Medication info
Traceta Tablet (Acetaminophen, Tramadol)

Traceta Tablet (Acetaminophen, Tramadol)

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
(주)대웅제약
Appearance
Pale yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 201906674 · Approved 2019.09.24 · Insurance code 641606950

Summary

Main use
Relief of moderate to severe acute/chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 years and older and adults: The dose should be adjusted according to the patient's level of pain and therapeutic response. It is recommended to administer an initial dose of 2 tablets, with subsequent doses taken at least 6 hours apart but not to exceed 8 tablets in one day. The lowest effective dose should be given for the shortest duration possible. Avoid unnecessary long-term use of this medication, and for cases requiring long-term use due to the nature and severity of the disease, regular monitoring should be conducted to evaluate the continuation of this medication.
Child dose
Children aged 12 years and older and adults: The dose should be adjusted according to the patient's level of pain and therapeutic response. It is recommended to administer an initial dose of 2 tablets, with subsequent doses taken at least 6 hours apart.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Relief of moderate to severe acute/chronic pain

  • Moderate to severe acute/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

Children aged 12 years and older and adults: The dose should be adjusted according to the patient's level of pain and therapeutic response. It is recommended to administer an initial dose of 2 tablets, with subsequent doses taken at least 6 hours apart but not to exceed 8 tablets in one day. The lowest effective dose should be given for the shortest duration possible. Avoid unnecessary long-term use of this medication, and for cases requiring long-term use due to the nature and severity of the disease, regular monitoring should be conducted to evaluate the continuation of this medication.

Child dose

Children aged 12 years and older and adults: The dose should be adjusted according to the patient's level of pain and therapeutic response. It is recommended to administer an initial dose of 2 tablets, with subsequent doses taken at least 6 hours apart.

Precautions

This medication is an analgesic containing acetaminophen and tramadol, which can cause liver damage; individuals who regularly consume more than three alcoholic drinks daily should consult a doctor or pharmacist. Due to the acetaminophen component, serious skin rashes or allergic reactions may occur rarely, so if a rash or hypersensitivity reaction occurs after taking it, stop taking the medication immediately. Exceeding the recommended dose of tramadol increases the risk of seizures, and taking it with certain antidepressants or narcotic analgesics may further increase the risk, so caution is advised. This medication can be life-threatening for patients with acute asthma who have difficulty breathing, so it should only be used in a monitored medical environment. Taking this medication with alcohol or central nervous system depressants can cause severe drowsiness, respiratory depression, and coma; extreme caution is required when co-administering. Patients with head injuries or brain diseases should be cautious as this medication may worsen symptoms due to increased intracranial pressure and respiratory depression. Additionally, this medication may cause dependence similar to narcotic analgesics, so long-term use should be closely monitored for signs of dependence. It should not be administered to patients with severe liver or kidney dysfunction, children under 12 years old, or children under 18 years old who have undergone tonsillectomy or adenoidectomy, and it is advisable for pregnant or breastfeeding women to avoid its use. Drowsiness or dizziness may occur while taking this medication, so care should be taken when driving or operating machinery. In case of overdose, severe respiratory depression, seizures, or liver damage may occur, so immediate medical attention is necessary. Do not take other acetaminophen products while using this medication, and consult a doctor immediately if any abnormal symptoms appear. Many drug interactions are possible, so if you are currently taking other medications, be sure to inform your healthcare provider, especially regarding concurrent use with antidepressants, anticonvulsants, narcotic analgesics, and central nervous system depressants. This medication should be kept out of the reach of children and stored securely to prevent misuse or abuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough with respiratory issues and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination problems

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
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • directional sense disorder
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremor
  • paresthesia
  • attention deficit

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is also advisable to store at room temperature, between 1 to 30 degrees Celsius, avoiding extreme heat or cold.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 500 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.