Medication info

Hybimadol Injection (Tramadol Hydrochloride)

Prescription medication근육 · 정맥
Ingredient · strength
Tramadol Hydrochloride›50mg / 1mL
Manufacturer / importer
(주)휴비스트제약
Appearance
A colorless, transparent ampule containing a colorless liquid
Packaging
1ml x 50 ampules/Box
Approval status
Active

MFDS item code 201706672 · Notified 2017.08.21

Summary

Main use
Relief of severe and moderate acute chronic pain (e.g., cancer, postoperative pain, etc.)
Who receives it
Adults
Adult administration
As Tramadol Hydrochloride, administer 50-100 mg intravenously or intramuscularly once, repeated every 4-5 hours as needed. The maximum daily dose is 400 mg.

Ingredients

Manufacturer
(주)휴비스트제약

Efficacy & effects

Relief of severe and moderate acute chronic pain (e.g., cancer, postoperative pain, etc.)

  • Severe acute chronic pain
  • moderate acute chronic pain
  • various cancer pain
  • post-diagnostic pain
  • postoperative pain
View approved original text

This medication is used to relieve severe and moderate acute and chronic pain, particularly pain caused by cancer and pain after diagnosis or surgery.

How it is given

Adult administration

As Tramadol Hydrochloride, administer 50-100 mg intravenously or intramuscularly once, repeated every 4-5 hours as needed. The maximum daily dose is 400 mg.

Precautions

This medication may cause seizures if taken in doses exceeding the recommended amount, so caution is required. It should only be used when necessary, especially in patients with a risk of epilepsy or seizures. Long-term use may lead to psychological and physical dependence, so it should be used for a limited time and under strict supervision in patients with a history of drug abuse or dependence. Taking this drug with alcohol or central nervous system depressants may pose a risk of severe sedation, respiratory depression, coma, or death; therefore, it should be avoided or administered with caution. Individuals genetically predisposed to metabolize this drug rapidly may have higher concentrations of the active ingredient, increasing the risk of respiratory depression; thus, dose adjustment and monitoring are essential. This drug should not be administered to children under 12 years or adolescents who have undergone tonsillectomy or adenoidectomy, and caution is recommended in adolescents aged 12 to under 18 years who are at risk. It should not be used in cases of acute alcohol intoxication, CNS drug overdose, severe respiratory depression, head injury, recent use of MAO inhibitors, severe liver or kidney impairment, and pregnant or nursing women. Caution is required when used in combination with morphine or in patients with liver disease, biliary disorders, or those who consume alcohol, as there is a risk of seizures in patients with a history of seizures. This medication may cause side effects such as drowsiness, dizziness, nausea, and vomiting; therefore, it is safer to avoid driving or operating hazardous machinery after taking it. Long-term use may develop tolerance, requiring increased dosages, and sudden discontinuation may lead to withdrawal symptoms; thus, it should be tapered gradually. This medication may interact with various other drugs; therefore, particularly when used in combination with central nervous system depressants, antidepressants, anticoagulants, etc., strict adherence to the physician's instructions is required. Pregnant or nursing women should not take this medication, as severe side effects may occur in the baby during nursing. In the case of overdose, severe respiratory depression and seizures may occur, requiring immediate emergency treatment, and antidotes such as naloxone may be used. This drug should be stored out of the reach of children and kept in its original container to prevent misuse or deterioration.

Side effects and when to seek care immediately

Serious side effects

Hives, shock, anaphylaxis, bronchospasm, angioedema, severe allergic reactions, severe seizures, convulsions, respiratory depression, difficulty breathing, worsening of asthma, life-threatening respiratory depression, increased liver enzyme levels, liver abnormalities (although jaundice symptoms have not been specified, classified as cholestasis), Stevens-Johnson syndrome, severe headache, coma, altered consciousness, loss of consciousness, increased blood pressure, cardiovascular abnormalities (edema associated with severe swelling or urinary disturbances)

Mild side effects

  • Drowsiness
  • dizziness
  • lightheadedness
  • nausea
  • vomiting
  • abdominal distension
  • abdominal discomfort
  • abdominal pain
  • loss of appetite
  • constipation
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  • dry mouth
  • headache
  • heaviness in the head
  • excitement
  • tremors
  • tinnitus
  • numbness in both hands
  • anxiety
  • fatigue
  • lethargy
  • sweating
  • discomfort
  • difficulty urinating
  • dry mouth
  • confusion
  • coordination impairment
  • restlessness
  • sleep disturbances
  • recognition disorders
  • hallucinations
  • forgetfulness
  • concentration difficulties
  • depression
  • changes in appetite
  • sensory disturbances
  • epileptic seizures (rarely)
  • involuntary movements

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container at a temperature between 1 and 30 degrees Celsius. Proper storage will maintain the drug's efficacy.

Appearance and packaging

Appearance

A colorless, transparent ampule containing a colorless liquid

Package unit

1ml x 50 ampules/Box

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.