Apadaz contains a combination of acetaminophen and benzhydrocodone. Benzhydrocodone is an opioid pain medication. An opioid medicine is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of benzhydrocodone.

Apadaz is a strong prescription pain medicine used for the short-term treatment of moderate to severe pain.

Apadaz may be habit-forming.

An overdose of Apadaz can damage your liver or cause death. Call your doctor at once if you have pain in your upper stomach, loss of appetite, dark urine, or jaundice (yellowing of your skin or eyes).

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Stop taking Apadaz and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Take Apadaz exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than 14 days. An overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share Apadaz with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away Apadaz is against the law.

If you need surgery or medical tests, tell the doctor ahead of time that you are using this medicine.

You should not stop using Apadaz suddenly. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using Apadaz accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Usual Adult Dose for Pain:

Individualize therapy taking into account severity of pain, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse:

As First Opioid Analgesic:
Initial dose: 1 or 2 tablets (acetaminophen 325 to 650 mg/benzhydrocodone 6.12 to 12.24 mg) orally every 4 to 6 hours as needed for pain
-Titrate to a dose that provides adequate analgesia and minimizes adverse reactions
Maximum dose: 12 tablets/24 hours
Maximum acetaminophen dose (including all acetaminophen-containing products): 4000 mg in a 24-hour period
Duration of therapy: 7 to 14 days

Equivalence to Hydrocodone Bitartrate:
-Benzhydrocodone 4.08 mg equivalent to hydrocodone bitartrate 5 mg
-Benzhydrocodone 6.12 mg equivalent to hydrocodone bitartrate 7.5 mg
-Benzhydrocodone 8.16 mg equivalent to hydrocodone bitartrate 10 mg

Comments:
-This drug should be reserved for patients for whom alternative treatment options (e.g. non-opoid analgesics) have not been tolerated or are not expected to be tolerated; OR have not provided adequate analgesia or are not expected to provide adequate analgesia.
-Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
-Monitor closely for respiratory depression, especially in the first 24 to 72 hours of initiating therapy and following any increase in dose.
-As with all opioid drugs and opioid formulations, inter-patient variability is possible; if converting from other opioids to this drug, it is safer to underestimate patient requirements than overestimate dose and manage an adverse reaction due to overdose.

Use: For the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

You should not use Apadaz if you are allergic to acetaminophen or hydrocodone, or if you have:

• severe asthma or breathing problems; or

• a blockage in your stomach or intestines.

To make sure Apadaz is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea (breathing stops during sleep);

• liver disease;

• a drug or alcohol addiction;

• kidney disease;

• a head injury or seizures;

• urination problems; or

• problems with your thyroid, pancreas, or gallbladder.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using Apadaz if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Since Apadaz is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Apadaz can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include nausea, vomiting, sweating, severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Avoid driving or operating machinery until you know how Apadaz will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking certain medications together can lead to a fatal overdose.

Get emergency medical help if you have signs of an allergic reaction to Apadaz: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Apadaz and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;

• a light-headed feeling, like you might pass out;

• liver problems - nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

• high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Apadaz side effects include:

• dizziness, drowsiness, feeling tired;

• nausea, vomiting, stomach pain;

• constipation; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other opioids - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;

• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with acetaminophen and benzhydrocodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.