Tramadol 50mg 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 Analgesic; Opioid Agonist; Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
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 and has serious risks.
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 potentially fatal overdose.
You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Storing and Disposing of Your Medication
To ensure the safety and efficacy of your medication:
Store it at room temperature in a dry place, avoiding bathrooms.
Keep it in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area for storage.
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 explore potential drug take-back programs in your area.
Managing Missed Doses
If you take this medication regularly and miss a dose:
Take the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses.
If you take this medication as needed, follow your doctor's instructions regarding frequency of use and do not take it more often than prescribed.
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 potentially fatal overdose.
You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Storing and Disposing of Your Medication
To ensure the safety and efficacy of your medication:
Store it at room temperature in a dry place, avoiding bathrooms.
Keep it in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area for storage.
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 explore potential drug take-back programs in your area.
Managing Missed Doses
If you take this medication regularly and miss a dose:
Take the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses.
If you take this medication as needed, follow your doctor's instructions regarding frequency of use and do not take it more often than prescribed.
Lifestyle & Tips
- Do not drink alcohol while taking tramadol, as it can increase the risk of serious side effects like extreme drowsiness and breathing problems.
- Avoid driving or operating heavy machinery until you know how tramadol affects you, as it can cause dizziness and drowsiness.
- Store tramadol securely away from children and pets, and dispose of unused medication properly to prevent accidental ingestion.
- Discuss all other medications, supplements, and herbal products you are taking with your doctor to avoid dangerous drug 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:
50 mg orally every 4-6 hours as needed for pain
Dose Range:
50 - 400 mg
Condition-Specific Dosing:
initialDose:
For moderate to moderately severe chronic pain, initiate with 25 mg once daily, titrate by 25 mg every 3 days to 50 mg four times daily. Then, titrate by 50 mg every 3 days to 50 mg four times daily.
maximumDailyDose:
400 mg/day (immediate-release)
elderly:
For patients >75 years, maximum daily dose is 300 mg/day (immediate-release).
Pediatric Dosing
Neonatal:
Not established (contraindicated in children <12 years)
Infant:
Not established (contraindicated in children <12 years)
Child:
Not established (contraindicated in children <12 years)
Adolescent:
For adolescents 12-17 years: 50-100 mg every 4-6 hours as needed for pain. Max 400 mg/day. Use with caution due to risk of serious adverse events including respiratory depression, especially in CYP2D6 ultra-rapid metabolizers.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl >30 mL/min)
Moderate:
For CrCl <30 mL/min: 50-100 mg every 12 hours. Maximum 200 mg/day.
Severe:
For CrCl <30 mL/min: 50-100 mg every 12 hours. Maximum 200 mg/day.
Dialysis:
Tramadol is removed by hemodialysis. Administer usual dose after dialysis on dialysis days. For chronic use, consider extended dosing interval.
Hepatic Impairment:
Mild:
No specific adjustment for mild impairment.
Moderate:
For cirrhotic patients: 50 mg every 12 hours. Maximum 100 mg/day.
Severe:
For cirrhotic patients: 50 mg every 12 hours. Maximum 100 mg/day.
Pharmacology
Mechanism of Action
Tramadol is a centrally acting synthetic opioid analgesic. Its analgesic effect is due to a dual mechanism: 1) binding of the parent drug and its active metabolite (M1, O-desmethyltramadol) to ΞΌ-opioid receptors, and 2) weak inhibition of norepinephrine and serotonin reuptake, which enhances the inhibitory effects of descending pain pathways.
Pharmacokinetics
Absorption:
Bioavailability:
75% (oral)
Tmax:
1.6-2 hours (parent drug); 3 hours (M1 metabolite)
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
2.6-3.0 L/kg
ProteinBinding:
20%
CnssPenetration:
Yes
Elimination:
HalfLife:
5-7 hours (parent drug); 7-9 hours (M1 metabolite)
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (approximately 90% as metabolites, 10% as unchanged drug)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
2-3 hours
DurationOfAction:
4-6 hours
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 patientβs risk prior to prescribing tramadol, and monitor all patients receiving tramadol for the development of these behaviors and conditions. RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase. 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. CYTOCHROME P450 2D6 ULTRA-RAPID METABOLISM: Life-threatening respiratory depression and death have occurred in children who received tramadol. Tramadol is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of tramadol in adolescents 12 to 18 years of age who have other risk factors for respiratory depression unless the benefits outweigh the risks. 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 increase the risk for adverse reactions, including serious respiratory depression. The concomitant use of tramadol with all CYP3A4 inducers or 2D6 inducers may result in a decrease in tramadol plasma concentrations and decrease efficacy. CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other 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
Rarely, allergic reactions can be fatal.
