Tramadol 5mg/ml Solution
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.Be sure that you know how to measure your dose. Dosing errors can lead to accidental overdose and death. If you have any questions, talk with your doctor or pharmacist.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 medicine used to treat moderate to moderately severe pain. It works in your brain to change how your body feels and responds to pain. It is important to take it exactly as prescribed by your doctor.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Take this medication by mouth only, as directed. Do not inject or snort this medication, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.
You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect. When taking the liquid form, measure your dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using a household teaspoon or tablespoon, as this can lead to an incorrect dose.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding storage in a bathroom. Keep it in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to ensure the medication's safety. Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are 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. If you are taking this medication as needed to manage pain, do not take it more frequently than directed by your doctor.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Take this medication by mouth only, as directed. Do not inject or snort this medication, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.
You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect. When taking the liquid form, measure your dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using a household teaspoon or tablespoon, as this can lead to an incorrect dose.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding storage in a bathroom. Keep it in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to ensure the medication's safety. Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are 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. If you are taking this medication as needed to manage pain, do not take it more frequently than directed by your doctor.
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.
- Do not stop taking tramadol suddenly if you have been taking it for a long time, as this can cause withdrawal symptoms. Your doctor will tell you how to slowly reduce your dose.
- Store tramadol securely 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:
Initial: 25 mg (5 ml) orally once daily, titrated by 25 mg (5 ml) increments every 3 days to 100 mg (20 ml) per day (25 mg (5 ml) four times daily). Maintenance: 50-100 mg (10-20 ml) every 4-6 hours as needed.
Dose Range:
50 - 400 mg
Condition-Specific Dosing:
acutePain:
50-100 mg (10-20 ml) every 4-6 hours as needed, not to exceed 400 mg (80 ml) per day.
chronicPain:
Initial titration as above, then 50-100 mg (10-20 ml) every 4-6 hours as needed, not to exceed 400 mg (80 ml) per day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Contraindicated for pain management in children younger than 12 years. Contraindicated for post-tonsillectomy/adenoidectomy pain in children younger than 18 years.
Adolescent:
Contraindicated for post-tonsillectomy/adenoidectomy pain in children younger than 18 years. For other indications in adolescents β₯12 years, use with extreme caution and consider lower doses due to risk of respiratory depression, especially in CYP2D6 ultra-rapid metabolizers.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed for CrCl >30 mL/min.
Moderate:
For CrCl <30 mL/min: Maximum 200 mg (40 ml) per day, administered every 12 hours.
Severe:
For CrCl <30 mL/min: Maximum 200 mg (40 ml) per day, administered every 12 hours.
Dialysis:
Tramadol is minimally removed by hemodialysis. Supplemental dose not typically required after dialysis, but monitor for prolonged effects.
Hepatic Impairment:
Mild:
No specific adjustment, but monitor closely.
Moderate:
Not available
Severe:
For severe hepatic impairment (e.g., Child-Pugh Class C): Maximum 50 mg (10 ml) every 12 hours.
Pharmacology
Mechanism of Action
Tramadol is a centrally acting synthetic opioid analgesic. Its analgesic effect is due to a dual mechanism: binding of the parent drug and its active metabolite (M1) to ΞΌ-opioid receptors, and weak inhibition of the reuptake of norepinephrine and serotonin. The M1 metabolite has a significantly higher affinity for ΞΌ-opioid receptors than the parent drug.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (oral)
Tmax:
Parent drug: 2 hours; M1 metabolite: 3 hours
FoodEffect:
Minimal effect on rate or extent of absorption.
Distribution:
Vd:
Approximately 2.7 L/kg
ProteinBinding:
Approximately 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Parent drug: Approximately 6.3 hours; M1 metabolite: Approximately 7.4 hours
Clearance:
Not available
ExcretionRoute:
Renal (approximately 90%)
Unchanged:
Approximately 30% (parent drug); Approximately 60% (metabolites)
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour
PeakEffect:
Approximately 2-3 hours
DurationOfAction:
Approximately 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 patientβs risk prior to prescribing tramadol, and monitor all patients receiving tramadol for signs of abuse, misuse, and addiction.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with 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 and Other Risk Factors for Life-Threatening Respiratory Depression in Children: Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy and were in children with evidence of being ultra-rapid metabolizers of tramadol due to a CYP2D6 polymorphism. 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 that may increase their sensitivity to the respiratory depressant effects of tramadol unless the benefits outweigh the risks. Risk factors include conditions associated with hypoventilation, such as obesity, obstructive sleep apnea, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.
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, which could increase or prolong adverse reactions, including serious respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in tramadol plasma concentration. Monitor patients receiving tramadol and any CYP3A4 inhibitor or 2D6 inhibitor, or discontinuing a CYP3A4 inducer for signs of respiratory depression or sedation.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with 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 and Other Risk Factors for Life-Threatening Respiratory Depression in Children: Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy and were in children with evidence of being ultra-rapid metabolizers of tramadol due to a CYP2D6 polymorphism. 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 that may increase their sensitivity to the respiratory depressant effects of tramadol unless the benefits outweigh the risks. Risk factors include conditions associated with hypoventilation, such as obesity, obstructive sleep apnea, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.
