Kyungdong Camphex Injection 50 mg (Tramadol Hydrochloride)

Adult administration

As Tramadol Hydrochloride, administer 50-100 mg intravenously or intramuscularly, then repeat every 4-5 hours as needed. The maximum daily dose can be up to 400 mg.

This medication may cause seizures if taken in excess of the recommended dosage, thus the dosage should be strictly followed. Patients at risk of seizures should use this drug cautiously only when necessary. Long-term use may lead to psychological and physical dependence, so patients with a history of drug abuse should use it under strict supervision for a short duration. Taking this drug with alcohol or central nervous system depressants (such as benzodiazepines) may result in severe sedation, respiratory depression, coma, or risk of death, so co-administration should be avoided or used very carefully. Individuals genetically metabolizing this drug rapidly may have increased concentration of active metabolites in the blood, leading to a higher risk of respiratory depression, thus dosage adjustment and monitoring is necessary. This medication should not be administered to children under 12 years old or adolescents under 18 years who have undergone tonsillectomy or adenoidectomy, and children aged 12 to 18 should also avoid use if there are risk factors. Particular care should be taken to prevent glass fragment contamination when cutting the container of the injection, especially when used in children and elderly individuals. This medication should not be given to specific patient groups, for example, patients with acute alcohol intoxication, severe respiratory depression, head trauma, those taking MAO inhibitors, patients with severe renal or hepatic impairment, pregnant or breastfeeding women, and patients with specific allergies. Furthermore, careful consideration should be given to patients taking morphine, those with liver impairment, drinkers, patients taking central nervous system depressants, or patients with a history of seizures. During treatment with this drug, symptoms such as drowsiness, dizziness, and nausea may occur, so driving or operating hazardous machinery should be avoided. In case of overdose, serious respiratory depression and seizures may occur, necessitating immediate emergency measures, with naloxone potentially being used as an antidote. This medication may interact with other central nervous system depressants, antidepressants, antipsychotic drugs, increasing the risk of side effects, so consulting a physician before co-administration is recommended. Women who are pregnant or breastfeeding should not use this medication, especially breastfeeding mothers, as the components may transfer to the infant, posing a risk of respiratory depression. Elderly patients (aged over 75 years) may experience increased blood concentration, thus dosage should be limited. Prolonged use of this medication may lead to tolerance, with sudden cessation potentially triggering withdrawal symptoms; therefore, the dosage should be gradually reduced. Patients receiving this medication should be closely monitored for seizures, respiratory depression, allergic reactions, mental abnormalities, and if any unusual symptoms occur, immediate consultation with healthcare professionals is imperative.

Serious side effects

• Seizures
• shock
• anaphylaxis
• hives
• bronchospasm
• angioedema
• respiratory depression
• dyspnea
• exacerbation of asthma
• facial pallor

Mild side effects

• Nausea
• vomiting
• drowsiness
• dizziness
• lightheadedness
• palpitations
• coldness
• vasodilation
• hypotension
• arrhythmia

This medication should be stored in a sealed container to prevent exposure to air, and it is safe to store it at a temperature between 1 and 30 degrees Celsius. Storing it in this manner will maintain the drug's efficacy and prevent degradation.

Appearance

Colorless transparent liquid or colorless ampoule.

Package unit

For domestic use: 1ml x 50 Ampoules, for export: 1ml x 50 Ampoules