Humedics Tramadol Hydrochloride Injection

Adult administration

As Tramadol Hydrochloride, administer 50-100mg by intravenous or intramuscular injection, then repeat every 4-5 hours as needed. A maximum of 400mg can be administered in one day.

Exceeding the recommended dosage may increase the risk of seizures. It should be used cautiously only if necessary in patients with a risk of seizures. Long-term use may lead to psychological and physical dependence, so it should be strictly managed and administered for a short duration in patients with a history of substance abuse or dependence. This medication should be avoided or used with extreme caution in combination with alcohol or central nervous system depressants, as it may lead to severe drowsiness, respiratory restraint, coma, or death. In patients with specific genotypes, this drug may be metabolized more quickly, leading to higher serum levels of the active metabolite and increased risk of respiratory depression, thus requiring dosage adjustment and monitoring as per physician's advice. This drug should not be used in children under 12 years or in adolescents under 18 years who have undergone tonsillectomy or adenoidectomy, and administration should be avoided in youths aged 12 to 18 with risk factors. This medication should not be administered to patients with acute alcohol intoxication, central nervous system drug toxicity, severe respiratory depression, head injury, those taking MAO inhibitors, severe renal or hepatic impairment, pregnant or breastfeeding women. Patients with hepatic or renal impairment, those who consume alcohol, patients with a history of seizures, and those hypersensitive to opioids should use this medication with caution and follow medical guidance. Drowsiness, dizziness, etc. may occur while taking this drug, so driving or operating dangerous machinery should be avoided. In case of overdose, severe respiratory depression, seizures, or coma may occur, necessitating immediate emergency treatment, and naloxone may be used as an antidote. This drug may interact with various medications, so if you are taking other drugs, be sure to inform your doctor or pharmacist, especially when combined with central nervous system depressants, antidepressants, anticoagulants, etc. It is safer for pregnant or breastfeeding women not to use this drug, as it may transmit to the infant through breast milk, posing a risk of respiratory depression. This medication should be stored out of reach of children, and it should be kept in its original container to maintain quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, cough with fever and respiratory abnormalities, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination problems.

Mild side effects

• Drowsiness
• dizziness
• unsteadiness
• nausea
• vomiting
• abdominal pain
• constipation
• loss of appetite
• headache
• feeling of heaviness in the head

This medication should be stored in a sealed container to prevent air and moisture ingress. It is recommended to keep it at room temperature between 1°C and 30°C. Proper storage will help maintain the drug's efficacy.

Appearance

A colorless, transparent ampoule containing a colorless liquid injection.

Package unit

1mL × 50 ampoules