Tramadol 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 analgesic; Opioid agonist; Serotonin-norepinephrine reuptake inhibitor (SNRI)
Pregnancy Category
Not available
FDA Approved
Sep 2007
DEA Schedule
Schedule IV
Overview
What is this medicine?
Tramadol ER is an extended-release pain medicine used to treat moderate to severe chronic pain. It works in the brain to change how your body feels and responds to pain. Because it's extended-release, it's taken once a day to provide continuous pain relief.
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 trouble breathing 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, away from the 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 store it safely.
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.
What to Do If You Miss 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 trouble breathing 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, away from the 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 store it safely.
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.
What to Do If You Miss 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
- Take exactly as prescribed; do not take more than directed or more often than directed.
- Swallow the tablet whole; do not crush, chew, or break it, as this can lead to a rapid release of the drug and potentially fatal overdose.
- Do not drink alcohol while taking tramadol, 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 or drowsiness.
- Store securely away from children and pets, as accidental ingestion can be fatal.
- Discuss all other medications, including over-the-counter drugs, supplements, and herbal products, with your doctor to avoid dangerous interactions.
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:
300 mg once daily
Dose Range:
100 - 300 mg
Condition-Specific Dosing:
chronic_pain:
Initial dose: 100 mg once daily. Titrate by 50 mg increments every 5 days to a maximum of 300 mg once daily. Do not exceed 300 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Contraindicated in children younger than 12 years of age. Contraindicated in adolescents younger than 18 years of age following tonsillectomy and/or adenoidectomy.
Adolescent:
Contraindicated in adolescents younger than 18 years of age following tonsillectomy and/or adenoidectomy. Use with caution in adolescents 12-18 years of age with other risk factors for respiratory depression.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for CrCl > 30 mL/min.
Moderate:
For CrCl < 30 mL/min, extended-release formulations are generally not recommended. If used, consider reducing dose and/or extending dosing interval.
Severe:
Not recommended for extended-release formulations.
Dialysis:
Not recommended for extended-release formulations due to prolonged half-life and accumulation.
Hepatic Impairment:
Mild:
No specific adjustment for mild impairment, but monitor closely.
Moderate:
Not recommended for extended-release formulations.
Severe:
Not recommended for extended-release formulations.
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 (O-desmethyltramadol, M1) to Îŧ-opioid receptors, and weak inhibition of the reuptake of norepinephrine and serotonin, which enhances the inhibitory effects of descending pain pathways.
Pharmacokinetics
Absorption:
Bioavailability:
75%
Tmax:
Approximately 12 hours (for ER formulations)
FoodEffect:
Food does not significantly affect the rate or extent of absorption of extended-release tramadol.
Distribution:
Vd:
Approximately 2.7 L/kg
ProteinBinding:
Approximately 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Parent drug: 6-7 hours; O-desmethyltramadol (M1): 7-9 hours
Clearance:
Approximately 0.5 L/hr/kg
ExcretionRoute:
Renal (approximately 90% of dose)
Unchanged:
Approximately 30% (parent drug)
Pharmacodynamics
OnsetOfAction:
Not available (for ER, gradual onset over hours)
PeakEffect:
Approximately 12 hours (for ER formulations)
DurationOfAction:
Approximately 24 hours (for ER formulations)
Safety & Warnings
BLACK BOX WARNING
Addiction, Abuse, and Misuse; Respiratory Depression; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants; Risks with CYP2D6 Ultra-Rapid Metabolizers.
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 medical attention immediately:
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
In rare cases, 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, such as:
+ Slow breathing
+ 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, may occur, 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, may occur, which can cause long-term health problems or even death. 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 do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Feeling dizzy, sleepy, tired, or weak
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 concerns or questions 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.
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 medical attention immediately:
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
In rare cases, 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, such as:
+ Slow breathing
+ 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, may occur, 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, may occur, which can cause long-term health problems or even death. 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 do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Feeling dizzy, sleepy, tired, or weak
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 concerns or questions 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:
- Difficulty breathing or shallow breathing
- Extreme drowsiness or feeling faint
- Confusion or disorientation
- Pinpoint pupils
- Cold, clammy skin
- Seizures
- Agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea (signs of serotonin syndrome)
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 reactions you have experienced.
Respiratory issues, such as asthma, breathing difficulties, or sleep apnea; elevated carbon dioxide levels in the blood; or any stomach or bowel blockage or narrowing.
Kidney or liver disease, as these conditions may affect how your body processes the medication.
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol or other drugs.
