Medication info

Cetraset Tablets

Prescription medicationTablet경구Expired
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
천우신약(주)
Appearance
Pale yellow oblong film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 202002815 · Approved 2020.04.21

This product's status changed to Expired on 2025.04.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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 according to the degree of pain and therapeutic response. The initial recommended dose is 2 tablets, and thereafter the dosing interval should be at least 6 hours apart, ensuring not to exceed 8 tablets per day. The lowest effective dose should be given for the shortest duration possible. Prolonged use of this medication beyond what is necessary should be avoided, but if prolonged treatment is necessary due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continuation of this medication. Elderly Aim to administer the standard adult dosage. However, since the elimination half-life of tramadol increases by 17% for elderly patients over 75 years, doses should be administered with an interval of at least 6 hours. Renal impairment For patients with moderate renal impairment (creatinine clearance 10-30 mL/min), the dosing interval should be extended to 12 hours. For patients with severe renal impairment (creatinine clearance less than 10 mL/min), administration is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, thus there is no need to re-administer this medication after dialysis for pain relief. Hepatic impairment 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.
Child dose
Children over 12 years and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. The initial recommended dose is 2 tablets, and thereafter the dosing interval should be at least 6 hours apart, with a maximum of one day.

Ingredients

Manufacturer
천우신약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • 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

Children over 12 years and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. The initial recommended dose is 2 tablets, and thereafter the dosing interval should be at least 6 hours apart, ensuring not to exceed 8 tablets per day. The lowest effective dose should be given for the shortest duration possible. Prolonged use of this medication beyond what is necessary should be avoided, but if prolonged treatment is necessary due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continuation of this medication. Elderly Aim to administer the standard adult dosage. However, since the elimination half-life of tramadol increases by 17% for elderly patients over 75 years, doses should be administered with an interval of at least 6 hours. Renal impairment For patients with moderate renal impairment (creatinine clearance 10-30 mL/min), the dosing interval should be extended to 12 hours. For patients with severe renal impairment (creatinine clearance less than 10 mL/min), administration is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, thus there is no need to re-administer this medication after dialysis for pain relief. Hepatic impairment 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.

Child dose

Children over 12 years and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. The initial recommended dose is 2 tablets, and thereafter the dosing interval should be at least 6 hours apart, with a maximum of one day.

Precautions

This medication may cause liver damage, so individuals who regularly consume alcohol in amounts exceeding a certain level daily should consult a doctor or pharmacist before use. Additionally, if a rash or hypersensitivity reaction occurs during the use of this medication, treatment should be discontinued immediately, and a doctor's evaluation should be sought. One of the ingredients in this medication may cause seizures, hence patients with a history of seizures or those at high risk for seizures should use with caution, as the risk of seizures may increase when taken with specific antidepressants or other medications. For patients with severe respiratory diseases, this medication may pose a risk of respiratory depression, so it should be administered carefully in a medically equipped facility. Taking this medication with alcohol or central nervous system depressants such as sedatives may result in severe drowsiness, respiratory depression, or coma; therefore, concurrent use should be avoided or taken according to a doctor's directions. Patients with head injuries or brain disorders should be cautious when taking this medication, as it may increase intracranial pressure. This medication may lead to dependence; thus, during long-term use, the dosage and duration should be adjusted according to a doctor's advice, and sudden cessation may lead to withdrawal symptoms. Patients with impaired liver or kidney function may be affected in the metabolism and excretion of this medication, so they must consult healthcare professionals before use. During the administration of this medication, driving or operating machinery should be approached with caution as drowsiness or dizziness may occur. In the event of overdose, serious respiratory depression, seizures, liver damage, etc., can occur, so the dosage must be strictly adhered to, and if abnormal symptoms arise, medical attention should be sought immediately. Pregnant or breastfeeding women should consult a doctor before taking this medication, and especially breastfeeding mothers are advised to avoid breastfeeding while on this medication. Finally, this medication should be stored in a safe place out of reach of children, and it is important to inform healthcare professionals about all medications being taken due to the possibility of interactions.

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, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and very severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

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
  • somnolence
  • sensory impairment
  • tremors
  • sensory disturbances

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, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Pale 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.