Tramadol Hcl ER 300mg Tablets
WARNING: For all patients taking this drug:This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing.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.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the 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.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.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life- threatening if not treated.Children:This drug is not approved for use in children. Severe and sometimes deadly breathing problems have happened with tramadol in children. Sometimes, this happened after surgery to remove tonsils or adenoids and in children who were rapid metabolizers of tramadol. Do not give to a child younger than 12 years of age. Do not give to a child younger than 18 years of age who is very overweight, has certain health problems like sleep apnea or other lung or breathing problems, or has had surgery to remove tonsils or adenoids. If your child has been given this drug, ask the doctor about the benefits and risks. @ COMMON USES: It is used to manage pain when daily pain treatment is needed for a long time. It is for use when non-opioid pain drugs do not treat your pain well enough or you cannot take them.
Drug Class
Opioid analgesic
Pharmacologic Class
Centrally acting synthetic opioid analgesic; Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Pregnancy Category
Category C
FDA Approved
Mar 1995
DEA Schedule
Schedule IV
Overview
What is this medicine?
Tramadol ER is an extended-release pain medicine that works in your brain to change how your body feels and responds to pain. It's used to treat moderate to moderately severe chronic pain around the clock. Because it's extended-release, you take it only once a day.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Take this medication by mouth only. Do not inject or snort it, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.
Swallow the medication whole. Do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and death.
You can take this medication with or without food. However, some products must be taken consistently, either always with food or always without food. Make sure you understand how to take your specific product in relation to food. If you are unsure, consult your doctor or pharmacist.
Take this medication at the same time every day.
Do not use this medication for rapid pain relief or on an as-needed basis.
If you have not been taking medications like this one, do not use it for pain relief after surgery.
If you have difficulty swallowing, discuss this with your doctor.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding storage in a bathroom.
Keep this medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep it safe.
Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist if you have questions about the best disposal method. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Take this medication by mouth only. Do not inject or snort it, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.
Swallow the medication whole. Do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and death.
You can take this medication with or without food. However, some products must be taken consistently, either always with food or always without food. Make sure you understand how to take your specific product in relation to food. If you are unsure, consult your doctor or pharmacist.
Take this medication at the same time every day.
Do not use this medication for rapid pain relief or on an as-needed basis.
If you have not been taking medications like this one, do not use it for pain relief after surgery.
If you have difficulty swallowing, discuss this with your doctor.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding storage in a bathroom.
Keep this medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep it safe.
Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist if you have questions about the best disposal method. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not drink alcohol while taking tramadol, as it can increase the risk of serious side effects like extreme drowsiness and breathing problems.
- Avoid driving or operating heavy machinery until you know how tramadol affects you, as it can cause dizziness and drowsiness.
- Store tramadol securely away from children and pets, as accidental ingestion can be fatal.
- Do not share your medication with anyone else, as it can be dangerous and is against the law.
- Discuss any other medications, supplements, or herbal products you are taking with your doctor to avoid dangerous interactions, especially with other sedatives or antidepressants.
Available Forms & Alternatives
Available Strengths:
- Tramadol 50mg Tablets
- Tramadol 50mg Tablets
- Tramadol Hcl ER 100mg (biphasic) Tb
- Tramadol ER 200mg Biphasic Tab
- Tramadol Hcl ER 300mg Tablets
- Tramadol ER 200mg Tablets
- Tramadol ER 100mg Tablets
- Tramadol ER 300mg Tablets
- Tramadol ER 100mg Tablets
- Tramadol ER 300mg Tablets
- Tramadol ER 200mg Tablets
- Tramadol ER 100mg Capsules
- Tramadol ER 200mg Capsules
- Tramadol ER 300mg Capsules
- Tramadol 100mg Tablets
- Tramadol 50mg Tablets
- Tramadol 100mg Tablets
- Tramadol 5mg/ml Solution
- Tramadol Hcl 25mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
For chronic moderate to moderately severe pain, Tramadol HCl ER 300mg is typically a maintenance dose for patients who have been titrated to this level or are converting from other opioid therapies. Initial ER dosing usually starts at 100mg or 150mg once daily and is titrated every 5 days by 50mg increments based on pain and tolerability. Maximum daily dose is 300mg.
