Medication info
Duraset Semi Tablet

Duraset Semi Tablet

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

MFDS item code 200804917 · Notified 2008.04.29 · Insurance code 649403050

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: The dosage should be adjusted based on the patient's pain level and treatment response. An initial dose of 4 tablets is recommended, with intervals between doses being at least 6 hours, not exceeding 16 tablets a day. The effective minimum dose should be used for the shortest duration possible. Avoid administering this drug for longer than necessary, and if prolonged administration is needed due to the nature of the disease and its severity, regular monitoring should be conducted to confirm the ongoing necessity of this drug. Elderly Administer the usual adult dose. However, it is important to note that in elderly patients over 75 years, the elimination half-life of tramadol may increase by 17% when taken orally, thus doses should be administered with at least a 6-hour interval. Renal Impairment For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. Severe renal impairment (creatinine clearance of less than 10 ml/min) should not receive this medication. Tramadol is removed very slowly during dialysis and filtration, so no need for re-administration of this drug for pain relief maintenance after dialysis. Hepatic Impairment For patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. It is not recommended for patients with severe hepatic impairment.
Child dose
Children over 12 years and adults: The dosage should be adjusted based on the patient's pain level and treatment response. An initial dose of 4 tablets is recommended, with intervals between doses being at least 6 hours.

Ingredients

Manufacturer
영일제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe 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

Children over 12 years and adults: The dosage should be adjusted based on the patient's pain level and treatment response. An initial dose of 4 tablets is recommended, with intervals between doses being at least 6 hours, not exceeding 16 tablets a day. The effective minimum dose should be used for the shortest duration possible. Avoid administering this drug for longer than necessary, and if prolonged administration is needed due to the nature of the disease and its severity, regular monitoring should be conducted to confirm the ongoing necessity of this drug. Elderly Administer the usual adult dose. However, it is important to note that in elderly patients over 75 years, the elimination half-life of tramadol may increase by 17% when taken orally, thus doses should be administered with at least a 6-hour interval. Renal Impairment For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. Severe renal impairment (creatinine clearance of less than 10 ml/min) should not receive this medication. Tramadol is removed very slowly during dialysis and filtration, so no need for re-administration of this drug for pain relief maintenance after dialysis. Hepatic Impairment For patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. It is not recommended for patients with severe hepatic impairment.

Child dose

Children over 12 years and adults: The dosage should be adjusted based on the patient's pain level and treatment response. An initial dose of 4 tablets is recommended, with intervals between doses being at least 6 hours.

Precautions

This drug can put stress on the liver, so individuals who regularly consume alcohol in excess of a certain amount daily should consult with a doctor or pharmacist before taking it. Due to the components included in this drug, there can be rare occurrences of severe skin reactions, so if a skin rash or allergic reaction occurs, discontinue use immediately and inform a healthcare provider. The components of this drug can increase the risk of seizures, so patients with a history of seizures or those at high risk should use it cautiously. The risk may be further increased if taken in conjunction with certain antidepressants or opioid analgesics. Rarely, severe allergic reactions can occur while taking this medication, so if symptoms such as difficulty breathing or severe skin rashes develop, seek medical attention immediately. Patients with acute and severe bronchial asthma may have greater difficulty breathing while taking this drug, so administration should occur only in a facility with medical personnel present. Taking this drug with alcohol or CNS depressants can cause severe drowsiness, respiratory depression, and coma, so it is best to avoid this combination. Patients with head injuries or increased intracranial pressure should exercise caution as respiratory depression from this drug may exacerbate symptoms. This medication can cause physical and psychological dependence, so long-term use should follow a doctor's instructions, and sudden discontinuation may induce withdrawal symptoms. Patients with impaired liver function should consult with a doctor prior to taking this medication, as there is a risk of liver damage, and it should not be taken together with other acetaminophen products. Patients with specific genetic metabolic traits may have excessive accumulation of the active ingredient in this drug, leading to significant respiratory depression, so caution is necessary. This medication should not be given to children under 12 years old or to adolescents under 18 years of age following specific surgeries, and adolescents over 12 years old should avoid taking it if there are particular risk factors. This drug can induce sleep apnea or hypoxia, so continuous monitoring for these symptoms or worsening is necessary, and dosage adjustments may be needed. Rarely, hyponatremia may occur during treatment with this drug, so particularly older adults or patients at risk of hyponatremia should closely monitor for symptoms. This drug can interact with certain other medications, so if taking other drugs, it is crucial to inform a doctor or pharmacist, especially if combining with antidepressants, antibiotics, or anticoagulants. Women who are pregnant or could become pregnant should consult a doctor before taking this medication, and it is safer for nursing mothers not to take this drug. Use caution while driving or operating machinery as this drug may cause drowsiness or dizziness.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by coughing and fever, jaundice (yellowing of skin or eyes), extreme drowsiness, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination changes

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 disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremor
  • paresthesia
  • inattention

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

Storage

Store this medication in a tightly sealed container to prevent air or moisture from entering, and keep it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablets

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.