Signs of depression, suicidal thoughts, or mood changes, such as:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Severe dizziness or fainting
Confusion
Seizures
Chest pain or pressure, or a rapid heartbeat
Difficulty 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 serious bowel problem
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek medical help immediately if you experience:
Agitation
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
A severe skin reaction may occur, which can cause serious health problems and even death. Seek medical help immediately if you notice:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Nausea or vomiting
Dry mouth
Headache
Itching
Trouble sleeping
Flushing
Excessive sweating
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.
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
Rarely, allergic reactions can be fatal.
Signs of depression, suicidal thoughts, or mood changes, such as:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Severe dizziness or fainting
Confusion
Seizures
Chest pain or pressure, or a rapid heartbeat
Difficulty 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 serious bowel problem
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek medical help immediately if you experience:
Agitation
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
A severe skin reaction may occur, which can cause serious health problems and even death. Seek medical help immediately if you notice:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Nausea or vomiting
Dry mouth
Headache
Itching
Trouble sleeping
Flushing
Excessive sweating
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 hallucinations
- Agitation, rapid heart rate, sweating, muscle stiffness, twitching, or uncontrolled movements (signs of serotonin syndrome)
- Seizures
- Severe constipation
- Rash, itching, or swelling of the face, lips, or tongue (allergic reaction)
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 issues, including asthma, breathing difficulties, sleep apnea, high blood carbon dioxide levels, or stomach and bowel problems like blockages 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 drugs that can slow your reactions, such as phenobarbital or certain pain medications like oxycodone.
Current or recent use of specific medications, including:
+ Carbamazepine
+ Other medications containing the same active ingredient as this drug
+ Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they can cause a dangerous increase in blood pressure.
If you are breastfeeding, as it is recommended not to 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 first.
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 issues, including asthma, breathing difficulties, sleep apnea, high blood carbon dioxide levels, or stomach and bowel problems like blockages 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 drugs that can slow your reactions, such as phenobarbital or certain pain medications like oxycodone.
Current or recent use of specific medications, including:
+ Carbamazepine
+ Other medications containing the same active ingredient as this drug
+ Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they can cause a dangerous increase in blood pressure.
If you are breastfeeding, as it is recommended not to 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 first.
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 tasks that require alertness. To minimize the risk of dizziness or fainting, rise 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 dose, or taking it more frequently or for a longer period, may increase the risk of severe side effects.
Interactions with Other Medications
Before taking this medication with other strong pain medications or using a pain patch, consult your doctor. If you experience increased pain, sensitivity to pain, or new pain, contact your doctor immediately. Do not take more than the prescribed dose.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific medications, or those who consume excessive alcohol. Discuss your risk of seizures with your doctor.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If the medication becomes less effective, contact your doctor. Do not take more than the prescribed dose.
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 stopping the medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Alcohol Interactions
Do not consume alcohol or products containing alcohol while taking this medication, as it may lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications may cause decreased sex hormone levels. If you experience reduced libido, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise 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 dose, or taking it more frequently or for a longer period, may increase the risk of severe side effects.
Interactions with Other Medications
Before taking this medication with other strong pain medications or using a pain patch, consult your doctor. If you experience increased pain, sensitivity to pain, or new pain, contact your doctor immediately. Do not take more than the prescribed dose.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific medications, or those who consume excessive alcohol. Discuss your risk of seizures with your doctor.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If the medication becomes less effective, contact your doctor. Do not take more than the prescribed dose.
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 stopping the medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Alcohol Interactions
Do not consume alcohol or products containing alcohol while taking this medication, as it may lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications may cause decreased sex hormone levels. If you experience reduced libido, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Bluish discoloration of lips or fingernails
- Loss of consciousness
- Seizures
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. If available, administer naloxone if the person is unresponsive or has severe breathing problems. Call 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome or seizures
- Linezolid (has MAOI activity)
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, anxiolytics, muscle relaxants, general anesthetics, phenothiazines) - increased risk of respiratory depression, profound sedation, coma, and death
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, St. John's Wort) - increased risk of serotonin syndrome
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may decrease formation of active M1 metabolite, reducing analgesic effect
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir) - may increase tramadol exposure, increasing risk of adverse effects
- CYP3A4 inducers (e.g., carbamazepine, rifampin, phenytoin) - may decrease tramadol exposure, reducing analgesic effect and increasing M1 formation (carbamazepine specifically can reduce tramadol levels by 50%)
- Naloxone - may precipitate withdrawal symptoms
Moderate Interactions
- Warfarin - isolated reports of increased INR/prothrombin time
- Digoxin - isolated reports of digoxin toxicity
- Carbamazepine - significantly reduces tramadol plasma concentrations, potentially reducing analgesic effect and increasing seizure risk
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
Respiratory rate and depth
Rationale: To assess baseline respiratory function, especially in patients at risk for respiratory depression.
Timing: Prior to initiation
Mental status (alertness, orientation)
Rationale: To assess baseline neurological function and identify risk for sedation.