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, which could increase or prolong adverse reactions, including serious respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in tramadol plasma concentration. Monitor patients receiving tramadol and any CYP3A4 inhibitor or 2D6 inhibitor, or discontinuing a CYP3A4 inducer for signs of respiratory depression or 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 or mood changes, such as:
+ Suicidal thoughts
+ 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
Feeling confused
Seizures
Chest pain or pressure, or a rapid heartbeat
Difficulty urinating
Frequent urination
Breathing difficulties, including:
+ 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, 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 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 serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling dizzy, sleepy, tired, or weak
Constipation, diarrhea, vomiting, or stomach upset
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 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 or mood changes, such as:
+ Suicidal thoughts
+ 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
Feeling confused
Seizures
Chest pain or pressure, or a rapid heartbeat
Difficulty urinating
Frequent urination
Breathing difficulties, including:
+ 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, 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 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 serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling dizzy, sleepy, tired, or weak
Constipation, diarrhea, vomiting, or stomach upset
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 slow, shallow breathing
- Extreme drowsiness, dizziness, or feeling like you might pass out
- Confusion or unusual thoughts/behavior
- Seizures (convulsions)
- Fast heartbeat, sweating, muscle stiffness, agitation, or hallucinations (signs of serotonin syndrome)
- Severe constipation
- Signs of an allergic reaction (hives, difficulty breathing, swelling of your face, lips, tongue, or throat)
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:
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.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction 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 drugs that may impair your reactions, such as phenobarbital or pain medications like oxycodone
Current use of carbamazepine
Use of another medication containing the same active ingredient
Concurrent use of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Use of certain medications for depression or Parkinson's disease 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 of this medication. 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:
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.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction 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 drugs that may impair your reactions, such as phenobarbital or pain medications like oxycodone
Current use of carbamazepine
Use of another medication containing the same active ingredient
Concurrent use of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Use of certain medications for depression or Parkinson's disease 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 of this medication. 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 using stairs.
Adhere strictly to your doctor's prescribed dosage and frequency. Do not exceed the recommended dose, take it more frequently, or use it for a longer duration than instructed, as this may increase the risk of severe side effects.
Before taking this medication with other strong pain relievers or using a pain patch, consult your doctor to avoid potential interactions. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not take more medication than prescribed.
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 factors with your doctor.
Long-term or high-dose use of this medication can lead to tolerance, reducing its effectiveness. If you find that the medication is no longer working as well, contact your doctor; do not increase the dose on your own.
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, drowsiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating.
The use of opioid medications like this one can lead to dependence. If you need to reduce the dose or stop taking the medication, consult your doctor to minimize the risk of withdrawal or other severe problems. 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.
Long-term use of opioid medications may cause a decrease in sex hormone levels. If you experience a decrease in libido, fertility issues, irregular menstrual periods, or ejaculation problems, contact your doctor.
Taking an opioid medication like this one can rarely cause 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 using stairs.
Adhere strictly to your doctor's prescribed dosage and frequency. Do not exceed the recommended dose, take it more frequently, or use it for a longer duration than instructed, as this may increase the risk of severe side effects.
Before taking this medication with other strong pain relievers or using a pain patch, consult your doctor to avoid potential interactions. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not take more medication than prescribed.
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 factors with your doctor.
Long-term or high-dose use of this medication can lead to tolerance, reducing its effectiveness. If you find that the medication is no longer working as well, contact your doctor; do not increase the dose on your own.
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, drowsiness, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating.
The use of opioid medications like this one can lead to dependence. If you need to reduce the dose or stop taking the medication, consult your doctor to minimize the risk of withdrawal or other severe problems. 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.
Long-term use of opioid medications may cause a decrease in sex hormone levels. If you experience a decrease in libido, fertility issues, irregular menstrual periods, or ejaculation problems, contact your doctor.
Taking an opioid medication like this one can rarely cause 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 inability to wake up
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Loss of consciousness
- Seizures
- Coma
What to Do:
If you suspect an overdose, seek emergency medical attention immediately. Call 911 or your local Poison Control Center (1-800-222-1222 in the US). Naloxone (Narcan) may be administered by emergency personnel.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of serotonin syndrome, seizures, respiratory depression)
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, St. John's Wort, mirtazapine, linezolid, fentanyl, lithium, buspirone): Increased risk of serotonin syndrome.
- CNS depressants (e.g., alcohol, benzodiazepines, other opioids, sedatives, hypnotics, anxiolytics, muscle relaxants, general anesthetics, phenothiazines): Increased risk of respiratory depression, profound sedation, coma, and death.
