Medication info
Atracool Tablets (Tramadol Hydrochloride, Acetaminophen)

Atracool Tablets (Tramadol Hydrochloride, Acetaminophen)

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

MFDS item code 200805273 · Notified 2008.05.08 · Insurance code 621802220

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children aged 12 and older and adults: The dosage should be adjusted based on the level of pain and therapeutic response. An initial dose of 2 tablets is recommended, and thereafter the interval between doses should be at least 6 hours, not exceeding 8 tablets per day. The effective minimum dose should be administered for the shortest period possible. Avoid prolonged administration beyond what is necessary, and if long-term administration is required due to the nature and severity of the condition, regular monitoring should be conducted to determine the continued need for this medication. Elderly Administer the standard adult dose. However, for elderly patients over 75 years of age, the elimination half-life of tramadol is prolonged by 17%, thus an interval of at least 6 hours should be observed between doses. Renal Impairment For moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. It is not recommended for severe renal impairment (creatinine clearance under 10 ml/min). Tramadol is removed very slowly during dialysis and filtration, so re-dosing after dialysis is not necessary for sustained analgesic effect. Hepatic Impairment For moderate hepatic impairment, careful consideration should be given to extending the dosing interval. It is advised not to administer this medication for patients with severe hepatic impairment.
Child dose
For children aged 12 and older and adults: The dosage should be adjusted based on the level of pain and therapeutic response. An initial dose of 2 tablets is recommended, and thereafter the interval between doses should be at least 6 hours, not exceeding 8 tablets per day.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute and 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 aged 12 and older and adults: The dosage should be adjusted based on the level of pain and therapeutic response. An initial dose of 2 tablets is recommended, and thereafter the interval between doses should be at least 6 hours, not exceeding 8 tablets per day. The effective minimum dose should be administered for the shortest period possible. Avoid prolonged administration beyond what is necessary, and if long-term administration is required due to the nature and severity of the condition, regular monitoring should be conducted to determine the continued need for this medication. Elderly Administer the standard adult dose. However, for elderly patients over 75 years of age, the elimination half-life of tramadol is prolonged by 17%, thus an interval of at least 6 hours should be observed between doses. Renal Impairment For moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. It is not recommended for severe renal impairment (creatinine clearance under 10 ml/min). Tramadol is removed very slowly during dialysis and filtration, so re-dosing after dialysis is not necessary for sustained analgesic effect. Hepatic Impairment For moderate hepatic impairment, careful consideration should be given to extending the dosing interval. It is advised not to administer this medication for patients with severe hepatic impairment.

Child dose

For children aged 12 and older and adults: The dosage should be adjusted based on the level of pain and therapeutic response. An initial dose of 2 tablets is recommended, and thereafter the interval between doses should be at least 6 hours, not exceeding 8 tablets per day.

Precautions

This medication may affect the liver, so individuals who regularly consume more than three alcoholic beverages a day should consult with their doctor or pharmacist before use. One of the ingredients in this medication can very rarely cause serious skin reactions, so if a rash or hypersensitivity occurs, stop taking this medication immediately and consult with a healthcare professional. Taking more than the prescribed dosage or using this medication in combination with certain antidepressants or narcotic analgesics can increase the risk of seizures, so caution is needed. Rarely, severe allergic reactions can occur, and symptoms such as sudden difficulty breathing or hives require immediate medical attention. Patients with compromised respiratory function may experience severe respiratory depression, so caution is particularly important when administering this medication to such individuals, and it should be administered in an environment equipped for cardiopulmonary resuscitation if necessary. Taking this medication in conjunction with central nervous system depressants or alcohol increases the risk of severe drowsiness, coma, or respiratory depression, so co-administration should be avoided or strictly managed under medical supervision. Patients with head injuries or brain disorders should exercise caution when taking this medication due to the risk of increased intracranial pressure. This medication can cause dependence, so dosage and duration should be adjusted according to a doctor's guidance when used for extended periods. Particularly, patients with liver or kidney impairment may be affected in terms of the metabolism and excretion of this medication, so they must consult a healthcare provider before use. This medication should not be used in children under 12 years of age or adolescents under 18 years who have undergone tonsillectomy or adenoidectomy, and special caution is needed for adolescents between 12 and 18 years of age. During the course of therapy with this medication, it is advised to refrain from driving or operating hazardous machinery, as drowsiness or dizziness may occur. In case of overdose, severe respiratory depression, seizures, or liver damage may occur, requiring immediate emergency treatment, and the administration of an antidote may be necessary. There may be potential interactions with other medications while taking this drug, so inform the healthcare provider of all medications currently being taken and be monitored closely. It is preferable for breastfeeding women to avoid using this medication, as side effects such as sedation or respiratory depression may occur in nursing infants.

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 high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever and respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, altered consciousness, 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
  • hypoglycemia
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory impairment
  • tremors
  • sensory deficit

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 entering, preferably at room temperature between 1 and 30 degrees Celsius. Storing it this way can help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Pale yellow oval 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.