Tracy Special Precautions

Seizures: 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 (SSRIs antidepressants or anorectics), Tricyclic Antidepressants (TCAs), and other tricyclic compounds (eg, cyclobenzaprine, promethazine, etc.), or opioids.
Administration of tramadol may enhance the seizure risk in patients taking: MAO inhibitors, neuroleptics or other drugs that reduce 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 (e.g., head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infection). In tramadol overdose, naloxone administration may increase the risk of seizure.
Anaphylactoid Reactions: Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive Paracetamol + Tramadol HCl.
Respiratory Depression: Administer Paracetamol + Tramadol HCl cautiously in patients at risk for respiratory depression. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Treat such cases as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Use with CNS Depressants: Paracetamol + Tramadol HCl should be used with caution and in reduced dosages when administered to patients receiving CNS depressant (e.g., alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics).
Increased Intracranial Pressure or Head Trauma: Paracetamol + Tramadol HCl should be used with caution in patients with increased intracranial pressure or head injury.
Use in Opioid-Dependent Patients: Paracetamol + Tramadol HCl should not be used in opioid-dependent patients. Tramadol has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids.
Use with Alcohol: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive paracetamol use.
Withdrawal: Withdrawal symptoms may occur if Paracetamol + Tramadol HCl is discontinued abruptly. Panic attacks, severe anxiety, hallucinations, paresthesia, tinnitus and unusual CNS symptoms have also been rarely reported with abrupt discontinuation of Tramadol HCl. Clinical experience suggests that withdrawal symptoms may be relieved by tapering the medication.
Use with MAO Inhibitors and Selective Serotonin Reuptake Inhibitors: Use Paracetamol + Tramadol HCl with great caution in patients taking monoamine oxidase inhibitors. Concomitant use of tramadol with MAO inhibitors or SSRIs increases the risk of adverse events, including seizure and serotonin syndrome.
Use in Renal Disease: Paracetamol + Tramadol HCl has not been studied in patients with impaired renal function. In patients with creatinine clearance of <30 mL per min, it is recommended that the dosing interval of Paracetamol + Tramadol HCl be increased not to exceed 2 tablets every 12 hrs.
Use in Hepatic Disease: The use of Paracetamol + Tramadol HCl in patients with severe hepatic impairment is not recommended.
Serious Skin Reactions: Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), have been reported very rarely in patients receiving paracetamol. Patients should be informed about the signs of serious reactions, and use of the drug should be discontinued at the first appearance of skin rash or any sign of hypersensitivity.
Hyponatremia: Has been reported very rarely with the use of Paracetamol + Tramadol HCl, usually in patients using concomitant medications that may cause hyponatremia. In some reports, this hyponatremia appeared to be result of the Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH) and resolve with discontinuation of Paracetamol + Tramadol HCl and appropriate treatment (e.g, fluid restriction). During Tramadol HCl + Paracetamol treatment, monitoring for signs and symptoms of hyponatremia is recommended for patients with predisposing risk factors.
General Precautions: The recommended dose of Paracetamol + Tramadol HCl should not be exceeded. This product, Tracy, should not be co-administered with other tramadol or paracetamol-containing products.