Medication info
Trimacet Semi Tablet

Trimacet Semi Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›18.75mg / 1 tablet
Manufacturer / importer
(주)유영제약
Appearance
Light yellow elliptical film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200705587 · Notified 2007.05.16 · Insurance code 648201830

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children aged 12 years and older and adults: Dosage should be adjusted based on the intensity of pain and treatment response. An initial dose of 4 tablets is recommended, and thereafter, the interval between doses should be at least 6 hours, ensuring it does not exceed 16 tablets in a day. Administer the lowest effective dose possible for as short a duration as necessary. Avoid prolonged use of this medication beyond what is necessary, and if prolonged use is needed due to the characteristics and severity of the condition, regular monitoring should be conducted to confirm the necessity of continued treatment with this medication. Elderly Administer the usual adult dosage. However, when administering tramadol orally to elderly patients over 75 years of age, since the elimination half-life of tramadol increases by 17%, the interval between doses should be at least 6 hours. Renal Impairments For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. This medication is not recommended for patients with severe renal impairment (creatinine clearance of less than 10 mL/min). Tramadol is very slowly removed during hemodialysis and filtration, so re-administration of this medication after dialysis is not necessary to maintain analgesic effects. Hepatic Impairments For patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. This medication should not be administered to patients with severe hepatic impairment.
Child dose
For children aged 12 years and older and adults: Dosage should be adjusted based on the intensity of pain and treatment response. An initial dose of 4 tablets is recommended, and thereafter, the interval between doses should be at least 6 hours, with a maximum of 16 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 to relieve acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

For children aged 12 years and older and adults: Dosage should be adjusted based on the intensity of pain and treatment response. An initial dose of 4 tablets is recommended, and thereafter, the interval between doses should be at least 6 hours, ensuring it does not exceed 16 tablets in a day. Administer the lowest effective dose possible for as short a duration as necessary. Avoid prolonged use of this medication beyond what is necessary, and if prolonged use is needed due to the characteristics and severity of the condition, regular monitoring should be conducted to confirm the necessity of continued treatment with this medication. Elderly Administer the usual adult dosage. However, when administering tramadol orally to elderly patients over 75 years of age, since the elimination half-life of tramadol increases by 17%, the interval between doses should be at least 6 hours. Renal Impairments For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. This medication is not recommended for patients with severe renal impairment (creatinine clearance of less than 10 mL/min). Tramadol is very slowly removed during hemodialysis and filtration, so re-administration of this medication after dialysis is not necessary to maintain analgesic effects. Hepatic Impairments For patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. This medication should not be administered to patients with severe hepatic impairment.

Child dose

For children aged 12 years and older and adults: Dosage should be adjusted based on the intensity of pain and treatment response. An initial dose of 4 tablets is recommended, and thereafter, the interval between doses should be at least 6 hours, with a maximum of 16 tablets per day.

Precautions

This medication may put a strain on the liver, so those who drink alcohol regularly in amounts greater than a certain daily limit should consult a doctor or pharmacist before taking it. Due to the acetaminophen component, serious skin rashes or allergic reactions can occur rarely, so if any unusual symptoms appear on the skin, discontinuation of use should occur immediately. The main component of this medication, tramadol, can increase the risk of seizures if taken in excess of the recommended dosage, and the risk of seizures is also increased when taken alongside certain antidepressants or other central nervous system medications, so caution is advised. Serious allergic reactions, such as anaphylaxis, can occur rarely, so if any allergy symptoms are suspected, medical personnel should be notified immediately. In patients with severe respiratory conditions, there is a high risk of respiratory depression, so it must be administered in an environment where medical personnel are present. Taking this medication along with alcohol or sedatives can lead to severe drowsiness, respiratory depression, or coma, so co-use should be avoided or strictly managed. Patients with head injuries or brain diseases should use this medication cautiously, as it carries a risk of increased intracranial pressure. This medication can cause dependability similar to that of narcotic analgesics, presenting a risk of dependence when taken for prolonged periods. Due to the acetaminophen component, liver damage can occur, so patients with poor liver function should take this medication only after consulting a doctor. Patients with certain genes may metabolize this medication quickly, increasing the risk of respiratory depression, and in such cases, dosage adjustment or alternative medication as per a doctor's guidance may be necessary. This medication should not be administered to children under 12 years of age or to adolescents under 18 years of age following tonsillectomy, and teens aged 12 to 18 years should avoid it if they have certain risk factors. Patients with sleep apnea or hypoxemia should be carefully monitored, as their symptoms may worsen after taking this medication. While taking this medication, hyponatremia can rarely occur, so monitoring for symptoms is especially necessary in the elderly or patients with risk factors. Patients with a history of allergy to this medication's components, severe respiratory depression, head injuries, or those on MAO inhibitors should not take this medication. Patients currently taking narcotic analgesics or central nervous system depressants, severely impaired liver or kidney functioning, or those who are alcoholics should use this medication cautiously. During use, do not exceed the recommended dosage, and exercise caution not to take it with other tramadol or acetaminophen products. Abrupt discontinuation of this medication can result in withdrawal symptoms such as anxiety, insomnia, and sweating, so dosage should be gradually reduced under a doctor's direction. Drowsiness or dizziness may occur while taking this medication, requiring caution during driving or operating machinery. In case of overdose, serious side effects such as respiratory depression, seizures, or liver damage may occur, necessitating strict adherence to dosage and immediate visits to healthcare facilities if in doubt. This medication should be stored in a safe place out of the reach of children, and access should be restricted to prevent 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 with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, 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
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremor
  • sensory impairment

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

Storage

This medication should be stored in a tightly closed container to protect it from air exposure and is best kept at room temperature below 25 degrees Celsius. This will maintain the medication's effectiveness and prevent it from deteriorating.

Appearance and packaging

Appearance

Light yellow elliptical film-coated tablet

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

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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.