Tramadol 100mg 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 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; mu-opioid receptor agonist; serotonin and norepinephrine reuptake inhibitor
Pregnancy Category
Category C
FDA Approved
Mar 1995
DEA Schedule
Schedule IV
Overview
What is this medicine?
Tramadol is a pain reliever that works in your brain to change how your body feels and responds to pain. It's used to treat moderate to moderately severe pain. It's important to take it exactly as prescribed because it can be habit-forming.
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 adhere to the guidelines.
Take this medication by mouth only. Do not inject or snort it, as this can lead to severe side effects, including respiratory distress and potentially fatal overdose.
You can take this medication with or without food. If it causes stomach upset, taking it with food may help alleviate this issue.
Storing and Disposing of Your Medication
To ensure the safety and efficacy of your medication:
Store it at room temperature in a dry location, avoiding bathrooms.
Keep it out of reach of children and pets, and secure it in a locked box or area to prevent unauthorized access.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.
Managing Missed Doses
If you take this medication regularly:
Take a missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at once or extra doses.
If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines.
Take this medication by mouth only. Do not inject or snort it, as this can lead to severe side effects, including respiratory distress and potentially fatal overdose.
You can take this medication with or without food. If it causes stomach upset, taking it with food may help alleviate this issue.
Storing and Disposing of Your Medication
To ensure the safety and efficacy of your medication:
Store it at room temperature in a dry location, avoiding bathrooms.
Keep it out of reach of children and pets, and secure it in a locked box or area to prevent unauthorized access.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.
Managing Missed Doses
If you take this medication regularly:
Take a missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at once or extra doses.
If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Avoid alcohol and other sedating medications (e.g., benzodiazepines, sleeping pills) as this can increase the risk of serious side effects like severe drowsiness and breathing problems.
- Do not drive or operate heavy machinery until you know how tramadol affects you, as it can cause dizziness and drowsiness.
- To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and consider over-the-counter laxatives as advised by your doctor.
- Do not stop taking tramadol suddenly, especially if you have been taking it for a long time, as this can cause withdrawal symptoms. Your doctor will guide you on how to safely reduce the dose.
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:
50-100 mg every 4-6 hours as needed for pain (immediate release)
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
initial_titration:
Initially 25 mg once daily, titrate by 25 mg every 3 days up to 100 mg/day in divided doses, then 50 mg every 3 days up to 200 mg/day. Max 400 mg/day.
chronic_pain_extended_release:
Initial 100 mg once daily, titrate by 100 mg every 5 days. Max 300 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children <12 years of age for pain. Contraindicated in children <12 years of age for post-operative pain management following tonsillectomy and/or adenoidectomy. Contraindicated in adolescents <18 years of age following tonsillectomy and/or adenoidectomy.
Adolescent:
Contraindicated in adolescents <18 years of age following tonsillectomy and/or adenoidectomy. Avoid in adolescents 12 to 18 years of age who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for CrCl >30 mL/min.
Moderate:
For CrCl <30 mL/min: Immediate release: 50 mg every 12 hours. Extended release: Not recommended.
Severe:
For CrCl <30 mL/min: Immediate release: 50 mg every 12 hours. Extended release: Not recommended.
Dialysis:
Tramadol is removed by hemodialysis. Administer after dialysis. For CrCl <30 mL/min: 50 mg every 12 hours.
Hepatic Impairment:
Mild:
No specific adjustment for mild impairment.
Moderate:
For severe hepatic impairment (Child-Pugh Class C): Immediate release: 50 mg every 12 hours. Extended release: Not recommended.
Severe:
For severe hepatic impairment (Child-Pugh Class C): Immediate release: 50 mg every 12 hours. Extended release: Not recommended.
Pharmacology
Mechanism of Action
Tramadol is a centrally acting synthetic opioid analgesic. It has a dual mechanism of action: it binds to mu-opioid receptors (weakly) and inhibits the reuptake of norepinephrine and serotonin, which contributes to its analgesic effects. The active metabolite, O-desmethyltramadol (M1), has a significantly higher affinity for mu-opioid receptors than tramadol itself.
