Ulcetra Warnings

Seizures Risk: Seizures have been reported in patients receiving Tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of Tramadol above the recommended range.
Concomitant use of Tramadol increases the seizure risk in patients taking: Selective serotonin reuptake inhibitors (SSRI anti depressants or anorectics), Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or Other opioids.
Administration of Tramadol may increase the seizure risk in patients taking: MAO inhibitors (see Use with MAO Inhibitors as follows), Neuroleptics, or Other drugs that lower the seizure threshold.
Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). In Tramadol overdose, naloxone administration may increase the risk of seizure.
Anaphylactoid Reactions: Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with Tramadol. When these events occurred it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis, and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive Ulcetra (see CONTRAINDICATIONS).
Respiratory Depression: Administer Ulcetra cautiously in patients at risk for respiratory depression. In these patients, alternative non-opioid analgesics should be considered. When large doses of Tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures (see Seizure Risk as previously mentioned, and OVERDOSAGE).
Ultra-Rapid CYP2D6 Metabolism of Tramadol: Patients who are CYP2D6 ultra-rapid metabolizers can convert Tramadol into its active metabolite (M1) faster and more complete than other patients. This rapid conversion can lead to higher than expected M1 serum levels that may lead to an increased risk of respiratory depression (see Human Experience: Tramadol under OVERDOSAGE). Alternative treatments, dose reduction and/or intensive monitoring of Tramadol overdosage signs, such as respiratory depression are recommended in patients known to be CYP2D6 ultra-rapid metabolizers.
Interaction with Central Nervous System (CNS) Depressants: Ulcetra should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers, or sedatives. Tramadol increases the risk of CNS and respiratory depression in these patients.
Increased Intracranial Pressure or Head Trauma: Ulcetra should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure and may be markedly exaggerated in these patients. Additionally, pupil changes (miosis) from Tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reactions when evaluating altered mental status in these patients if they are receiving Ulcetra (see Respiratory Depression as previously mentioned).
Use in Ambulatory Patients: Tramadol may impair mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Patients using this drug should be cautioned accordingly.
Use with MAO Inhibitors and Serotonin Re-uptake Inhibitors: Use Ulcetra with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration of MAO inhibitors and tramadol. Concomitant use of Tramadol with MAO inhibitors or SSRIs increases the risk of adverse events, including seizure and serotonin syndrome.
Use with Alcohol: Ulcetra should not be used concomitantly with alcohol consumption. The use of Ulcetra in patients with liver disease is not recommended.
Use With Other Paracetamol-containing Products: Due to the potential for Paracetamol hepatotoxicity at doses higher than the recommended dose, Ulcetra should not be used concomitantly with other Paracetamol-containing products.
Withdrawal: Withdrawal symptoms may occur if Ulcetra is discontinued abruptly (see also Drug Abuse And Dependency as follows). Reported symptoms have included anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been reported less frequently with Ulcetra discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience indicated that withdrawal symptoms may be avoided by tapering Ulcetra at the time of discontinuation.
Physical Dependability and Abuse: Tramadol can cause physical dependence from its morphine type (m-opiod). Tramadol should not be used in opioid-dependent patients. Tramadol has been shown to restart physical dependence on some patients who have previously been dependent on other opioids. Dependency and abuse, including drug addiction behaviors and unlawful acts to obtain drugs are not limited to patients with a prior history of opioid dependency.
Risk of Overdosage: Serious potential consequences of overdosage with Tramadol are central nervous system depression, respiratory depression, and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment (see OVERDOSAGE). Serious potential consequences of overdosage with acetaminophen are hepatic (centrilobular) necrosis, leading to hepatic failure and death. Emergency help should be sought immediately and treatment initiated immediately if overdose is suspected, even if symptoms are not apparent.
Hyponatremia: Hyponatremia has been reported but very rarely with the use of Ulcetra, usually in patients with predisposing risk factors, such as elderly patients and/or patients taking concurrent drugs that may cause hyponatremia. In some reports, this hyponatremia appears to be the result of the syndrome of antidiuretic hormone secretion syndrome (SIADH) and is treated with Ulcetra termination and appropriate treatment (eg fluid restriction). During treatment with Ulcetra, monitoring of signs and symptoms of hyponatremia is recommended for patients with predisposing risk factors.