Tramadol ER 100mg Capsules

Tramadol is a centrally acting synthetic opioid analgesic. It binds to mu-opioid receptors, leading to inhibition of pain transmission. It also weakly inhibits the reuptake of norepinephrine and serotonin, which contributes to its analgesic effect by enhancing descending inhibitory pain pathways.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, allergic reactions can be fatal.
Signs of depression, suicidal thoughts, or mood changes, such as:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Severe dizziness or fainting
Feeling confused
Seizures
Chest pain or pressure, or a rapid heartbeat
Trouble urinating
Frequent urination
Breathing difficulties, such as:
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Changes in vision
Severe constipation or stomach pain, which may indicate a severe bowel problem
Serotonin syndrome, a potentially life-threatening condition, which may occur, especially when taking certain other medications. Symptoms include:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, nausea, or vomiting
+ Severe headache
Stevens-Johnson syndrome/toxic epidermal necrolysis, a severe skin reaction, which can cause serious health problems and may be fatal. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Feeling dizzy, sleepy, tired, or weak
Constipation, diarrhea, nausea, or vomiting
Dry mouth
Headache
Itching
Trouble sleeping
Flushing
* Excessive sweating

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
Respiratory problems, such as asthma, breathing difficulties, or sleep apnea, as well as high levels of carbon dioxide in the blood.
Gastrointestinal issues, including stomach or bowel blockage or narrowing.
Kidney or liver disease, as these conditions may affect how your body processes the medication.
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol or other drugs.
If your doctor has informed you that you are a rapid metabolizer of certain medications.
Recent consumption of large amounts of alcohol or use of medications that may cause drowsiness, such as phenobarbital or pain relievers like oxycodone.
Current or recent use of carbamazepine or other medications containing the same active ingredient.
Concurrent use of medications like buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain antidepressant or Parkinson's disease medications within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
* If you are breastfeeding, as it is not recommended to breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine the safety of taking this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without consulting your doctor.

Important Warnings and Cautions

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other activities that require your full attention. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when navigating stairs.

Dosage and Administration
Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase your risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor.

Monitoring Your Condition
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more medication than ordered, as this may exacerbate the issue.

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. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses are required to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more medication than prescribed, as this may worsen the issue.

Low Blood Sugar
This medication has been associated with 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. If you need to reduce your dose or stop taking this medication, consult your doctor first, as sudden changes may increase 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.

Interactions with Alcohol
Do not consume alcohol or use products containing alcohol while taking this medication, as this may lead to unsafe and potentially fatal interactions.

Hormonal Effects
Long-term use of opioid medications may cause a decrease in sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation issues, contact your doctor.

Adrenal Gland Problems
Taking an opioid medication like this one may increase the risk of 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.

• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy
• Linezolid
• Methylene blue

• Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines): Increased risk of respiratory depression, profound sedation, coma, and death.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, 5-HT3 receptor antagonists, St. John's Wort, mirtazapine, trazodone, cyclobenzaprine, fentanyl, lithium): Increased risk of serotonin syndrome.
• Carbamazepine: Significantly decreases tramadol plasma concentrations, reducing analgesic effect.
• Quinidine: Inhibits CYP2D6, increasing tramadol and decreasing M1 concentrations, potentially reducing analgesic effect and increasing risk of adverse effects from tramadol.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, bupropion): May increase tramadol exposure and decrease M1 exposure, potentially reducing efficacy and increasing risk of adverse effects.
• 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, reducing efficacy.

• Warfarin: Isolated reports of increased INR/prothrombin time with concomitant use.
• Digoxin: Isolated reports of digoxin toxicity.

• Respiratory depression (slow, shallow breathing)
• Excessive sedation or somnolence
• Dizziness or lightheadedness
• Nausea and vomiting
• Constipation
• Seizures
• Symptoms of serotonin syndrome (agitation, confusion, rapid heart rate, sweating, muscle stiffness, twitching, fever, diarrhea)
• Allergic reactions (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)

Category C. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which can be life-threatening. Use only if the potential benefit justifies the potential risk to the fetus. Advise pregnant patients of the risk of NOWS.

Tramadol and its active metabolite (M1) are present in breast milk. Not recommended for use in breastfeeding mothers due to the risk of serious adverse reactions in breastfed infants, including sedation, respiratory depression, and death. If use is unavoidable, monitor infants for signs of sedation and respiratory depression.

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.

Start with lower doses and titrate slowly due to increased risk of respiratory depression, falls, and other adverse effects. Monitor closely for CNS effects (sedation, confusion) and constipation. Renal and hepatic function should be assessed.

• Tramadol ER is for chronic pain and should not be used for acute pain or on an as-needed basis.
• Do not crush, chew, or dissolve Tramadol ER capsules, as this can lead to rapid release of a potentially fatal dose.
• Be aware of the risk of serotonin syndrome, especially when co-administered with other serotonergic drugs (e.g., SSRIs, SNRIs, triptans).
• Tramadol lowers the seizure threshold; use with caution in patients with a history of seizures or those taking medications that also lower the seizure threshold.
• Patients should be educated on the signs of respiratory depression and overdose, and naloxone availability should be considered.
• Titrate dose slowly to minimize adverse effects and assess efficacy.
• Monitor for signs of addiction, abuse, and misuse throughout therapy.

• Other opioid analgesics (e.g., oxycodone ER, morphine ER, hydrocodone ER)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
• Adjuvant analgesics (e.g., gabapentin, pregabalin, duloxetine, tricyclic antidepressants)
• Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy, exercise)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. 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 is a patient fact sheet that provides crucial information. It is vital 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.

In the event of an overdose, a medication called naloxone can be administered to help treat it. 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 immediately. When seeking help, be prepared to provide information about what was taken, the quantity, and the time of the incident.