It acts on the central nervous system CNS to relieve pain. When codeine is used for a long time, it may become habit-forming, causing mental or physical dependence.
However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence addiction is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make.
For this medicine, the following should be considered:. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies have not been performed on the relationship of age to the effects of acetaminophen and codeine combination oral suspension in children younger than 3 years of age.
Safety and efficacy have not been established. Use of acetaminophen and codeine combination oral solution or tablets is not recommended in children younger than 12 years of age. Acetaminophen and codeine combination should not be used to relieve pain after surgery to remove tonsils or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of acetaminophen and codeine combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving acetaminophen and codeine combination.
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary.
When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended.
Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases.
If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:. Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines.
If too much of this medicine is taken for a long time, it may become habit-forming causing mental or physical dependence or cause an overdose. Also, large amounts of acetaminophen may cause liver damage if taken for a long time. It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of acetaminophen and codeine combination.
This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions. Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen.
It is not safe to use more than 4 grams 4, milligrams of acetaminophen in one day 24 hours , as this may increase the risk for serious liver problems.
Shake the oral suspension well before each use. Read the information carefully and ask your doctor or pharmacist if you have any questions.
The combination of acetaminophen and codeine is used to relieve mild to moderate pain. Acetaminophen is in a class of medications called analgesics pain relievers and antipyretics fever reducers.
It works by changing the way the body senses pain and by cooling the body. Codeine belongs to a class of medications called opiate narcotic analgesics and to a class of medications called antitussives.
When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing.
The combination of acetaminophen and codeine comes as a tablet, capsule, and liquid to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
If you have taken acetaminophen and codeine for several weeks or longer, do not stop taking the medication without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop taking acetaminophen and codeine, you may experience withdrawal symptoms such as restlessness, widened pupils black circles in the center of the eyes , teary eyes, irritability, anxiety, runny nose, difficulty falling asleep or staying asleep, yawning, sweating, fast breathing, fast heartbeat, chills, nausea, loss of appetite, vomiting, diarrhea, stomach cramps, or muscle aches.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. This medication usually is taken as needed. If your doctor has told you to take acetaminophen and codeine regularly, take the missed dose as soon as you remember it.
However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Acetaminophen and codeine may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture not in the bathroom. It is important to keep all medication out of sight and reach of children as many containers such as weekly pill minders and those for eye drops, creams, patches, and inhalers are not child-resistant and young children can open them easily.
To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them.
However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. In case of overdose, call the poison control helpline at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at While taking acetaminophen and codeine, you should talk to your doctor about having a rescue medication called naloxone readily available e.
Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs.
You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call immediately, and stay with you and watch you closely until emergency medical help arrives.
Your symptoms may return within a few minutes after you receive naloxone. While not contraindicated for use, Tylenol 3 should be used with extreme caution during pregnancy. Doing so may cause neonatal opioid withdrawal syndrome, a condition that can be life-threatening to a newborn. If an opioid of any sort is needed during pregnancy, it is important to speak with your healthcare provider to fully weigh the benefits and risks.
Breastfeeding is not recommended when taking Tylenol 3. Other narcotic analgesic combinations can be used to treat breakthrough pain, although the risk of addiction is generally no less and in some cases greater than with Tylenol 3. These include:. Tylenol 3 is available as a tablet or as an oral solution. Generally speaking, the analgesic effect of Tylenol 3 will reach a peak within two hours of taking a dose and last for between four and six hours.
The lowest dose able to deliver pain relief should always be used. For children 12 and over, the dosage is determined by a healthcare provider. Because the oral solution can be divided into smaller doses, it is more commonly used in smaller or younger children.
Older adolescents and teens may be able to take tablets. When first starting treatment, your healthcare provider will want to monitor for signs of respiratory depression for the first 24 to 72 hours and do the same if the dose is ever increased. This may involve an arterial blood gas test or pulse oximetry to measure oxygen saturation levels. This is especially important for people with cancer, who are often prescribed the drug to treat chronic pain.
Tylenol 3 can be taken with or without food. If taking the oral solution, be sure to shake the bottle thoroughly before use. Always measure the oral solution with a medication-measuring device, which you can get from your healthcare provider or pharmacist. Avoid "eyeballing" doses, as this can lead to overdosing. Tylenol 3 tablets or oral solution can be stored at room temperature, between 68 F and 77 F 20 C to 25 C.
It is best to keep the medication in a cool, dry room in its original light-resistant container. Never use a drug past its expiration date.
Be sure to keep this medication out of reach of children or pets. Tylenol 3 can cause a number of side effects related to acetaminophen or codeine. Some are low-grade and tend to resolve on their own without treatment. Others are severe and may require the discontinuation of treatment.
Less commonly, diarrhea, abdominal pain, cramps, fainting, heart palpitations, insomnia, nervousness, and fatigue may occur. Adrenal insufficiency reduced adrenal gland function can develop when opioids are used for longer than one month.
Symptoms include nausea, vomiting, loss of appetite, fatigue, weakness, and dizziness. The gradual discontinuation of Tylenol 3 along with the short-term use of oral corticosteroid drugs to support adrenal function can usually set things right. Even in healthy adults, high doses of acetaminophen can cause liver injury. Taking 4, mg within 24 hours can significantly increase the risk of hepatoxicity liver poisoning and permanent liver damage. Taking two tablets of Tylenol 3 every four hours pushes you uncomfortably close to that daily limit 3, mg.
Drinking alcohol while taking acetaminophen significantly amplifies the risk of liver damage. On rare occasions, Tylenol 3 has also been known to cause a potentially life-threatening, whole-body allergic reaction known as anaphylaxis. In most cases, codeine is the responsible culprit, triggering symptoms within minutes of taking a dose. Call or seek emergency care if you experience some or all of the following after taking Tylenol If left untreated, anaphylaxis can lead to shock, coma, asphyxiation, heart or respiratory failure, and even death.
Tylenol 3 should be used with caution in certain groups. The drug may not be contraindicated, per se, but specialist insight may be needed to determine how appropriate the drug is on a case-by-case basis for people with some conditions. Some people with epilepsy , for example, may experience a greater frequency of seizures when taking Tylenol 3. Elderly people with reduced kidney function may also experience seizures.
Because there is no way to know who might be affected, healthcare providers should monitor those with a risk of seizures and discontinue treatment if seizures occur or worsen. Because of the stress acetaminophen can place on the liver, people with chronic liver disease should limit their daily intake to no more than 2, mg per day, according to the American College of Gastroenterology, or even less if severe liver disease is present. In addition, even if you don't have liver disease, always use the smallest amount of acetaminophen possible.
The risk of respiratory depression and death is greater when Tylenol 3 is taken with benzodiazepines and other drugs including alcohol that suppress the central nervous system. To avoid this, most healthcare providers will simply find alternatives to Tylenol 3.
If this is not possible and there are no reasonable alternatives for chronic benzodiazepine users such as people with generalized anxiety disorder , panic disorder , or agoraphobia , the lowest possible dose should be used for the shortest amount of time under constant medical supervision.
Tylenol 3 can also interact with a wide range of drugs that use the enzyme cytochrome P CYP for metabolism. Tylenol 3 also utilizes CYP, and, by taking these drugs together, you might experience increases or decreases in blood concentration of one or both drugs.
Decreased drug concentrations are associated with a loss of clinical effects, while increased drug concentrations correspond to a worsening of side effects. With Tylenol 3, any drug interaction that causes a drop in blood concentration can lead to significant and sometimes profound opioid withdrawal symptoms.
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