Algesia Warnings

Addiction, Abuse, and Misuse: The use of tramadol HCl exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. The patient's risk should be assessed prior to prescribing tramadol, and the development of related behaviors and conditions should be monitored regularly. (See Precautions.)
Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with the use of tramadol. Close monitoring for respiratory depression should be performed, especially during initiation of tramadol and following a dose increase. (See Precautions.)
Accidental Ingestion: Accidental ingestion of even one tramadol dose, particularly by children, can result in respiratory depression and death. Patients should be instructed that medicines containing tramadol should be securely stored. Unused tramadol-containing medicines should also be disposed accordingly.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of tramadol during pregnancy may lead to opioid withdrawal in the neonate. Neonatal opioid may be fatal if not immediately recognized and treated. It also requires management according to protocols developed by neonatology experts. Signs of neonatal opioid withdrawal syndrome should be observed in newborns and should be managed accordingly. If the prolonged use of opioid is necessary during pregnancy, the patient should be advised of the risk of neonatal opioid withdrawal syndrome and guarantee that the appropriate treatment will be available.
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes: The concomitant use or discontinuation of cytochrome (CYP) P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol produces complex effects. Therefore, careful considered on the effects of the concomitant use of these agents on tramadol (a weak serotonin and norepinephrine reuptake inhibitor and µ-opioid agonist) and M1 (which is more potent than tramadol in µ-opioid receptor binding) is required. (See Precautions.)
Hepatotoxicity: Paracetamol is associated with cases of acute liver failure, at times leading to liver transplant and death. Majority of these cases involved the use of more than one paracetamol-containing product and with the use of paracetamol at doses exceeding four grams per day. The excessive intake of paracetamol may be intentional (to inflict self-harm) or unintentional (to attain more pain relief or unknowingly taking other products containing paracetamol). (See Precautions.)
Risks from Concomitant Use with Benzodiazepines or Other Central Nervous System (CNS) Depressants: The concurrent use of opioids with CNS depressants (e.g., benzodiazepines, alcohol) can result in respiratory depression, coma, and death. (See Precautions.) The concomitant prescribing of tramadol with benzodiazepines or other CNS depressants should be reserved for use in patients for whom alternative treatment options are inadequate. Treatment should be limited to the minimum effective dosages and durations. Monitor patients for signs and symptoms of respiratory depression and sedation.