Medication info
Dualset Semi Tablet

Dualset Semi Tablet

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

MFDS item code 200804631 · Notified 2008.04.24 · Insurance code 053300240

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
Children aged 12 and older and adults: Dosage should be adjusted based on the patient's pain level and therapeutic response. A starting dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, not exceeding 16 tablets per day. The lowest effective dose should be administered for the shortest duration possible. Avoid prolonged use beyond what is necessary, and in cases where long-term use is required due to the nature and severity of the condition, regular monitoring should be conducted to determine whether to continue taking this medication. Elderly: Administer the usual adult dose. However, for elderly patients aged 75 and older receiving oral tramadol, the half-life of tramadol elimination is increased by 17%, so administer with a minimum interval of 6 hours. Renal impairment: For patients with moderate renal impairment (creatinine clearance 10-30 mL/min), extend the dosing interval to 12 hours. Severe renal impairment (creatinine clearance below 10 mL/min) is not recommended for this medication. Tramadol is very slowly removed during dialysis, so it is not necessary to re-administer this medication after dialysis to maintain analgesic effects. Hepatic impairment: Caution is advised regarding extending the dosing interval for patients with moderate hepatic impairment. This medication should not be administered to patients with severe hepatic impairment.

Ingredients

Manufacturer
(주)중헌제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute pain
  • moderate to severe 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 aged 12 and older and adults: Dosage should be adjusted based on the patient's pain level and therapeutic response. A starting dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, not exceeding 16 tablets per day. The lowest effective dose should be administered for the shortest duration possible. Avoid prolonged use beyond what is necessary, and in cases where long-term use is required due to the nature and severity of the condition, regular monitoring should be conducted to determine whether to continue taking this medication. Elderly: Administer the usual adult dose. However, for elderly patients aged 75 and older receiving oral tramadol, the half-life of tramadol elimination is increased by 17%, so administer with a minimum interval of 6 hours. Renal impairment: For patients with moderate renal impairment (creatinine clearance 10-30 mL/min), extend the dosing interval to 12 hours. Severe renal impairment (creatinine clearance below 10 mL/min) is not recommended for this medication. Tramadol is very slowly removed during dialysis, so it is not necessary to re-administer this medication after dialysis to maintain analgesic effects. Hepatic impairment: Caution is advised regarding extending the dosing interval for patients with moderate hepatic impairment. This medication should not be administered to patients with severe hepatic impairment.

Precautions

This medication can burden the liver, so individuals who regularly consume three or more alcoholic drinks a day should consult with a doctor or pharmacist before taking it. One of the ingredients in this medication, acetaminophen, can rarely cause serious skin reactions. If a rash or other allergic symptoms occur after taking this medication, discontinue use immediately and seek medical attention. Tramadol, included in this medication, may increase the risk of seizures, so patients with a history of seizures or risk factors for seizures should use caution, and the risk of seizures may increase when used in combination with certain antidepressants or other narcotic analgesics. Rarely, serious allergic reactions may occur with tramadol use, so if symptoms such as difficulty breathing, hives, or swelling occur, seek medical care immediately. Administering this medication to patients with acute or severe asthma poses a risk of respiratory depression; thus, it should only be administered in a professional setting with appropriate equipment, and consideration should be given to other non-narcotic analgesics. Taking this medication with alcohol or benzodiazepine medications can cause severe drowsiness, respiratory depression, and coma, so it should be avoided. If co-administration is unavoidable, use the lowest possible dose for the shortest duration. Patients with elevated intracranial pressure or head injuries should exercise caution when taking this medication as respiratory depression could further increase intracranial pressure. Tramadol has the potential to cause physical and psychological dependence, so long-term use should be monitored carefully for dependency. The acetaminophen included in this medication can cause liver damage in case of overdose, so do not take it with other acetaminophen-containing medications, and patients with impaired liver function should consult a doctor before use. Patients with certain genotypes may metabolize this medication faster, which can increase the risk of respiratory depression; therefore, these patients may require dose adjustments or alternative medications. This medication should not be administered to children, especially those under 12 years of age or adolescents under 18 who have undergone tonsillectomy or adenoidectomy. Some children aged between 12 and 18 may also require caution. This medication can cause sleep apnea or hypoxemia; thus, if such symptoms occur or worsen, consider reducing the dose or discontinuing use. Elderly patients or those at risk of hyponatremia should carefully monitor for symptoms of hyponatremia while taking this medication. This medication can interact with certain drugs, so inform your doctor or pharmacist if you are taking other medications, paying particular attention to combinations with MAO inhibitors, antidepressants, antibiotics, and central nervous system depressants. Women who are pregnant or may become pregnant should consult a doctor before use as this medication may affect the fetus. Nursing mothers should avoid breastfeeding during the use of this medication. This medication can cause drowsiness or dizziness, so caution is required when driving or operating dangerous machinery. In case of overdose, serious adverse effects such as respiratory depression, seizures, and liver damage may occur; therefore, do not exceed the prescribed dose, and seek emergency treatment if overdose is suspected. This medication should be kept in a safe place out of reach of children and precautions should be taken to prevent drug abuse and accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest pain, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, Stevens-Johnson syndrome, toxic epidermal necrolysis, severe skin adverse reactions, difficulty breathing or shortness of breath, asthmatic attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver failure

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
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory loss
  • tremor
  • sensory alterations

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, preferably at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain its effectiveness.

Appearance and packaging

Appearance

Pale yellow, rectangular 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.