Hanol Tramadol Hydrochloride Injection

Key information summary

Efficacy & effects

This medication is used for the relief of severe and moderate acute and chronic pain, especially pain caused by various cancers and pain that occurs after diagnosis or surgery.

Dosage

Administer 50 to 100mg of tramadol hydrochloride by intravenous or intramuscular injection. If needed, repeat administration every 4 to 5 hours, with a maximum daily dose of 400mg. For elderly patients, those aged 75 and younger do not require dose adjustment, but those over 75 may require adjustment of the administration interval. For patients with renal or hepatic impairment, consideration should be given to extending the administration interval.

Precautions

This medication must be taken at the prescribed dosage, as exceeding the recommended dosage may result in seizures. Patients at risk of seizures or those with epilepsy should use this medication only when absolutely necessary, with caution as the risk of seizures may increase. Long-term use may lead to psychological and physical dependence, thus it should be administered to patients with a history of drug abuse or dependence only for a short period under strict supervision. This medication should be used very cautiously in conjunction with alcohol or central nervous system depressants such as benzodiazepines, as there is a risk of severe drowsiness, respiratory depression, coma, and even death. Individuals who metabolize this medication rapidly may have an increased risk of respiratory depression due to higher serum concentrations of active metabolites, thus dosage adjustment and monitoring is necessary. This medication should not be administered to children under 12 years of age or to those under 18 years of age who have undergone tonsillectomy or adenoidectomy, and caution is also advised for children aged 12 to 18 with special risk factors. When using the ampule injection, the container must be carefully cut to avoid glass fragment contamination, particularly when administering to children or the elderly. This medication should not be given to patients with acute alcohol intoxication, central nervous system drug intoxication, severe respiratory depression, head injury, those taking MAO inhibitors, patients with severe renal or hepatic impairment, pregnant or nursing women, and those with certain genetic disorders. When combined with morphine or for patients with liver impairment, renal impairment, or those who are alcohol-consuming, caution should be exercised, and patients with a history of seizures should be monitored closely for seizure occurrences during administration. This medication may interact with various drugs, so dose adjustments and careful monitoring are necessary when taken with other CNS depressants, antidepressants, anticoagulants, etc. It should not be given to pregnant or nursing women, especially since it may transfer into breast milk and cause serious side effects in infants. Elderly patients (aged 75 and over) should be cautious as blood concentration may increase, ensuring not to exceed 300mg per day. In case of overdose, severe respiratory depression and seizures may occur, necessitating immediate emergency treatment and, if needed, the administration of the antidote naloxone. Patients receiving this medication may experience drowsiness, dizziness, etc., and should avoid driving or operating hazardous machinery; sudden discontinuation may induce dependence and withdrawal symptoms, so the dosage should be gradually reduced. Patients receiving this medication should immediately inform healthcare providers of any unusual symptoms such as seizures, respiratory depression, or allergic reactions, and during treatment, signs of dependence and drug abuse should be closely monitored.

Side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the oral/eye mucosa, difficulty or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, altered consciousness, visual disturbances, paralysis, urination changes

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