Pharmacokinetics
Absorption:
Bioavailability:
75%
Tmax:
1.6-2 hours (immediate release)
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
2.7 L/kg
ProteinBinding:
Approximately 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
5-7 hours (tramadol); 7-9 hours (M1)
Clearance:
Not available
ExcretionRoute:
Renal
Unchanged:
Approximately 30% (tramadol); 10% (M1)
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour
PeakEffect:
2-3 hours
DurationOfAction:
4-6 hours
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 patient’s risk prior to prescribing tramadol, and monitor all patients receiving tramadol regularly for the development of these behaviors and conditions. Life-Threatening 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 neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. CYP2D6 Ultra-Rapid Metabolism: Patients who are ultra-rapid metabolizers of tramadol due to a CYP2D6 polymorphism may have higher than anticipated serum tramadol and M1 (active metabolite) concentrations, which can lead to an increased risk of respiratory depression. 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 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
Note: 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, which may occur, especially when taking certain other medications. Seek medical help immediately if you experience:
+ Agitation
+ Changes 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, which can cause serious health problems and may be fatal. 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 many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
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 questions or concerns about side effects, consult 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
Note: 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, which may occur, especially when taking certain other medications. Seek medical help immediately if you experience:
+ Agitation
+ Changes 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, which can cause serious health problems and may be fatal. 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 many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
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 questions or concerns about side effects, consult 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
- Agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea (signs of serotonin syndrome)
- Seizures
- Severe constipation or abdominal pain
- Signs of an allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble 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. Describe the allergic reaction and its 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 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. Describe the allergic reaction and its 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 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
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
Adhere strictly to your doctor's prescribed dosage and frequency. Taking more than prescribed, or taking it more often or for a longer duration, can increase the risk of severe side effects.
Do not combine this medication with other strong pain medications or use a pain patch without first consulting your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not exceed the prescribed dosage.
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific other medications, or those who consume excessive alcohol. Discuss your risk factors with your doctor.
Long-term or high-dose use of this medication can lead to tolerance, reducing its effectiveness. If you find that this medication is no longer working as well as it should, contact your doctor. Do not increase your dosage without medical guidance.
Low blood sugar (hypoglycemia) has been reported with this medication, sometimes requiring hospitalization. Seek immediate medical attention if you experience symptoms such as dizziness, headache, sleepiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating.
The long-term or regular use of opioid medications like this one can result in dependence. Suddenly lowering the dose or stopping the medication can increase the risk of withdrawal or other severe issues. Consult your doctor before making any changes to your dosage. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal interactions.
Prolonged 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 issues, contact your doctor.
Taking an opioid medication like this one can rarely lead to a severe adrenal gland problem. Seek immediate medical attention if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
Adhere strictly to your doctor's prescribed dosage and frequency. Taking more than prescribed, or taking it more often or for a longer duration, can increase the risk of severe side effects.
Do not combine this medication with other strong pain medications or use a pain patch without first consulting your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not exceed the prescribed dosage.
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific other medications, or those who consume excessive alcohol. Discuss your risk factors with your doctor.
Long-term or high-dose use of this medication can lead to tolerance, reducing its effectiveness. If you find that this medication is no longer working as well as it should, contact your doctor. Do not increase your dosage without medical guidance.
Low blood sugar (hypoglycemia) has been reported with this medication, sometimes requiring hospitalization. Seek immediate medical attention if you experience symptoms such as dizziness, headache, sleepiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating.
The long-term or regular use of opioid medications like this one can result in dependence. Suddenly lowering the dose or stopping the medication can increase the risk of withdrawal or other severe issues. Consult your doctor before making any changes to your dosage. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal interactions.
Prolonged 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 issues, contact your doctor.
Taking an opioid medication like this one can rarely lead to a severe adrenal gland problem. Seek immediate medical attention if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.
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
- Coma
What to Do:
Seek immediate emergency medical attention. Call 911 or the Poison Control Center at 1-800-222-1222. Naloxone may be administered by emergency personnel.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of serotonin syndrome, seizures)
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, St. John's Wort, mirtazapine, trazodone, linezolid) - increased risk of serotonin syndrome
- Drugs that lower seizure threshold (e.g., bupropion, tricyclic antidepressants, SSRIs, antipsychotics) - increased risk of seizures
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - decreased formation of active M1 metabolite, potentially reducing efficacy
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir) - increased tramadol exposure, potentially increasing adverse effects
- CYP2D6 inducers (e.g., rifampin, carbamazepine, phenytoin) - increased formation of active M1 metabolite, potentially increasing adverse effects or toxicity
- CYP3A4 inducers (e.g., carbamazepine, rifampin, phenytoin) - decreased tramadol exposure, potentially reducing efficacy
Moderate Interactions
- Warfarin - increased INR and bleeding risk
- Digoxin - isolated reports of digoxin toxicity
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
Respiratory rate and depth
Rationale: To assess baseline respiratory function, especially in patients with respiratory compromise.
