Medication info
Ksets Semi Tablet

Ksets Semi Tablet

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

MFDS item code 202003800 · Approved 2020.05.26 · Insurance code 059000960

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and treatment response. A loading dose of 4 tablets is recommended; subsequent dosing intervals should be at least 6 hours, but should not exceed 16 tablets per day. Administer the effective lowest dose for the shortest duration possible. Avoid prescribing this medication for longer than necessary, and if the characteristics of the illness or severity require long-term use, periodic monitoring should be conducted to assess the continued use of this medication. Elderly The usual adult dosage should be administered. However, for elderly patients over 75 years, the mean elimination half-life of tramadol has increased by 17% when taken orally, so dosing should occur at least every 6 hours. Renal Impairment Patients For moderate renal impairment patients (creatinine clearance 10-30 mL/min), extend the dosing interval to 12 hours. For severe renal impairment patients (creatinine clearance less than 10 mL/min), the administration of this medication is not recommended. Tramadol is very slowly removed by hemodialysis and filtration; therefore, there is no need to re-administer this medication after dialysis to maintain analgesic effect. Hepatic Impairment Patients For moderate hepatic impairment patients, cautiously consider extending the dosing interval. For severe hepatic impairment patients, do not administer this medication.
Child dose
Children aged 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and treatment response. A loading dose of 4 tablets is recommended; subsequent dosing intervals should be at least 6 hours, but no more than 16 tablets per day.

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • 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 aged 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and treatment response. A loading dose of 4 tablets is recommended; subsequent dosing intervals should be at least 6 hours, but should not exceed 16 tablets per day. Administer the effective lowest dose for the shortest duration possible. Avoid prescribing this medication for longer than necessary, and if the characteristics of the illness or severity require long-term use, periodic monitoring should be conducted to assess the continued use of this medication. Elderly The usual adult dosage should be administered. However, for elderly patients over 75 years, the mean elimination half-life of tramadol has increased by 17% when taken orally, so dosing should occur at least every 6 hours. Renal Impairment Patients For moderate renal impairment patients (creatinine clearance 10-30 mL/min), extend the dosing interval to 12 hours. For severe renal impairment patients (creatinine clearance less than 10 mL/min), the administration of this medication is not recommended. Tramadol is very slowly removed by hemodialysis and filtration; therefore, there is no need to re-administer this medication after dialysis to maintain analgesic effect. Hepatic Impairment Patients For moderate hepatic impairment patients, cautiously consider extending the dosing interval. For severe hepatic impairment patients, do not administer this medication.

Child dose

Children aged 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and treatment response. A loading dose of 4 tablets is recommended; subsequent dosing intervals should be at least 6 hours, but no more than 16 tablets per day.

Precautions

This medicine may pose a risk of liver damage if taken regularly by patients who consume more than three drinks a day. It is essential to consult a doctor or pharmacist. Due to the acetaminophen component, serious skin reactions may occur rarely, so if a rash or hypersensitivity reaction appears, discontinue immediately. The tramadol component increases the risk of seizures if taken in excess of the recommended dose, and caution is needed as the risk of seizures may be higher when taken with certain antidepressants or narcotics. During the use of this medication, life-threatening anaphylaxis reactions may occur rarely, so if allergic symptoms appear, inform medical personnel immediately. Patients with acute and severe bronchial asthma are at an increased risk of respiratory depression when receiving this medication; therefore, it must be administered in a facility equipped with medical equipment. Taking this medication with alcohol or central nervous system depressants can lead to severe sedation or respiratory depression, thus should be avoided or taken according to a physician's instructions. Patients with increased intracranial pressure or head injuries should be cautious because this medication may worsen symptoms due to respiratory depression. Tramadol can cause both psychological and physical dependence; hence, long-term use may lead to a possibility of dependency. The acetaminophen component is metabolized in the liver; patients with liver impairment must consult a doctor prior to use and avoid exceeding the daily maximum dose. Especially ultra-rapid metabolizers of CYP2D6 may experience higher concentrations of the active metabolite, which increases the risk of respiratory depression, necessitating dose adjustments and monitoring. Children under 12 years and patients aged under 18 who have undergone tonsillectomy or adenoidectomy should not take this medication. Adolescents aged 12 to 18 should also avoid use if there are specific risk factors. This medication can cause sleep apnea and hypoxia, and the risk increases with higher doses; thus, symptoms should be monitored continuously. Hyponatremia may rarely occur, so elderly patients or those with risk factors should periodically check their serum sodium levels. This medication is contraindicated in specific patients, such as those with hypersensitivity to the ingredients, those in severe respiratory depression, those with head injuries, or those taking MAO inhibitors. Adhere to the recommended doses during use, and take care not to combine with other acetaminophen or tramadol preparations. Sudden discontinuation during use can lead to withdrawal symptoms such as anxiety, insomnia, sweating, etc., so tapering off gradually under a doctor's guidance is safer. Caution is advised when driving or operating machinery as drowsiness or dizziness may occur. In case of overdose, serious respiratory depression, seizures, or liver damage can occur, so contact a medical facility immediately and seek emergency treatment. This medication should be stored in a secure place out of reach of children to prevent misuse or 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 peeling, pain in the mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough+fever, yellowing of the skin or eyes (jaundice), profound drowsiness, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination difficulty

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
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory impairment
  • tremors
  • paresthesia
  • inattention

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 exposure, in a cool place at or below room temperature (25 degrees Celsius). Storing it this way will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pale yellow oval 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.