If your doctor has informed you that you are a rapid metabolizer of certain medications, as this may impact the effectiveness and safety of the treatment.
Recent consumption of large amounts of alcohol or use of medications that can slow your reactions, such as phenobarbital or certain pain relievers like oxycodone.
Current or recent use of carbamazepine, as it may interact with this medication.
Use of another medication containing the same active ingredient, as this can increase the risk of adverse effects.
Concurrent use of buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine, as these medications can interact with this drug.
Use of certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, due to the risk of severely high blood pressure.
Additionally, if you are breast-feeding, please note that you should not breast-feed while taking this medication.
This list is not exhaustive, and it is essential to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Do not start, stop, or change the dose of any medication without first 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 reactions you have experienced.
Respiratory issues, such as asthma, breathing difficulties, or sleep apnea; elevated carbon dioxide levels in the blood; or any stomach or bowel blockage or narrowing.
Kidney or liver disease, as these conditions may affect how your body processes the medication.
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol or other drugs.
If your doctor has informed you that you are a rapid metabolizer of certain medications, as this may impact the effectiveness and safety of the treatment.
Recent consumption of large amounts of alcohol or use of medications that can slow your reactions, such as phenobarbital or certain pain relievers like oxycodone.
Current or recent use of carbamazepine, as it may interact with this medication.
Use of another medication containing the same active ingredient, as this can increase the risk of adverse effects.
Concurrent use of buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine, as these medications can interact with this drug.
Use of certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, due to the risk of severely high blood pressure.
Additionally, if you are breast-feeding, please note that you should not breast-feed while taking this medication.
This list is not exhaustive, and it is essential to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Precautions
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when navigating stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may 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 may lead to tolerance, requiring higher doses to achieve the same effect. If you find that this medication is no longer effective, contact your doctor. Do not take more than the prescribed amount.
Low Blood Sugar
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 lowering the dose or stopping the medication may increase the risk of withdrawal or other severe problems. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions carefully. Inform your doctor if you experience increased pain, mood changes, suicidal thoughts, or other adverse effects.
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 crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when navigating stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may 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 may lead to tolerance, requiring higher doses to achieve the same effect. If you find that this medication is no longer effective, contact your doctor. Do not take more than the prescribed amount.
Low Blood Sugar
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 lowering the dose or stopping the medication may increase the risk of withdrawal or other severe problems. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions carefully. Inform your doctor if you experience increased pain, mood changes, suicidal thoughts, or other adverse effects.
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:
- Respiratory depression (slow, shallow breathing)
- Extreme drowsiness leading to stupor or coma
- Pinpoint pupils
- Flaccid skeletal muscles
- Cold and clammy skin
- Bradycardia
- Hypotension
- Circulatory collapse
- Cardiac arrest
- Death
- Seizures (can occur with or without other opioid overdose symptoms)
What to Do:
Seek immediate emergency medical attention. Call 911 or Poison Control at 1-800-222-1222. Naloxone may 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 use (risk of serotonin syndrome, seizures)
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Significant respiratory depression
- Known or suspected paralytic ileus
- Hypersensitivity to tramadol or any component of the formulation
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants): Increased risk of respiratory depression, profound sedation, coma, and death.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, linezolid, St. John's Wort): Increased risk of serotonin syndrome.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May increase tramadol exposure and decrease M1 exposure, potentially reducing analgesic effect and increasing risk of adverse effects from parent drug.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir): May increase tramadol exposure, increasing risk of adverse effects.
- Carbamazepine: Significantly decreases tramadol plasma concentrations, reducing analgesic effect.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, phenytoin): May decrease tramadol plasma concentrations, reducing analgesic effect.
- Warfarin: Isolated reports of increased INR/prothrombin time; monitor coagulation parameters.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy
Medical history (including substance abuse, seizure disorder, respiratory conditions)
Rationale: To identify contraindications, risk factors for adverse effects (e.g., respiratory depression, seizures), and potential for abuse.
Timing: Prior to initiation of therapy
Concomitant medications review
Rationale: To identify potential drug-drug interactions (e.g., CNS depressants, serotonergic drugs, CYP inhibitors/inducers).
Timing: Prior to initiation of therapy
Routine Monitoring
Pain relief and functional improvement
Frequency: Regularly, especially during titration and dose changes
Target: Individualized, aiming for acceptable pain control with minimal side effects
Action Threshold: Inadequate pain control or intolerable side effects warrant dose adjustment or alternative therapy.
