Medication info
Mega Acetodol Tablet

Mega Acetodol Tablet

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

MFDS item code 202002678 · Approved 2020.04.16 · Insurance code 060500320

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children over 12 years and adults: The dosage should be adjusted based on the severity of pain and treatment response. A starting dose of 2 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, not exceeding 8 tablets per day. The lowest effective dose should be used for the shortest duration possible. Avoid prolonged use of this medication beyond what's necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to evaluate the ongoing need for this medication. Elderly Administer usual adult dosage. However, in elderly patients over 75 years taking tramadol orally, the elimination half-life of tramadol is increased by 17%, so doses should be administered at least 6 hours apart. Renal impairment patients For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. It is not recommended for patients with severe renal impairment (creatinine clearance of less than 10 mL/min). Tramadol is removed very slowly during hemodialysis and filtration, so there is no need to re-dose this medication after dialysis to maintain analgesic effects. Liver impairment patients For patients with moderate liver impairment, careful consideration should be given to extending the dosing interval. Do not administer this medication to patients with severe liver impairment.
Child dose
For children over 12 years of age: The dosage should be adjusted based on the severity of pain and treatment response. A starting dose of 2 tablets is recommended, with subsequent doses spaced at least 6 hours apart, but no more than 8 tablets per day.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Relief of moderate to severe acute and chronic 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

For children over 12 years and adults: The dosage should be adjusted based on the severity of pain and treatment response. A starting dose of 2 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, not exceeding 8 tablets per day. The lowest effective dose should be used for the shortest duration possible. Avoid prolonged use of this medication beyond what's necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to evaluate the ongoing need for this medication. Elderly Administer usual adult dosage. However, in elderly patients over 75 years taking tramadol orally, the elimination half-life of tramadol is increased by 17%, so doses should be administered at least 6 hours apart. Renal impairment patients For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. It is not recommended for patients with severe renal impairment (creatinine clearance of less than 10 mL/min). Tramadol is removed very slowly during hemodialysis and filtration, so there is no need to re-dose this medication after dialysis to maintain analgesic effects. Liver impairment patients For patients with moderate liver impairment, careful consideration should be given to extending the dosing interval. Do not administer this medication to patients with severe liver impairment.

Child dose

For children over 12 years of age: The dosage should be adjusted based on the severity of pain and treatment response. A starting dose of 2 tablets is recommended, with subsequent doses spaced at least 6 hours apart, but no more than 8 tablets per day.

Precautions

This medication should be discussed with a doctor or pharmacist before use in individuals who regularly consume more than three glasses of alcohol daily, as it may cause liver damage when taken with alcohol. If any adverse reactions such as rash or itching occur during treatment, discontinue use immediately and consult a doctor, as there is a risk of serious skin disorders occurring. The ingredients in this medication may increase the risk of seizures, therefore caution is needed for patients with a history of seizures or those at risk. The risk of seizures may also increase when combined with certain antidepressants or other narcotic analgesics. When administering this medication to patients with acute bronchial asthma, there is a risk of respiratory suppression, which can be life-threatening; therefore, it should only be administered in a medical facility equipped for such treatments. This medication may cause severe sedation, respiratory suppression, or coma when taken with central nervous system depressants or alcohol, so concurrent use should be avoided or done with extreme caution. Patients with head trauma or brain disorders should be cautious when taking this medication due to the risk of increased intracranial pressure and respiratory suppression. This medication may lead to physical and psychological dependence, so long-term use should be closely monitored for signs of dependency. Patients with impaired liver function should consult a doctor before taking this medication and should not exceed the recommended dosage due to the risk of liver toxicity. Particularly, patients who are ultra-rapid metabolizers of CYP2D6 may have increased levels of the active ingredient, raising the risk of respiratory suppression; hence, dosage adjustments and monitoring are necessary. This medication should not be administered to children under 12 years old or to those under 18 years who have undergone tonsillectomy or adenoidectomy. Children with sleep apnea should also avoid usage. This medication can cause sleep apnea and hypoxia, so continuous monitoring for these symptoms or any worsening is essential, with dosage adjustments or discontinuation if needed. Patients at risk of hyponatremia are advised to monitor their serum sodium levels during treatment. This medication should not be used in individuals with hypersensitivity to specific components, central nervous system drug toxicity, severe respiratory suppression, head injury, or those taking MAO inhibitors. Sudden discontinuation of this medication can cause withdrawal symptoms, so dosage should be gradually reduced under a doctor's guidance. Caution is advised when driving or operating machinery, as drowsiness or dizziness may occur, and these symptoms may worsen when taken with alcohol or other central nervous system depressants. In case of overdose, serious side effects such as respiratory suppression, seizures, or liver damage may occur; therefore, contact a medical institution immediately for appropriate treatment. This medication should be stored out of reach of children and should not be taken with other acetaminophen products to reduce the risk of liver damage.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory issues accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, disorientation, visual disturbances, paralysis, decreased urine output,

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
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • impaired sense of direction
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory impairment
  • tremors
  • paraesthesia
  • attention

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 exposure to air or moisture. The storage temperature should be kept between 1 and 30 degrees Celsius at room temperature.

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.