Medication info
Acetraldol Tablets

Acetraldol Tablets

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
독립바이오제약(주)
Appearance
Pale yellow oblong film-coated tablets
Packaging
Domestic use - 30 tablets/bottle, Domestic use - 500 tablets/bottle
Approval status
Active

MFDS item code 201905955 · Approved 2019.08.23

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: Dosage should be adjusted based on the patient's level of pain and therapeutic response. A starting dose of 2 tablets is recommended, and subsequent dosing intervals should be no less than 6 hours while ensuring no more than 8 tablets are taken in one day. Administer the lowest effective dosage for the shortest duration necessary. Elderly patients: The usual adult dose should be administered, and for patients aged 75 years and older, an interval of at least 6 hours between doses is recommended.
Child dose
Children aged 12 years and older and adults: Dosage should be adjusted based on the patient's level of pain and therapeutic response. A starting dose of 2 tablets is recommended, and subsequent dosing intervals should be no less than 6 hours, but not exceeding 1 day.

Ingredients

Manufacturer
독립바이오제약(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 moderate to severe acute and chronic pain.

How to take

Adult dose

Children aged 12 years and older and adults: Dosage should be adjusted based on the patient's level of pain and therapeutic response. A starting dose of 2 tablets is recommended, and subsequent dosing intervals should be no less than 6 hours while ensuring no more than 8 tablets are taken in one day. Administer the lowest effective dosage for the shortest duration necessary. Elderly patients: The usual adult dose should be administered, and for patients aged 75 years and older, an interval of at least 6 hours between doses is recommended.

Child dose

Children aged 12 years and older and adults: Dosage should be adjusted based on the patient's level of pain and therapeutic response. A starting dose of 2 tablets is recommended, and subsequent dosing intervals should be no less than 6 hours, but not exceeding 1 day.

Precautions

This medication can cause serious liver damage if taken by individuals who regularly consume more than three alcoholic drinks a day, so it must be discussed with a doctor or pharmacist. Rarely, serious skin rashes or allergic reactions may occur, and if any rash or signs of hypersensitivity appear, the medication should be discontinued immediately. The active ingredient, tramadol, can increase the risk of seizures if taken in excess of the recommended dosage, and the risk may be heightened when taken with certain antidepressants or other central nervous system medications. Rarely, a serious allergic reaction called anaphylaxis may occur after taking this medication, so caution is advised. Patients with acute and severe asthma are at risk of severe respiratory depression while using this medication, and it must be administered in an environment where healthcare personnel can monitor it. Combining this medication with alcohol or other central nervous system depressants can lead to severe drowsiness, respiratory depression, or coma, so co-administration should be avoided. Patients with elevated intracranial pressure or head injuries should be cautious, as respiratory depression could further increase intracranial pressure. This medication can cause dependence similar to morphine, so caution is necessary with long-term or excessive use. Patients with poor liver function may experience exacerbated liver damage due to the acetaminophen component, so it is important to consult a doctor before taking it. Particularly, patients who metabolize tramadol rapidly due to genetic factors may experience heightened effects of the medication, increasing the risk of respiratory depression, so dosage adjustments and careful monitoring are necessary. This medication should not be prescribed to children under 12 years old or adolescents under 18 who have undergone certain surgeries, and it should be avoided in adolescents who are at high risk for respiratory depression. This medication can exacerbate sleep-related breathing issues such as sleep apnea, so dosage adjustments or discontinuation should be considered if symptoms occur. Elderly patients or those at risk of hyponatremia should be carefully monitored for symptoms of hyponatremia. This medication may interact with certain drugs, increasing the risk of seizures, serotonin syndrome, or respiratory depression, so discuss all medications being taken with a healthcare professional. During pregnancy, the safety for the fetus has not been established, so it should be used cautiously, and nursing mothers should avoid use as the drug can be transmitted to the baby through breast milk, posing a risk. This medication may cause drowsiness or dizziness, so caution is needed while driving or operating machinery. In case of overdose, serious side effects such as respiratory depression, seizures, or liver damage may occur, so the prescribed dosage must be strictly adhered to, and immediate medical attention should be sought if overdose is suspected. This medication should be kept in a safe place out of reach of children to prevent accidental ingestion or misuse.

Side effects and when to seek care immediately

Serious side effects

Acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, seizures, fatal anaphylactic reactions, severe respiratory depression, severe bronchial asthma, liver damage, liver abnormalities (jaundice), urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe skin adverse reactions, respiratory issues, serious neurological symptoms, severe edema or urinary abnormalities

Mild side effects

  • Loss of 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 disorders
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors

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 exposure and ideally kept at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablets

Package unit

Domestic use - 30 tablets/bottle, Domestic use - 500 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.