Tramadol ER 200mg 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 and norepinephrine reuptake inhibitor (SNRI)
Pregnancy Category
Not available
FDA Approved
Sep 2003
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 your brain to change how your body feels and responds to pain. Because it's extended-release, it releases the medicine slowly over time 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 death from overdose.
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 fast pain relief or on an as-needed basis.
* Do not use this medication for pain relief after surgery if you have not been taking similar medications.
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 it in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to secure the medication. 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. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, 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 death from overdose.
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 fast pain relief or on an as-needed basis.
* Do not use this medication for pain relief after surgery if you have not been taking similar medications.
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 it in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to secure the medication. 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. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not crush, chew, or break the extended-release tablet. Swallow it whole.
- Take exactly as prescribed; do not take more or less than directed.
- Do not stop taking this medication suddenly without talking to your doctor, as withdrawal symptoms can occur.
- Avoid alcohol while taking this medication, as it can increase the risk of serious side effects like respiratory depression.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
- To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and consider over-the-counter laxatives if needed.
- Store in a safe place away from children and pets, as accidental ingestion can be fatal.
Available Forms & Alternatives
Available Strengths:
- Tramadol 50mg Tablets
- Tramadol 50mg Tablets
- Tramadol Hcl ER 100mg (biphasic) Tb
- Tramadol ER 200mg Biphasic Tab
- Tramadol Hcl ER 300mg Tablets
- Tramadol ER 200mg Tablets
- Tramadol ER 100mg Tablets
- Tramadol ER 300mg Tablets
- Tramadol ER 100mg Tablets
- Tramadol ER 300mg Tablets
- Tramadol ER 200mg Tablets
- Tramadol ER 100mg Capsules
- Tramadol ER 200mg Capsules
- Tramadol ER 300mg Capsules
- Tramadol 100mg Tablets
- Tramadol 50mg Tablets
- Tramadol 100mg Tablets
- Tramadol 5mg/ml Solution
- Tramadol Hcl 25mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
100 mg once daily, titrated by 50 mg every 5 days to an effective dose. Max 300 mg/day.
Dose Range:
100 - 300 mg
Condition-Specific Dosing:
chronic_pain:
Initial 100 mg once daily, titrate by 50 mg every 5 days to an effective dose. Max 300 mg/day. Doses should be individualized.
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; Contraindicated in adolescents <18 years post-tonsillectomy/adenoidectomy)
Adolescent:
Not established (Contraindicated in adolescents <18 years post-tonsillectomy/adenoidectomy)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for CrCl > 30 mL/min.
Moderate:
Not recommended for patients with CrCl < 30 mL/min due to extended-release formulation.
Severe:
Not recommended for patients with CrCl < 30 mL/min due to extended-release formulation.
Dialysis:
Not recommended for patients on dialysis due to extended-release formulation.
Hepatic Impairment:
Mild:
No specific adjustment for mild impairment.
Moderate:
Not recommended for patients with severe hepatic impairment due to extended-release formulation.
Severe:
Not recommended for patients with severe hepatic impairment (Child-Pugh Class C) due to extended-release formulation.
Pharmacology
Mechanism of Action
Tramadol is a centrally acting synthetic opioid analgesic. Its analgesic effect is due to both binding of the parent drug and its active metabolite (O-desmethyltramadol, M1) to Îŧ-opioid receptors and to weak inhibition of norepinephrine and serotonin reuptake. The M1 metabolite has a significantly higher affinity for Îŧ-opioid receptors than tramadol.
Pharmacokinetics
Absorption:
Bioavailability:
75% (oral)
Tmax:
4-6 hours (for ER formulation)
FoodEffect:
Minimal effect on absorption of ER formulation; can be taken with or without food.
