Tramadol Hcl ER 100mg (biphasic) Tb
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
Sep 2004
DEA Schedule
Schedule IV
Overview
What is this medicine?
Tramadol HCl ER is an extended-release tablet used to manage moderate to moderately severe chronic pain. It works in the brain to change how your body feels and responds to pain. The extended-release form means it releases the medicine slowly over time, so you usually 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. Be sure to 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 ensure safety.
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 for guidance on 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. Be sure to 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 ensure safety.
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 for guidance on 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 this medication, as it can increase the risk of serious side effects like respiratory depression.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- Store this medication securely away from children and pets, preferably in a locked cabinet, to prevent accidental ingestion.
- Do not crush, chew, or break the extended-release tablet, as this can lead to rapid release and absorption of a potentially fatal dose.
- Discuss all other medications, supplements, and herbal products you are taking with your doctor to avoid dangerous drug interactions.
- Maintain regular bowel movements by increasing fiber and fluid intake, as constipation is a common side effect.
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:
100 mg orally once daily (for extended-release, after titration)
Dose Range:
100 - 300 mg
Condition-Specific Dosing:
chronic pain:
Initial dose typically 100 mg once daily, titrated by 50 mg increments every 5 days to a maximum of 300 mg/day. For biphasic formulations, the 100mg dose is a common starting or maintenance dose.
Pediatric Dosing
Neonatal:
Not established; contraindicated in children younger than 12 years for pain, and younger than 18 years for post-tonsillectomy/adenoidectomy pain.
Infant:
Not established; contraindicated in children younger than 12 years.
Child:
Not established; contraindicated in children younger than 12 years.
Adolescent:
Not established for ER formulations; contraindicated in adolescents younger than 18 years for post-tonsillectomy/adenoidectomy pain. Use with caution and at lowest effective dose if prescribed for other indications, considering CYP2D6 ultra-rapid metabolizer risk.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for CrCl > 30 mL/min for ER formulations, but monitor closely.
Moderate:
CrCl < 30 mL/min: Not recommended for extended-release formulations due to prolonged half-life of active metabolite. If used, consider reducing dose and/or extending dosing interval for immediate-release, but ER is generally contraindicated.
Severe:
CrCl < 30 mL/min: Not recommended for extended-release formulations.
Dialysis:
Tramadol and its metabolites are slowly removed by hemodialysis. Extended-release formulations are not recommended in patients requiring dialysis.
Hepatic Impairment:
Mild:
No specific adjustment for mild impairment, but monitor closely.
Moderate:
Not recommended for extended-release formulations due to prolonged half-life. If immediate-release is used, consider reducing dose and/or extending dosing interval.
Severe:
Not recommended for extended-release formulations due to prolonged half-life.
Pharmacology
Mechanism of Action
Tramadol is a centrally acting synthetic opioid analgesic. It has a dual mechanism of action: 1) It is a weak agonist at mu-opioid receptors. 2) It inhibits the reuptake of norepinephrine and serotonin, which contributes to its analgesic effect by modulating descending pain pathways. The active metabolite, O-desmethyltramadol (M1), has a significantly higher affinity for mu-opioid receptors than tramadol itself.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (oral)
Tmax:
Approximately 12 hours for extended-release formulations (may vary slightly for biphasic, with an earlier initial peak and a later sustained peak)
FoodEffect:
Minimal effect on absorption for extended-release formulations; can be taken with or without food.
Distribution:
Vd:
Approximately 2.7 L/kg
ProteinBinding:
Approximately 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Tramadol: Approximately 6.3 hours; O-desmethyltramadol (M1): Approximately 7.4 hours (for immediate-release, extended-release half-life is effectively longer due to sustained release)
Clearance:
Approximately 0.8 L/hr/kg
ExcretionRoute:
Renal (approximately 90% as metabolites, 10% as unchanged drug)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour (for immediate-release; for ER, initial onset may be delayed but sustained)
PeakEffect:
Approximately 12 hours (for extended-release)
DurationOfAction:
Approximately 24 hours (for extended-release)
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
RISK OF 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 patient’s risk prior to prescribing tramadol, and monitor all patients regularly for the development of these behaviors and conditions.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of tramadol. 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 NOWS 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 of the reported cases occurred following tonsillectomy and/or adenoidectomy and were associated with evidence of ultra-rapid metabolism of tramadol to O-desmethyltramadol (an opioid agonist) due to a CYP2D6 polymorphism. Tramadol is contraindicated in children younger than 12 years of age and in adolescents 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 that may increase their sensitivity to the respiratory depressant effects of tramadol unless the benefits outweigh the risks.
INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES: The concomitant use of tramadol with all cytochrome P450 3A4 inhibitors or 2D6 inhibitors may result in an increase in tramadol plasma concentrations and may cause potentially fatal respiratory depression. In addition, concomitant use with CYP3A4 inducers may decrease tramadol plasma concentrations, resulting in decreased efficacy or opioid withdrawal symptoms.
RISK FROM 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 with use of tramadol. 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 NOWS 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 of the reported cases occurred following tonsillectomy and/or adenoidectomy and were associated with evidence of ultra-rapid metabolism of tramadol to O-desmethyltramadol (an opioid agonist) due to a CYP2D6 polymorphism. Tramadol is contraindicated in children younger than 12 years of age and in adolescents 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 that may increase their sensitivity to the respiratory depressant effects of tramadol unless the benefits outweigh the risks.
INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES: The concomitant use of tramadol with all cytochrome P450 3A4 inhibitors or 2D6 inhibitors may result in an increase in tramadol plasma concentrations and may cause potentially fatal respiratory depression. In addition, concomitant use with CYP3A4 inducers may decrease tramadol plasma concentrations, resulting in decreased efficacy or opioid withdrawal symptoms.
RISK FROM 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
While rare, some people may experience severe and potentially life-threatening side effects when 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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of depression, suicidal thoughts, or mood changes, including:
+ Emotional ups and downs
+ Abnormal thinking or anxiety
+ Lack of interest in life
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Severe dizziness or fainting
Feeling confused or disoriented
Seizures
Chest pain or pressure, or a rapid heartbeat
Difficulty urinating or frequent urination
Breathing difficulties, slow or shallow breathing, or noisy breathing
Sleep apnea (breathing problems during sleep)
Changes in vision
Severe constipation or stomach pain, which may indicate a serious bowel problem
Serotonin syndrome, a potentially life-threatening condition, may occur, especially when taking certain other medications. Seek medical help immediately if you experience:
+ Agitation
+ Changes in balance or coordination
+ 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 or toxic epidermal necrolysis, a severe skin reaction, may occur. Seek medical help immediately if you experience:
+ 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 experience few or no side effects when taking this medication. However, some people may experience:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, nausea, or vomiting
Dry mouth
Headache
Itching
Sleep disturbances
Flushing
* Excessive sweating
If any of these side effects or other symptoms bother you or persist, contact your doctor or seek medical attention.
Reporting Side Effects
If you have questions or concerns about side effects, 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of depression, suicidal thoughts, or mood changes, including:
+ Emotional ups and downs
+ Abnormal thinking or anxiety
+ Lack of interest in life
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Severe dizziness or fainting
Feeling confused or disoriented
Seizures
Chest pain or pressure, or a rapid heartbeat
Difficulty urinating or frequent urination
Breathing difficulties, slow or shallow breathing, or noisy breathing
Sleep apnea (breathing problems during sleep)
Changes in vision
Severe constipation or stomach pain, which may indicate a serious bowel problem
Serotonin syndrome, a potentially life-threatening condition, may occur, especially when taking certain other medications. Seek medical help immediately if you experience:
+ Agitation
+ Changes in balance or coordination
+ 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 or toxic epidermal necrolysis, a severe skin reaction, may occur. Seek medical help immediately if you experience:
+ 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 experience few or no side effects when taking this medication. However, some people may experience:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, nausea, or vomiting
Dry mouth
Headache
Itching
Sleep disturbances
Flushing
* Excessive sweating
If any of these side effects or other symptoms bother you or persist, contact your doctor or seek medical attention.
Reporting Side Effects
If you have questions or concerns about side effects, 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:
- Slow or shallow breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion or unusual thoughts
- Seizures (convulsions)
- Symptoms of serotonin syndrome: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea
- Severe constipation or abdominal pain
- Signs of an allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential 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, such as foods or drugs. Describe the allergic reaction and its symptoms.
