Medication info

Atradol Tablets

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
(주)유앤생명과학
Appearance
Light yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001486 · Approved 2020.03.03

This product's status changed to Approval withdrawn on 2025.02.27. 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 · Children
Adult dose
For children aged 12 years and older and adults: Adjust the dose according to the level of pain and therapeutic response. It is recommended to administer an initial dose of 2 tablets, and subsequent doses should be taken with an interval of at least 6 hours, but not exceeding 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Do not use this medication for longer than necessary, and if long-term use is required due to the nature and severity of the disease, regular monitoring should be conducted to assess the continued use of this medication. Elderly: Administer the usual adult dosage. However, in elderly patients over 75 years of age, the half-life of tramadol is increased by 17% when taken orally, so ensure to administer with an interval of at least 6 hours. Renal impairment: For moderate renal impairment (creatinine clearance of 10-30ml/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance of less than 10ml/min), administration is not recommended. Tramadol is removed very slowly during blood dialysis and filtration; therefore, there is no need to re-administer this medication after dialysis to maintain analgesic effects. Hepatic impairment: In patients with moderate hepatic impairment, consider carefully extending the dosing interval. In cases of severe hepatic impairment, do not administer this medication.
Child dose
For children aged 12 years and older and adults: Adjust the dose according to the level of pain and therapeutic response. It is recommended to administer an initial dose of 2 tablets, and subsequent doses should be taken with an interval of at least 6 hours, but not exceeding 8 tablets per day.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute and chronic pain
View approved original text

This medication is used to relieve acute or chronic pain ranging from moderate to severe.

How to take

Adult dose

For children aged 12 years and older and adults: Adjust the dose according to the level of pain and therapeutic response. It is recommended to administer an initial dose of 2 tablets, and subsequent doses should be taken with an interval of at least 6 hours, but not exceeding 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Do not use this medication for longer than necessary, and if long-term use is required due to the nature and severity of the disease, regular monitoring should be conducted to assess the continued use of this medication. Elderly: Administer the usual adult dosage. However, in elderly patients over 75 years of age, the half-life of tramadol is increased by 17% when taken orally, so ensure to administer with an interval of at least 6 hours. Renal impairment: For moderate renal impairment (creatinine clearance of 10-30ml/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance of less than 10ml/min), administration is not recommended. Tramadol is removed very slowly during blood dialysis and filtration; therefore, there is no need to re-administer this medication after dialysis to maintain analgesic effects. Hepatic impairment: In patients with moderate hepatic impairment, consider carefully extending the dosing interval. In cases of severe hepatic impairment, do not administer this medication.

Child dose

For children aged 12 years and older and adults: Adjust the dose according to the level of pain and therapeutic response. It is recommended to administer an initial dose of 2 tablets, and subsequent doses should be taken with an interval of at least 6 hours, but not exceeding 8 tablets per day.

Precautions

This medication may put strain on the liver; therefore, individuals who regularly consume more than three drinks of alcohol per day should consult a physician or pharmacist before use. If you experience serious skin rashes, blisters, red spots, or other symptoms after taking this medication, discontinue use immediately and seek medical attention. Components in this medication may induce seizures, so caution is needed in patients with a history of seizures or risk factors for seizures. Taking this medication along with central nervous system depressants or alcohol can lead to severe drowsiness, respiratory depression, or coma; thus, concurrent use should be avoided or done under a doctor's guidance. In patients with acute asthma, this medication may make breathing more difficult, thus it should only be administered in a medically equipped environment. This medication has a potential for dependence and abuse, so long-term use should be under medical supervision, and sudden discontinuation may lead to withdrawal symptoms. It should particularly not be administered to children under 12 years old or adolescents under 18 years who have undergone tonsillectomy or adenoidectomy, as this age group has a higher risk of respiratory depression. Women who are pregnant or breastfeeding should consult a physician before taking this medication, and breastfeeding mothers should carefully monitor infants for signs of sedation or respiratory depression. Be cautious as this medication may cause drowsiness or dizziness when driving or operating machinery. During the use of this medication, do not exceed the recommended dosage and avoid taking other acetaminophen or tramadol-containing medications. Due to numerous drug interactions, inform your doctor or pharmacist of any medications you are currently taking, especially when combining with MAO inhibitors, antidepressants, anticonvulsants, central nervous system depressants, warfarin, etc.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with fever, blistering, skin peeling, pain in oral/ocular mucosa, severe cutaneous adverse reaction, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, respiratory issues, yellowing of the skin or eyes (jaundice), an overall state of extreme lethargy, liver abnormalities (jaundice), sudden

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
Show 28 more
  • diarrhea
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • itching
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • restlessness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disorders
  • confusion
  • spatial disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory loss
  • tremor.

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

Storage

Store this medication in a tightly closed container to prevent air or moisture from entering. It is best to keep it at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Light yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 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.

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.