Medication info

Tracan Sustained-release Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Tramadol Hydrochloride›75mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
성원애드콕제약(주)
Appearance
Pale yellow oblong sustained-release film-coated tablet
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle
Approval status
Expired

MFDS item code 201905488 · Approved 2019.08.02

This product's status changed to Expired on 2024.08.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
The dosage is adjusted according to the patient's pain level and therapeutic response. It is recommended to start with a single tablet, with subsequent dosing intervals of at least 12 hours apart, and not to exceed 4 tablets in one day. Avoid prolonged use unless necessary, and perform regular monitoring during extended use. For the elderly, the usual adult dose should be given, but for those over 75 years old, dosing intervals should be at least 12 hours apart.
Child dose
The safety and efficacy of this medication in children have not been established, hence its use is not recommended.

Ingredients

Manufacturer
성원애드콕제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medication is used to relieve moderate to severe acute and chronic pain.

How to take

Adult dose

The dosage is adjusted according to the patient's pain level and therapeutic response. It is recommended to start with a single tablet, with subsequent dosing intervals of at least 12 hours apart, and not to exceed 4 tablets in one day. Avoid prolonged use unless necessary, and perform regular monitoring during extended use. For the elderly, the usual adult dose should be given, but for those over 75 years old, dosing intervals should be at least 12 hours apart.

Child dose

The safety and efficacy of this medication in children have not been established, hence its use is not recommended.

Precautions

This medication may pose a risk of liver damage in individuals who regularly consume more than three glasses of alcohol per day; therefore, consultation with a doctor or pharmacist is mandatory. One of the ingredients, acetaminophen, can cause rare but severe skin reactions, so if a rash or allergic symptoms occur, discontinue use immediately. The tramadol component in this medication can increase the risk of seizures if the recommended dose is exceeded, and the risk may be higher when used in combination with certain antidepressants or other narcotics, hence caution is required. Tramadol may rarely cause severe allergic reactions; hence, notify medical personnel immediately if any allergy symptoms occur. If administered to patients with acute and severe bronchial asthma, this medication may cause life-threatening respiratory depression; therefore, it must only be used in settings with appropriate medical equipment available. When taken with CNS depressants like alcohol or benzodiazepines, this medication can increase the risk of severe sedation, respiratory depression, stupor, or death; hence, concomitant use should be carefully considered. In patients with increased intracranial pressure or head trauma, the risk of respiratory depression may worsen the condition, so caution is necessary. The tramadol component may lead to psychological and physical dependence, so potential for dependence should be considered with prolonged use. Acetaminophen can cause liver damage in cases of overdose, so care must be taken to avoid exceeding the dose and to not take other acetaminophen products concurrently. In particular, for patients who are ultra-rapid metabolizers of CYP2D6, the components of this medication may metabolize quickly in the body, increasing the risk of respiratory depression; thus, dose adjustments and monitoring are necessary. It is not safe to administer this medication to children under 12 years of age or to teenagers under 18 years of age who have undergone tonsillectomy and adenoidectomy. This medication may rarely cause hyponatremia, so elderly patients or those at risk of hyponatremia should periodically monitor sodium levels in the blood. This medication should not be administered to patients who have hypersensitivity to the components, severe respiratory depression, head injuries, or are currently taking MAO inhibitors. Patients with severe impairment of liver, kidney, or heart functions, nursing mothers, and children below a specific age should also avoid use. This medication may cause drowsiness or dizziness when driving or operating machinery, so caution is advised during such activities. In the event of overdose, serious respiratory depression, liver damage may occur, necessitating immediate visit to a medical institution for appropriate treatment. When using this medication, it is important to adhere to the recommended dosage, avoid combining it with other medications of similar composition, and carefully observe for signs of dependence and side effects.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden severe headaches, thunderclap headaches, seizures, altered consciousness, visual disturbances, paralysis, urinary retention

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • stiffness
  • fainting
  • withdrawal symptoms
  • hypertension
  • worsening of hypertension
  • hypotension
  • arrhythmias
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremors
  • ataxia
  • hypertonia
  • migraine
  • worsening of migraine
  • involuntary muscle contractions
  • sensory abnormalities
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • dysphagia
  • blood in stool
  • tongue swelling
  • loss of appetite
  • anxiety
  • confusion
  • euphoria
  • insomnia
  • irritability

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

Storage

Store this medication in a tightly sealed container to avoid contact with air or moisture. Additionally, it is advisable to keep it at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pale yellow oblong sustained-release film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle

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.