Medication info
Atrafen Tablet

Atrafen Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Light yellow oblong film-coated tablet
Packaging
(For domestic use) 30 tablets/bottle, 300 tablets/bottle (For export) 50 tablets (10 tablets/PTP x 5)
Approval status
Active

MFDS item code 200804586 · Notified 2008.04.24 · Insurance code 663602810

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: The dose should be adjusted based on the level of the patient's pain and treatment response. The recommended initial dose is 2 tablets, and subsequent doses should be at least 6 hours apart, ensuring that no more than 8 tablets are taken in a day. Administer the lowest effective dose for the shortest duration possible. Avoid taking this medication longer than necessary, and if prolonged use is required, regular monitoring should be conducted.
Child dose
Children aged 12 and older and adults: The dose should be adjusted based on the level of the patient's pain and treatment response. The recommended initial dose is 2 tablets, and subsequent doses should be at least 6 hours apart, not exceeding 8 tablets per day.

Ingredients

Manufacturer
한국프라임제약(주)

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 moderate to severe acute and chronic pain.

How to take

Adult dose

Children aged 12 and older and adults: The dose should be adjusted based on the level of the patient's pain and treatment response. The recommended initial dose is 2 tablets, and subsequent doses should be at least 6 hours apart, ensuring that no more than 8 tablets are taken in a day. Administer the lowest effective dose for the shortest duration possible. Avoid taking this medication longer than necessary, and if prolonged use is required, regular monitoring should be conducted.

Child dose

Children aged 12 and older and adults: The dose should be adjusted based on the level of the patient's pain and treatment response. The recommended initial dose is 2 tablets, and subsequent doses should be at least 6 hours apart, not exceeding 8 tablets per day.

Precautions

This medication may pose a risk of liver damage for those who regularly consume more than three alcoholic drinks a day, so it is essential to consult a doctor or pharmacist. This medication can rarely cause severe skin reactions; therefore, if a skin rash or hypersensitivity occurs, you must stop taking it immediately. Due to the presence of tramadol, exceeding the recommended dose can increase the risk of seizures, and the risk is further heightened when taken with certain antidepressants or narcotics. In rare cases, fatal allergic reactions such as anaphylaxis may occur, so notify medical personnel immediately if unusual symptoms arise. Patients with acute or severe bronchial asthma face a risk of respiratory depression when using this medication, so it must be administered in a setting equipped with appropriate medical equipment. Taking this medication with alcohol or central nervous system inhibitors can lead to severe sedation and respiratory depression, so co-administration should be avoided or monitored carefully. Patients with increased intracranial pressure or head injuries should exercise caution with this medication, as respiratory depression may worsen symptoms. The tramadol in this medication can lead to psychological and physical dependence, so caution is necessary for prolonged use. Patients with reduced liver function must consult a doctor before taking this medication, and care should be taken to avoid taking it in combination with other acetaminophen formulations. Patients with a genetic predisposition to the rapid metabolism of the drug face a higher risk of respiratory depression, so dosage adjustment and monitoring are essential. This medication should not be administered to children under 12 years of age or to children after specific surgeries, and it should also be avoided in adolescents aged 12 to 18 if there are risk factors. This medication can cause sleep apnea or hypoxia, so its impact should be continuously evaluated. Elderly patients or those at risk of hyponatremia should be carefully monitored for symptoms of hyponatremia while on this medication. This medication is not administered to patients with hypersensitivity or certain conditions (severe respiratory depression, head injury, MAO inhibitors, etc.). When co-administered with other central nervous system depressants, the risk of sedation and respiratory depression increases, so it should be dosed at the minimal effective dose for the shortest duration, with careful observation of the patient's condition. Pregnant or breastfeeding individuals should consult a doctor before taking this medication, as it may pose risks to the fetus or newborn; it should not be taken while breastfeeding. Caution is necessary when driving or operating machinery due to potential drowsiness or dizziness. In case of overdose, serious respiratory depression, seizures, and liver damage may occur; therefore, the dosage must be strictly adhered to, and emergency treatment should be sought in case of overdose. This medication should be stored in a safe place out of the reach of children, and it is crucial to consult a doctor about potential interactions when taking it with other medications.

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 fever, blisters, skin shedding, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormality accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypersensitivity
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • 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

This medication should be stored in a tightly sealed container to prevent air and moisture from entering, at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for a longer time.

Appearance and packaging

Appearance

Light yellow oblong film-coated tablet

Package unit

(For domestic use) 30 tablets/bottle, 300 tablets/bottle (For export) 50 tablets (10 tablets/PTP x 5)

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.