Medication info

Atradol Sustained-Release Tablets

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 202002319 · Approved 2020.04.02

This product's status changed to Approval withdrawn on 2025.02.21. 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 dosage is adjusted based on the level of pain and treatment response. The initial recommended dose is one tablet, with subsequent dosing intervals of at least 12 hours. Do not exceed four tablets in a day. For long-term administration, regular monitoring should be conducted to assess the need for continued therapy. In the elderly, a standard adult dosage is administered, but for those over 75 years, dosing should be given at intervals of at least 12 hours.

Ingredients

Manufacturer
(주)유앤생명과학

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 acute or chronic pain that ranges from moderate to severe.

How to take

Adult dose

The dosage is adjusted based on the level of pain and treatment response. The initial recommended dose is one tablet, with subsequent dosing intervals of at least 12 hours. Do not exceed four tablets in a day. For long-term administration, regular monitoring should be conducted to assess the need for continued therapy. In the elderly, a standard adult dosage is administered, but for those over 75 years, dosing should be given at intervals of at least 12 hours.

Precautions

This medication may affect liver function, so individuals who regularly consume more than three alcoholic drinks a day should consult a physician or pharmacist before use. If a rash or hypersensitivity reaction occurs during treatment, the medication should be discontinued immediately and a specialist consulted. One of the ingredients in this medication may increase the risk of seizures, so caution is advised for individuals with a history of seizures or those at high risk for seizures. Particularly, the risk of seizures may be higher when this medication is taken with certain antidepressants or other narcotic analgesics, so it should be used according to the instructions of a specialist when used together. Patients with acute bronchial asthma or severe respiratory depression may find their breathing more difficult while taking this medication, so use should be avoided or administered under professional supervision. This medication affects the central nervous system, and its use in conjunction with alcohol, sedatives, or tranquilizers may lead to severe drowsiness, respiratory depression, or even coma; thus, caution is necessary when combining medications. Patients with head injuries or elevated intracranial pressure should be cautious as respiratory depression from this medication may worsen their symptoms. This medication may cause dependency, so individuals on long-term use should periodically check for signs of dependency and adjust the dosage if necessary. Patients with impaired liver or kidney function may have slower metabolism and excretion of this medication, which may require dosage adjustments or extended dosing intervals. This medication is not to be administered to children under 12 years old or adolescents under 18 years of age who have undergone tonsillectomy and adenoidectomy, and use should be avoided in adolescents aged 12 to 18 with special risk factors. Care should be taken when administering this medication to women who are pregnant or breastfeeding, particularly during breastfeeding, as it may affect the baby; consultation with a specialist is essential before use. Drowsiness or dizziness may occur when driving or operating machinery while taking this medication, so caution is advised during such activities. Excessive use of this medication may pose risks such as severe respiratory depression or liver damage, so it is vital to adhere to the prescribed dosage and contact a medical facility immediately in cases of overdose. It is important to report any unusual symptoms immediately to a specialist for consultation during use of this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), cold sweat, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, changes in breathing, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headaches, thunderclap headache, seizures.

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • rigidity
  • fainting
  • withdrawal symptoms
  • hypertension
  • worsened hypertension
  • hypotension
  • arrhythmia
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremor
  • ataxia
  • anxiety
  • insomnia
  • restlessness
  • drowsiness
  • forgetfulness
  • depersonalization

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The ideal storage temperature is between 1 and 30 degrees Celsius at room temperature. Storing it this way will help maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Pale yellow rectangular 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

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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.