Tramadol Hcl 25mg Tablets

Tramadol is a centrally acting synthetic opioid analgesic. It has a dual mechanism of action: 1) It binds to mu-opioid receptors, albeit weakly, leading to analgesia. 2) It inhibits the reuptake of norepinephrine and serotonin in the central nervous system, which contributes to its analgesic effect by enhancing 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 medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or 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 or anxiety
+ Lack of interest in life
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Severe dizziness or fainting
Feeling confused or disoriented
Seizures
Chest pain or pressure, or a rapid heartbeat
Difficulty urinating or frequent urination
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing or breathing problems during sleep (sleep apnea)
Changes in vision
Severe constipation or stomach pain, which may be signs of 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 or changes in balance
Confusion or hallucinations
Fever or rapid heartbeat
Flushing or muscle twitching or stiffness
Seizures or shivering and shaking
Excessive sweating or severe diarrhea, nausea, or vomiting
Severe headache

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

A severe skin reaction may occur, causing serious health problems that may not be reversible and can 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 severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

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

Reporting Side Effects

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 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 issues, including asthma, breathing difficulties, sleep apnea, high blood carbon dioxide levels, or stomach and bowel problems like blockages 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, as this may impact the effectiveness and safety of the treatment.
Recent consumption of large amounts of alcohol or use of medications that can slow your reactions, such as phenobarbital or pain relievers like oxycodone.
Current or recent use of carbamazepine, as well as any other medications containing the same active ingredient.
Use of specific drugs, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine, as these can interact with the medication.
* If you have taken certain medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, due to the risk of severely high blood pressure.

Additionally, if you are breast-feeding, please note that you should not breast-feed 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 you may have. This will help ensure your safety while taking this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor.

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 navigating 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 to determine if you are more susceptible to seizures while taking this medication.

Long-term or high-dose use of this medication may lead to tolerance, reducing its effectiveness. If you find that the medication is no longer working as well, contact your doctor; do not take more than prescribed.

Low blood sugar (hypoglycemia) has been reported with this medication, sometimes requiring hospitalization. If you experience symptoms such as dizziness, headache, fatigue, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating, contact your doctor immediately.

Prolonged or regular use of opioid medications like this one may result in dependence. If you need to reduce the dose or stop taking this medication, consult your doctor to minimize the risk of withdrawal or other severe complications. 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 may 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 decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation difficulties, contact your doctor.

Taking an opioid medication like this one may rarely cause a severe adrenal gland problem. If you feel extremely tired or weak, experience fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)
• Linezolid
• Methylene Blue

• 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, St. John's Wort): Increased risk of serotonin syndrome.
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May decrease formation of active M1 metabolite, potentially reducing 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, potentially reducing efficacy.
• Carbamazepine: Significantly reduces tramadol plasma concentrations, reducing analgesic effect and increasing seizure risk.

• Warfarin: Isolated reports of increased INR/prothrombin time.
• Digoxin: Rare reports of digoxin toxicity.
• Diuretics: May increase risk of orthostatic hypotension.

• Not available

• Respiratory depression
• Excessive sedation
• Dizziness
• Nausea
• Vomiting
• Constipation
• Seizures
• Serotonin Syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)
• Signs of opioid withdrawal (anxiety, sweating, muscle aches, insomnia, diarrhea, vomiting, piloerection, tremors)

Use during pregnancy is generally not recommended due to potential for neonatal opioid withdrawal syndrome (NOWS) and respiratory depression in the neonate. Category C.

Tramadol and its active metabolite (M1) are excreted into breast milk. Risk of serious adverse reactions in breastfed infants, including respiratory depression and sedation. Not recommended for breastfeeding mothers. L3 (Moderate risk).

Contraindicated in children younger than 12 years of age. Contraindicated in adolescents younger than 18 years of age following tonsillectomy and/or adenoidectomy. Use with extreme caution in adolescents 12-18 years, only if benefits outweigh risks, due to risk of respiratory depression, especially in CYP2D6 ultra-rapid metabolizers.

Start with lower doses (e.g., 25 mg daily) and titrate slowly due to increased sensitivity to adverse effects, particularly respiratory depression and CNS effects. Max dose typically 300 mg/day for immediate release in patients >75 years. Increased risk of falls, constipation, and cognitive impairment.

• Tramadol has a dual mechanism of action (weak opioid agonist and SNRI), which contributes to its analgesic effect but also increases the risk of serotonin syndrome.
• The 25mg dose is primarily for initiation and titration to minimize side effects, especially in opioid-naïve or sensitive patients.
• Be aware of the Black Box Warnings, particularly regarding respiratory depression, addiction, and interactions with CNS depressants and CYP2D6 ultra-rapid metabolizers.
• Patients should be educated on the signs of serotonin syndrome and opioid overdose.
• Due to its SNRI activity, tramadol can lower the seizure threshold, especially in patients with a history of seizures or those taking other drugs that lower the seizure threshold.
• Withdrawal symptoms can occur if discontinued abruptly, especially after prolonged use. Tapering is recommended.

• NSAIDs (e.g., ibuprofen, naproxen)
• Acetaminophen
• Other opioid analgesics (e.g., hydrocodone, oxycodone, morphine) - generally reserved for more severe pain or when tramadol is ineffective/contraindicated.
• Non-pharmacological therapies (e.g., physical therapy, acupuncture, massage, cognitive behavioral therapy)
• Other centrally acting analgesics (e.g., tapentadol - also has SNRI activity)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is important to read this guide carefully and review it again whenever 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 an overdose is suspected, 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 without delay. When seeking help, be prepared to provide or show what was taken, the quantity, and the time of the incident to ensure appropriate treatment.