Medication info
DuoSet Tablet

DuoSet Tablet

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

MFDS item code 200804561 · Notified 2008.04.23 · Insurance code 651202540

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 according to the patient's pain level and therapeutic response. A starting dose of 2 tablets is recommended, and thereafter the interval should be at least 6 hours, while not exceeding 8 tablets per day. The effective lowest dose should be administered for the shortest duration possible. Long-term use of this medication should be avoided unless necessary due to the nature and severity of the disease.
Child dose
For children aged 12 years and older and adults: Dosage should be adjusted according to the patient's pain level and therapeutic response. A starting dose of 2 tablets is recommended, and thereafter the interval should be at least 6 hours, with a limit of 8 tablets per day.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute and chronic pain
View approved original text

This medicine is used to relieve acute and chronic pain from moderate to severe.

How to take

Adult dose

For children aged 12 years and older and adults: Dosage should be adjusted according to the patient's pain level and therapeutic response. A starting dose of 2 tablets is recommended, and thereafter the interval should be at least 6 hours, while not exceeding 8 tablets per day. The effective lowest dose should be administered for the shortest duration possible. Long-term use of this medication should be avoided unless necessary due to the nature and severity of the disease.

Child dose

For children aged 12 years and older and adults: Dosage should be adjusted according to the patient's pain level and therapeutic response. A starting dose of 2 tablets is recommended, and thereafter the interval should be at least 6 hours, with a limit of 8 tablets per day.

Precautions

This medication can cause liver damage in individuals who regularly consume more than three alcoholic drinks per day, so consultation with a doctor or pharmacist is necessary. This drug can rarely cause serious skin reactions, and if skin rash or hypersensitivity occurs, it should be discontinued immediately. The active ingredient tramadol can increase the risk of seizures if exceeding the recommended dosage, and the risk may be higher when taken with certain antidepressants or narcotics. Anaphylaxis reactions that threaten life can rarely occur during tramadol use, so consultation with medical personnel is required if allergic symptoms appear. Patients with acute or severe bronchial asthma are at risk of respiratory depression when taking this medication, and must only be administered under medical supervision. Taking this medication with alcohol or central nervous system depressants can cause severe sedation and respiratory depression, so co-administration should be avoided, and if unavoidable, should be used in the minimum dose for a short period. Patients with increased intracranial pressure or head injuries may find that symptoms worsen with administration of this medication. Tramadol may cause mental and physical dependence, so careful monitoring for dependence is needed with long-term use. Acetaminophen, included in this medication, can burden the liver, so patients with liver disorders must consult a doctor before taking it. For those with ultra-rapid CYP2D6 metabolism, the active ingredient of this medication can accumulate excessively in the body, increasing the risk of serious side effects such as respiratory depression, thus requiring special attention. Children under 12 years old or adolescents under 18 who have undergone certain surgeries should not be given this medication, and adolescents aged 12 to 18 should avoid it if there are risk factors. This medication can cause sleep apnea or hypoxia, so continuous monitoring of symptoms is required, and dosage adjustment or discontinuation should be considered if symptoms worsen. Elderly patients or those at risk for hyponatremia should be monitored closely for the possibility of developing hyponatremia. This medication can interact with certain medications, so if currently taking any other medications, it is crucial to inform medical personnel, as co-administration may increase risks of seizures, serotonin syndrome, and respiratory depression. Pregnant or nursing women must consult with a doctor before taking this medication, especially when nursing, as this medication can be transmitted to the infant through breast milk and cause serious side effects. Drowsiness or dizziness may occur due to this medication while driving or operating machinery, so caution is necessary. In cases of overdose, severe symptoms such as respiratory depression, seizures, and liver damage may arise, so it is crucial to adhere strictly to prescribed dosages and visit a medical institution immediately if in doubt. This medication should be stored in a safe place out of reach of children, and care should be taken to prevent misuse or abuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty or trouble breathing, asthma attacks, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme drowsiness, sudden and severe headache, thunderclap headache, seizures, altered 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
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disorders
  • confusion
  • disturbances in spatial perception
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • numbness
  • tremors
  • sensory disturbances
  • attention issues

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

Storage

This medication should be stored in a tightly closed container that protects against air. For both domestic and export versions, it is advisable to store at room temperature below 25 degrees Celsius. For export version 2, it should be kept at room temperature between 1 and 30 degrees Celsius. By storing this way, the effectiveness of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

Light yellow rectangular film-coated tablet

Package unit

For export - 100 tablets/PTP [(10 tablets/PTP X 10)], for domestic use - 30 tablets/bottle, for domestic use - 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.