Tramadol Injection 50mg (Tramadol Hydrochloride)

Adult administration

As Tramadol hydrochloride, administer 50-100mg via intravenous or intramuscular injection once. Repeat injection every 4-5 hours as needed. Maximum daily dosage of 400mg.

Care must be taken when using this medication with glass ampules as glass fragments may be introduced. Particularly, it should be used with caution when administered to children or the elderly. Administering this medication above the recommended dosage may increase the risk of seizures, and it should only be given to patients at risk of seizures when absolutely necessary. Long-term use may lead to psychological and physical dependence; therefore, it should be administered strictly and short-term to patients with a history of drug abuse or dependency. Taking this medication with alcohol or central nervous system depressants can lead to severe sedation, respiratory depression, coma, or death, so concomitant use should be avoided if possible. Additionally, patients with certain genotypes may metabolize this medication rapidly, leading to increased blood concentrations and an elevated risk of respiratory depression. Specifically, it should not be administered to pediatric patients under 12 years old or adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy, and it should also be avoided in adolescents between 12 to 18 years old with risk factors. This medication should not be administered to patients with certain conditions such as acute alcohol intoxication, central nervous system drug poisoning, severe respiratory depression, or head injury. Patients with severely impaired liver or kidney functions, pregnant or nursing women, and patients with hypersensitivity to this medication or opioids are also contraindicated for administration. When administering this medication, careful consideration should be given to seizure history, alcohol habits, and drug abuse history, and dosage adjustments may be necessary as required. During use, symptoms such as drowsiness, dizziness, and nausea may appear, so it is advisable to avoid driving or operating dangerous machinery. Moreover, this medication may cause tolerance, and abrupt discontinuation after long-term use may trigger withdrawal symptoms; therefore, dosage should be reduced gradually. Using this medication with other central nervous system depressants may enhance respiratory depression and sedation, so dose reduction and close monitoring of the patient are necessary. It is safest not to administer this medication to pregnant or nursing women, as significant adverse reactions may occur in the infant while nursing. In cases of overdose, severe respiratory depression and seizures can occur, requiring immediate emergency treatment, and naloxone may be used as an antidote if necessary. This medication should be stored out of reach of children and kept in its original container to prevent misuse or quality deterioration.

Serious side effects

Hives, angioedema, chest pain (tightness in the chest), breathing difficulties, cold sweat, pallor, severe allergic reactions (shock, anaphylaxis), severe rash with high fever, blisters, skin peeling, pain in mouth/eyes mucous membranes, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice of skin or eyes, systemic lethargy, liver dysfunction symptoms, sudden and severe headaches, lightheadedness

Mild side effects

• Nausea
• vomiting
• drowsiness
• dizziness
• unsteadiness
• palpitations
• vasodilation
• hypotension
• arrhythmia
• facial pallor

This medication may be sensitive to light and should be stored in a light-protected container. Furthermore, it is important to store the medication at room temperature, which is not too hot or cold, to maintain its efficacy.

Appearance

Colorless transparent liquid in brown ampule

Package unit

1mL×10 ampules/box