Respiratory problems, including asthma, breathing difficulties, or sleep apnea, as well as high levels of carbon dioxide in the blood.
Gastrointestinal issues, such as 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 cause drowsiness, 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 crucial 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 essential 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, such as foods or drugs. Describe the allergic reaction and its symptoms.
Respiratory problems, including asthma, breathing difficulties, or sleep apnea, as well as high levels of carbon dioxide in the blood.
Gastrointestinal issues, such as 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 cause drowsiness, 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 crucial 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
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount can increase your risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor.
Monitoring Your Condition
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 amount.
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 can lead to tolerance, where the medication may not work as effectively, and you may require 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 amount.
Low Blood Sugar
This medication can cause low blood sugar, which may 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 can lead to dependence. Suddenly stopping or reducing the dose can increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dosage, 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 it can lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications can 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 can 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
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount can increase your risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor.
Monitoring Your Condition
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 amount.
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 can lead to tolerance, where the medication may not work as effectively, and you may require 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 amount.
Low Blood Sugar
This medication can cause low blood sugar, which may 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 can lead to dependence. Suddenly stopping or reducing the dose can increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dosage, 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 it can lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications can 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 can 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:
- Respiratory depression (slowed or stopped breathing)
- Extreme drowsiness leading to stupor or coma
- Pinpoint pupils
- Flaccid skeletal muscles
- Cold, clammy skin
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Circulatory collapse
- Cardiac arrest
- Seizures
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Naloxone may be administered to reverse opioid effects, but may not fully reverse seizures. Supportive care including maintaining a patent airway and assisted ventilation is crucial.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome, seizures)
- Linezolid (MAOI activity)
- Methylene blue (MAOI activity)
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers): Increased risk of respiratory depression, profound sedation, coma, and death.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, St. John's Wort, fentanyl, lithium, buspirone): Increased risk of serotonin syndrome.
- Carbamazepine: Significantly decreases tramadol plasma concentrations, reducing analgesic effect.
- Quinidine (CYP2D6 inhibitor): Increases tramadol plasma concentrations and decreases M1, potentially reducing efficacy and increasing adverse effects.
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, bupropion): May decrease formation of active M1 metabolite, 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, phenytoin): May decrease tramadol exposure, potentially reducing efficacy.
Moderate Interactions
- Warfarin: Increased INR and bleeding risk (monitor INR closely).
- Digoxin: Possible increased digoxin levels (monitor digoxin levels).
Minor Interactions
- Not specifically categorized as minor for tramadol due to significant risks associated with most interactions.
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy
Renal function (CrCl, BUN, creatinine)
Rationale: To assess need for dose adjustment due to renal elimination.
Timing: Prior to initiation of therapy
Hepatic function (ALT, AST, bilirubin)
Rationale: To assess need for dose adjustment due to hepatic metabolism.
Timing: Prior to initiation of therapy
History of substance abuse, mental health disorders
Rationale: To assess risk of addiction, abuse, and misuse.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain relief and functional improvement
Frequency: Regularly, at each follow-up visit (e.g., monthly or quarterly)
Target: Patient-specific goals for pain reduction and improved function
Action Threshold: Inadequate pain control or worsening pain may indicate need for dose adjustment or alternative therapy; excessive sedation or adverse effects may indicate need for dose reduction.
Signs of respiratory depression (respiratory rate, depth, oxygen saturation)
Frequency: Regularly, especially during initiation and dose titration, and if co-administered with other CNS depressants.
Target: Respiratory rate > 12 breaths/min, SpO2 > 92%
Action Threshold: Respiratory rate < 10 breaths/min, shallow breathing, cyanosis, somnolence; requires immediate intervention.
Signs of addiction, abuse, or misuse
Frequency: Regularly, at each follow-up visit
Target: Absence of drug-seeking behavior, diversion, or escalation of use beyond prescribed.
Action Threshold: Evidence of drug-seeking behavior, diversion, or escalation of use; requires intervention, including potential discontinuation or referral for addiction treatment.