Timing: Prior to initiation
Renal and hepatic function tests (CrCl, LFTs)
Rationale: To determine need for dose adjustment in patients with organ impairment.
Timing: Prior to initiation, if impairment is suspected or known
Routine Monitoring
Pain assessment
Frequency: Regularly, as clinically indicated (e.g., daily, weekly, or at each visit)
Target: Achieve acceptable pain control with minimal adverse 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, cyanosis)
Frequency: Regularly, especially during initiation or dose escalation
Target: Normal respiratory rate and effort
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoxia require immediate intervention (e.g., naloxone, respiratory support).
Level of sedation/alertness
Frequency: Regularly, especially during initiation or dose escalation
Target: Patient remains alert and able to participate in activities of daily living.
Action Threshold: Excessive sedation (e.g., somnolence, difficulty arousing) requires dose reduction or discontinuation.
Bowel function (constipation)
Frequency: Regularly
Target: Regular bowel movements
Action Threshold: Severe constipation requires laxative regimen or dose adjustment.
Signs of serotonin syndrome (e.g., agitation, hallucinations, tachycardia, fever, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
Frequency: Monitor closely, especially when co-administered with other serotonergic drugs
Target: Absence of symptoms
Action Threshold: Presence of symptoms requires immediate discontinuation of tramadol and supportive care.
Signs of abuse, misuse, or addiction
Frequency: Ongoing assessment at each visit
Target: Absence of aberrant drug-taking behaviors
Action Threshold: Evidence of abuse/misuse requires re-evaluation of treatment plan, referral to addiction specialist.
Symptom Monitoring
- Respiratory depression
- Excessive sedation
- Nausea
- Vomiting
- Constipation
- Dizziness
- Headache
- Seizures
- Serotonin syndrome symptoms (agitation, confusion, rapid heart rate, fever, muscle rigidity, sweating, diarrhea)
- Allergic reactions (rash, itching, swelling)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to the risk of neonatal opioid withdrawal syndrome (NOWS) and potential for respiratory depression in the neonate. Only use if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations cannot be ruled out. Animal studies show some developmental toxicity.
Second Trimester:
Risk of NOWS increases with prolonged use.
Third Trimester:
High risk of NOWS with prolonged use. Neonates may experience respiratory depression, feeding difficulties, irritability, and seizures.
Lactation
Not recommended. Tramadol and its active metabolite (M1) are excreted into breast milk. M1 can reach clinically relevant levels in breastfed infants, especially in mothers who are CYP2D6 ultra-rapid metabolizers, leading to serious adverse reactions including respiratory depression and death. The American Academy of Pediatrics considers tramadol to be a drug for which the effect on a nursing infant is unknown but may be of concern.
Infant Risk:
High risk, especially for infants of CYP2D6 ultra-rapid metabolizer mothers. Potential for serious adverse effects including respiratory depression, sedation, and death.
Pediatric Use
Contraindicated in children younger than 12 years of age. Contraindicated in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Use with caution in adolescents 12 to 18 years of age who have other risk factors for respiratory depression (e.g., obesity, sleep apnea, severe pulmonary disease) unless the benefits outweigh the risks. Individualize dosing and monitor closely.
Geriatric Use
Lower initial doses (e.g., 25 mg daily) and slower titration are recommended for patients over 75 years of age due to increased sensitivity and potential for reduced clearance. Maximum daily dose for patients >75 years is 300 mg (immediate-release). Increased risk of falls, constipation, and CNS effects.
Clinical Information
Clinical Pearls
- Tramadol has a dual mechanism of action (opioid agonism and monoamine reuptake inhibition), which contributes to its analgesic effect but also increases the risk of serotonin syndrome and seizures.
- Always assess for risk factors for addiction, abuse, and misuse before prescribing and monitor throughout therapy.
- Due to the risk of respiratory depression, especially in CYP2D6 ultra-rapid metabolizers, tramadol is contraindicated in children <12 years and in adolescents <18 years post-tonsillectomy/adenoidectomy.
- Initiate tramadol at the lowest effective dose and titrate slowly to minimize adverse effects, particularly in opioid-naive patients, elderly patients, and those with renal or hepatic impairment.
- Counsel patients on the serious risks of concomitant use with alcohol, benzodiazepines, or other CNS depressants.
- Be vigilant for signs of serotonin syndrome when tramadol is co-administered with other serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans).
- Warn patients about the potential for seizures, especially at higher doses or in patients with a history of epilepsy or other risk factors.
Alternative Therapies
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
- Other opioid analgesics (e.g., hydrocodone, oxycodone, morphine)
- Adjuvant analgesics (e.g., gabapentin, pregabalin, duloxetine for neuropathic pain)
- Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (50mg)
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 you refill your prescription. 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 involved, including the dose and timing of administration.
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 you refill your prescription. 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 involved, including the dose and timing of administration.