Medication info

Mega Acetodol Sustained-release Tablets

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›75mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
Light yellow oblong sustained-release film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001290 · Approved 2020.02.24

This product's status changed to Approval withdrawn on 2024.07.03. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
The recommended initial dose is one tablet, with subsequent dosing intervals of at least 12 hours and not to exceed four tablets per day. Do not take this medication longer than necessary, and if long-term use is needed, regular monitoring should be done to determine the continuation of therapy. For the elderly, the usual adult dose can be given, but for those over 75, dosing intervals should be at least 12 hours apart.

Ingredients

Manufacturer
(주)엘앤씨바이오

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 acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

The recommended initial dose is one tablet, with subsequent dosing intervals of at least 12 hours and not to exceed four tablets per day. Do not take this medication longer than necessary, and if long-term use is needed, regular monitoring should be done to determine the continuation of therapy. For the elderly, the usual adult dose can be given, but for those over 75, dosing intervals should be at least 12 hours apart.

Precautions

This medication may cause liver damage, so those who regularly consume more than three glasses of alcohol daily should consult a doctor or pharmacist before taking it. Serious skin reactions such as rashes or blisters may occur after taking this medication, so if such symptoms appear, stop taking it immediately and seek medical attention. The ingredients in this medication can cause seizures, so caution is advised for individuals with a history of seizures or those at risk of them. Rarely, life-threatening allergic reactions may occur during the use of this medication; symptoms such as difficulty breathing, rash, or facial swelling require immediate medical attention. For patients with severe asthma, breathing may become more difficult when administering this medication, so it should only be given in a medically supervised setting. Taking this medication with alcohol or central nervous system depressants can lead to severe drowsiness, respiratory depression, or coma, so it should be avoided or carefully monitored. Patients with head injury or increased intracranial pressure should use this medication cautiously as symptoms may worsen. This medication may lead to dependency similar to that of opioids, so the possibility of dependency should be carefully monitored during long-term use. Patients with compromised liver function should consult a doctor before taking this medication and be aware not to exceed a daily intake of 4,000 mg of acetaminophen. Patients with specific genotypes may metabolize this medication rapidly, increasing the risk of respiratory depression, thus requiring dose adjustments and symptom monitoring. This medication should not be used in children under 12 years old or in adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy. This medication may rarely lower sodium levels in the blood, requiring monitoring of symptoms in patients at risk of hyponatremia. Patients allergic to the ingredients of this medication or those in severe respiratory depression, central nervous system drug overdose, severe liver, kidney or heart function impairment, pregnant or nursing women, children under 12, and pediatric patients requiring postoperative care should not take this medication. The risk of side effects may increase when taken with other central nervous system depressants, therefore the dose should be adjusted and carefully monitored under a doctor's guidance. Drowsiness or dizziness may occur during driving or operating machinery; such activities should be approached with caution. Overdosage can lead to serious respiratory depression, liver damage, or seizures; adherence to prescribed doses is crucial, and immediate emergency treatment is required in case of an overdose. Dosing adjustments are necessary for patients with impaired liver and kidney function, and consideration of dependency risk during prolonged use should be addressed by adjusting the duration of treatment or including drug-free intervals. The effects of this medication on the fetus during pregnancy are not clear, so it is essential to consult a doctor before use, and breastfeeding women should avoid taking this medication.

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 fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory issues with cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination problems

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • stiffness
  • fainting
  • withdrawal symptoms
  • hypertension
  • worsening of hypertension
  • hypotension
  • arrhythmia
Show 30 more
  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremor
  • ataxia
  • increased tension
  • migraine
  • worsening of migraine
  • involuntary muscle contractions
  • paresthesia
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • indigestion
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • dysphagia
  • 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 tightly closed container to protect it from air and moisture. It is best to maintain storage temperatures between 1°C and 30°C at room temperature.

Appearance and packaging

Appearance

Light yellow oblong sustained-release film-coated tablets

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.

Related searches

Search tags

Suggested searches

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.