Timing: Prior to initiation of therapy
Mental status (sedation level, alertness)
Rationale: To assess baseline neurological status and identify risk for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function
Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain level
Frequency: Regularly, as clinically indicated (e.g., daily, before/after dose)
Target: Acceptable pain control with minimal side effects
Action Threshold: Uncontrolled pain or excessive side effects warrant dose adjustment or alternative therapy
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration
Target: Normal for patient (e.g., 12-20 breaths/min)
Action Threshold: Respiratory depression (<10 breaths/min, shallow breathing) requires immediate intervention
Sedation level
Frequency: Regularly, especially during initiation and dose titration
Target: Alert and oriented, or easily aroused
Action Threshold: Excessive sedation (difficult to arouse, somnolence) requires dose reduction or discontinuation
Bowel function
Frequency: Daily
Target: Regular bowel movements
Action Threshold: Constipation requires prophylactic measures or treatment
Signs of Serotonin Syndrome
Frequency: Regularly, especially with concomitant serotonergic drugs
Target: Absence of symptoms
Action Threshold: Agitation, hallucinations, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea require immediate medical attention
Signs of Seizure Activity
Frequency: Regularly, especially in patients with risk factors or on concomitant seizure-lowering drugs
Target: Absence of seizures
Action Threshold: Any seizure activity requires immediate medical attention and re-evaluation of therapy
Symptom Monitoring
- Drowsiness
- Nausea
- Vomiting
- Constipation
- Dizziness
- Headache
- Pruritus
- Sweating
- Signs of respiratory depression (slow, shallow breathing, blue lips/skin)
- Signs of serotonin syndrome (agitation, confusion, rapid heart rate, fever, muscle rigidity, sweating, diarrhea)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of opioid withdrawal (restlessness, yawning, sweating, tearing, runny nose, muscle aches, chills, dilated pupils, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, increased blood pressure, respiratory rate, heart rate)
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 patients of the risk of NOWS.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure.
Second Trimester:
Risk of NOWS increases with prolonged use.
Third Trimester:
High risk of NOWS with prolonged use. Risk of respiratory depression in the neonate if used close to delivery.
Lactation
Tramadol and its active metabolite (M1) are present in breast milk. There are reports of serious adverse reactions in breastfed infants, including excess sedation and respiratory depression. Breastfeeding is not recommended during treatment with tramadol due to the potential for serious adverse reactions in breastfed infants.
Infant Risk:
High (L3 - Moderately Safe, but with significant caveats and warnings due to M1 exposure and potential for serious adverse effects in infants, especially those of mothers who are CYP2D6 ultra-rapid metabolizers).
Pediatric Use
Contraindicated in children <12 years of age for pain. Contraindicated in children <18 years of age following tonsillectomy and/or adenoidectomy. Avoid in adolescents 12 to 18 years of age with certain risk factors (e.g., obesity, sleep apnea, severe lung disease) due to increased risk of serious breathing problems. Generally, use is not recommended due to variable metabolism and risk of respiratory depression.
Geriatric Use
Start with lower doses and titrate slowly due to increased sensitivity to adverse effects (e.g., respiratory depression, constipation, dizziness, falls). Increased risk of seizures. Monitor renal and hepatic function closely.
Clinical Information
Clinical Pearls
- Tramadol is a prodrug; its analgesic effect is largely dependent on its active metabolite, O-desmethyltramadol (M1), formed by CYP2D6. Genetic variations in CYP2D6 can significantly impact efficacy and safety.
- Unlike traditional opioids, tramadol also inhibits norepinephrine and serotonin reuptake, contributing to its analgesic effect but also increasing the risk of serotonin syndrome when combined with other serotonergic agents.
- Tramadol lowers the seizure threshold; use with caution in patients with a history of seizures or those taking medications that also lower the seizure threshold.
- Despite being a Schedule IV controlled substance, it carries significant risks of addiction, abuse, and misuse similar to other opioids.
- Extended-release formulations should not be crushed, chewed, or dissolved, as this can lead to rapid release and absorption of a potentially fatal dose.
Alternative Therapies
- Other opioid analgesics (e.g., hydrocodone, oxycodone, morphine, codeine)
- Non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, celecoxib)
- Acetaminophen
- Gabapentin
- Pregabalin
- Duloxetine
- Tapentadol (another centrally acting opioid with SNRI properties)
- Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 50mg-100mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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 safe use, do not share your medication with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe and effective use. It is essential to read this guide carefully and review it again each time 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 used as part of the treatment. 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. When seeking help, be prepared to provide information about the medication taken, the amount, 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 reporting the incident, 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 and effective use. It is essential to read this guide carefully and review it again each time 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 used as part of the treatment. 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. When seeking help, be prepared to provide information about the medication taken, the amount, 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 reporting the incident, be prepared to provide detailed information about the medication, including the amount taken and the time of ingestion.