Medication info

Megaacetadolsemisuspension Tablets

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
Light yellow round sustained-release film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001289 · 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This product's status changed to Approval withdrawn on 2024.07.03.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
Adjust the dosage based on the patient's level of pain and treatment response. For the initial dose, administer 2 tablets, with a minimum dosing interval of 12 hours. Do not exceed 8 tablets in one day. Avoid prolonged use beyond what is necessary, and ensure regular monitoring during long-term use. While administering, patients may experience nausea, vomiting, itching, constipation, dizziness, and drowsiness; monitor patient's responses closely.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate acute pain
  • 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

Adjust the dosage based on the patient's level of pain and treatment response. For the initial dose, administer 2 tablets, with a minimum dosing interval of 12 hours. Do not exceed 8 tablets in one day. Avoid prolonged use beyond what is necessary, and ensure regular monitoring during long-term use. While administering, patients may experience nausea, vomiting, itching, constipation, dizziness, and drowsiness; monitor patient's responses closely.

Precautions

This medication may put strain on the liver, so individuals who consume large amounts of alcohol regularly should consult a doctor or pharmacist before taking it. The ingredients in this medication can very rarely cause severe allergic skin reactions; if symptoms such as skin rashes or itching occur, discontinue use immediately and seek medical attention. The ingredients in this medication may pose a risk of seizures, so patients with a history of seizures or those at high risk for seizures should take caution when using this medication. Severe allergic reactions can rarely occur when taking this medication, so if symptoms such as difficulty breathing or hives occur, seek medical care immediately. Patients with acute asthma may find it difficult to breathe while taking this medication; it should only be administered under medical supervision, and alternative pain relievers should be considered if possible. Taking this medication in combination with alcohol or other central nervous system depressants can increase the risk of severe drowsiness, respiratory depression, and coma; co-administration should be avoided if possible. Patients with head injuries or brain disorders should exercise caution when taking this medication as it may increase intracranial pressure. This medication may lead to physical or mental dependence, so long-term use should be managed under a doctor's direction, and sudden discontinuation should be avoided. Patients with impaired liver function must consult a doctor before taking this medication, and should not exceed the recommended dosage due to the risk of liver damage. In patients with certain genetic predispositions, the active ingredient may be metabolized excessively, increasing the risk of respiratory depression; these patients will need dosage adjustments and monitoring. Children under 12 years old and adolescents under 18 years old after certain surgeries should not take this medication; those between 12 and 18 years old with special risk factors should also avoid using it. Taking this medication may cause rare cases of hyponatremia, which is a decrease in sodium concentration in the blood; therefore, older patients or those with risk factors should have regular blood tests. This medication is contraindicated for patients with allergies to certain ingredients, those suffering from central nervous system drug addiction, severe respiratory depression, head trauma, and those taking MAO inhibitors. Pregnant or breastfeeding women should consult healthcare providers before taking this medication, and breastfeeding mothers should either discontinue breastfeeding or observe their condition carefully when using this medication. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating dangerous machinery.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), pallor, severe allergic reactions, severe skin adverse reactions (acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis), seizures, confusion, speech disorders, loss of consciousness, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, difficulty breathing, asthma attacks, chest tightness, trouble breathing, severe respiratory depression, acute and severe bronchial asthma, jaundice, liver abnormalities (liver dysfunction)

Mild side effects

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

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

Storage

This medication is sensitive to air and humidity and must be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

Light yellow round 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

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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.