Medication info

Tracompa Injection (Tramadol Hydrochloride)

Prescription medicationInjections근육 · 정맥
Ingredient · strength
Tramadol Hydrochloride›50mg / 1 ampoule
Manufacturer / importer
영일제약(주)
Appearance
Brown ampule injection containing a colorless and transparent liquid
Packaging
1 milliliter/ampule x 50
Approval status
Active

MFDS item code 201607026 · Notified 2016.12.08 · Insurance code 649405001

Summary

Main use
Relief of severe and moderate acute and chronic pain (including cancer-related pain, post-diagnostic and post-surgical pain)
Who receives it
Adults
Adult administration
Tramadol hydrochloride: Administer 50-100 mg by intravenous or intramuscular injection once, then repeat as needed every 4-5 hours. The maximum daily dosage can be up to 400 mg.

Ingredients

Manufacturer
영일제약(주)

Efficacy & effects

Relief of severe and moderate acute and chronic pain (including cancer-related pain, post-diagnostic and post-surgical pain)

  • Severe pain
  • moderate acute and chronic pain
  • various cancer pain
  • pain after diagnosis
  • post-surgical pain
View approved original text

This medication is used for the relief of severe and moderate acute and chronic pain, for example, pain occurring in various cancers and pain that arises after diagnosis and surgery.

How it is given

Adult administration

Tramadol hydrochloride: Administer 50-100 mg by intravenous or intramuscular injection once, then repeat as needed every 4-5 hours. The maximum daily dosage can be up to 400 mg.

Precautions

This medication may cause seizures if taken in excess of the recommended dosage, so the prescribed dose must be adhered to. This medication should be administered cautiously in patients at risk of seizures only if absolutely necessary. Prolonged use may lead to psychological and physical dependence, so it should be used under strict management in patients with potential for abuse for a short period. Concomitant use of this medication with alcohol or central nervous system depressants can lead to severe drowsiness, respiratory depression, coma, and in severe cases, death, so it should be avoided or used with extreme caution. In patients with certain genetic types, excessive production of the active metabolite of this medication may increase the risk of respiratory depression, so these patients should consider dosage adjustment or alternative medication. This medication should not be administered to children under 12 years old or to adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy. It should not be used in patients with acute alcohol intoxication, central nervous system drug intoxication, severe respiratory depression, head injury, those taking MAO inhibitors, patients with severe renal or hepatic impairment, pregnant or breastfeeding women. Patients taking morphine, those with impaired liver and kidney function, those who consume alcohol, and those with a history of seizures should use this medication cautiously, and dosage adjustments may be necessary. This medication may cause side effects such as drowsiness, dizziness, nausea, etc., so driving or operating hazardous machinery should be avoided after taking it. Additionally, when used in conjunction with other central nervous system depressants, side effects may be exacerbated, so dosage should be reduced, and the patient's condition should be closely monitored. Pregnant or breastfeeding women should not use this medication, especially during breastfeeding, as it may be transmitted to the baby through breast milk and pose risks. In cases of overdose, severe respiratory depression and seizures may occur, requiring immediate emergency treatment, and naloxone may be used as an antidote. When storing this medication, keep it out of reach of children, and store it in its original container to prevent misuse or degradation of quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, pain in the oral or ocular mucosa, severe skin anomalies, shortness of breath, asthma attacks, respiratory abnormalities accompanied by coughing and fever, respiratory issues, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden

Mild side effects

  • Drowsiness
  • dizziness
  • unsteadiness
  • 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
  • lethargy
  • fatigue
  • malaise
  • sweating
  • dysuria
  • dry mucous membranes
  • confusion
  • coordination difficulties
  • hyperesthesia
  • restlessness
  • sleep disturbances
  • cognitive disturbances
  • hallucinations
  • forgetfulness
  • concentration difficulties
  • depression
  • changes in appetite
  • sensory abnormalities
  • interstitial seizures
  • involuntary muscle movements

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

Storage

This medication is sensitive to light, so it should be stored in a container that protects it from light. Furthermore, it is best to store the medication at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness over time.

Appearance and packaging

Appearance

Brown ampule injection containing a colorless and transparent liquid

Package unit

1 milliliter/ampule x 50

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.