Tramadol Hcl (er Biphasic) Coupons & Savings Card – Discount Prices from $29.45

Tramadol hydrochloride extended-release (ER) tablets carry several important safety warnings that patients should be aware of:

Addiction, Abuse, and Misuse: Tramadol ER has the potential for addiction, abuse, and misuse, which can lead to overdose and death. It's essential to assess each patient's risk before prescribing and to monitor regularly for these behaviors.

Life-Threatening Respiratory Depression: Serious, potentially fatal respiratory depression can occur, especially during the initiation of therapy or following a dosage increase. Close monitoring is crucial during these periods.

Accidental Ingestion: Even a single accidental dose, particularly by children, can result in a fatal overdose. Proper storage out of reach of children is imperative.

Ultra-Rapid Metabolism in Children: Some children may metabolize tramadol more rapidly, leading to dangerously high levels of the active metabolite. Tramadol ER is contraindicated in children under 12 years and in those under 18 years following tonsillectomy and/or adenoidectomy.

Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can result in withdrawal symptoms in newborns, which may be life-threatening if not recognized and treated promptly.

Interactions with Cytochrome P450 Enzymes: Concomitant use with drugs affecting CYP2D6 and CYP3A4 enzymes can alter tramadol metabolism, leading to increased risks. Careful consideration is needed when tramadol is used with these medications.

Concomitant Use with CNS Depressants: Using tramadol ER alongside benzodiazepines or other central nervous system depressants, including alcohol, can result in profound sedation, respiratory depression, coma, and death. Such combinations should be reserved for patients with no alternative treatment options.

Serotonin Syndrome: This potentially life-threatening condition can occur when tramadol is used with other serotonergic drugs. Symptoms include agitation, hallucinations, rapid heartbeat, high blood pressure, fever, nausea, vomiting, diarrhea, muscle rigidity, dizziness, tremor, and incoordination.

Seizure Risk: Seizures have been reported in patients receiving tramadol, even within the recommended dosage range. The risk increases with higher doses and in patients with a history of seizures or those taking medications that lower the seizure threshold.

Hyponatremia: Low sodium levels in the blood have been reported, particularly in females over 65 years and within the first week of therapy. Monitoring for signs such as confusion and disorientation is advised.

Hypoglycemia: Low blood sugar levels have been reported, especially in patients with risk factors like diabetes. Monitoring blood glucose levels is recommended if hypoglycemia is suspected.

QT Prolongation and Torsade de Pointes: Cases of prolonged QT interval and a specific type of abnormal heart rhythm have been reported, particularly in patients with risk factors or in overdose situations.

Adrenal Insufficiency: Long-term use of opioids like tramadol can lead to adrenal insufficiency, a condition where the adrenal glands don't produce adequate hormones.

Androgen Deficiency: Chronic opioid use may result in decreased levels of sex hormones, leading to symptoms like reduced libido, energy, and strength.

Severe Hypotension: Tramadol may cause severe low blood pressure, including orthostatic hypotension and syncope, especially in patients with compromised blood volume or those taking certain medications.

Use in Patients with Increased Intracranial Pressure or Head Injury: Tramadol can reduce respiratory drive, leading to increased intracranial pressure. Caution is advised in patients susceptible to these effects.

Use in Patients with Gastrointestinal Conditions: Tramadol is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.

Anaphylaxis and Other Hypersensitivity Reactions: Serious allergic reactions, including anaphylaxis, have been reported, often following the first dose. Symptoms may include hives, difficulty breathing, and swelling of the face, lips, tongue, or throat.

Patients should discuss these risks with their healthcare provider to determine if tramadol ER is appropriate for their condition.

When taking Tramadol HCl ER (Extended-Release), it's important to be aware of potential interactions with other medications, as these can affect how tramadol works and may lead to serious side effects. Here are some key interactions to consider:

Medications Affecting Liver Enzymes:

• CYP2D6 Inhibitors: Drugs like quinidine, Fluoxetine, paroxetine, and bupropion can inhibit the CYP2D6 enzyme. This may lead to higher levels of tramadol in your body and lower levels of its active metabolite, M1. Since M1 is more effective in relieving pain, reduced levels might decrease tramadol's effectiveness. Additionally, increased tramadol levels can raise the risk of seizures and a condition called serotonin syndrome.

• CYP3A4 Inhibitors: Medications such as Erythromycin, Ketoconazole, and Ritonavir can inhibit the CYP3A4 enzyme. This can result in higher tramadol concentrations and increased M1 levels, potentially leading to serious side effects like seizures, serotonin syndrome, and dangerous respiratory depression.

• CYP3A4 Inducers: Drugs like Rifampin, Carbamazepine, and Phenytoin can increase the activity of the CYP3A4 enzyme, leading to lower tramadol levels. This may reduce pain relief and, in some cases, cause withdrawal symptoms in individuals dependent on tramadol.

Other Medication Interactions:

• Benzodiazepines and CNS Depressants: Combining tramadol with medications like benzodiazepines, other sedatives, or alcohol can result in profound sedation, respiratory depression, coma, or even death. It's crucial to avoid using these substances together unless supervised by a healthcare provider.

• Serotonergic Drugs: Using tramadol alongside medications that increase serotonin levels, such as certain antidepressants (SSRIs, SNRIs, tricyclics), can lead to serotonin syndrome. This serious condition may cause symptoms like agitation, hallucinations, rapid heartbeat, fever, nausea, vomiting, diarrhea, muscle rigidity, dizziness, tremor, and in severe cases, coma.

• Monoamine Oxidase Inhibitors (MAOIs): Taking tramadol with MAOIs or within 14 days of stopping an MAOI can increase the risk of serotonin syndrome or opioid toxicity.

• Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Medications like Butorphanol, Nalbuphine, pentazocine, and Buprenorphine may reduce tramadol's pain-relieving effects and could trigger withdrawal symptoms.

• Muscle Relaxants: Combining tramadol with muscle relaxants can enhance muscle relaxation effects, increasing the risk of respiratory depression.

• Diuretics: Tramadol may reduce the effectiveness of diuretics by promoting the release of antidiuretic hormone, potentially leading to fluid retention.

• Anticholinergic Drugs: Using tramadol with anticholinergic medications can raise the risk of urinary retention and severe constipation, which may lead to a condition called paralytic ileus.

Always inform your healthcare provider about all medications you're currently taking, including over-the-counter drugs and supplements, to ensure safe and effective use of tramadol.