Distribution:
Vd:
2.7 L/kg
ProteinBinding:
Approximately 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
6-7 hours (tramadol); 7-9 hours (M1)
Clearance:
Not available
ExcretionRoute:
Renal (approximately 90%)
Unchanged:
Approximately 30% (tramadol); 10% (M1)
Pharmacodynamics
OnsetOfAction:
Not available (for ER formulation, gradual onset)
PeakEffect:
Not available (for ER formulation, prolonged effect)
DurationOfAction:
24 hours (for ER formulation)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
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
Difficulty urinating
Frequent urination
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Changes in vision
Severe constipation or stomach pain, which may indicate a severe bowel problem
A potentially life-threatening condition called serotonin syndrome may occur, especially if you are 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
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) 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
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
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, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
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
Difficulty urinating
Frequent urination
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Changes in vision
Severe constipation or stomach pain, which may indicate a severe bowel problem
A potentially life-threatening condition called serotonin syndrome may occur, especially if you are 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
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) 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
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
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, 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
- Dizziness or confusion
- Cold, clammy skin
- Pinpoint pupils
- Seizures
- Agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea (signs of serotonin syndrome)
- Severe constipation
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Respiratory problems, including asthma, breathing difficulties, or sleep apnea, as well as high levels of carbon dioxide in the blood.
Gastrointestinal issues, such as stomach or bowel blockage or narrowing.
Kidney or liver disease.
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol or other drugs.
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 actions, such as phenobarbital or pain relievers like oxycodone.
Current use of carbamazepine or another medication containing the same active ingredient.
Concurrent use of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain antidepressants or Parkinson's disease medications within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
* If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Respiratory problems, including asthma, breathing difficulties, or sleep apnea, as well as high levels of carbon dioxide in the blood.
Gastrointestinal issues, such as stomach or bowel blockage or narrowing.
Kidney or liver disease.
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol or other drugs.
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 actions, such as phenobarbital or pain relievers like oxycodone.
Current use of carbamazepine or another medication containing the same active ingredient.
Concurrent use of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain antidepressants or Parkinson's disease medications within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
* If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring Pain and Side Effects
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific medications, or those who consume excessive alcohol. Discuss your risk of seizures with your doctor.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Low Blood Sugar Risk
This medication may cause low blood sugar, which can be severe enough to require hospitalization. If you experience symptoms such as dizziness, headache, fatigue, shaking, rapid heartbeat, confusion, hunger, or sweating, contact your doctor immediately.
Dependence and Withdrawal
Long-term or regular use of opioid medications like this one may lead to dependence. Suddenly 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. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Interactions with Alcohol
Do not consume alcohol or products containing alcohol while taking this medication, as this may lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications may cause a decrease in sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
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 position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring Pain and Side Effects
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with certain health conditions, those taking specific medications, or those who consume excessive alcohol. Discuss your risk of seizures with your doctor.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Low Blood Sugar Risk
This medication may cause low blood sugar, which can be severe enough to require hospitalization. If you experience symptoms such as dizziness, headache, fatigue, shaking, rapid heartbeat, confusion, hunger, or sweating, contact your doctor immediately.
Dependence and Withdrawal
Long-term or regular use of opioid medications like this one may lead to dependence. Suddenly 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. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Interactions with Alcohol
Do not consume alcohol or products containing alcohol while taking this medication, as this may lead to unsafe and potentially fatal effects.
Hormonal Effects
Long-term use of opioid medications may cause a decrease in sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Low blood pressure
- Slowed heart rate
- Seizures
- Coma
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. If available, administer naloxone if opioid overdose is suspected and trained to do so. Call 1-800-222-1222 for poison control advice.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants)
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, linezolid, St. John's Wort) - risk of serotonin syndrome
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may reduce M1 formation, decreasing efficacy
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir) - may increase tramadol exposure, increasing risk of adverse effects
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - may decrease tramadol exposure, decreasing efficacy
Moderate Interactions
- Coumarin derivatives (e.g., 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 and identify risk for respiratory depression.
Timing: Prior to initiation of therapy
Mental status (alertness, sedation)
Rationale: To assess baseline neurological status and identify risk for CNS depression.
