Medication info
Tramadol Tablet

Tramadol Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
제일약품(주)
Appearance
Light yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201310118 · Approved 2013.11.13 · Insurance code 645404170

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
It is recommended to administer an initial dose of 2 tablets, after which the dosing interval should be at least 6 hours apart, and should not exceed 8 tablets per day. The effective minimum dosage should be administered for the shortest duration possible. For elderly patients over 75 years, the dosing interval should be at least 6 hours. In patients with renal impairment, moderate renal impairment patients should have their dosing interval extended to 12 hours. In severe renal impairment patients and severe
Child dose
Children over the age of 12 should follow the same dosage and administration intervals as adults.

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate acute pain
  • moderate chronic pain
  • severe acute pain
  • severe 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

It is recommended to administer an initial dose of 2 tablets, after which the dosing interval should be at least 6 hours apart, and should not exceed 8 tablets per day. The effective minimum dosage should be administered for the shortest duration possible. For elderly patients over 75 years, the dosing interval should be at least 6 hours. In patients with renal impairment, moderate renal impairment patients should have their dosing interval extended to 12 hours. In severe renal impairment patients and severe

Child dose

Children over the age of 12 should follow the same dosage and administration intervals as adults.

Precautions

This medication carries a risk of liver damage; therefore, individuals who regularly consume more than three glasses of alcohol daily must consult a doctor or pharmacist before taking this medication or any other analgesics. If a rash or allergic reaction occurs while taking this medication, stop use immediately and seek medical attention. Exceeding the recommended dosage may increase the risk of seizures, and concomitant use with certain antidepressants or opioid analgesics may further heighten the risk of seizures. This medication may rarely cause severe allergic reactions; thus, individuals with hypersensitivity should not use it. Caution is needed when administering this medication to patients with severely compromised respiratory function, as it may pose a life-threatening risk, and it should be given in a monitored environment. Concomitant use with alcohol or central nervous system depressants may lead to severe sedation or respiratory depression, so either avoid it or consult a physician. Caution is necessary for patients with head injuries or increased intracranial pressure as respiratory depression may worsen symptoms. This medication can cause physical and psychological dependence; thus, careful monitoring for potential dependency is necessary during prolonged use. Patients with impaired liver function must consult a doctor before taking this medication, as the acetaminophen component may burden the liver. Patients who are ultra-rapid metabolizers of the CYP2D6 gene may rapidly generate the active metabolite of this medication, increasing the risk of respiratory depression. This medication should not be administered to children under 12 years or adolescents under 18 who have undergone tonsillectomy or adenoidectomy. This medication may cause sleep apnea or hypoxia, so symptoms should be periodically assessed and dosage adjusted if necessary. Elderly patients or those at risk of hyponatremia should be closely monitored for symptoms of hyponatremia while taking this medication. This medication should not be exceeded the recommended dosage, nor should it be used concurrently with other tramadol or acetaminophen-containing medications. Sudden discontinuation may lead to withdrawal symptoms, so it should be tapered gradually under a physician's guidance. Pregnant or nursing women must consult a doctor before taking this medication, and it is safer not to use this medication while breastfeeding. Caution is necessary while driving or operating machinery due to the potential for drowsiness or dizziness. In case of overdose, severe respiratory depression, seizures, liver damage, etc., may occur, requiring immediate emergency treatment. This medication must be kept out of the reach of children and stored safely to prevent misuse.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by coughing and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizure, confusion of consciousness, visual disturbances, paralysis, urinary retention

Mild side effects

  • Decreased 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
  • tremor
  • sensation

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

Storage

This medication should be stored in an airtight container to prevent air exposure, ideally at room temperature between 1°C and 30°C. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Light yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 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.