Tramofal Plus Special Precautions

Seizure risk has been reported in patients receiving Tramadol in the recommended dosage range. The post-market report indicates that seizure risk increases with the dose of Tramadol above the recommended dose range. The risk of seizures can be increased in patients receiving Tramadol together with: Selective Serotonin Reuptake Inhibitors (SSRi or anorectic antidepressants); Tricyclic antidepressants (TCAs) and other tricyclic components (such as Cyclobenzaprine, Promethazine, etc.); Other Opioids. Giving Tramadol may increase the risk of seizures in patients who receive: MAO Inhibitors; Neuroleptics & other drugs that reduce the seizure threshold. The risk of convulsions can be increased in epilepsy patients, patients who have a history of seizures, or patients with a risk of seizures (such as head trauma, metabolic disorders, alcohol, and drug withdrawal, CNS infection). In the case of Tramadol overdose, administration of Naloxone can increase the risk of seizures.
Rare yet serious events of anaphylactic reactions have been reported in patients receiving therapy with Tramadol. This happens when after the first dose is given. Other allergic reactions have been reported including pruritus, red spots and swelling, bronchospasm, angioedema, toxic epidermal necrolysis, and Steven-Johnson syndrome. Patients with a history of anaphylactic reactions with other Codeines and opioids may be able to increase their risk and however they may not accept Tramofal Plus.
Administration of Tramofal Plus to patients who experience respiratory depression must be done cautiously. In these patients, alternative therapy of non-opioid analgesics must be considered. Respiratory depression may occur when large doses of Tramadol are given with an anesthetic or alcohol. Respiratory depression must be treated like an overdose. If Naloxone is given, be careful because it may lead to seizures.
Patients with CYP2D6 ultra-rapid metabolizer can turn Tramadol into an active metabolite (M1) more quickly and intact than other patients. This rapid change results in a serum level M1 higher than expected which can lead to an increased risk of respiratory depression. Alternative medicine, reduced doses or monitoring of symptoms of enhanced Tramadol overdose, such as respiratory depression is recommended in patients known as CYP2D6 ultra-rapid metabolizer.
Patients with increased intracranial pressure or head trauma should be used this drug with caution. The effects of respiratory depression from opioids include carbon dioxide and the second elevation of excessive fluid pressure in these patients.
Use in patients with liver disease is also not recommended.
Withdrawal syndrome may occur if the use of Tramofal Plus is suddenly stopped. Symptoms include anxiety, excessive sweating, insomnia, stiffness, pain, nausea, trembling, diarrhea, upper respiratory tract symptoms, piloerection. and rarely hallucinations occur. Other symptoms that rarely appear with termination of Tramofal Plus include panic attack, severe anxiety, and paresthesia.
During treatment with Tramofal Plus, monitoring for signs and symptoms of hyponatremia is recommended for patients who have a tendency for risk factors.
May affect the ability to drive or operate machine due to lack of concentration.