Medication info

Acetraleth Extended-Release Tablet

Prescription medicationApproval withdrawn
Ingredient · strength
Acetaminophen›Strength being verifiedTramadol Hydrochloride›Strength being verified
Manufacturer / importer
풍림무약(주)
Appearance
Light yellow rectangular extended-release film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201900998 · Approved 2019.02.19

This product's status changed to Approval withdrawn on 2023.08.21. 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 uses it
Adults
Adult dosage
Dosage is adjusted according to the patient's pain level and therapeutic response. Administer 1 tablet as an initial dose, and subsequent doses should have an interval of at least 12 hours. Do not exceed 4 tablets per day. In case of prolonged administration, conduct regular monitoring to confirm the continuation of treatment. Elderly patients should generally receive the standard adult dosage, but for those 75 years or older, doses should be administered at least 12 hours apart.

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

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

Dosage and Administration

Adult dosage

Dosage is adjusted according to the patient's pain level and therapeutic response. Administer 1 tablet as an initial dose, and subsequent doses should have an interval of at least 12 hours. Do not exceed 4 tablets per day. In case of prolonged administration, conduct regular monitoring to confirm the continuation of treatment. Elderly patients should generally receive the standard adult dosage, but for those 75 years or older, doses should be administered at least 12 hours apart.

Precautions

This medicine may pose a risk of liver damage, so those who regularly drink more than three glasses of alcohol daily should consult a doctor or pharmacist before taking it. If a rash, itching, or blisters appear on the skin while taking this medication, discontinue use immediately and inform medical personnel. Caution is needed if there is a history of seizures or if medications that can trigger seizures are taken concurrently due to the risk of seizures. This medication may infrequently cause severe allergic reactions, so if symptoms such as shortness of breath, hives, or facial swelling occur, inform medical personnel immediately. Patients with severe respiratory diseases should be monitored in a hospital while using this medication due to the risk of respiratory depression. Using this medication with alcohol or sedatives may cause severe drowsiness, respiratory depression, or a state of unconsciousness, so concurrent use should be avoided or undertaken following a doctor's instructions. Patients with head injuries or brain diseases need to be cautious as this medication may increase intracranial pressure or worsen symptoms during use. This medication can cause physical and psychological dependence, so strict adherence to a doctor's instructions is required for long-term use. Patients with liver or kidney impairment must consult a doctor before taking this medication, as dosage adjustments may be necessary. This medication is not to be administered to children under 12 years of age and adolescents under 18 years who have undergone tonsillectomy or adenoidectomy. This medication can cause hyponatremia (reduced sodium concentration in the blood), so elderly patients or those with risk factors should be closely observed for symptoms. Pregnant or breastfeeding women must consult medical personnel before taking this medication; particularly breastfeeding mothers should either discontinue breastfeeding or follow medical advice while using this medication. Drowsiness or dizziness may occur when taking this medication, so caution is advised when driving or operating machinery. Do not exceed the recommended dosage, and be careful not to take this medication with other pain relievers, as sudden discontinuation may lead to withdrawal symptoms; dosage should be gradually reduced according to a doctor's guidance. Overdosing on this medication can lead to severe respiratory depression or liver damage, so strict adherence to the dosage is required, and in the event of overdose, seek emergency treatment immediately.

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 high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough+fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urinary retention

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
  • anxiety
  • migraines
  • worsening of migraines
  • involuntary muscle contractions
  • paresthesia
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • dysphagia
  • bloody stools
  • tongue swelling
  • reduced appetite
  • restlessness
  • delirium
  • intoxication
  • insomnia
  • irritability

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 sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius. This will help to preserve the medication's efficacy and safety over time.

Appearance and packaging

Appearance

Light yellow rectangular extended-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

No questions yet.

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.