Medication info
Trakan Tablets

Trakan Tablets

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
성원애드콕제약(주)
Appearance
Light yellow, rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200713092 · Notified 2007.12.06 · Insurance code 664900670

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children older than 12 years and adults: Dosages should be adjusted based on the level of pain and treatment response. The initial dose of 2 tablets is recommended, with subsequent doses administered no less than 6 hours apart, not exceeding 8 tablets in one day. The effective minimum dose should be administered for as short a duration as possible. Avoid prolonged use beyond necessity, and if prolonged treatment is needed due to the nature and severity of the disease, regular monitoring should be conducted to confirm the necessity for continued use of this medication. Elderly Normal adult dosage should be administered. However, for elderly patients over 75 years, the elimination half-life of tramadol may increase by 17%; therefore, this medication should be administered no less than 6 hours apart. Renal Impairment For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. In severe renal impairment (creatinine clearance of less than 10 mL/min), this medication is not recommended. Tramadol is removed very slowly during hemodialysis and filtration; re-administration after dialysis is not necessary to maintain analgesic effects. Hepatic Impairment In patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. In severe hepatic impairment, this medication should not be administered.
Child dose
Applies the same as for children aged 12 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 medication is used to relieve acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

For children older than 12 years and adults: Dosages should be adjusted based on the level of pain and treatment response. The initial dose of 2 tablets is recommended, with subsequent doses administered no less than 6 hours apart, not exceeding 8 tablets in one day. The effective minimum dose should be administered for as short a duration as possible. Avoid prolonged use beyond necessity, and if prolonged treatment is needed due to the nature and severity of the disease, regular monitoring should be conducted to confirm the necessity for continued use of this medication. Elderly Normal adult dosage should be administered. However, for elderly patients over 75 years, the elimination half-life of tramadol may increase by 17%; therefore, this medication should be administered no less than 6 hours apart. Renal Impairment For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. In severe renal impairment (creatinine clearance of less than 10 mL/min), this medication is not recommended. Tramadol is removed very slowly during hemodialysis and filtration; re-administration after dialysis is not necessary to maintain analgesic effects. Hepatic Impairment In patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. In severe hepatic impairment, this medication should not be administered.

Child dose

Applies the same as for children aged 12 and older and adults.

Precautions

This medication may cause liver damage if taken by individuals who regularly consume more than three alcoholic drinks a day, and consultation with a doctor or pharmacist is essential. This medication can rarely cause serious skin reactions; therefore, if a rash or hypersensitivity reaction occurs after taking it, such as rash, treatment should be stopped immediately and a specialist consulted. The active ingredient tramadol may increase seizure risk if taken in excess of the recommended dose, and this risk may be further heightened when combined with certain antidepressants or other narcotic analgesics. Severe allergic reactions can rarely occur while taking this medication, so any symptoms like shortness of breath or hives should be reported to medical personnel immediately. Patients with acute or severe bronchial asthma may experience life-threatening respiratory depression; therefore, the medication must be administered in a medically equipped setting. Combining this medication with alcohol or central nervous system depressants may lead to deep sedation, respiratory depression, coma, or death, so concurrent use should be avoided whenever possible, or minimized in dosage and duration if absolutely necessary. Patients with head injuries or increased intracranial pressure should be cautious, as respiratory depression from this medication can exacerbate symptoms. This medication may lead to psychological and physical dependence; therefore, careful monitoring for dependency is needed during long-term use. Patients with compromised liver function may be at risk for liver damage from the components of this medication, and they should consult a doctor before use. Some patients may metabolize this medication rapidly, leading to increased blood concentration and risk of respiratory depression; such cases require dose adjustment and close monitoring. The medication should not be administered to children under 12 years of age or to adolescents under 18 years of age who have undergone tonsillectomy or adenoidectomy, and caution should be observed for adolescents between 12 and 18 years of age if any special risk factors are present. This medication may cause sleep apnea or hypoxia, so ongoing observation for these symptoms is necessary during use; dosage may need to be reduced or discontinued if symptoms worsen. Elderly patients or those at risk of hyponatremia should be carefully monitored for symptoms of hyponatremia while taking this medication. Certain patient populations should not be treated with this medication, particularly those with allergies to its components or severe respiratory depression, head injury, and those currently taking MAO inhibitors. Patients should not exceed the recommended dose while taking this medication and should not take it in conjunction with other tramadol or acetaminophen formulations. Discontinuation of this medication may result in withdrawal symptoms; therefore, any cessation of use should be carried out gradually according to physician's instructions. This medication may cause drowsiness or dizziness; caution should be exercised when driving or operating machinery after taking it. In cases of overdose, respiratory depression, seizures, and liver damage may occur, requiring immediate emergency treatment, which may include the administration of acetylcysteine.

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 the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, abnormal breathing accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary retention

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
Show 29 more
  • diarrhea
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypersensitivity
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremor

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 also recommended to keep it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Light yellow, rectangular 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.