Medication info
Tracetsemi Tablets

Tracetsemi Tablets

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›18.75mg / 1 tabletAcetaminophen›162.5mg / 1 tablet
Manufacturer / importer
유니메드제약(주)
Appearance
Pale yellow oblong film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200805915 · Notified 2008.05.27 · Insurance code 649504980

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Starting with an initial dosage of 4 tablets, subsequent dosing intervals should be at least 6 hours apart, and the daily limit should not exceed 16 tablets. Administer the lowest effective dose for the shortest duration possible. Elderly patients should receive the usual adult dosage, with those over 75 receiving treatment at intervals of at least 6 hours. Moderate renal impairment patients should extend the dosing interval to 12 hours. Severe renal impairment patients are contraindicated for use.
Child dose
Children over 12 years should follow the same dosage as adults.

Ingredients

Manufacturer
유니메드제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute pain
  • moderate to severe chronic pain
View approved original text

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

How to take

Adult dose

Starting with an initial dosage of 4 tablets, subsequent dosing intervals should be at least 6 hours apart, and the daily limit should not exceed 16 tablets. Administer the lowest effective dose for the shortest duration possible. Elderly patients should receive the usual adult dosage, with those over 75 receiving treatment at intervals of at least 6 hours. Moderate renal impairment patients should extend the dosing interval to 12 hours. Severe renal impairment patients are contraindicated for use.

Child dose

Children over 12 years should follow the same dosage as adults.

Precautions

This medication may burden the liver, so individuals who consume alcohol daily should consult a doctor or pharmacist before taking it. Serious skin reactions such as rashes or blisters may occur while taking this medication, so if these symptoms appear, stop taking it immediately and consult a healthcare professional. The ingredients in this medication can cause seizures, so patients with a history of seizures or at high risk of seizures need to be cautious. Rarely, severe allergic reactions may occur while taking this medication, so if sudden difficulty in breathing or swelling occurs, visit a medical institution immediately. Patients with severe asthma may experience difficulty breathing while taking this medication, so it should only be used in facilities equipped with medical equipment. Taking this medication with alcohol or other central nervous system depressants can lead to severe drowsiness, respiratory depression, and coma, so concurrent use should be avoided. Patients who have head injuries or brain disorders should be cautious as this medication may increase intracranial pressure. This medication can cause physical and psychological dependence, so long-term use should be according to a doctor's instructions, as abrupt cessation may trigger withdrawal symptoms. Patients with impaired liver function should consult with a doctor before taking this medication and be careful not to take it with other acetaminophen products. Patients with certain genotypes may metabolize this medication quickly, increasing the risk of respiratory depression; therefore, dosage adjustments or alternative medications may be required in these cases. This medication should not be administered to children under the age of 12 or to adolescents under 18 who have undergone tonsillectomy or adenoidectomy. This medication can induce sleep apnea or hypoxia; therefore, relevant symptoms should be continuously monitored for worsening. Elderly patients or those at risk for hyponatremia should be carefully observed for symptoms of hyponatremia while taking this medication. This medication can interact with certain drugs, so if other medications are being taken, be sure to inform a doctor or pharmacist. Pregnant or nursing women should consult with a healthcare professional before taking this medication, and nursing mothers are particularly advised to discontinue breastfeeding while taking it. This medication may cause drowsiness or dizziness, so caution is needed when driving or operating machinery. In case of overdose, there is a risk of serious respiratory depression and liver damage, so prescribed dosages must be strictly adhered to, and if abnormal symptoms occur, visit a medical institution immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • anaphylactic reaction
  • severe allergic reaction
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • severe skin adverse reactions
  • seizures
  • serious neurological symptoms
  • difficulty breathing
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  • asthma attacks
  • respiratory distress
  • respiratory problems
  • increased liver enzymes
  • hepatitis
  • jaundice
  • liver dysfunction
  • increased blood pressure
  • severe edema
  • urination abnormalities
  • altered consciousness
  • severe headache
  • thunderclap headache
  • paralysis
  • severe swelling

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • directional sense disturbance
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremors
  • sensory loss

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

Storage

This medication should be stored in an airtight container, and it is best kept at room temperature below 25 degrees Celsius. This will help maintain the medication's effectiveness for a long time.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablets

Package unit

30 tablets/bottle, 300 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

No questions yet.

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.