- Carbamazepine: Significantly decreases tramadol plasma concentrations, reducing analgesic effect.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, bupropion): May increase tramadol levels and decrease M1 levels, potentially reducing efficacy and increasing adverse effects.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir): May increase tramadol exposure, leading to increased opioid adverse reactions.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease tramadol exposure, leading to reduced efficacy.
Moderate Interactions
- Warfarin: Increased INR and bleeding risk.
- Digoxin: Increased digoxin levels.
- Diuretics: Reduced natriuretic effect of diuretics.
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 important due to risk of respiratory depression.
Timing: Prior to initiation of therapy
Mental status (alertness, sedation level)
Rationale: To assess baseline neurological function and identify pre-existing CNS depression.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (CrCl, LFTs)
Rationale: To guide dose adjustments in patients with organ impairment.
Timing: Prior to initiation of therapy in patients with suspected impairment
Routine Monitoring
Pain assessment
Frequency: Regularly, as clinically indicated (e.g., daily, weekly, or at each visit) to assess efficacy and need for dose adjustment.
Target: Patient-specific pain relief goals.
Action Threshold: Inadequate pain control or excessive adverse effects warrant dose adjustment or alternative therapy.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration, or if signs of respiratory depression are present.
Target: Normal respiratory rate (e.g., 12-20 breaths/min) and adequate depth.
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention.
Sedation level
Frequency: Regularly, especially during initiation and dose titration.
Target: Alert and oriented, able to engage in activities of daily living.
Action Threshold: Excessive drowsiness, difficulty arousing, or somnolence require dose reduction or discontinuation.
Bowel function (for constipation)
Frequency: Regularly throughout therapy.
Target: Regular bowel movements.
Action Threshold: Constipation requires prophylactic measures (e.g., stool softeners, laxatives) or management.
Signs of opioid use disorder (OUD)
Frequency: Periodically, as part of ongoing risk assessment.
Target: Absence of aberrant drug-related behaviors.
Action Threshold: Signs of OUD require referral for specialized treatment.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or somnolence
- Dizziness or lightheadedness
- Nausea and vomiting
- Constipation
- Seizures (especially with higher doses or concomitant medications)
- Signs of serotonin syndrome (agitation, hallucinations, tachycardia, fever, hyperreflexia, incoordination, sweating, shivering, severe diarrhea)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Category C. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of birth defects, though data are limited and conflicting.
Second Trimester:
Risk of neonatal opioid withdrawal syndrome with prolonged use.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome with prolonged use. Risk of respiratory depression in the neonate if used close to delivery.
Lactation
Not recommended. Tramadol and its active metabolite (M1) are present in breast milk. Serious adverse reactions, including respiratory depression and death, have occurred in breastfed infants. The risks to the infant outweigh the benefits of breastfeeding.
Infant Risk:
High risk of sedation, respiratory depression, and death, especially in infants of mothers who are CYP2D6 ultra-rapid metabolizers.
Pediatric Use
Contraindicated for pain management in children younger than 12 years. Contraindicated for post-tonsillectomy/adenoidectomy pain in children younger than 18 years. Avoid use in adolescents 12 to 18 years of age with other risk factors for respiratory depression. Children are at increased risk of life-threatening respiratory depression, especially those who are CYP2D6 ultra-rapid metabolizers.
Geriatric Use
Use lower initial doses and titrate slowly. Elderly patients may be more sensitive to the adverse effects of tramadol, including respiratory depression, sedation, and increased risk of falls. The maximum daily dose for patients over 75 years is typically 300 mg (60 ml).
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 to its unique side effect profile, including seizure risk and serotonin syndrome.
- The risk of seizures is dose-dependent and increased with concomitant use of other drugs that lower the seizure threshold (e.g., SSRIs, TCAs, bupropion, antipsychotics).
- Serotonin syndrome is a serious, potentially fatal condition that can occur when tramadol is used with other serotonergic drugs. Patients should be educated on the symptoms.
- Tramadol is a Schedule IV controlled substance, indicating a potential for abuse, dependence, and withdrawal symptoms upon abrupt discontinuation, especially after prolonged use.
- Genetic variations in CYP2D6 metabolism can significantly impact tramadol's efficacy and safety. Ultra-rapid metabolizers may experience increased opioid effects, while poor metabolizers may have reduced efficacy.
- Not recommended for PRN use in opioid-tolerant patients due to its unique pharmacology and potential for withdrawal symptoms if used in place of a full opioid agonist.
Alternative Therapies
- Other opioid analgesics (e.g., hydrocodone, oxycodone, codeine)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
- Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain; duloxetine for chronic musculoskeletal pain)
- Non-pharmacological pain management strategies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Not available Not available
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for 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 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 an emergency 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 details about the medication, including the dose, time of ingestion, and any other relevant information.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe 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 an emergency 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 details about the medication, including the dose, time of ingestion, and any other relevant information.