What to Know About Tylenol #3 (Acetaminophen and Codeine): Usage, side effects, dosage, precautions.

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Tylenol No. 3 is an oral prescription medication used to relieve mild to moderately severe pain. It contains two active ingredients: the non-opioid pain reliever acetaminophen and the opioid pain reliever codeine.

Also known as Tylenol with codeine, Tylenol # 3 is used in adults and children 12 years and older, along with other non-opioid pain relievers such as over-the-counter Tylenol or non-steroidal anti -inflammatory drugs such as Advil (ibuprofen) or Aleve (naproxen). – unable to provide assistance. Still, Tylenol No. 3 should be used with caution due to the risk of dependency and abuse.

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In addition to the Tylenol No. 3 brand, this drug is marketed under various brand names such as APAP-Codeine, Capital with Codeine, Pyregesic-C, Vopac, and others.

Applications

Tylenol No. 3 is classified as a combination of narcotics and pain relievers. The term " drug " is used to refer to opiates (which are drugs, such as morphine , made from opium) and opioids (drugs, such as codeine, which have effects similar to opiates). Pain reliever is any medicine designed to relieve pain.

Tylenol No. 3 is rarely, if ever, used in the treatment of first-line pain. The drug is usually prescribed when sudden pain occurs (pain that cannot be relieved with over-the-counter pain relievers). Tylenol # 3 may also be considered if non-opioid pain relievers are causing excruciating side effects.

Inappropriate use

The combination of acetaminophen and codeine has long been used by dentists, surgeons, pediatricians, and family doctors to treat disease-related cough (such as tonsillitis ) or cough after a surgical procedure (such as tonsillectomy ).

Today, this practice is frowned upon due to the risk of respiratory depression (abnormally slow and ineffective breathing). The risk is especially high in children, the elderly, the sick, or people with severe wasting ( cachexia ) .

Before drinking

Tylenol # 3 is not for everyone. As an opioid drug, codeine can cause physical and mental dependence . To avoid this, healthcare providers must ensure that the benefits of treatment outweigh the risks.

This includes assessing whether the patient is at risk for addiction and providing the necessary counseling to ensure the safe use of the drug. Risk factors include a history of substance abuse , a family history of substance abuse, or a mental illness (such as major depression ).

To reduce the risk of abuse, Tylenol No. 3 is available in the United States through a restricted distribution program called the Opioid Analgesics Risk Assessment and Mitigation Strategy (REMS) program .

As part of the REMS program, the U.S. Food and Drug Administration (FDA) requires manufacturers of drugs with a high risk of serious side effects to train healthcare providers so they know when a drug is appropriate. and when not.

A history of substance abuse does not automatically exclude you from using Tylenol No. 3 when medically appropriate. It simply indicates a greater need for pre-treatment counseling and medical supervision.

Tylenol No. 3 should not be used by people with untreated alcoholism or substance abuse.

Precautions and contraindications.

There are certain groups in which Tylenol No. 3 should not be used. Most of the concerns are related to the effects of codeine on the respiratory system .

Codeine, found in some cough suppressants , reduces activity in the part of the brain that triggers the cough reflex. In young children and people with breathing problems, this action can lead to respiratory depression, hypoxia (low oxygen in the blood) and, in severe cases, death.

Due to the risk of these life-threatening side effects, the FDA contraindicates the use of Tylenol # 3 in:

  • Children under 12 years old
  • Children younger than 18 years after a tonsillectomy or adenoidectomy
  • People with pre-existing respiratory depression
  • People with acute or severe bronchial asthma who are not controlled or who do not have access to resuscitation equipment.
  • People taking antidepressants with monoamine oxidase inhibitors (MAOIs) (due to the risk of serotonin syndrome )
  • People with intestinal obstruction, in whom codeine can further affect bowel movements ( peristalsis )
  • People with a known allergy to acetaminophen, codeine, or any other ingredient in the drug.

Tylenol No. 3 is not contraindicated, but should be used with extreme caution during pregnancy. This can lead to opioid withdrawal in newborns, a life-threatening condition for the newborn .

If any opioids are required 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 combinations of narcotic pain relievers

Other combinations of narcotic pain relievers can be used to treat sudden pain, although the risk of addiction is generally not lower and in some cases higher than with Tylenol No. 3. This includes:

Dose

Tylenol No. 3 is available as a tablet or oral solution.

  • All three tablets contain 300 milligrams (mg) of acetaminophen combined with 15, 30, or 60 mg of codeine.
  • The oral solution is offered in one form: acetaminophen 120 mg and codeine 12 mg per 5 milliliter (ml) dose.

Recommended dosage for adults :

  • Tablets : 1 to 2 tablets every four hours as needed to relieve acute pain.
  • Oral solution : 15 ml every four hours as needed.

Typically, the pain relieving effect of Tylenol No. 3 peaks within two hours of a dose and lasts for four to six hours .

Modifications

The lowest dose that can relieve pain should always be used. For children 12 years and older, the dose is determined by the doctor. Because the oral solution can be divided into smaller doses, it is most commonly used for young children and young children. Older teens and teens can take pills.

When you first start 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 increased). This may include arterial blood gas analysis or pulse oximetry to measure oxygen saturation levels. This is especially important for cancer patients who are often prescribed medications to treat chronic pain.

How to take and store

Tylenol No. 3 can be taken with or without food. If you are taking an oral solution, be sure to shake the bottle well before use.

Always measure your oral solution with a drug tester that you can obtain from your doctor or pharmacist. Avoid the eye dose as this can lead to an overdose.

Tylenol No. 3 tablets or oral solution can be stored at room temperature, 20-25 ° C. It is best to store the medication in a cool, dry place in the original light-resistant container. Never use an expired medicine. Make sure to keep this medicine out of the reach of children or pets.

