Medication info
Troset Tablet

Troset Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
Pale yellow rectangular film-coated tablets
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 200805556 · Notified 2008.05.13 · Insurance code 652902240

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children aged 12 and older and adults: The dosage is adjusted based on the patient's pain level and therapeutic response. An initial dose of 2 tablets is recommended, followed by intervals of at least 6 hours, but it should not exceed 8 tablets per day. The effective minimum dose should be administered for the shortest duration possible. Avoid using this medication for longer than necessary, and if prolonged use is required due to disease characteristics and severity, regular monitoring should be conducted to confirm the continued use of this medication. Elderly The usual adult dosage should be administered. However, in patients aged 75 and older, the half-life of tramadol may increase by 17% when administered orally, so doses must be spaced at least 6 hours apart. Patients with renal impairment In moderately impaired renal patients (creatinine clearance of 10-30ml/min), the dosing interval should be extended to 12 hours. Severe renal impairment patients (creatinine clearance of less than 10ml/min) should not be administered this medication. Tramadol is removed very slowly during dialysis, so there is no need to re-administer this medication after dialysis for prolonged analgesic effects. Patients with liver impairment In moderately impaired liver patients, careful consideration should be given to extending the dosing interval. This medication should not be administered to severely impaired liver patients.
Child dose
For children aged 12 and older and adults: The dosage is adjusted based on the patient's pain level and therapeutic response. An initial dose of 2 tablets is recommended, followed by intervals of at least 6 hours, but no more than 8 tablets per day.

Ingredients

Manufacturer
(주)서울제약

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 and older and adults: The dosage is adjusted based on the patient's pain level and therapeutic response. An initial dose of 2 tablets is recommended, followed by intervals of at least 6 hours, but it should not exceed 8 tablets per day. The effective minimum dose should be administered for the shortest duration possible. Avoid using this medication for longer than necessary, and if prolonged use is required due to disease characteristics and severity, regular monitoring should be conducted to confirm the continued use of this medication. Elderly The usual adult dosage should be administered. However, in patients aged 75 and older, the half-life of tramadol may increase by 17% when administered orally, so doses must be spaced at least 6 hours apart. Patients with renal impairment In moderately impaired renal patients (creatinine clearance of 10-30ml/min), the dosing interval should be extended to 12 hours. Severe renal impairment patients (creatinine clearance of less than 10ml/min) should not be administered this medication. Tramadol is removed very slowly during dialysis, so there is no need to re-administer this medication after dialysis for prolonged analgesic effects. Patients with liver impairment In moderately impaired liver patients, careful consideration should be given to extending the dosing interval. This medication should not be administered to severely impaired liver patients.

Child dose

For children aged 12 and older and adults: The dosage is adjusted based on the patient's pain level and therapeutic response. An initial dose of 2 tablets is recommended, followed by intervals of at least 6 hours, but no more than 8 tablets per day.

Precautions

This medication can put strain on the liver, so individuals who regularly consume more than three glasses of alcohol per day should consult a doctor or pharmacist before taking it. If any unusual symptoms such as rash or itching occur while taking this medication, it should be stopped immediately and a doctor consulted. The ingredients in this medication can provoke seizures, so patients with a history of seizures or epilepsy need to be particularly cautious. Severe asthma patients may be at risk of respiratory difficulty when using this medication, so it must be administered under medical supervision. This medication can cause severe drowsiness or respiratory suppression when taken with other central nervous system depressants or alcohol, thus caution is required when used in combination. Patients with head injuries or brain diseases may experience exacerbated confusion or respiratory issues while using this medication and should use it with care. This medication has the potential to lead to dependence, and dosages and duration of use should be adjusted under a doctor's guidance with prolonged use. Patients with impaired liver or kidney function may experience slower metabolism and excretion of this medication, necessitating dosage adjustments. This medication is not administered to children under 12 years old or adolescents under 18 after certain surgeries. Pregnant or breastfeeding women must consult a doctor before taking this medication; if breastfeeding, they should consider stopping breastfeeding or exploring alternative treatments. Caution is needed when driving or operating machinery while using this medication, as drowsiness or dizziness may occur. In the case of an overdose, serious side effects such as respiratory depression, coma, seizures, etc., may occur, so dosage must be strictly observed, and if suspected, immediate medical attention should be sought. This medication should be stored out of reach of children, and it should not be shared with others to prevent misuse or abuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, paleness, severe rash accompanied by high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty or wheezing, asthma attack, respiratory issues with associated cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine retention.

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
  • gas
  • itching
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors
  • and sensations.

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

Storage

This medication must be stored in a tightly sealed container to prevent air and moisture ingress. Additionally, avoid extremely hot or cold environments, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablets

Package unit

30 tablets/bottle, 200 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.