Analab Special Precautions

Seizures: Seizure have occurred during tramadol hydrochloride therapy with recommended dosages. Seizure can occur following the first dose. Naloxone administration in patients with tramadol hydrochloride overdose also may increase the risk of seizure.
Sensitivity reactions: Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving tramadol hydrochloride. These reactions often occur following the first dose. Other reported hypersensitivity reactions include pruritus, hives, bronchospasm, urticaria, 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 tramadol hydrochloride.
Respiratory depression: Tramadol hydrochloride should be administered with caution to patients at risk for respiratory depression. Respiratory depression may result when large doses of tramadol hydrochloride are administered with anesthetic medications or alcohol, and should be treated as a tramadol hydrochloride overdose.
Increased intracranial pressure or head injury: Tramadol hydrochloride should be used with caution in patients with increased intracranial pressure or head injury, since the respiratory depressant effects of opiate agonists include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and such effects may be markedly exaggerated in these patients. Also, pupillary changes (miosis) from tramadol hydrochloride may obscure the existence, extent, or course of intracranial pathology. Clinicians also should maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving tramadol hydrochloride.
Withdrawal: Withdrawal symptoms may occur if tramadol hydrochloride is discontinued abruptly. Symptoms may include anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Clinical experience suggests that withdrawal symptoms may be relieved by tapering the dosage.
Acute abdominal conditions: Tramadol hydrochloride administration also may complicate the clinical assessment of patients with acute abdominal conditions.
Renal and hepatic impairment: Impaired renal function results in a decreased rate and extent of excretion of tramadol hydrochloride and its active metabolite, M1. Tramadol hydrochloride and M1 metabolism are reduced in patients with advanced hepatic cirrhosis; therefore, dosage reduction also is recommended in these patients