Adverse effects (e.g., constipation, nausea, dizziness, sedation, seizures, serotonin syndrome symptoms)
Frequency: Regularly, at each follow-up visit
Target: Tolerable or absent adverse effects
Action Threshold: Intolerable or severe adverse effects; requires dose adjustment or discontinuation.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or somnolence
- Dizziness, lightheadedness
- Nausea, vomiting, constipation
- Seizures (especially with higher doses or predisposing factors)
- Symptoms of serotonin syndrome (agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle stiffness/twitching, loss of coordination, nausea, vomiting, diarrhea)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Symptoms of adrenal insufficiency (nausea, vomiting, anorexia, fatigue, weakness, dizziness, low blood pressure)
Special Patient Groups
Pregnancy
Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which can be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus. Advise pregnant patients of the risk of NOWS.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure. Risk of NOWS if prolonged use continues.
Second Trimester:
Risk of NOWS if prolonged use continues.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used for prolonged periods. Risk of respiratory depression in the neonate if used close to delivery.
Lactation
Tramadol and its active metabolite (M1) are present in breast milk. Infants exposed to tramadol through breast milk are at risk of serious adverse reactions, including excess sedation and respiratory depression. Breastfeeding is not recommended during tramadol treatment. If breastfeeding cannot be avoided, monitor the infant closely for signs of sedation and respiratory depression.
Infant Risk:
Moderate to high risk of sedation, respiratory depression, and withdrawal symptoms in the infant.
Pediatric Use
Contraindicated in children younger than 12 years of age for pain. Contraindicated in adolescents younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid use in adolescents 12 to 18 years of age with other risk factors for respiratory depression (e.g., obesity, sleep apnea, severe lung disease) unless benefits outweigh risks, due to risk of ultra-rapid metabolism via CYP2D6.
Geriatric Use
Use with caution in elderly patients (65 years and older). Start with lower doses and titrate slowly due to increased sensitivity to adverse effects (e.g., respiratory depression, constipation, falls) and potential for decreased renal/hepatic function. The maximum daily dose for patients over 75 years of age is generally lower (e.g., 300 mg/day for immediate-release, similar caution for ER).
Clinical Information
Clinical Pearls
- Tramadol has a dual mechanism of action (opioid agonism and monoamine reuptake inhibition), which contributes to its analgesic efficacy but also its unique side effect profile, including a risk of serotonin syndrome and seizures.
- The extended-release formulation is designed for chronic pain management and should not be used for acute pain or on an as-needed basis.
- Patients who are CYP2D6 ultra-rapid metabolizers may experience increased opioid effects (e.g., respiratory depression) due to higher conversion to the active M1 metabolite, while poor metabolizers may experience reduced efficacy.
- Always assess for risk factors for addiction, abuse, and misuse before initiating and throughout therapy.
- Educate patients on the critical importance of not crushing, chewing, or breaking the extended-release tablets to avoid rapid release of a potentially fatal dose.
- Be vigilant for signs of serotonin syndrome, especially when co-administered with other serotonergic drugs.
- Tramadol lowers the seizure threshold; use with caution in patients with a history of seizures or those taking other medications that lower the seizure threshold.
Alternative Therapies
- Other opioid analgesics (e.g., hydrocodone, oxycodone, morphine - for moderate to severe chronic pain)
- NSAIDs (e.g., ibuprofen, naproxen - for mild to moderate pain, often as adjuncts)
- Acetaminophen (for mild to moderate pain, often as adjunct)
- SNRIs (e.g., duloxetine, venlafaxine - for neuropathic pain, with analgesic properties)
- Gabapentinoids (e.g., gabapentin, pregabalin - for neuropathic pain)
- Tricyclic antidepressants (e.g., amitriptyline - for neuropathic pain)
- Physical therapy, occupational therapy, acupuncture, cognitive behavioral therapy (non-pharmacological approaches for chronic pain)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$100+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic ER formulations), Tier 3 (for brand-name ER formulations)
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 effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Consult with your doctor or pharmacist to learn more about accessing and using naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide the necessary information, including the substance involved, the quantity taken, and the time of the incident, to ensure you receive appropriate treatment and care.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Consult with your doctor or pharmacist to learn more about accessing and using naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide the necessary information, including the substance involved, the quantity taken, and the time of the incident, to ensure you receive appropriate treatment and care.