Due to the risk of addiction, tramadol is only available with a prescription and is regulated by a drug program (REMS). Your doctor will give you a Medication Guide that includes important information about how to take this medication.
Tramadol should not be used during pregnancy unless the benefits outweigh the risks. It may cause life-threatening withdrawal symptoms in the unborn baby and can lead to respiratory depression in newborn babies.
What is tramadol?
Tramadol is in a group of medications called opioid analgesics. It works in the brain and nervous system to relieve pain. It is used to treat moderate to severe pain after surgery. It is also used to treat pain that does not respond to other medicines. Tramadol may cause drowsiness. Do not drive or operate machinery if you are affected.
This medicine should not be used in children under 12 years of age. It is not safe to use in children with certain health conditions, including risk of slowed or stopped breathing (such as a history of surgery or surgery to remove the tonsils and/or adenoids). There have been reports of life-threatening side effects in such children. It is not safe to drink alcohol or take other prescription or nonprescription medications that can make you sleepy while taking this medication. Talk to your doctor for more information.
Serotonin syndrome can occur with this medicine. Symptoms of this reaction include agitation, hallucinations, fever, sweating, fast heart rate, shivering, muscle stiffness or spasms, difficulty moving and vomiting. If you have these symptoms, get emergency medical help right away.
This medication can interact with other drugs or vitamins and supplements that you are taking. Tell your doctor about all the medicines you are taking, especially any other opioid analgesics, sedatives or tranquilizers; and vitamins and herbs. Also tell your doctor if you smoke or use illegal drugs. These can affect how well tramadol works. This medication is a controlled substance in some states. Keep track of how much medicine you have taken and do not exceed the prescribed dose. Overdose can be dangerous and can lead to death.
How is tramadol prescribed?
The dosage and duration of tramadol treatment must be individualized according to the patient’s needs. The dosage may be increased or decreased gradually to achieve the desired effect. It is usually taken by mouth orally (up to every 4 hours) as needed for pain relief. If nausea occurs, taking it with food or using a special measuring device/spoon to ensure you get the correct dose may help.
Tramadol is available only with a doctor’s prescription. This medicine is a Schedule 3 controlled drug. It can cause addiction, misuse, and overdose which can lead to death. It should never be shared, even with someone you know. Never use more of this medication or take it more often than prescribed by your doctor. Overdose can occur if you take more than the recommended amount or with other drugs that depress the central nervous system such as alcohol, sedatives (including cough suppressants), hypnotics, and antidepressants.
Some people are at higher risk of getting addicted to this drug. This includes those who have a history of mental illness or substance abuse, or certain medical conditions such as lung disease, a neuromuscular disorder, or sleep apnea. The risk is also increased in older adults and those who are debilitated or have a wasting syndrome.
Before prescribing this medicine your doctor will assess your risk of misusing or becoming dependent on it. They will also check your liver function and may require blood tests during treatment. It is important to tell your doctor if you have a history of stomach ulcers or liver problems, a recent head injury, or any other health concerns. They may need to adjust your dose or prescribe a different drug for you.
What should I discuss with my doctor before taking tramadol?
As with any medication, there are things to consider before taking tramadol. This includes telling your doctor if you have a history of depression, suicidal thoughts or behavior, or alcohol use disorder. You should also tell your doctor if you have certain medical conditions, such as liver disease, kidney disease, stomach or gallbladder disease, a head injury, brain tumor, or breathing problems like slowed or troubled breathing (like asthma or chronic obstructive pulmonary disease). You should not take tramadol if you are pregnant or breastfeeding.
Your doctor may want to start you on a lower dose to help avoid side effects such as nausea and vomiting, dizziness, flushing, itchy skin, or trouble sleeping. You should also discuss whether you should have a rescue medication called naloxone available to you in case of overdose. Naloxone reverses the life-threatening symptoms of an opioid overdose and can save a person’s life. Ask your doctor if you should have this medication on hand, especially if you live in a household with small children or someone who uses street or prescription drugs.
Tramadol can increase your risk of seizures, if you have a condition such as epilepsy or a history of them. It can also make the heart beat too fast or slow, and can cause a serious breathing problem that can be life-threatening, especially if you take large doses or combine it with other medications that affect the central nervous system or respiratory tract. Your doctor should monitor you for these problems, and will probably want to stop your treatment if they occur.
Tramadol can cause a serious, life-threatening reaction if you take too much of it, or if you mix it with other drugs that can affect the brain’s activity, such as St. John’s wort, SSRI or MAOI antidepressants, sedatives, narcotics, or some other pain medicines. This combination can cause a dangerously high level of serotonin in your body, which can lead to agitation, hallucinations, coma, or death. Because of this, tramadol is a controlled substance and must be stored in a safe place to prevent theft or accidental overdose.
What should I avoid while taking tramadol?
It’s important to keep in mind that tramadol can cause side effects, including dizziness and extreme sleepiness. These effects can impair your ability to think and react. It’s a good idea to avoid driving or operating machinery until you know how this medication affects you. Alcohol can enhance these effects, so it’s best to avoid it while taking tramadol.
Tramadol may also cause nausea. If you get this side effect, try eating a light meal or taking an anti-sickness medication. If your nausea persists, talk to your doctor.
You should not take tramadol with benzodiazepines (or any other sedative, hypnotic or tranquilizer), NSAIDs (such as ibuprofen) or other opioid medications. These drugs interact with tramadol and increase the risk of side effects, including respiratory depression, slowed breathing and overdose. Using this medication with any of these medications can also lead to life-threatening withdrawal symptoms and a lack of pain control.
The extended-release tablet and capsule must be swallowed whole and intact; do not split, chew or crush them. Tramadol is available as a generic drug in both the immediate-release and extended-release forms. Ask your pharmacist to help you save money by getting the generic form of this medication.
Tramadol should not be used in children 12 to 18 years of age who have other risk factors for slowed or stopped breathing, such as severe lung disease, neuromuscular disorder, obesity, or a history of substance misuse. It may also not be safe to use during pregnancy or breastfeeding. It can pass into breast milk and cause serious or fatal problems in infants, including slowed breathing. Talk to your doctor before breastfeeding.
How should I store tramadol?
Tramadol should be kept in a safe place, out of the reach of children, and at room temperature. It should not be stored in a bathroom, as it can easily absorb moisture and degrade the medicine. This medication should not be mixed with alcohol or other sedatives, as it may increase the risk of side effects. If you have any questions about how to store tramadol, ask your pharmacist. If you have any unused tramadol, ask your pharmacist about a drug take-back program. Otherwise, you can mix the unused medication with cat litter or coffee grounds in a sealed plastic bag and throw it away.
The new guidance will provide a clear overview of good professional practice for storing and administering tramadol in residential health and justice settings in Wales. It is intended to be a helpful resource for healthcare professionals, pharmacy service providers and health and justice commissioners. It is also hoped that the guidance will support improvements in the management of pain and distress in these settings.
It is important to note that although tramadol has been rescheduled to Schedule IV, it is still a controlled drug and therefore needs to be handled with appropriate security. The DEA’s NPRM and supporting eight factor analyses found that tramadol, its salts, and isomers have the same abuse potential as propoxyphene (a Schedule II narcotic) and therefore warrant scheduling in Schedule IV of the Controlled Substances Act.
In contrast to other rescheduling actions, this 45-day period will allow sufficient time for registrants to implement the handling requirements of Schedule IV in order to ensure continued availability and appropriate levels of protection against misuse, diversion, and abuse.