Shinil Tramadol Hydrochloride Injection

Adult administration

As Tramadol Hydrochloride, administer 50-100mg intravenously or intramuscularly, and may be repeated every 4-5 hours as needed. A maximum of 400mg can be administered daily.

Caution should be exercised as seizures may occur if the recommended dose is exceeded. In particular, it should only be used in patients with epilepsy or a risk of seizures when absolutely necessary. Long-term use may lead to psychological and physical dependence, so it should only be administered for a short duration under strict supervision in patients with a history of drug abuse or dependence. Using this drug with alcohol or central nervous system depressants may lead to severe sedation, respiratory depression, coma, or even death, so combinations should be avoided or used with extreme caution. Patients with the CYP2D6 ultra-rapid metabolizer genotype may metabolize the active ingredient of this drug more quickly, increasing the risk of respiratory depression; therefore, dosage adjustment and monitoring may be required. This drug should not be administered to children under 12 years old or certain patients under the age of 18 who have undergone specific surgeries, and adolescents over 12 should also avoid it if there are risk factors. It should not be administered to patients with acute alcohol intoxication, central nervous system drug overdose, severe respiratory depression, head injury, or those taking MAO inhibitors. Patients with severely impaired liver or kidney function, pregnant or nursing women, or those with hypersensitivity to opioid medications should also not use this medication. While using this drug, drowsiness, dizziness, and other side effects may occur, so driving or operating hazardous machinery should be avoided. Long-term use may lead to tolerance and increased dosages, and sudden discontinuation may cause withdrawal symptoms; therefore, gradual dose reduction is recommended. This drug may interact with various medications, so patients taking other medications should consult healthcare professionals. In cases of overdose, severe respiratory depression and seizures may occur, requiring emergency treatment. When storing, keep it out of reach of children and store in its original container for safety.

Serious side effects

Rash, angioedema, severe allergic reactions, anaphylaxis, seizures, severe anaphylactic symptoms, respiratory depression, dyspnea, exacerbation of asthma, facial pallor, fainting, orthostatic hypotension, tachycardia, bradycardia, hypertension, elevated liver enzyme levels, liver dysfunction (jaundice), severe edema, elevated blood pressure, severe respiratory depression, severe skin adverse reactions (Stevens-Johnson syndrome), severe allergic reactions, severe rash, blisters, skin peeling

Mild side effects

• Drowsiness
• dizziness
• unsteadiness
• nausea
• vomiting
• abdominal distension
• abdominal discomfort
• abdominal pain
• loss of appetite
• constipation

This medication should be stored in a sealed container that blocks light and prevents air entry. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to safely preserve the drug's effectiveness.

Appearance

A brown ampoule filled with a colorless transparent liquid for injection

Package unit

1 milliliter/ampoule X 50