Side effects

Tylenol # 3 can cause a number of side effects associated with acetaminophen or codeine. Some are mild and usually go away on their own without treatment. Others are serious and may require discontinuation of treatment.

general

The most common side effects of Tylenol # 3 are:

  • Drowsiness
  • Lightheadedness or dizziness
  • Difficulty breathing
  • Nausea
  • Threw up
  • Heavy sweating
  • Dry mouth
  • Headache
  • Constipation

Less frequently, diarrhea, abdominal pain, cramps, fainting, palpitations, insomnia, nervousness, and fatigue may occur.

Adrenal insufficiency (decreased adrenal function ) can develop when opioids are taken for more than a month. Symptoms include nausea, vomiting, loss of appetite, fatigue, weakness, and dizziness. Gradual discontinuation of Tylenol # 3 along with short-term oral corticosteroids (to support adrenal function) can generally improve the situation .

Severe form

Even in healthy adults, high doses of acetaminophen can cause liver damage. Taking 4000 mg over 24 hours can significantly increase the risk of hepatotoxicity (liver poisoning) and irreversible liver damage .

Taking two tablets of Tylenol No. 3 every four hours brings you closer to your daily limit (3600 mg). Drinking alcohol while taking acetaminophen significantly increases the risk of liver damage.

Signs of acetaminophen-induced hepatotoxicity include :

  • Abdominal pain
  • Loss of appetite
  • Nausea
  • Threw up
  • Fatigue
  • Pale stools
  • Dark urine
  • Jaundice (yellowing of the eyes and / or skin)

In the United States, acetaminophen hepatotoxicity is responsible for more than 50% of overdose-related acute liver failure and for approximately 20% of all liver transplants .

In rare cases, Tylenol # 3 is known to cause a life-threatening, whole-body allergic reaction known as anaphylaxis . In most cases, codeine is the culprit, causing symptoms within minutes of taking a dose.

When to call 911

Call 911 or seek emergency help if you experience any or all of the following events after taking Tylenol # 3:

  • Hives or rashes
  • Difficulty breathing
  • Wheezing
  • Dizziness or fainting
  • Nausea or vomiting
  • Swelling of the face, tongue, or throat

If left untreated, anaphylaxis can lead to shock, coma, suffocation, heart or respiratory failure, and even death.

Warnings and interactions

Tylenol No. 3 should be used with caution in certain groups. The drug itself may be contraindicated, but expert judgment may be required to determine whether the drug is appropriate for a particular case of people with certain medical conditions.

For example, some people with epilepsy may experience seizures more often when taking Tylenol No. 3. Older people with reduced kidney function may also experience seizures. Since it is not possible to know who may be affected, healthcare providers should monitor people at risk for seizures and stop treatment if seizures occur or get worse.

Due to the stress that acetaminophen can put on the liver, people with chronic liver disease should limit their daily intake to no more than 2,000 mg per day, or even less if there is severe liver disease, according to the American College of Gastroenterology. Also, even if you don't have liver disease, always use the least amount of acetaminophen you can.

Interactions

The risk of respiratory depression and death is greater when Tylenol No. 3 is taken with benzodiazepines and other drugs (including alcohol) that suppress the central nervous system .

To avoid this, most healthcare professionals will simply find alternatives to Tylenol # 3. If this is not possible and there are no reasonable alternatives for chronic benzodiazepine users (eg, people with generalized anxiety disorder, generalized anxiety disorder, panic or agoraphobia ), the lowest possible dose should be used for the shortest possible time under close medical supervision.

Tylenol No. 3 can also interact with a wide range of medications that use the enzyme cytochrome P450 (CYP450) for metabolism. Tylenol # 3 also uses CYP450, and if you take these medications together, you may experience an increase or decrease in the blood concentration of one or both medications. A decrease in drug concentration is associated with a loss of clinical effects, while an increase in drug concentration corresponds to a worsening of side effects.

With Tylenol No. 3, any drug interaction that causes a drop in blood concentration can result in significant and sometimes profound opioid withdrawal symptoms .

Some of the drugs most at risk for CYP450 interactions include:

  • Azilekt (rasagiline)
  • Emsam (selegiline)
  • MAOI inhibitors
  • Marplan (isocarboxazid)
  • Matulan (procarbazine)
  • Parnat (tranylcypromine)
  • Nardil (phenelzine)
  • ProvayBlue (methylene blue)
  • Selincro (nalmefene)
  • St. John's Wort (Hypericum perforatum)
  • Zyvox (linezolid)
  • Vivitrol (naltrexone)
  • Xadago (safinamide)

Due to the severity of the interactions, Tylenol No. 3 should not be used with any of these medications.

There are literally dozens of other drugs that can interact with Tylenol # 3. Some of these interacting drugs may require dose adjustments or dose splits from one to six hours.

To avoid drug interactions, always tell your doctor about any medications you are taking, whether they are prescription, over-the-counter, herbal, or recreational.

Retirement

One of the main concerns with the increased use of Tylenol No. 3 is the risk of opioid dependence and abuse. Equally concerning are withdrawal symptoms that can occur when treatment is suddenly stopped.

If you have been taking Tylenol No. 3 for a long period of time and / or show signs of opioid dependence, it is important that you never suddenly stop taking it. This can cause a number of side effects, including nausea, vomiting, diarrhea, sweating, abdominal cramps, agitation, and a rapid return of pain.

To avoid this, your doctor will prescribe a taper program so that you gradually stop. Current guidance from the Centers for Disease Control and Prevention recommends a weekly dose reduction of 10% as a starting point.

If you can't stop using Tylenol No. 3 and you have signs of physical or mental dependence, talk to your doctor about an addiction treatment program that can help you overcome the addiction.

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