Timing: Prior to initiation of therapy
History of substance abuse or mental health disorders
Rationale: To identify patients at increased risk for addiction, abuse, or misuse.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain relief and functional improvement
Frequency: Regularly, especially during titration and dose changes
Target: Individualized based on patient goals
Action Threshold: Inadequate pain control or worsening pain may require dose adjustment or alternative therapy.
Signs of respiratory depression (e.g., decreased respiratory rate, shallow breathing, cyanosis)
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 signs of hypoxia require immediate intervention.
Signs of CNS depression (e.g., excessive sedation, somnolence, confusion)
Frequency: Regularly, especially during initiation and dose escalation
Target: Patient remains alert and oriented
Action Threshold: Excessive sedation (e.g., unable to arouse), confusion, or altered mental status require dose reduction or discontinuation.
Bowel function (constipation)
Frequency: Regularly
Target: Regular bowel movements
Action Threshold: Severe constipation requires intervention (e.g., laxatives, stool softeners).
Signs of abuse, misuse, or addiction
Frequency: Ongoing, at each visit
Target: Absence of aberrant drug-related behaviors
Action Threshold: Evidence of diversion, dose escalation without clinical justification, or other aberrant behaviors requires reassessment and potential intervention.
Seizure activity
Frequency: Monitor for new onset or worsening seizures
Target: Absence of seizures
Action Threshold: New onset or increased frequency of seizures requires discontinuation and evaluation.
Symptom Monitoring
- Respiratory depression
- Excessive sedation
- Nausea
- Vomiting
- Constipation
- Dizziness
- Headache
- Seizures
- Signs of serotonin syndrome (agitation, hallucinations, tachycardia, fever, sweating, muscle rigidity, tremor, incoordination, nausea, vomiting, diarrhea)
- Signs of adrenal insufficiency (nausea, vomiting, anorexia, fatigue, weakness, dizziness, low blood pressure)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to the risk of neonatal opioid withdrawal syndrome (NOWS) in the newborn. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure.
Second Trimester:
Risk of NOWS increases with prolonged use during pregnancy.
Third Trimester:
High risk of NOWS if used chronically during the third trimester. Monitor neonates for signs of withdrawal.
Lactation
Not recommended during breastfeeding. Tramadol and its active metabolite (M1) are excreted into breast milk. Serious adverse reactions, including respiratory depression and death, have occurred in breastfed infants whose mothers were taking tramadol. If tramadol is essential, consider alternative feeding methods or monitor the infant closely for signs of sedation and respiratory depression.
Infant Risk:
Moderate to high risk (L3). Risk of sedation, respiratory depression, and death in breastfed infants.
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. Not recommended for use in pediatric patients due to risks of serious adverse events, including respiratory depression and death.
Geriatric Use
Use with caution in elderly patients (âĨ65 years of age). Start with lower doses and titrate slowly due to increased risk of respiratory depression, CNS effects, and falls. Monitor renal and hepatic function.
Clinical Information
Clinical Pearls
- Tramadol ER is for chronic pain and should not be used for as-needed pain relief.
- Do not crush or chew the tablets; this can lead to rapid release of tramadol and potentially fatal overdose.
- Be aware of the dual mechanism of action (opioid agonism and monoamine reuptake inhibition), which contributes to its analgesic effect but also to potential drug interactions (e.g., serotonin syndrome).
- Patients who are ultra-rapid metabolizers of CYP2D6 may experience higher than normal M1 levels, leading to increased opioid effects and potentially fatal respiratory depression.
- Patients who are poor metabolizers of CYP2D6 may experience reduced efficacy due to lower M1 levels.
- Always assess for risk factors for opioid addiction, abuse, and misuse prior to initiation and throughout therapy.
Alternative Therapies
- Other opioid analgesics (e.g., oxycodone ER, morphine ER, hydromorphone ER)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
- Adjuvant analgesics (e.g., gabapentin, pregabalin, duloxetine, tricyclic antidepressants for neuropathic pain)
- Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health problems do not improve 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, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract its 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 administered. 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 information about what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract its 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 administered. 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 information about what was taken, the quantity, and the time of the incident.