Tramadol ER 200mg Capsules

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 mu-opioid receptors and to weak inhibition of norepinephrine and serotonin reuptake. M1 has a significantly higher affinity for mu-opioid receptors than tramadol.

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
Feeling confused
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 severe bowel problem
Serotonin syndrome, a potentially life-threatening condition, 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, may occur. 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 experience few or no side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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:

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 blockage or narrowing
Kidney or liver disease
A history of suicidal thoughts or previous substance abuse or dependence, including alcohol
If your doctor has informed you that you are a rapid metabolizer of certain medications
Recent consumption of large amounts of alcohol or use of medications that may impair your actions, such as phenobarbital or pain relievers 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
+ Pentazocine
Use of certain medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: 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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Ensure that it is safe to take this medication with your other medications and health conditions before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes.

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
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.

Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount 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 amount.

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 amount.

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 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 use 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.

• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of serotonin syndrome, seizures)
• Patients with significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected paralytic ileus
• Hypersensitivity to tramadol or any component of the formulation

• Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines): Increased risk of profound sedation, respiratory depression, coma, and death.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, linezolid, St. John's Wort): Risk of serotonin syndrome.
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May increase tramadol exposure and decrease M1 exposure, potentially reducing analgesic effect and increasing risk of adverse events from tramadol.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir): May increase tramadol exposure, leading to increased risk of adverse events.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease tramadol exposure and increase M1 exposure, potentially reducing analgesic effect and increasing risk of M1-related adverse events.
• Carbamazepine: Significantly reduces tramadol plasma concentrations, reducing analgesic effect. Concomitant use is not recommended.
• Warfarin: Increased INR and ecchymoses have been reported; monitor prothrombin time/INR.

• Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
• Anticholinergic drugs: Increased risk of urinary retention and/or severe constipation.

• Not available

• Respiratory depression (slow, shallow breathing)
• Excessive sedation or somnolence
• Dizziness, lightheadedness
• Nausea, vomiting, constipation
• Seizures
• Symptoms of serotonin syndrome (agitation, confusion, rapid heart rate, fever, sweating, muscle rigidity, tremors, twitching, loss of coordination, severe diarrhea)
• Symptoms of opioid withdrawal (in patients physically dependent who abruptly discontinue)

Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus.

Tramadol and its active metabolite (M1) are present in breast milk. Infants exposed to tramadol through breast milk are at risk of serious adverse reactions, including excess sedation and respiratory depression. Breastfeeding is not recommended during treatment with tramadol.

Contraindicated in children younger than 12 years of age. Contraindicated in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid use in adolescents 12 to 18 years of age who have other risk factors for respiratory depression unless benefits outweigh risks. Safety and efficacy not established for chronic pain in pediatric patients.

Use with caution in elderly patients (≥65 years) due to increased risk of respiratory depression, falls, and CNS effects. Start with lower doses and titrate slowly. Monitor renal function, as clearance may be reduced.

• Tramadol ER is for chronic, around-the-clock pain, not for as-needed or acute pain.
• Do not crush, chew, or dissolve ER capsules; this can lead to rapid release and fatal overdose.
• Be aware of the Black Box Warnings, especially regarding addiction, respiratory depression, and concomitant use with CNS depressants.
• Monitor for serotonin syndrome, especially if co-administered with other serotonergic agents.
• Patients who are CYP2D6 ultra-rapid metabolizers may experience increased M1 levels, leading to increased opioid effects and respiratory depression.
• Titrate dose slowly to minimize adverse effects and optimize pain control.
• Consider a bowel regimen to prevent opioid-induced constipation.

• Other extended-release opioid analgesics (e.g., morphine ER, oxycodone ER, hydromorphone ER)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts
• Adjuvant analgesics (e.g., gabapentin, pregabalin, duloxetine, tricyclic antidepressants) for neuropathic pain or chronic pain syndromes
• Interventional pain management techniques
• Physical therapy, occupational therapy
• Cognitive behavioral therapy (CBT)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or 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 the condition. 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 reporting the incident, be prepared to disclose the substance involved, the quantity taken, and the time of the incident to ensure timely and effective treatment.