Signs of respiratory depression (e.g., decreased respiratory rate, shallow breathing, somnolence)
Frequency: Regularly, especially during initiation and dose escalation
Target: Respiratory rate > 12 breaths/min, normal depth
Action Threshold: Respiratory rate < 10 breaths/min, shallow breathing, or increased somnolence requires immediate intervention.
Signs of CNS depression (e.g., sedation, dizziness, confusion)
Frequency: Regularly
Target: Alert and oriented, minimal sedation
Action Threshold: Excessive sedation, confusion, or impaired consciousness.
Bowel function (constipation)
Frequency: Regularly
Target: Regular bowel movements
Action Threshold: Constipation requiring intervention (e.g., laxatives, stool softeners).
Signs of abuse, misuse, or addiction
Frequency: Regularly, at each visit
Target: Absence of aberrant drug-related behaviors
Action Threshold: Evidence of drug-seeking behavior, escalating use, or diversion.
Signs of serotonin syndrome (e.g., 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 any symptoms requires immediate medical attention and discontinuation of tramadol.
Seizure activity
Frequency: Monitor closely, especially in patients with risk factors
Target: Absence of seizures
Action Threshold: Occurrence of seizure.
Symptom Monitoring
- Respiratory depression
- Excessive sedation
- Dizziness
- Nausea
- Vomiting
- Constipation
- Seizures
- Agitation
- Hallucinations
- Tachycardia
- Fever
- Hyperreflexia
- Incoordination
- Diarrhea
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to the risk of neonatal opioid withdrawal syndrome (NOWS) in the newborn. Prolonged use during pregnancy can lead to physical dependence in the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure.
Second Trimester:
Risk of fetal growth restriction and other adverse outcomes with prolonged opioid use.
Third Trimester:
High risk of Neonatal Opioid Withdrawal Syndrome (NOWS) if used chronically. Symptoms include irritability, hyperactivity, abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, and failure to gain weight.
Lactation
Tramadol and its active metabolite (M1) are excreted into breast milk. While levels are generally low, there is a risk of serious adverse reactions in breastfed infants, including sedation, respiratory depression, and death. Breastfeeding is generally not recommended.
Infant Risk:
Risk of sedation, respiratory depression, poor feeding, and death. Monitor infants for increased sleepiness, difficulty breathing, or limpness.
Pediatric Use
Contraindicated in children younger than 12 years of age. Contraindicated in adolescents younger than 18 years of age following tonsillectomy and/or adenoidectomy. Use with caution in adolescents 12-18 years of age with other risk factors for respiratory depression (e.g., obesity, sleep apnea, severe pulmonary disease).
Geriatric Use
Start with lower doses and titrate slowly due to increased sensitivity to adverse effects (e.g., respiratory depression, constipation, dizziness) and potential for decreased renal/hepatic function. Monitor closely for CNS and respiratory depression.
Clinical Information
Clinical Pearls
- Tramadol has a dual mechanism of action (opioid agonism and monoamine reuptake inhibition), contributing to its analgesic effect but also increasing the risk of serotonin syndrome and seizures.
- Extended-release formulations are designed for once-daily dosing for chronic pain and should NEVER be crushed, chewed, or dissolved due to the risk of rapid drug release and fatal overdose.
- Be aware of the Black Box Warnings, especially regarding addiction, respiratory depression, and the risks of concomitant use with other CNS depressants.
- Patients who are CYP2D6 ultra-rapid metabolizers may experience higher than normal levels of the active M1 metabolite, leading to increased opioid effects and potentially fatal respiratory depression.
- Tramadol lowers the seizure threshold; use with caution in patients with a history of seizures, head trauma, metabolic disorders, or those taking other medications that lower the seizure threshold (e.g., antidepressants, antipsychotics).
- Educate patients on the signs of serotonin syndrome and the importance of avoiding other serotonergic drugs unless specifically approved by their physician.
- Due to its opioid properties, tramadol carries a risk of physical dependence and withdrawal symptoms upon abrupt discontinuation. Taper slowly when discontinuing therapy.
Alternative Therapies
- Other opioid analgesics (e.g., oxycodone ER, morphine ER, hydromorphone ER)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin)
- Adjuvant analgesics (e.g., tricyclic antidepressants, SNRIs like duloxetine for neuropathic pain)
- Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$150 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, contact your doctor immediately. It is essential to use your prescribed medication responsibly: do not share it with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been used. 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 seeking help, be prepared to provide the necessary information, including what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been used. 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 seeking help, be prepared to provide the necessary information, including what was taken, the quantity, and the time of the incident.