Medication info
Thiosetsami Tablet

Thiosetsami Tablet

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

MFDS item code 200805734 · Notified 2008.05.21 · Insurance code 052700520

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and response to treatment. For the initial dose, 4 tablets are recommended, and thereafter the dosing interval should be no less than 6 hours, but should not exceed 16 tablets per day. The effective minimum dose should be administered for the shortest possible duration. Avoid prolonged use of this medication beyond necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to assess the need for continued administration of this medication. Elderly Administer the usual adult dose; however, for elderly patients over 75, if tramadol is taken orally, the half-life of tramadol increases by 17%, so ensure that the medication is given with an interval of at least 6 hours. Patients with renal impairment For moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance less than 10 ml/min), administration of this medication is not recommended. Tramadol is removed very slowly during dialysis and filtration, so there is no need to re-administer this medication after dialysis to maintain analgesic effect. Patients with hepatic impairment For moderate hepatic impairment, consider extending the dosing interval carefully. For severe hepatic impairment, this medication should not be administered.
Child dose
For children 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and response to treatment. For the initial dose, 4 tablets are recommended, and thereafter the dosing interval should be no less than 6 hours, but should not exceed 16 tablets per day.

Ingredients

Manufacturer
(주)휴메딕스
Manufacturer
(주)휴온스생명과학

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute and 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 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and response to treatment. For the initial dose, 4 tablets are recommended, and thereafter the dosing interval should be no less than 6 hours, but should not exceed 16 tablets per day. The effective minimum dose should be administered for the shortest possible duration. Avoid prolonged use of this medication beyond necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to assess the need for continued administration of this medication. Elderly Administer the usual adult dose; however, for elderly patients over 75, if tramadol is taken orally, the half-life of tramadol increases by 17%, so ensure that the medication is given with an interval of at least 6 hours. Patients with renal impairment For moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance less than 10 ml/min), administration of this medication is not recommended. Tramadol is removed very slowly during dialysis and filtration, so there is no need to re-administer this medication after dialysis to maintain analgesic effect. Patients with hepatic impairment For moderate hepatic impairment, consider extending the dosing interval carefully. For severe hepatic impairment, this medication should not be administered.

Child dose

For children 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and response to treatment. For the initial dose, 4 tablets are recommended, and thereafter the dosing interval should be no less than 6 hours, but should not exceed 16 tablets per day.

Precautions

This medicine may be burdensome to the liver, so individuals who regularly consume more than three alcoholic drinks a day must consult a doctor or pharmacist before use. This medication can rarely cause serious skin reactions; therefore, if a rash or hypersensitivity reaction occurs, immediate discontinuation and consultation with a doctor is necessary. The tramadol component in this medication may increase the risk of seizures, so those with a history of seizures or those at high risk of seizures should take caution when using it. Tramadol can rarely trigger serious allergic reactions, so if any allergic symptoms arise, medical personnel must be informed immediately. Patients with acute and severe asthma may experience difficulty breathing when taking this medication; therefore, it should only be administered in equipped medical facilities. This medication can cause severe drowsiness or respiratory depression if taken with alcohol or sedatives; caution is required. Patients with head injuries or brain disorders should use this medication carefully, as it may increase intracranial pressure. This medication may cause physical or psychological dependence, so long-term use should be under a doctor's guidance. Patients with poor liver function must consult a doctor before taking this medication, and should not exceed the recommended dose due to the risk of liver toxicity. Patients with a fast drug metabolism rate may have the components of this medication act more quickly in their bodies, increasing the risk of respiratory depression and other side effects, so care is needed. Children under 12 years of age or adolescents under 18 years who have undergone specific surgeries should not take this medication, and those aged between 12 and 18 should do so carefully. This medication may induce sleep apnea or hypoxia, so continuous monitoring for worsening symptoms is necessary. Elderly patients or those at risk of hyponatremia should be monitored carefully for symptoms of hyponatremia during treatment with this medication. There may be an increased risk of seizures, serotonin syndrome, or respiratory depression when combined with certain medications, hence it's imperative to discuss other medications being taken. Women who are pregnant or nursing should consult a doctor before taking this medication; nursing mothers are advised to avoid this medication for safety reasons. This medication can cause drowsiness or dizziness, so caution is advised when driving or operating machinery. In cases of overdose, severe respiratory depression, seizures, and liver damage may occur, so the recommended dose must be strictly adhered to; in emergencies, immediate medical attention is required. This medication should be stored in a safe place out of the reach of children, and care should be taken to prevent misuse and accidental ingestion.

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 fever, blisters, skin sloughing, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, jaundice (yellowing of the skin or eyes), profound drowsiness, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination issues

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
  • hypoglycemia
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • unusual dreams
  • drug abuse
  • hallucination
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory impairment
  • tremors
  • numbness

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 it at room temperature between 1°C and 30°C, away from direct sunlight.

Appearance and packaging

Appearance

Light yellow oblong 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.