Acetaminophen, caffeine, and dihydrocodeine

Name: Acetaminophen, caffeine, and dihydrocodeine

What should I discuss with my healthcare provider before taking acetaminophen, caffeine, and dihydrocodeine?

You should not use this medicine if you are allergic to acetaminophen (Tylenol) or dihydrocodeine, or if you have:

  • severe or uncontrolled asthma; or

  • a stomach condition called paralytic ileus.

Do not use acetaminophen, caffeine, and dihydrocodeine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

This medicine is not approved for use by anyone younger than 18 years old.

Some medicines can interact with dihydrocodeine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure this medicine is safe for you, tell your doctor if you have:

  • liver disease, cirrhosis, a history of alcoholism, or if you drink alcohol;

  • sleep apnea or other breathing disorders;

  • kidney disease;

  • a history of head injury or brain tumor;

  • epilepsy or other seizure disorder;

  • low blood pressure;

  • a stomach or intestinal disorder;

  • underactive thyroid;

  • a pancreas disorder;

  • Addison's disease or other adrenal gland disorder;

  • enlarged prostate, urination problems;

  • abnormal curvature of the spine;

  • mental illness;

  • a history of drug or alcohol addiction; or

  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Tell your doctor if you are pregnant. If you use dihydrocodeine 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 habit-forming medicine may need medical treatment for several weeks.

This medicine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include extreme drowsiness or insomnia, tremors, fast heart rate, pinpoint pupils, fainting, weak pulse, vomiting, loss of appetite, stomach pain, dark urine, seizure (convulsions), blue lips, shallow breathing, or no breathing.

What other drugs will affect acetaminophen, caffeine, and dihydrocodeine?

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

  • other narcotic medications--opioid pain medicine or prescription cough medicine;

  • drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

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

This list is not complete. Other drugs may interact with acetaminophen, caffeine, and dihydrocodeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

acetaminophen, caffeine, and dihydrocodeine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Abdominal or stomach pain or tenderness
  • bleeding gums
  • blood in the urine or stools
  • bloody, black, or tarry stools
  • chest pain
  • chills
  • clay colored stools
  • cough
  • dark urine
  • decreased appetite
  • dizziness
  • drowsiness
  • fever
  • headache
  • high fever
  • itching or skin rash
  • lightheadedness
  • loss of appetite
  • nausea and vomiting
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the feet or lower legs
  • swollen glands
  • unexplained or unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin
Rare
  • Agitation
  • coma
  • confusion
  • decreased urine output
  • difficulty with swallowing
  • fast heartbeat
  • hives
  • hostility
  • irritability
  • lethargy
  • muscle twitching
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • seeing, hearing, or feeling things that are not there
  • seizures
  • stupor
  • swelling of the face, ankles, or hands
  • tightness in the chest
Incidence not known
  • Cold sweats
  • darkening of the skin
  • decrease in the frequency of urination
  • decrease in the urine volume
  • difficult or troubled breathing
  • difficulty in passing urine (dribbling)
  • dizziness, faintness, or lightheadedness when getting up from lying or sitting position
  • fainting
  • irregular, fast or slow, or shallow breathing
  • overactive reflexes
  • pale or blue lips, fingernails, or skin
  • poor coordination
  • shivering
  • talking or acting with excitement you cannot control
  • trembling or shaking

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Difficulty having a bowel movement (stool)
  • drowsiness
  • relaxed and calm
  • sleepiness
Incidence not known
  • Constricted, pinpoint, or small pupils (black part of the eye)
  • diarrhea
  • dry mouth
  • gas in the stomach
  • heartburn
  • seeing, hearing, or feeling things that are not there

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about acetaminophen, caffeine, and dihydrocodeine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 acetaminophen, caffeine, and dihydrocodeine. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using acetaminophen, caffeine, and dihydrocodeine.

Review Date: October 4, 2017

Brand Names U.S.

  • Trezix

Contraindications

Hypersensitivity (eg, anaphylaxis) to acetaminophen, caffeine, dihydrocodeine, codeine, or any component of the formulation; postoperative pain management in pediatric patients who have undergone tonsillectomy and/or adenoidectomy; significant respiratory depression in unmonitored settings or in the absence of resuscitative equipment; acute or severe bronchial asthma in unmonitored settings or in the absence of resuscitative equipment; hypercapnia; GI obstruction, including paralytic ileus (known or suspected).

Documentation of allergenic cross-reactivity for opioid analgesics is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution and monitor carefully.

Test Interactions

See individual agents.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, or sweating a lot. Have patient report immediately to prescriber signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), confusion, severe dizziness, passing out, change in balance, anxiety, severe loss of strength and energy, severe constipation, urinary retention, change in amount of urine passed, bradycardia, tachycardia, abnormal heartbeat, chills, pharyngitis, hallucinations, mood changes, tinnitus, severe headache, severe fatigue, difficulty breathing, slow breathing, shallow breathing, noisy breathing, bruising, bleeding, vision changes, seizures, sexual dysfunction (males), amenorrhea, decreased libido, infertility, signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, arrhythmia, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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