Dvorah, Trezix

Acetaminophen, Caffeine, and Dihydrocodeine

(a seet a MIN oh fen, KAF een, & dye hye droe KOE deen)

Panlor [DSC], Trezix

This drug is a strong pain drug that can put you at risk for addiction, abuse, and misuse. Misuse or abuse of this drug can lead to overdose and death. Talk with your doctor. This drug has acetaminophen in it. Liver problems have happened with the use of acetaminophen. Sometimes, this has led to a liver transplant or death. Most of the time, liver problems happened in people taking more than 4,000 mg (milligrams) of acetaminophen in a day. People were also often taking more than 1 drug that had acetaminophen. This drug may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing. The chance of very bad and sometimes deadly breathing problems may be greater when you first start this drug or anytime your dose is raised. Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away. This drug has an opioid drug in it. Severe side effects have happened when opioid drugs were used with benzodiazepines or other drugs that may make you drowsy or slow your actions. This includes slow or troubled breathing and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepines may be used to treat many health problems like anxiety, trouble sleeping, or seizures. If you have questions, talk with your doctor. Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs. Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen. Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor. This drug is not approved for use in children. Do not give to a child younger than 12 years of age. Children between 12 and 18 years of age who are very overweight or have certain other health problems like sleep apnea or other lung or breathing problems must not use this drug. If your child has been given this drug, ask the doctor for information about the benefits and risks. Some children have had very bad and sometimes deadly breathing problems when using codeine after surgery to remove tonsils or adenoids. Do not give to a child younger than 18 years of age who has had surgery to remove tonsils or adenoids. Talk with your child's doctor.

It is used to ease pain.

If you have an allergy to acetaminophen, caffeine, dihydrocodeine, or any other part of this drug. If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing. If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine. If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen. If you are taking any of these drugs: Linezolid or methylene blue. If you have been told by your doctor that you are a rapid metabolizer of some drugs. If you are breast-feeding. Do not breast-feed while you take this drug. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you. To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs. If you have been taking this drug for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this drug stops working well. Do not take more than ordered. Long-term or regular use of opioid drugs like this drug may lead to dependence. Lowering the dose or stopping this drug all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your doctor before you lower the dose or stop this drug. You will need to follow your doctor’s instructions. Tell your doctor if you have more pain, mood changes, thoughts of suicide, or any other bad effects. Avoid taking other products that have acetaminophen in them. Check labels closely. Too much acetaminophen may cause liver problems. Follow the directions exactly. Do not take more acetaminophen in a day than directed. If you do not know how much acetaminophen you can take in a day, ask your doctor or pharmacist. Some people may take up to 4,000 mg (milligrams) in a day if told to do so by the doctor. Some people (like people with liver problems and children) should take less acetaminophen. Call your doctor right away if you have taken too much acetaminophen in a day, even if you feel well. This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug. Be careful if you have G6PD deficiency. Anemia may happen. Taking an opioid drug like this drug may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak. Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men). If you are 65 or older, use this drug with care. You could have more side effects. The chance of very bad side effects may be higher in children. This may be more likely to happen in children who have breathing problems. Deadly breathing problems have happened with the use of codeine in some children. Talk with the doctor. This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. Very bad dizziness or passing out. Change in balance. Feeling confused. Very nervous and excitable. Feeling very tired or weak. Very bad constipation. Not able to pass urine or change in how much urine is passed. Fast or slow heartbeat. A heartbeat that does not feel normal. Fever or chills. Sore throat. Hallucinations (seeing or hearing things that are not there). Mood changes. Ringing in ears. Seizures. Very bad headache. Trouble breathing, slow breathing, or shallow breathing. Noisy breathing. Feeling very sleepy. Any unexplained bruising or bleeding. Change in eyesight. 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. A severe and sometimes deadly problem called serotonin syndrome may happen if you take this drug with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Constipation. Dizziness. Feeling sleepy. Headache. Upset stomach or throwing up. Sweating a lot. Feeling tired or weak. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take with or without food. Take with food if it causes an upset stomach. Do not take more than what your doctor told you to take. Liver problems may happen. Do not take this drug with other strong pain drugs or if you are using a pain patch without talking to your doctor first. Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with this drug may cause nervousness, shakiness, and a fast heartbeat. You will be watched closely to make sure you do not misuse, abuse, or become addicted to this drug.

If you take this drug on a regular basis, take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses. Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.

Store at room temperature in a dry place. Do not store in a bathroom. Store this drug in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep this drug safe. Keep all drugs away from pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

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. This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, 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 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.