Medication info
Jetrasemi Tablet

Jetrasemi Tablet

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

MFDS item code 201401376 · Approved 2014.03.26

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 according to the patient's pain level and treatment response. It is recommended to start with an initial dose of 4 tablets, with subsequent doses taken at intervals of at least 6 hours, ensuring that no more than 16 tablets are taken in a day. The lowest effective dose should be administered for the shortest possible duration. Avoid unnecessary prolonged treatment with this medication; in cases where long-term treatment is necessary due to the nature and severity of the disease, regular monitoring should be conducted to confirm the necessity of continued use of this medication. Elderly Typically administer the usual adult dose. However, in patients aged 75 and older, oral administration of tramadol has been shown to increase the elimination half-life by 17%, so doses of this medication should be administered with intervals of at least 6 hours. Renal Impaired Patients Moderate renal impairment patients (creatinine clearance of 10-30 mL/min) should have the dosing interval extended to 12 hours. Severe renal impairment patients (creatinine clearance of less than 10 mL/min) should not be recommended for dosing. Tramadol is eliminated very slowly during hemodialysis and filtration, so re-dosing of this medication after dialysis is not necessary to maintain analgesic effects. Hepatic Impaired Patients For patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. This medication should not be administered to patients with severe hepatic impairment.

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute and 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

Children aged 12 and older and adults: Dosage should be adjusted according to the patient's pain level and treatment response. It is recommended to start with an initial dose of 4 tablets, with subsequent doses taken at intervals of at least 6 hours, ensuring that no more than 16 tablets are taken in a day. The lowest effective dose should be administered for the shortest possible duration. Avoid unnecessary prolonged treatment with this medication; in cases where long-term treatment is necessary due to the nature and severity of the disease, regular monitoring should be conducted to confirm the necessity of continued use of this medication. Elderly Typically administer the usual adult dose. However, in patients aged 75 and older, oral administration of tramadol has been shown to increase the elimination half-life by 17%, so doses of this medication should be administered with intervals of at least 6 hours. Renal Impaired Patients Moderate renal impairment patients (creatinine clearance of 10-30 mL/min) should have the dosing interval extended to 12 hours. Severe renal impairment patients (creatinine clearance of less than 10 mL/min) should not be recommended for dosing. Tramadol is eliminated very slowly during hemodialysis and filtration, so re-dosing of this medication after dialysis is not necessary to maintain analgesic effects. Hepatic Impaired Patients For patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. This medication should not be administered to patients with severe hepatic impairment.

Precautions

This medication may cause liver damage in individuals who regularly consume more than three alcoholic drinks daily, so consultation with a doctor or pharmacist is essential. If any rashes or hypersensitivity reactions occur during treatment, discontinue use immediately and seek medical attention. Due to the presence of tramadol, the risk of seizures increases if the recommended dosage is exceeded, and the risk is further heightened when taken with certain antidepressants or narcotics. This medication should only be used in settings equipped for severe respiratory depression when administered to patients with acute bronchial asthma who have difficulty breathing. Concurrent use of this medication with alcohol or central nervous system depressants can lead to severe sedation, respiratory depression, or coma, so such combinations should be avoided. Patients with elevated intracranial pressure or head injuries should exercise caution as respiratory depression effects of this medication could exacerbate their symptoms. Tramadol may induce psychological and physical dependence, requiring careful monitoring for dependency during prolonged use. Patients with impaired liver function must consult a doctor prior to taking this medication, as dose adjustments may be necessary to mitigate hepatotoxicity risks. Certain genotypes may cause rapid metabolism of this medication, leading to serious side effects such as respiratory depression, so vigilance is needed. This medication should not be used in children under 12 years old or in children under 18 who have had tonsillectomy or adenoidectomy. Careful administration is required for adolescents aged 12 to 18 years. This medication can cause sleep apnea and hypoxemia; symptoms should be continuously monitored and doses reduced or discontinued as necessary. Hyponatremia may occur, so elderly patients and those at risk of hyponatremia should be closely observed for symptoms. This medication should not be administered to those with hypersensitivity to specific ingredients, severe respiratory depression, head injuries, or those taking MAO inhibitors. During administration, care should be taken to avoid concurrent use with other narcotic analgesics or central nervous system depressants, as sudden discontinuation may lead to withdrawal symptoms. Pregnant or breastfeeding women should consult healthcare professionals, as this medication can pose risks to the fetus or newborn. This medication can cause drowsiness or dizziness, so it is advisable to avoid driving or operating hazardous machinery. In cases of overdose, severe respiratory depression, seizures, liver damage, etc., immediate emergency treatment should be sought. This medication should be stored in a secure location out of reach of children, and caution should be exercised to prevent misuse by others.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, desquamation, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination difficulties

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
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • spatial disorientation
  • excitability
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors
  • paresthesia
  • attention deficit

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture, preferably at room temperature, between 1 degree and 30 degrees Celsius, avoiding extremes of temperature.

Appearance and packaging

Appearance

Light yellow oblong 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.