), and avoid taking other medications that can cause slowed breathing and sedation. If you're not sure which medications are safe to take with Apadaz (benzhydrocodone / acetaminophen), ask your provider or pharmacist. Store this medication safely away from children. If children take this medication accidentally, even one dose, they can experience life-threatening breathing problems.

If you or someone you know has overdosed on Apadaz (benzhydrocodone / acetaminophen), or is experiencing sleepiness, slowed or irregular breathing, or isn't responding normally to sound or touch, call 911 and get medical help right away. A medication called naloxone (Narcan) is available to reverse the side effects of an opioid overdose quickly. Speak to your provider to learn more.

• Risk factors: Long-term use during pregnancy

During pregnancy, opioids can be passed from you to your unborn baby. Long-term use during pregnancy can cause your unborn baby to become dependent on opioids, and once your baby is born, they can experience withdrawal symptoms. Withdrawal symptoms in your newborn can include high-pitched crying, poor feeding and sucking behavior, trembling, irritability, abnormal sleep patterns, and seizures. This condition is called neonatal opioid withdrawal syndrome and can be life-threatening. Let your provider know if you took Apadaz (benzhydrocodone / acetaminophen) during pregnancy. Your baby may need special care after birth to prevent potentially deadly side effects.

Certain medications can affect the amount of Apadaz (benzhydrocodone / acetaminophen) in your body, how well it works, and the risk of side effects. Some medications, like ritonavir (Norvir), can cause higher levels of Apadaz (benzhydrocodone / acetaminophen) in the blood. Having higher levels of Apadaz (benzhydrocodone / acetaminophen) can cause more side effects, including slowed breathing. There can also be an additive effect of slowed breathing and sleepiness when taking Apadaz (benzhydrocodone / acetaminophen) with medications that cause similar side effects, like alcohol, muscle relaxants, or sedatives. On the other hand, starting or stopping certain other medications can cause your body to break down Apadaz (benzhydrocodone / acetaminophen) better, which can lead to withdrawal symptoms.

In addition, don't take Apadaz (benzhydrocodone / acetaminophen) within 14 days of stopping a monoamine oxidase inhibitor (MAOI) to avoid a life-threatening condition called serotonin syndrome, where there is too much serotonin in your brain. Symptoms include fever, chills, seizures, and fast heartbeat.

Make sure you tell your provider and pharmacist about all the medications you're taking before starting Apadaz (benzhydrocodone / acetaminophen) or planning to take during treatment, and discuss any changes with your provider.

• Risk factors: History of or current liver problems | Taking Apadaz (benzhydrocodone / acetaminophen) with alcohol | Taking other medicines containing acetaminophen

Acetaminophen in Apadaz (benzhydrocodone / acetaminophen) can cause serious damage to your liver, and sometimes can cause death. Using more than 4 grams of acetaminophen daily or taking it with alcohol can cause liver damage. Acetaminophen is also found in many over-the-counter and prescription products. Talk to your provider to make sure you're not taking too much. Let your provider know if you notice stomach pain, dark urine, yellowing of your skin or eyes, or sweating. These can be symptoms of liver damage.

• Risk factors: Taking high doses | Age 65 years or older | Taking other medications that can cause drowsiness | Alcohol use

Apadaz (benzhydrocodone / acetaminophen) can cause extreme drowsiness and lower your ability to think, react, and focus. Alcohol and other medications, like benzodiazepines, sedatives, anxiety medications, and certain muscle relaxants, can make you feel even more sleepy and less alert. Avoid drinking alcohol or taking these medications while taking Apadaz (benzhydrocodone / acetaminophen). Make sure you know how this medication affects you before driving a car or doing activities that require your concentration. Talk to your provider right away if you feel too sleepy from taking Apadaz (benzhydrocodone / acetaminophen).

• Risk factors: Using Apadaz (benzhydrocodone / acetaminophen) for more than one month

Opioids can cause certain hormone levels to drop. This is more likely to happen if you take the medication longer than a month. Symptoms of very low hormone levels include nausea, vomiting, loss of appetite, tiredness, dizziness, and low blood pressure. Let your provider know if you experience these symptoms.

Apadaz (benzhydrocodone / acetaminophen) 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. If dizziness or lightheadedness doesn't go away, talk to your provider.

Although rare, acetaminophen can cause serious, life-threatening skin reactions. These reactions can look like reddening or peeling of the skin, painful rash, or fluid-filled blisters. If you notice these skin reactions, stop taking Apadaz (benzhydrocodone / acetaminophen) and go to the emergency room right away.

• Risk factors: Raised pressure inside your skull | Brain tumors | Head injury | Loss of consciousness

Apadaz (benzhydrocodone / acetaminophen) can cause a rise in pressure inside of the skull in people who have a history of this condition or brain tumors. It can also affect healing in people who've had head injuries, and worsen the condition of people who've had a loss of consciousness or are in a coma. Talk to your provider about your full medical history before taking Apadaz (benzhydrocodone / acetaminophen).

• Risk factors: History of seizure conditions

Opioids can cause people with a history of seizures to have seizures more often. Apadaz (benzhydrocodone / acetaminophen) can also raise your risk of seizures in certain situations. Let your provider know if you have seizures more often while taking Apadaz (benzhydrocodone / acetaminophen).

• Risk factors: Long-term use of Apadaz (benzhydrocodone / acetaminophen)

If taken regularly for a long time, Apadaz (benzhydrocodone / acetaminophen) can cause physical dependence and tolerance. This means your body relies on the medication to function and that you might need higher doses to get the same pain relief. You might experience withdrawal (anxiety, suicidal thoughts, runny nose, yawning, sweating, chills, wide pupils, trouble sleeping) if you stop taking the medication suddenly. Don't lower your dose or stop taking the medication suddenly without talking to your provider first. Your provider will slowly lower your dose to prevent withdrawal symptoms.