Tramadol ER 200mg Biphasic Tab

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 mu-opioid receptors, and weak inhibition of norepinephrine and serotonin reuptake, which enhances descending inhibitory pain pathways.

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, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Severe dizziness or fainting
Confusion
Seizures
Chest pain or pressure, or a rapid heartbeat
Difficulty urinating
Frequent urination
Breathing difficulties, including:
+ Slow or 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

There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek medical help immediately if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Severe Skin Reaction

This medication may cause a severe skin reaction, which can lead to 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

While many people may not experience any side effects or only mild ones, it's essential to be aware of the following:

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

If any of these side effects bother you or persist, contact your doctor for guidance. 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 and its symptoms.
Respiratory problems, such as asthma, breathing difficulties, or sleep apnea; high carbon dioxide levels in the blood; or stomach or bowel obstruction or narrowing.
Kidney or liver disease.
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 or another medication containing the same active ingredient.
Use of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
Use of certain antidepressants or Parkinson's disease medications in 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.

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 performing tasks 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 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)
• Linezolid (MAOI activity)

• Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers): Increased risk of respiratory depression, profound sedation, coma, and death.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, St. John's Wort): Increased risk of serotonin syndrome.
• 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 parent drug.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): May increase tramadol exposure and decrease M1 exposure, potentially reducing analgesic effect and increasing risk of adverse effects from parent drug.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir): May increase tramadol exposure, increasing risk of adverse effects.
• CYP3A4 inducers (e.g., rifampin, phenytoin): May decrease tramadol exposure, reducing analgesic effect.

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

• Not available

• Respiratory depression
• Excessive sedation
• Dizziness
• Nausea
• Vomiting
• Constipation
• Seizures
• Serotonin syndrome symptoms (agitation, confusion, rapid heart rate, fever, sweating, muscle rigidity, tremors, twitching, loss of coordination, nausea, vomiting, diarrhea)
• Adrenal insufficiency symptoms (nausea, vomiting, anorexia, fatigue, weakness, dizziness, low blood pressure)

Use during pregnancy is generally not recommended, especially prolonged use during the third trimester, due to the risk of neonatal opioid withdrawal syndrome. Benefits must clearly outweigh risks.

Tramadol and its active metabolite (M1) are excreted into breast milk. Not recommended for breastfeeding mothers due to potential for serious adverse reactions in breastfed infants, including respiratory depression and sedation. If used, monitor infant closely for signs of sedation, difficulty feeding, and breathing problems.

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 with risk factors for respiratory depression (e.g., obesity, sleep apnea, severe pulmonary disease) unless benefits outweigh risks.

Use with caution in elderly patients (≥65 years) due to increased sensitivity to adverse effects, particularly respiratory depression and CNS effects. Start with lower doses and titrate slowly. Consider age-related decreases in renal and hepatic function.

• Tramadol has a dual mechanism of action (opioid agonism and monoamine reuptake inhibition), which contributes to its analgesic effect but also increases the risk of serotonin syndrome and seizures.
• Extended-release formulations are designed for around-the-clock treatment of chronic pain and should not be used for as-needed pain relief.
• Patients should be educated on the importance of swallowing the tablet whole and not crushing, chewing, or breaking it, as this can lead to rapid release and potentially fatal overdose.
• Due to the risk of addiction, abuse, and misuse, tramadol ER should be prescribed with caution, and patients should be monitored for signs of aberrant drug-taking behavior.
• Be vigilant for signs of respiratory depression, especially during initiation and dose escalation, and in patients with risk factors.
• Concomitant use with other CNS depressants (e.g., benzodiazepines, alcohol) significantly increases the risk of serious adverse events, including respiratory depression and death.
• Patients on serotonergic drugs should be closely monitored for signs of serotonin syndrome.
• Consider genetic testing for CYP2D6 ultra-rapid metabolizers if there is concern for inadequate pain control or unexpected adverse effects, although routine testing is not typically recommended.

• Other opioid analgesics (e.g., oxycodone ER, morphine ER, hydromorphone ER)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin)
• Adjuvant analgesics (e.g., tricyclic antidepressants, SNRIs)
• Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)

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 used as part of the treatment. 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.