Dose Range:
100 - 300 mg
Condition-Specific Dosing:
chronic_pain:
Once daily, titrated from lower doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Contraindicated for acute pain in children younger than 12 years. Not recommended for children 12 to 18 years of age who are obese or have conditions that may increase risk of respiratory depression.
Adolescent:
Not recommended for children 12 to 18 years of age who are obese or have conditions that may increase risk of respiratory depression. Use with caution and at lowest effective dose if necessary, considering risks of respiratory depression.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for CrCl > 30 mL/min.
Moderate:
For CrCl < 30 mL/min, Tramadol ER is not recommended. For immediate-release, extend dosing interval to 12 hours.
Severe:
Tramadol ER is not recommended for CrCl < 30 mL/min.
Dialysis:
Tramadol is minimally removed by hemodialysis. Tramadol ER is not recommended in patients with end-stage renal disease requiring dialysis.
Hepatic Impairment:
Mild:
No specific adjustment for mild impairment.
Moderate:
For moderate hepatic impairment, Tramadol ER is not recommended. For immediate-release, extend dosing interval to 12 hours.
Severe:
Tramadol ER is not recommended for severe hepatic impairment (Child-Pugh Class C).
Pharmacology
Mechanism of Action
Tramadol is a centrally acting synthetic opioid analgesic. Its analgesic effect is due to a dual mechanism: binding of the parent drug and its active metabolite (M1, O-desmethyltramadol) to ΞΌ-opioid receptors, and weak inhibition of the reuptake of norepinephrine and serotonin. The M1 metabolite has a significantly higher affinity for the ΞΌ-opioid receptor than the parent drug.
Pharmacokinetics
Absorption:
Bioavailability:
75% (oral, immediate-release)
Tmax:
12 hours (Tramadol ER)
FoodEffect:
Food does not significantly affect the rate or extent of absorption of Tramadol ER.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
20%
CnssPenetration:
Yes
Elimination:
HalfLife:
6.3 hours (Tramadol), 7.4 hours (M1) for ER formulation
Clearance:
Not available (variable)
ExcretionRoute:
Renal (approximately 90%), Fecal (approximately 10%)
Unchanged:
Approximately 30% (parent drug), 6% (M1)
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour (immediate-release), slower for ER
PeakEffect:
Approximately 12 hours (Tramadol ER)
DurationOfAction:
24 hours (Tramadol ER)
Safety & Warnings
BLACK BOX WARNING
Addiction, Abuse, and Misuse: Tramadol exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientβs risk prior to prescribing tramadol, and monitor all patients receiving tramadol for signs of addiction, abuse, and misuse.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of tramadol or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of tramadol, especially by children, can result in a fatal overdose of tramadol.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of tramadol during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
CYP2D6 Ultra-Rapid Metabolism: Life-threatening respiratory depression and death have occurred in children who received tramadol. Some individuals are ultra-rapid metabolizers of tramadol due to a genetic variation (CYP2D6 polymorphism). These individuals convert tramadol into its active metabolite, O-desmethyltramadol (M1), more rapidly and completely than other people. Individuals who are ultra-rapid metabolizers may have higher than anticipated M1 levels in their blood after tramadol administration, which can lead to an increased risk of respiratory depression. Even at labeled doses, ultra-rapid metabolizers may have life-threatening or fatal respiratory depression. Because of the risk of life-threatening respiratory depression and death, tramadol is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of tramadol in adolescents 12 to 18 years of age who have other risk factors for respiratory depression unless the benefits outweigh the risks. When prescribing tramadol, healthcare providers should choose the lowest effective dose for the shortest duration of time and advise patients and caregivers about these risks.
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes: The concomitant use of tramadol with all cytochrome P450 3A4 (CYP3A4) inhibitors or 2D6 (CYP2D6) inhibitors may result in an increase in tramadol plasma concentrations and an increase in the risk of adverse reactions, including serious respiratory depression. The concomitant use of tramadol with CYP3A4 inducers may decrease tramadol plasma concentrations, resulting in decreased efficacy and, possibly, opioid withdrawal syndrome. Avoid the use of CYP3A4 inhibitors or inducers in patients taking tramadol. If concomitant use is necessary, monitor patients for signs of respiratory depression or reduced efficacy.
Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of tramadol or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of tramadol, especially by children, can result in a fatal overdose of tramadol.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of tramadol during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
CYP2D6 Ultra-Rapid Metabolism: Life-threatening respiratory depression and death have occurred in children who received tramadol. Some individuals are ultra-rapid metabolizers of tramadol due to a genetic variation (CYP2D6 polymorphism). These individuals convert tramadol into its active metabolite, O-desmethyltramadol (M1), more rapidly and completely than other people. Individuals who are ultra-rapid metabolizers may have higher than anticipated M1 levels in their blood after tramadol administration, which can lead to an increased risk of respiratory depression. Even at labeled doses, ultra-rapid metabolizers may have life-threatening or fatal respiratory depression. Because of the risk of life-threatening respiratory depression and death, tramadol is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of tramadol in adolescents 12 to 18 years of age who have other risk factors for respiratory depression unless the benefits outweigh the risks. When prescribing tramadol, healthcare providers should choose the lowest effective dose for the shortest duration of time and advise patients and caregivers about these risks.
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes: The concomitant use of tramadol with all cytochrome P450 3A4 (CYP3A4) inhibitors or 2D6 (CYP2D6) inhibitors may result in an increase in tramadol plasma concentrations and an increase in the risk of adverse reactions, including serious respiratory depression. The concomitant use of tramadol with CYP3A4 inducers may decrease tramadol plasma concentrations, resulting in decreased efficacy and, possibly, opioid withdrawal syndrome. Avoid the use of CYP3A4 inhibitors or inducers in patients taking tramadol. If concomitant use is necessary, monitor patients for signs of respiratory depression or reduced efficacy.
Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of depression, suicidal thoughts, or mood changes, such as:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Change in balance
Severe dizziness or fainting
Feeling confused
Seizures
Chest pain or pressure, or a rapid heartbeat
Trouble urinating
Frequent urination
Breathing difficulties, slow breathing, or shallow breathing
Noisy breathing
Sleep apnea (breathing problems during sleep)
Changes in vision
Severe constipation or stomach pain, which may indicate a severe bowel problem
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Severe Skin Reaction
This medication may cause a severe skin reaction, which can lead to serious health problems and even death. Seek medical help immediately if you notice:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, nausea, or vomiting
Dry mouth
Headache
Itching
Trouble sleeping
Flushing
* Excessive sweating
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of depression, suicidal thoughts, or mood changes, such as:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Change in balance
Severe dizziness or fainting
Feeling confused
Seizures
Chest pain or pressure, or a rapid heartbeat
Trouble urinating
Frequent urination
Breathing difficulties, slow breathing, or shallow breathing
Noisy breathing
Sleep apnea (breathing problems during sleep)
Changes in vision
Severe constipation or stomach pain, which may indicate a severe bowel problem
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Severe Skin Reaction
This medication may cause a severe skin reaction, which can lead to serious health problems and even death. Seek medical help immediately if you notice:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, nausea, or vomiting
Dry mouth
Headache
Itching
Trouble sleeping
Flushing
* Excessive sweating
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Difficulty breathing or shallow breathing
- Extreme drowsiness or feeling like you might pass out
- Confusion, agitation, or hallucinations (signs of serotonin syndrome)
- Fast heartbeat, sweating, muscle stiffness, twitching, or loss of coordination (signs of serotonin syndrome)
- Seizures
- Severe constipation
- Swelling of your face, lips, tongue, or throat (allergic reaction)
- Signs of adrenal insufficiency (severe tiredness, weakness, dizziness, nausea, vomiting, loss of appetite)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms.
Respiratory issues, such as asthma, breathing difficulties, or sleep apnea, as well as high carbon dioxide levels in the blood.
Gastrointestinal problems, including stomach or bowel blockage or narrowing.
Kidney or liver disease.
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol.
If your doctor has informed you that you are a rapid metabolizer of certain medications.
Recent consumption of large amounts of alcohol or use of medications that may impair your reactions, such as phenobarbital or pain relievers like oxycodone.
Current or recent use of carbamazepine.
Use of another medication containing the same active ingredient.
Concurrent use of buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain antidepressants or Parkinson's disease medications within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
It is crucial to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms.
Respiratory issues, such as asthma, breathing difficulties, or sleep apnea, as well as high carbon dioxide levels in the blood.
