Medication info

Atradol Semi Tablet

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›18.75mg / 1 tablet
Manufacturer / importer
(주)유앤생명과학
Appearance
Light yellow, oblong, film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle, 500 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001487 · 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This product's status changed to Approval withdrawn on 2025.02.27.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
Children aged 12 and older and adults: Dosage is adjusted based on the patient's level of pain and treatment response. A loading dose of four tablets is recommended, followed by administration at intervals of at least 6 hours, with a maximum of 16 tablets per day. Administer for the shortest duration possible at the effective minimum dose. Do not administer this medication for longer than necessary; if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continued administration of this medication. Elderly patients: Administer the typical adult dose. However, for elderly patients aged 75 and older, the elimination half-life of tramadol increases by 17% when taken orally, therefore administer at least 6 hours apart. Renal impairment: For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), the administration interval should be extended to 12 hours. Severe renal impairment patients (creatinine clearance below 10 ml/min) are not recommended for administration. Tramadol is removed very slowly during blood dialysis and filtration; therefore, it is unnecessary to re-administer this drug after dialysis to maintain its analgesic effect. Liver failure patients: For patients with moderate liver failure, it should be administered with an extended interval cautiously. For patients with severe liver failure, administration of this medication is contraindicated.
Child dose
Children aged 12 and older and adults: Dosage is adjusted based on the patient's level of pain and treatment response. A loading dose of four tablets is recommended, followed by administration at intervals of at least 6 hours, with a maximum of 16 tablets per day.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

Used for the relief of acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

Children aged 12 and older and adults: Dosage is adjusted based on the patient's level of pain and treatment response. A loading dose of four tablets is recommended, followed by administration at intervals of at least 6 hours, with a maximum of 16 tablets per day. Administer for the shortest duration possible at the effective minimum dose. Do not administer this medication for longer than necessary; if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continued administration of this medication. Elderly patients: Administer the typical adult dose. However, for elderly patients aged 75 and older, the elimination half-life of tramadol increases by 17% when taken orally, therefore administer at least 6 hours apart. Renal impairment: For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), the administration interval should be extended to 12 hours. Severe renal impairment patients (creatinine clearance below 10 ml/min) are not recommended for administration. Tramadol is removed very slowly during blood dialysis and filtration; therefore, it is unnecessary to re-administer this drug after dialysis to maintain its analgesic effect. Liver failure patients: For patients with moderate liver failure, it should be administered with an extended interval cautiously. For patients with severe liver failure, administration of this medication is contraindicated.

Child dose

Children aged 12 and older and adults: Dosage is adjusted based on the patient's level of pain and treatment response. A loading dose of four tablets is recommended, followed by administration at intervals of at least 6 hours, with a maximum of 16 tablets per day.

Precautions

This medication can burden the liver, so those who regularly consume more than three drinks a day must consult a doctor or pharmacist before taking it. Since this medication contains acetaminophen, severe skin reactions may occur rarely; discontinue use immediately if skin rash or hypersensitivity occurs. Due to the tramadol component, there is a risk of seizures, so caution is needed for those with a history of seizures or risk factors for seizures. Particularly, taking it with certain antidepressants or narcotics may increase seizure risk, so consultation with a specialist is essential. This medication can rarely cause life-threatening allergic reactions, so if allergic symptoms occur, immediate medical attention is required. For patients with severe bronchial asthma, careful observation is necessary due to the risk of respiratory depression; alternative analgesics should be considered if possible. Taking it with alcohol or benzodiazepines may lead to severe sedation and respiratory depression, thus should be used at minimal doses for the shortest duration. Patients with head trauma or elevated intracranial pressure should be cautious as this medication's respiratory depressant effect may worsen their condition. This medication may lead to psychological and physical dependence; thus, the possibility of dependence should be considered if used for a long period. Patients with impaired liver function should consult a doctor before taking it due to the risk of liver damage from acetaminophen. Some patients with rapid drug metabolism may experience excessive effects from the active ingredients, leading to a high risk of severe respiratory depression, requiring special caution. This medication should not be administered to children under 12 years old or adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy. Patients with sleep apnea or hypoxia may experience worsening symptoms after taking this medication; therefore, continuous evaluation and dosage adjustment may be necessary. Elderly patients or those at risk of hyponatremia may experience hyponatremia, necessitating monitoring through blood tests. Those with hypersensitivity or those taking certain medications concurrently should not use this medication, and special caution is needed when taken with central nervous system depressants. Pregnant or breastfeeding women should consult a doctor as this medication may pose risks to the fetus or newborn. Drowsiness or dizziness may occur during use, requiring caution while driving or operating machinery. In case of overdose, there is a risk of severe respiratory depression, seizures, liver damage, etc.; thus, the specified dosage must be strictly followed, and in emergencies, seek immediate medical attention. This medication should be stored out of reach of children to prevent misuse or accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • hypersensitivity
  • anaphylaxis
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • seizures
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweat
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  • pallor
  • severe allergic reactions
  • severe skin adverse reactions
  • respiratory distress
  • asthma
  • jaundice
  • hepatitis
  • sudden and very severe headaches
  • thunderclap headache
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • severe neurological symptoms
  • significantly decreased urine output.

Mild side effects

  • Loss of appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • sense of direction impairment
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors.

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

Storage

Store this medication in a sealed container that prevents air from entering, ideally at room temperature between 1 to 30 degrees Celsius. This helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

Light yellow, oblong, film-coated tablet

Package unit

30 tablets/bottle, 300 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

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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.