Medication info
Tracom Tablet (Tramadol Hydrochloride, Acetaminophen)

Tracom Tablet (Tramadol Hydrochloride, Acetaminophen)

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

MFDS item code 200804958 · Notified 2008.04.30 · Insurance code 658601980

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 years and older and adults: It is recommended to take 2 tablets as a starting dose, with subsequent dosing intervals of at least 6 hours, not to exceed 8 tablets in a day. Use the lowest effective dose for as short a duration as possible. Do not use this medication for longer than necessary; if long-term use is required, regular monitoring should be conducted. Elderly: Administer the usual adult dosage; however, for those over 75 years, the half-life of tramadol may increase by 17%, requiring at least 6 hours between doses.
Child dose
Children aged 12 years and older and adults: It is recommended to take 2 tablets as a starting dose, with subsequent dosing intervals of at least 6 hours, not to exceed 8 tablets in a day. Use the lowest effective dose possible for the shortest duration.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

This medication is used to relieve moderate to severe acute and chronic pain.

How to take

Adult dose

Children aged 12 years and older and adults: It is recommended to take 2 tablets as a starting dose, with subsequent dosing intervals of at least 6 hours, not to exceed 8 tablets in a day. Use the lowest effective dose for as short a duration as possible. Do not use this medication for longer than necessary; if long-term use is required, regular monitoring should be conducted. Elderly: Administer the usual adult dosage; however, for those over 75 years, the half-life of tramadol may increase by 17%, requiring at least 6 hours between doses.

Child dose

Children aged 12 years and older and adults: It is recommended to take 2 tablets as a starting dose, with subsequent dosing intervals of at least 6 hours, not to exceed 8 tablets in a day. Use the lowest effective dose possible for the shortest duration.

Precautions

This medication can put strain on the liver; therefore, individuals who regularly consume more than three alcoholic drinks a day should consult with a doctor or pharmacist before taking it. Due to the acetaminophen component, serious skin rashes or allergic reactions may rarely occur. If a rash or hypersensitivity symptoms appear, discontinue use immediately and seek medical attention. The main ingredient, tramadol, can increase the risk of seizures if the recommended dosage is exceeded, and taking it with certain antidepressants or narcotics can further increase this risk. For patients with severe respiratory conditions, there is a risk of respiratory depression, so such patients should be monitored carefully when this medication is administered in a facility equipped for this purpose. Taking this medication with alcohol or central nervous system depressants can cause severe drowsiness, respiratory depression, or coma, so co-administration should be avoided or should only be done at the minimal dose for a short period when necessary. Patients with increased intracranial pressure or head injuries may experience worsened symptoms while taking this medication, which requires caution. This medication can cause dependence, so if it is used for a long time, the duration and dosage should be adjusted to consider the risk of dependence and abuse. Patients with impaired liver function should consult a doctor before taking this medication, and caution should be taken to avoid concurrent use with other acetaminophen products. For patients with specific genotypes, metabolism of this medication may be accelerated, increasing the risk of respiratory depression, necessitating the use of alternative medications or dose adjustments. This medication should not be administered to children under 12 years old or adolescents under 18 years old who have undergone tonsillectomy and adenoidectomy. Patients with sleep apnea or at risk of hypoxia should be continuously monitored for symptom exacerbation during treatment with this medication. Dose adjustments or discontinuation should be considered as needed. This medication can rarely cause hyponatremia, so patients, especially elderly or at-risk individuals, should periodically check their serum sodium levels. This medication should not be administered to individuals with certain allergies, central nervous system drug intoxication, severe respiratory depression, head trauma, or those taking MAO inhibitors. Drowsiness, dizziness, nausea, constipation, and other side effects may occur during use, so caution is needed when driving or operating machinery. In case of overdose, serious respiratory depression, seizures, liver damage, etc., may occur, so do not exceed the prescribed dose, and if overdose is suspected, seek medical attention immediately. This medication should be kept out of reach of children in a safe place, and precautions should be taken to prevent misuse or abuse by blocking access to others.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, skin peeling, pain in the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, 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
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • dysphoria
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory impairment
  • tremor
  • dysesthesia
  • caution

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 or moisture from penetrating. Additionally, avoid storing it in excessively hot or cold places; it is best to store it at room temperature between 1°C and 30°C.

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.