Trezix

Generic Name: acetaminophen/caffeine/dihydrocodeine (a-SEET-a-MIN-oh-fen/KAF-een/dye-HYE-droe-KOE-deen)
Brand Name: Trezix

Trezix contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

Some children have had serious and sometimes fatal breathing problems when uing codeine after surgery to remove tonsils or adenoids. Talk with your doctor for more information.


Trezix is used for:

Relieving moderate to moderately severe pain. It may also be used for other conditions as determined by your doctor.

Trezix is an analgesic, stimulant, and narcotic combination. It works in the brain and nervous system to decrease pain.

Do NOT use Trezix if:

  • you are allergic to any ingredient in Trezix or to codeine
  • you have very slow or difficult breathing, high blood levels of carbon dioxide (hypercapnia or hypercarbia), or severe asthma, or if you are having an asthma attack
  • you have known or suspected bowel blockage (paralytic ileus)
  • you are taking quinidine or sodium oxybate (GHB)
  • the patient is a child and has just had surgery to remove tonsils or adenoids

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Trezix:

Some medical conditions may interact with Trezix. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are allergic to other narcotic medicines (eg, hydrocodone, morphine, oxycodone)
  • if you drink alcohol; have a history of alcohol or substance abuse or dependence, mood or mental problems, or suicidal thoughts or behavior; or are going through withdrawal from alcohol or other substances
  • if you have severe drowsiness, or you have or recently had a head injury, increased pressure in the brain, growths in the brain (eg, tumors), or an infection of the brain or nervous system
  • if you have a history of asthma or other lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD], emphysema), hypercapnia or hypercarbia, low blood oxygen levels (hypoxia), stomach or bowel problems (eg, blockage, inflammation, paralysis), gallbladder problems, inflammation of the pancreas (pancreatitis), adrenal gland problems (eg, Addison disease), heart problems (eg, cor pulmonale; fast, slow, or irregular heartbeat), low blood pressure, curvature of the spine (scoliosis), liver problems (eg, hepatitis), seizures, thyroid problems, prostate problems (eg, an enlarged prostate), kidney problems, or trouble urinating
  • if you have recently had surgery (eg, stomach or bowel surgery) or are scheduled to have surgery
  • if you are in very poor health; are very overweight; are dehydrated or have low blood volume; or have stomach pain or constipation

Some MEDICINES MAY INTERACT with Trezix. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
  • Carbamazepine, cobicistat, disulfiram, isoniazid, linezolid, other narcotic pain medicine (eg, oxycodone), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), perampanel, phenytoin, protease inhibitors (eg, boceprevir, ritonavir), quinolone antibiotics (eg, ciprofloxacin), sleep medicines (eg, zolpidem), or sodium oxybate (GHB) because they may increase the risk of Trezix's side effects
  • Mixed agonist/antagonist pain medicines (eg, buprenorphine, pentazocine), naltrexone, or quinidine because they may decrease Trezix's effectiveness
  • Beta-blockers (eg, atenolol) or theophylline because the risk of their side effects may be increased by Trezix
  • Aspirin or phenobarbital because their effectiveness may be decreased by Trezix
  • Medicines that may harm the liver (eg, methotrexate, ketoconazole, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trezix may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Trezix:

Use Trezix as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Trezix by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • If you have been taking Trezix regularly or for longer than a few weeks, do not suddenly stop taking it without checking with your doctor. Your doctor may need to gradually lower your dose.
  • If you miss a dose of Trezix and you still have pain, follow your doctor's dosing instructions. Contact your doctor if you are unsure what to do if you miss a dose. Do not take Trezix more often than prescribed. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Trezix.

Important safety information:

  • Trezix may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Trezix with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Trezix may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do not drink alcohol while you are using Trezix.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, muscle relaxers, sleep aids) while you are using Trezix; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose, take more often than prescribed, or take for longer than prescribed without checking with your doctor.
  • Trezix has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Trezix may harm your liver. Your risk may be greater if you drink alcohol while you are using Trezix. Talk to your doctor before you take Trezix or other fever reducers if you drink alcohol.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Contact your doctor right away if you take more than 4,000 mg of acetaminophen per day, even if you feel well.
  • Trezix may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking Trezix, talk with your doctor or pharmacist.
  • Tell your doctor or dentist that you take Trezix before you receive any medical or dental care, emergency care, or surgery.
  • Trezix may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Trezix.
  • Use Trezix with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, and breathing problems.
  • Trezix should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Trezix while you are pregnant. Long-term use of Trezix during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Trezix is found in breast milk. Do not breast-feed while taking Trezix.

When used for long periods of time or at high doses, Trezix may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Trezix stops working well. Do not take more than prescribed.

Some people who use Trezix for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Trezix, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Trezix:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; light-headedness; mild itching; nausea; sweating; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); change in the amount of urine produced; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, agitation, anxiety, depression); red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, headache, or light-headedness; shortness of breath; slow, shallow, or difficult breathing; symptoms of liver problems (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, unusual or severe stomach pain); trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately. Symptoms may include bluish skin or nails; cold and clammy skin; coma; decreased urination; delirium; fainting; fast, slow, or irregular heartbeat; limp muscles; loss of consciousness; muscle pain or weakness; nausea or vomiting; pinpoint pupils; restlessness; seizures; severe dizziness, drowsiness, or light-headedness; shortness of breath; slow, shallow, or difficult breathing; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, loss of appetite, unusual or severe stomach pain); tremors; trouble sleeping; unusual bruising or bleeding; unusual sweating or tiredness.

Proper storage of Trezix:

Store Trezix at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Trezix out of the reach of children and away from pets.

General information:

  • If you have any questions about Trezix, please talk with your doctor, pharmacist, or other health care provider.
  • Trezix is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Trezix or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Trezix. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Trezix. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Trezix.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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