Gastrointestinal problems, including stomach or bowel blockage or narrowing.
Kidney or liver disease.
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol.
If your doctor has informed you that you are a rapid metabolizer of certain medications.
Recent consumption of large amounts of alcohol or use of medications that may impair your reactions, such as phenobarbital or pain relievers like oxycodone.
Current or recent use of carbamazepine.
Use of another medication containing the same active ingredient.
Concurrent use of buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain antidepressants or Parkinson's disease medications within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring Pain and Side Effects
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific medications, or those who consume excessive alcohol. Discuss your risk of seizures with your doctor.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Low Blood Sugar Risk
This medication may cause low blood sugar, which can be severe enough to require hospitalization. If you experience symptoms such as dizziness, headache, fatigue, shaking, rapid heartbeat, confusion, hunger, or sweating, contact your doctor immediately.
Dependence and Withdrawal
Long-term or regular use of opioid medications like this one may lead to dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dose, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Interactions with Alcohol
Do not consume alcohol or use products containing alcohol while taking this medication, as this may lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications may cause a decrease in sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring Pain and Side Effects
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific medications, or those who consume excessive alcohol. Discuss your risk of seizures with your doctor.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Low Blood Sugar Risk
This medication may cause low blood sugar, which can be severe enough to require hospitalization. If you experience symptoms such as dizziness, headache, fatigue, shaking, rapid heartbeat, confusion, hunger, or sweating, contact your doctor immediately.
Dependence and Withdrawal
Long-term or regular use of opioid medications like this one may lead to dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dose, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Interactions with Alcohol
Do not consume alcohol or use products containing alcohol while taking this medication, as this may lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications may cause a decrease in sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Loss of consciousness
- Seizures
- Bradycardia (slow heart rate)
What to Do:
Seek emergency medical attention immediately. Call 911 or the Poison Control Center at 1-800-222-1222. Naloxone (Narcan) may be administered by emergency personnel. Be prepared to provide information about the medication taken.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of serotonin syndrome, seizures)
- Linezolid (MAOI activity)
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines): Increased risk of profound sedation, respiratory depression, coma, and death.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, St. John's Wort): Increased risk of serotonin syndrome.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May decrease formation of M1, potentially reducing analgesic effect.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir): May increase tramadol exposure, increasing risk of adverse effects.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease tramadol exposure, potentially reducing analgesic effect and increasing M1 concentration.
- Carbamazepine: Significantly reduces tramadol plasma concentrations, potentially reducing analgesic effect and increasing seizure risk.
Moderate Interactions
- Coumarin derivatives (e.g., warfarin): Reports of increased INR/prothrombin time; monitor coagulation parameters.
- Digoxin: Possible increased digoxin levels; monitor.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, character, location)
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy
Respiratory rate and depth
Rationale: To assess baseline respiratory function and identify risk factors for respiratory depression.
Timing: Prior to initiation of therapy
Mental status (alertness, orientation)
Rationale: To assess baseline neurological function and identify risk factors for sedation.
Timing: Prior to initiation of therapy
Renal function (CrCl, BUN, creatinine)
Rationale: To assess kidney function, as tramadol and its metabolites are primarily renally excreted; adjust dose if impaired.
Timing: Prior to initiation of therapy
Hepatic function (ALT, AST, bilirubin)
Rationale: To assess liver function, as tramadol is metabolized in the liver; adjust dose if impaired.
Timing: Prior to initiation of therapy
History of substance abuse or mental health disorders
Rationale: To identify patients at higher risk for addiction, abuse, or misuse.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain level and functional status
Frequency: Regularly, at each visit or as clinically indicated
Target: Patient-specific pain reduction goals
Action Threshold: Inadequate pain control or worsening pain may require dose adjustment or alternative therapy.
Signs of respiratory depression (bradypnea, shallow breathing, cyanosis)
Frequency: Regularly, especially during initiation and dose titration
Target: Respiratory rate > 12 breaths/min, normal depth
Action Threshold: Respiratory rate < 10 breaths/min, shallow breathing, or signs of hypoxia require immediate intervention (e.g., naloxone, respiratory support).
Level of sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during initiation and dose titration
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Somnolent, difficult to arouse, or unarousable requires immediate intervention.
