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Generic Name: acetaminophen and benzhydrocodone
Dosage Form: Tablets
Date of Approval: February 23, 2018
Company: KemPharm, Inc.

Treatment for: Pain

Medically reviewed on Nov 9, 2018

FDA Approves Apadaz

The U.S. Food and Drug Administration (FDA) has approved Apadaz (acetaminophen and benzhydrocodone), an immediate release combination of acetaminophen and benzhydrocodone, a prodrug of the opioid agonist hydrocodone, indicated for the short-term management of acute pain.

Medication Guide

Read this Medication Guide carefully before you start treatment. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is Apadaz?

Apadaz is:

  • a strong prescription pain medicine that contains an opioid (narcotic) and the medicine acetaminophen. It is used to manage short-term pain (no more than 14 days), when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • an opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information

  • Get emergency help right away if you take too much Apadaz, or overdose. When you first start taking Apadaz, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
  • Taking Apadaz with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your Apadaz. They could die from taking it. Store this medicine away from children and in a safe place to prevent stealing or abuse. Selling or giving away Apadaz is against the law.
  • Get emergency help right away if you take more than 4,000 mg of acetaminophen in 1 day. Taking Apadaz with other products that contain acetaminophen can lead to serious liver problems and death.

Who should not take Apadaz?

Do not take Apadaz if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.
  • an allergy to hydrocodone or acetaminophen.

Before taking Apadaz

Before taking Apadaz, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • problems urinating
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.
  • severe liver problems
  • kidney, thyroid, pancreas or gallbladder problems

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of Apadaz during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Apadaz passes into breast milk and may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Apadaz with certain other medicines can cause serious side effects that could lead to death.

While you are taking Apadaz

  • Do not change your dose. Take this medicine exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every 4 to 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking Apadaz regularly, do not stop abruptly without talking to your healthcare provider.
  • After you stop taking Apadaz, flush any unused tablets down the toilet or contact the Drug Enforcement Agency (DEA) at 1­ 800—882-9539 for an authorized collector.
  • Do not drive or operate heavy machinery, until you know how Apadaz affects you. Apadaz can make you sleepy, dizzy, or lightheaded.
  • Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Apadaz may cause you to overdose and die.
  • Do not take other products that contain acetaminophen.

Apadaz side effects

Possible side effects include:

  • itching, constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, and skin rash. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, lightheadedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
  • rash with hives, sores in your mouth or eyes, or your skin blisters and peels.

These are not all the possible side effects of Apadaz. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.