Acetaminophen (a-seet-a-MIN-oh-fen), Benzhydrocodone (benz-hye-droe-KOE-done)

Treats pain. This medicine contains an opioid pain reliever.

Brand Name(s):

Apadaz

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone and other medicines to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary.
• This medicine contains acetaminophen. Read the labels of all other medicines you are using to see if they also contain acetaminophen, or ask your doctor or pharmacist. Do not use more than 4 grams (4,000 milligrams) total of acetaminophen in one day.
• This medicine is not for long-term use.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, take your next dose at your usual time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines web site: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how benzhydrocodone/acetaminophen works. Tell your doctor if you are using any of the following:
  • Carbamazepine, erythromycin, ketoconazole, mirtazapine, phenytoin, rifampin, ritonavir, tramadol, trazodone
  • Benzodiazepine medicine
  • Diuretic (water pill)
  • Medicine to treat anxiety, depression, or mental health problems (including SNRIs, SSRIs, TCAs)
  • Triptan medicine to treat migraine headaches
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer (including cyclobenzaprine, metaxalone).
• Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver, and your risk is higher if you also drink alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lung or breathing problems, adrenal problems, gallbladder problems, pancreas problems, thyroid problems, stomach problems, or a history of head injury or brain tumor, seizures, mental illness, or drug or alcohol use disorder.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Liver problems
  • Worsening of pain
  • Adrenal gland problems
  • Low blood pressure
  • Serious skin reactions (including acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis)
  • Seizures
  • Serotonin syndrome (when used with certain medicines)
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Blue lips, fingernails, or skin
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Cold feeling, tiredness, weight loss
• Dark urine or pale stools, loss of appetite, nausea, vomiting, stomach pain, yellow skin or eyes
• Extreme weakness, shallow breathing, slow heartbeat, sweating, seizures, cold or clammy skin
• Lightheadedness, dizziness, fainting
• Worsening of pain, increased sensitivity to pain

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Headache
• Sleepiness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088