Medication info
Tramacet Sustained-Release Tablet

Tramacet Sustained-Release Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›75mg / 1 tablet
Manufacturer / importer
제이더블유신약(주)
Appearance
Light yellow rectangular sustained-release film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201505164 · Approved 2015.07.30 · Insurance code 644102690

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
Adjust the dose according to the patient's level of pain and response to treatment. Administer 1 tablet for the initial dose, and the dosing interval should be at least 12 hours, without exceeding 4 tablets a day. Avoid unnecessary long-term use, and if long-term use is required, conduct regular monitoring of the need for continued use. During administration, side effects such as nausea, vomiting, itching, constipation, dizziness, and drowsiness may occur; thus, the patient's response should be closely monitored and adjusted accordingly.

Ingredients

Manufacturer
제이더블유신약(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 acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

Adjust the dose according to the patient's level of pain and response to treatment. Administer 1 tablet for the initial dose, and the dosing interval should be at least 12 hours, without exceeding 4 tablets a day. Avoid unnecessary long-term use, and if long-term use is required, conduct regular monitoring of the need for continued use. During administration, side effects such as nausea, vomiting, itching, constipation, dizziness, and drowsiness may occur; thus, the patient's response should be closely monitored and adjusted accordingly.

Precautions

This medication can cause liver damage; therefore, individuals who regularly consume more than three alcoholic drinks a day should consult a doctor or pharmacist before use. If a rash or allergic reaction occurs during treatment, stop taking the medication immediately and inform healthcare providers. This medication may cause seizures, so patients with a history of seizures or those at high risk of seizures should use it with caution, as the risk of seizures may increase when combined with certain antidepressants or other drugs. Patients with severe respiratory conditions or those experiencing acute asthma attacks may experience life-threatening respiratory depression when taking this medication; thus, it should be administered in a hospital with appropriate equipment. Combining this medication with alcohol or central nervous system depressants, such as benzodiazepines, can lead to severe sedation or respiratory depression and coma, requiring caution. Patients with head injuries or increased intracranial pressure should use this medication cautiously, as respiratory depression may further elevate intracranial pressure. This medication can cause physical and psychological dependence, so careful monitoring is necessary for dependence when used long-term. Patients with impaired liver function or liver disease must consult a physician before taking this medication, and drug manufacturers should check the acetaminophen content to reduce the risk of hepatotoxicity. Individuals with rapid genetic metabolic rates may produce excessive active metabolites from this drug, increasing the risk of side effects such as respiratory depression, and should be careful. It is not safe to use this medication in children under 12 years old or adolescents under 18 years old who have had tonsillectomy or adenoidectomy. This medication may lead to hyponatremia (low blood sodium levels); thus, especially elderly patients or those at risk of hyponatremia should monitor symptoms. Patients with a history of allergy to this medication or those with severe respiratory depression, head injuries, or taking certain medications should not take this medication. Pregnant or breastfeeding women should consult healthcare providers before taking this medication, as it may pose risks to the fetus or newborn. This medication may cause drowsiness or dizziness when driving or operating machinery, so caution is advised. In case of overdose, serious side effects such as respiratory depression and liver damage may occur; therefore, contact a medical institution immediately for appropriate treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe allergic reactions, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, respiratory problems, eyes or skin turning yellow (jaundice), extreme fatigue, liver abnormalities (jaundice), sudden

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • rigidity
  • fainting
  • withdrawal symptoms
  • hypertension
  • exacerbation of hypertension
  • hypotension
  • arrhythmia
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremor
  • ataxia
  • hypertonia
  • migraine
  • exacerbation of migraine
  • involuntary muscle contractions
  • sensory disturbances
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • dysphagia
  • hematochezia
  • tongue swelling
  • decreased appetite
  • anxiety
  • disorientation
  • euphoria
  • insomnia
  • irritability

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

Storage

This medication may be sensitive to air or humidity; therefore, it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature to preserve its effectiveness for a longer period.

Appearance and packaging

Appearance

Light yellow rectangular sustained-release film-coated tablet

Package unit

30 tablets/bottle, 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

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.