Bowel function (constipation)
Frequency: Regularly
Target: Regular bowel movements
Action Threshold: Severe constipation or impaction requires laxative intervention or change in therapy.
Signs of abuse, misuse, or diversion
Frequency: Regularly, at each visit
Target: Absence of aberrant drug-related behaviors
Action Threshold: Evidence of abuse/misuse requires re-evaluation of treatment plan, potential referral to addiction specialist.
Signs of serotonin syndrome (agitation, hallucinations, tachycardia, fever, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
Frequency: Monitor closely, especially with concomitant serotonergic drugs
Target: Absence of symptoms
Action Threshold: Presence of symptoms requires immediate discontinuation of tramadol and supportive care.
Symptom Monitoring
- Respiratory depression
- Excessive sedation/somnolence
- Dizziness
- Nausea
- Vomiting
- Constipation
- Seizures
- Serotonin syndrome (agitation, confusion, rapid heart rate, fever, sweating, muscle rigidity, tremors, twitching, loss of coordination, gastrointestinal symptoms)
- Adrenal insufficiency (fatigue, weakness, dizziness, nausea, vomiting, loss of appetite)
- Androgen deficiency (decreased libido, impotence, erectile dysfunction, amenorrhea, infertility)
Special Patient Groups
Pregnancy
Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which can be life-threatening. Use only if the potential benefit justifies the potential risk to the fetus. Advise pregnant women of the risk of NOWS and ensure appropriate treatment will be available.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure. Risk of NOWS increases with prolonged use.
Second Trimester:
Risk of NOWS increases with prolonged use.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used for prolonged periods. Risk of respiratory depression in the neonate if used near delivery.
Lactation
Tramadol and its active metabolite (M1) are present in breast milk. Breastfeeding is not recommended during treatment with tramadol due to the potential for serious adverse reactions in breastfed infants, including excess sedation, respiratory depression, and death. Monitor infants for signs of sedation and respiratory depression if breastfeeding cannot be avoided.
Infant Risk:
High (L3 - Moderate risk, but due to serious potential for respiratory depression and death, often advised against)
Pediatric Use
Contraindicated for acute pain in children younger than 12 years of age. Not recommended for children 12 to 18 years of age who are obese or have conditions that may increase risk of respiratory depression (e.g., sleep apnea, severe pulmonary disease). Due to the risk of life-threatening respiratory depression, tramadol is contraindicated in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.
Geriatric Use
Start with lower doses and titrate slowly due to increased risk of respiratory depression, sedation, and falls. Elderly patients may be more sensitive to the effects of tramadol and its active metabolite, especially those with renal or hepatic impairment. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Tramadol has a dual mechanism of action (opioid and SNRI), which contributes to its analgesic efficacy but also increases the risk of serotonin syndrome when combined with other serotonergic agents.
- Due to the risk of seizures, tramadol should be used with caution in patients with a history of epilepsy or other risk factors for seizures, or those taking medications that lower the seizure threshold.
- Tramadol ER is designed for once-daily dosing for chronic pain; it should not be used on an as-needed basis or for acute pain.
- Patients who are CYP2D6 ultra-rapid metabolizers may experience increased opioid effects and respiratory depression due to higher M1 concentrations. Genetic testing is not routinely performed but awareness of this risk is crucial.
- Always counsel patients on the safe storage and disposal of tramadol to prevent accidental ingestion, especially by children.
- Tapering is necessary when discontinuing tramadol, especially after prolonged use, to avoid withdrawal symptoms.
Alternative Therapies
- Other opioid analgesics (e.g., oxycodone ER, morphine ER, hydromorphone ER)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin)
- Antidepressants (e.g., duloxetine, venlafaxine for neuropathic pain)
- Physical therapy
- Cognitive behavioral therapy
- Interventional pain procedures
Cost & Coverage
Average Cost:
$50 - $200 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed to someone else.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. Discuss the availability and use of naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the medication taken, the quantity, and the time it was taken.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When seeking help, be prepared to provide detailed information about the medication, including the amount taken and the time of ingestion.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. Discuss the availability and use of naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the medication taken, the quantity, and the time it was taken.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When seeking help, be prepared to provide detailed information about the medication, including the amount taken and the time of ingestion.