Medication info
Atracool Sustained-release Tablet

Atracool Sustained-release Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›75mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
Pale yellow rectangular sustained-release film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201902454 · Approved 2019.04.19 · Insurance code 621803580

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
It is recommended to take 1 tablet as the initial dose, and thereafter maintain a minimum interval of 12 hours between doses, not exceeding 4 tablets in one day. Avoid taking this medication longer than necessary, and if prolonged use is needed, regular monitoring should be conducted to evaluate the continuation of the medication.

Ingredients

Manufacturer
(주)한국파비스제약

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 for relief of acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

It is recommended to take 1 tablet as the initial dose, and thereafter maintain a minimum interval of 12 hours between doses, not exceeding 4 tablets in one day. Avoid taking this medication longer than necessary, and if prolonged use is needed, regular monitoring should be conducted to evaluate the continuation of the medication.

Precautions

This medication may cause liver damage if taken by individuals who regularly consume more than three alcoholic beverages a day, so consultation with a doctor or pharmacist is essential. One of the ingredients in this medication, acetaminophen, can cause rare but serious skin reactions, so if a skin rash or hypersensitivity occurs, discontinue use immediately. Tramadol, one of the ingredients, may increase the risk of seizures if taken in excess of the recommended dosage, and when taken with certain antidepressants or other narcotics, this risk may further increase. When administering this medication to patients with severe respiratory diseases, there is a significant risk of respiratory depression, so it should be administered in a monitored environment, and alternative non-opioid analgesics should be considered. Co-administration of this medication with alcohol or central nervous system depressants may cause severe sedation, respiratory depression, or even death, so it should be avoided. If unavoidable, it should be used at the minimal dose for a short period and monitored closely. Patients with elevated intracranial pressure or head injuries should be cautious while taking this medication, as respiratory depression can exacerbate symptoms. Tramadol may lead to physical and psychological dependence; thus, if this medication is taken for an extended period, the duration and dosage should be adjusted considering the potential for dependence. Patients with compromised liver function must consult a doctor before taking this medication and should be careful to ensure that the total daily dosage of acetaminophen does not exceed 4,000 mg when taking other acetaminophen products. Particularly in the case of ultra-rapid metabolizers of CYP2D6, the active metabolite of this medication may be produced quickly, increasing the risk of respiratory depression, necessitating dose adjustment and symptom monitoring. This medication should not be administered to children under 12 years or adolescents under 18 years following certain surgeries. Even for adolescents aged 12 to 18, it should be avoided if there are risk factors. This medication may cause hyponatremia, so elderly patients or those with risk factors must be closely observed for symptoms of hyponatremia during treatment. Additionally, patients who have hypersensitivity to the components of this medication or are experiencing central nervous system drug overdose, severe respiratory depression, head injury, or are taking MAO inhibitors should not take it. While taking this medication, drowsiness or dizziness may occur, so caution is required when driving or operating machinery. In case of overdose, severe respiratory depression, liver damage, etc. may occur, so contact a medical institution immediately for appropriate treatment.

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 high fever, blisters, skin peeling, mucosal pain in mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, vision abnormalities, paralysis, urination

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • rigidity
  • fainting
  • withdrawal symptoms
  • hypertension
  • worsening hypertension
  • hypotension
  • arrhythmia
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  • palpitations
  • dizziness
  • headache
  • tremor
  • ataxia
  • tension
  • migraine
  • worsening migraine
  • involuntary muscle contractions
  • paresthesia
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • difficulty swallowing
  • blood in stool
  • tongue swelling
  • loss of appetite
  • anxiety
  • confusion
  • euphoria
  • insomnia
  • nervousness

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture, preferably at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Pale yellow rectangular sustained-release 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

No questions yet.

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.