Medication info
Highset Tablet

Highset Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
Pale yellow, rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200705994 · Notified 2007.05.25 · Insurance code 643702580

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
For children aged 12 years and above and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. A starting dose of 2 tablets is recommended, with a minimum interval of 6 hours between doses, ensuring that the total daily dose does not exceed 8 tablets. The minimum effective dose should be given for the shortest duration possible. Avoid using this medication for longer than necessary, and if prolonged use is required due to the nature and severity of the illness, regular monitoring should be conducted to determine whether to continue this medication. Elderly The usual adult dosage should be administered. However, in elderly patients aged 75 years and older, the half-life of tramadol has been increased by 17% when administered orally; therefore, this medication should be given at intervals of at least 6 hours. Renal Impairment Patients For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to every 12 hours. For patients with severe renal impairment (creatinine clearance of less than 10 mL/min), administration is not recommended. Tramadol is very slowly removed during hemodialysis and filtration; therefore, re-administration of this medication after dialysis is not necessary for maintaining analgesic effects. Hepatic Impairment Patients For patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval for administration. This medication should not be administered to patients with severe hepatic impairment.

Ingredients

Manufacturer
국제약품(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 for the relief of acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

For children aged 12 years and above and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. A starting dose of 2 tablets is recommended, with a minimum interval of 6 hours between doses, ensuring that the total daily dose does not exceed 8 tablets. The minimum effective dose should be given for the shortest duration possible. Avoid using this medication for longer than necessary, and if prolonged use is required due to the nature and severity of the illness, regular monitoring should be conducted to determine whether to continue this medication. Elderly The usual adult dosage should be administered. However, in elderly patients aged 75 years and older, the half-life of tramadol has been increased by 17% when administered orally; therefore, this medication should be given at intervals of at least 6 hours. Renal Impairment Patients For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to every 12 hours. For patients with severe renal impairment (creatinine clearance of less than 10 mL/min), administration is not recommended. Tramadol is very slowly removed during hemodialysis and filtration; therefore, re-administration of this medication after dialysis is not necessary for maintaining analgesic effects. Hepatic Impairment Patients For patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval for administration. This medication should not be administered to patients with severe hepatic impairment.

Precautions

This medication can affect the liver, so individuals who regularly consume more than three servings of alcohol per day should consult a doctor or pharmacist before use. Additionally, serious skin reactions, such as severe rashes or pustules, may occur rarely; if skin rashes or hypersensitivity reactions are observed after taking this medication, use should be discontinued immediately. The tramadol component of this medication may increase the risk of seizures, especially if taken in larger than recommended amounts or in combination with certain antidepressants or narcotics. Severe allergic reactions may occur rarely, so symptoms like difficulty breathing or hives should be reported to medical personnel immediately. Patients with acute bronchial asthma may experience significant respiratory depression while taking this medication; therefore, it must be taken in a medically-equipped environment. This medication, when taken with alcohol or CNS depressants such as benzodiazepines, can cause severe drowsiness, respiratory depression, or even coma, so caution is required. Patients with head injuries or increased intracranial pressure should be cautious as symptoms may worsen with this medication. This medication can lead to psychological and physical dependence; therefore, prolonged use should be monitored closely for signs of dependency. Patients with liver dysfunction should consult a physician before taking this medication and should avoid taking other acetaminophen products simultaneously. Particularly, patients with the CYP2D6 enzyme that acts very quickly may excessively produce the active metabolite, leading to life-threatening respiratory depression, and should be cautious. Children under 12 years old and adolescents under 18 who have had tonsillectomy or adenoidectomy should not be administered this medication, especially if they have sleep apnea. Drowsiness or dizziness may occur after taking this medication; therefore, caution is advised when driving or operating machinery. Overdose can lead to serious respiratory depression, seizures, liver damage, etc., so the dosage must be strictly followed, and immediate medical attention should be sought in cases of emergency. This medication may interact with other drugs; therefore, individuals who are currently taking any medications should inform medical personnel, especially when taking MAO inhibitors, antidepressants, antibiotics, and CNS depressants concurrently. Women who are pregnant or breastfeeding should definitely consult a physician before taking this medication, and it is advisable not to administer it during breastfeeding due to potential risks to the baby. Elderly patients may have weakened liver, kidney, and heart functions and should exercise increased caution when using this medication. During the course of taking this medication, patients should discuss treatment goals and discontinuation plans thoroughly with their physician, and if signs of dependency or adverse reactions occur, they should seek immediate consultation.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rashes with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied by respiratory abnormality, yellowing of the skin or eyes (jaundice), extreme lethargy throughout the body, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision anomalies, paralysis, urination.

Mild side effects

  • Loss of 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 disorders
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug dependence
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory decrease
  • tremors
  • sensation.

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

Storage

This medication should be stored in a sealed container to prevent air from entering and kept in a cool place at or below room temperature (25 degrees). Storing it this way will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Pale yellow, rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 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.