Medication info
Tracan Semi Tablets

Tracan Semi Tablets

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

MFDS item code 200805289 · Notified 2008.05.08 · Insurance code 664900690

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 is adjusted according to the level of pain and treatment response. An initial dosage of 4 tablets is recommended, and thereafter, the interval between doses should be at least 6 hours, with a maximum of 16 tablets per day. The effective lowest dose should be administered for the shortest time possible. Do not administer this medication longer than necessary, and if prolonged use is needed due to the nature and severity of the disease, regular monitoring should be conducted to determine whether to continue this medication. Elderly Administer the usual adult dosage. However, for elderly individuals over 75 years of age, the elimination half-life of tramadol may increase by 17%, therefore, administer this medication at intervals of at least 6 hours. Renal Impairment Patients For moderate renal impairment patients (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. For severe renal impairment patients (creatinine clearance of less than 10 ml/min), administration is not recommended. Tramadol is removed very slowly during blood dialysis and filtration; hence, re-administration of this medication after dialysis for pain relief is not necessary. Liver Impairment Patients For moderate liver impairment patients, caution should be exercised regarding extending the dosing interval. This medication should not be administered to patients with severe liver impairment.
Child dose
The same dosage is applied to children aged 12 years and older and adults.

Ingredients

Manufacturer
성원애드콕제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate pain
  • severe pain
  • acute pain
  • chronic pain
View approved original text

This medicine is used to relieve acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

Children over 12 years and adults: The dosage is adjusted according to the level of pain and treatment response. An initial dosage of 4 tablets is recommended, and thereafter, the interval between doses should be at least 6 hours, with a maximum of 16 tablets per day. The effective lowest dose should be administered for the shortest time possible. Do not administer this medication longer than necessary, and if prolonged use is needed due to the nature and severity of the disease, regular monitoring should be conducted to determine whether to continue this medication. Elderly Administer the usual adult dosage. However, for elderly individuals over 75 years of age, the elimination half-life of tramadol may increase by 17%, therefore, administer this medication at intervals of at least 6 hours. Renal Impairment Patients For moderate renal impairment patients (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. For severe renal impairment patients (creatinine clearance of less than 10 ml/min), administration is not recommended. Tramadol is removed very slowly during blood dialysis and filtration; hence, re-administration of this medication after dialysis for pain relief is not necessary. Liver Impairment Patients For moderate liver impairment patients, caution should be exercised regarding extending the dosing interval. This medication should not be administered to patients with severe liver impairment.

Child dose

The same dosage is applied to children aged 12 years and older and adults.

Precautions

This medication can put strain on the liver, so those who consume a certain amount of alcohol daily should definitely consult a doctor or pharmacist before taking it. If any abnormal symptoms such as skin rash or allergic reactions occur during the use of this medication, the usage should be stopped immediately and medical attention should be sought. Due to the risk of seizures, do not exceed the recommended dosage, and be especially cautious when taken together with certain antidepressants or other narcotic analgesics. Severe allergic reactions may occur, so immediate emergency treatment must be sought if symptoms such as difficulty breathing or severe skin rash develop. Patients with acute asthma may find it difficult to breathe when using this medication, so it must be administered in a medical environment with preparedness. Taking this medication with alcohol or other central nervous system depressants, such as sleeping pills, may result in severe drowsiness, respiratory depression, or coma, so such combinations should be avoided. Patients with head injuries or brain diseases should exercise caution when taking this medication as there is a risk of increased intracranial pressure. This medication may cause physical and psychological dependence, so careful monitoring for dependence is necessary with long-term use. Patients with impaired liver function must consult a doctor before taking this medication, as the acetaminophen component may burden the liver. Some individuals may metabolize this medication at a very high rate, increasing the risk of respiratory depression with overdose, so caution is needed. It is not safe to use this medication in children under 12 years old or in adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy. Patients with sleep apnea should regularly monitor their condition as symptoms may worsen after taking this medication. Elderly patients or those at risk of hyponatremia should carefully observe for symptoms of hyponatremia while taking this medication. Do not exceed the recommended dosage while taking this medication, and avoid combining it with other medications containing acetaminophen or tramadol. Sudden discontinuation may lead to withdrawal symptoms such as anxiety, insomnia, and tremors; therefore, it is advisable to taper the dosage gradually under a doctor's guidance. Drowsiness or dizziness may occur while driving or operating machines, so caution is required. Overdose may result in serious side effects such as respiratory depression, seizures, and liver damage, necessitating immediate emergency treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing+fever, skin or eyes turning yellow (jaundice), profound lethargy, sudden and severe headache, lightning-like headache, seizures, altered consciousness, visual disturbances, paralysis, urination issues

Mild side effects

  • Loss of appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory loss
  • tremors
  • sensory dysfunction

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. It is best stored at room temperature between 1 and 30 degrees Celsius in a cool place.

Appearance and packaging

Appearance

Pale yellow rectangular 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.