Medication info
Trimacet Tablet

Trimacet Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
(주)유영제약
Appearance
Light yellow, rectangular film-coated tablets
Packaging
[For domestic use] 30 tablets/bottle, 300 tablets/bottle, [For export] 100 tablets (10 tablets/ PTP packaging x 10)
Approval status
Active

MFDS item code 200705588 · Notified 2007.05.16 · Insurance code 648201840

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children over 12 years and adults: Dosage should be adjusted based on the severity of pain and treatment response. An initial dose of 2 tablets is recommended, with subsequent dosing intervals of at least 6 hours, ensuring not to exceed 8 tablets per day. Maintain the lowest effective dose for as short a duration as possible. Avoid unnecessary prolonged use of this medication; if long-term use is needed due to disease characteristics or severity, regular monitoring is required to confirm the necessity of continued use of this medication. Elderly Administer the usual adult dosage. However, since the half-life of tramadol increases by 17% for elderly patients over 75 years, ensure to administer the medication at intervals of at least 6 hours. Renal impairment For moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. It is not recommended for severe renal impairment (creatinine clearance less than 10 mL/min). Tramadol is eliminated very slowly during hemodialysis and filtration; therefore, there is no need to re-administer this medication after dialysis for maintaining analgesic effect. Hepatic impairment For moderate hepatic impairment, consider extending the dosing interval carefully. It is not recommended for severe hepatic impairment.
Child dose
Children over 12 years and adults: Dosage should be adjusted based on the severity of pain and treatment response. An initial dose of 2 tablets is recommended, with subsequent dosing intervals of at least 6 hours, limiting to a maximum of 8 tablets per day.

Ingredients

Manufacturer
(주)유영제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medication is used for the relief of acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

Children over 12 years and adults: Dosage should be adjusted based on the severity of pain and treatment response. An initial dose of 2 tablets is recommended, with subsequent dosing intervals of at least 6 hours, ensuring not to exceed 8 tablets per day. Maintain the lowest effective dose for as short a duration as possible. Avoid unnecessary prolonged use of this medication; if long-term use is needed due to disease characteristics or severity, regular monitoring is required to confirm the necessity of continued use of this medication. Elderly Administer the usual adult dosage. However, since the half-life of tramadol increases by 17% for elderly patients over 75 years, ensure to administer the medication at intervals of at least 6 hours. Renal impairment For moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. It is not recommended for severe renal impairment (creatinine clearance less than 10 mL/min). Tramadol is eliminated very slowly during hemodialysis and filtration; therefore, there is no need to re-administer this medication after dialysis for maintaining analgesic effect. Hepatic impairment For moderate hepatic impairment, consider extending the dosing interval carefully. It is not recommended for severe hepatic impairment.

Child dose

Children over 12 years and adults: Dosage should be adjusted based on the severity of pain and treatment response. An initial dose of 2 tablets is recommended, with subsequent dosing intervals of at least 6 hours, limiting to a maximum of 8 tablets per day.

Precautions

This medication may pose a risk of liver damage if taken by individuals who regularly consume more than three glasses of alcohol per day; consultation with a physician or pharmacist is essential. The ingredients in this medication can rarely cause serious skin reactions; if skin rashes or allergic symptoms appear, discontinue use immediately and inform a specialist. The main ingredient of this medication may increase the risk of seizures, hence caution is needed for those with a history of seizures or those taking other medications that may induce seizures. Rarely, serious allergic reactions may occur while using this medication; if symptoms like breathing difficulty or hives occur, immediate medical attention is required. Patients with acute and severe bronchial asthma may experience severe respiratory suppression during use, thus administration must be under medical supervision. Concurrent use of this medication with alcohol or central nervous system depressants may lead to severe drowsiness, respiratory depression, and coma; therefore, such combinations should be avoided or done under professional guidance. Patients with elevated intracranial pressure or head injuries should be cautious as their symptoms may worsen upon taking this medication. This medication can lead to psychological and physical dependency; therefore, long-term use should be closely monitored for signs of dependency. Acetaminophen in this medication can cause severe liver damage in the event of overdose; care must be taken to ensure the total daily dosage does not exceed 4,000mg, and those with poor liver function should consult a physician before use. Some patients may metabolize this medication very quickly, leading to stronger side effects than expected; dosage adjustment or alternative medications may be necessary in such cases. This medication should not be used in children under 12 years of age or in specific cases among children due to the risk of respiratory suppression; for adolescents over 12, administration should be avoided if specific risk factors are present. Patients with sleep apnea or hypoxemia may see their symptoms worsen following the use of this medication, necessitating regular monitoring and possible dosage adjustments. Elderly patients or those at risk for hyponatremia may experience the potential for developing hyponatremia during use, so monitoring for symptoms is essential. This medication is contraindicated or requires cautious administration in patients with certain diseases or those taking other medications, thus consulting with healthcare professionals is crucial. Sudden discontinuation of this medication can lead to withdrawal symptoms; therefore, tapering off should be done gradually under a professional's guidance. This medication may cause drowsiness or dizziness; therefore, it is safest to avoid driving or operating dangerous machinery after use. In cases of overdose, severe respiratory depression, seizures, and liver damage may occur; if suspected, immediate emergency treatment must be sought. This medication should be kept out of reach of children and handled safely to prevent misuse and abuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Loss of 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
  • irritability
  • emotional instability
  • euphoria
  • reduced libido
  • sleep disturbances
  • confusion
  • direction sense impairment
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremors
  • sensation.

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

Storage

This medication should be stored in a tightly sealed container that allows for proper air circulation and kept at room temperature below 25 degrees Celsius. Proper storage will help maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

Light yellow, rectangular film-coated tablets

Package unit

[For domestic use] 30 tablets/bottle, 300 tablets/bottle, [For export] 100 tablets (10 tablets/ PTP packaging x 10)

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.