Medication info
Tracet Tablets

Tracet Tablets

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
유니메드제약(주)
Appearance
Pale yellow oblong film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200805064 · Notified 2008.05.01 · Insurance code 649504940

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children over 12 years and adults, adjust the dose according to the patient's pain level and therapeutic response. A loading dose of 2 tablets is recommended, and the subsequent dosing interval should be at least 6 hours, but should not exceed 8 tablets per day. Administer the lowest effective dose for the shortest possible duration, and do not use it for longer than necessary. Elderly patients should generally receive the standard adult dose, but for those over 75 years, the minimum
Child dose
For children over 12 years, adjust the dose according to the level of the patient's pain and therapeutic response. A loading dose of 2 tablets is recommended, and the subsequent dosing interval should be at least 6 hours, with a maximum of 8 tablets per day.

Ingredients

Manufacturer
유니메드제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute and chronic pain
View approved original text

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

How to take

Adult dose

For children over 12 years and adults, adjust the dose according to the patient's pain level and therapeutic response. A loading dose of 2 tablets is recommended, and the subsequent dosing interval should be at least 6 hours, but should not exceed 8 tablets per day. Administer the lowest effective dose for the shortest possible duration, and do not use it for longer than necessary. Elderly patients should generally receive the standard adult dose, but for those over 75 years, the minimum

Child dose

For children over 12 years, adjust the dose according to the level of the patient's pain and therapeutic response. A loading dose of 2 tablets is recommended, and the subsequent dosing interval should be at least 6 hours, with a maximum of 8 tablets per day.

Precautions

This medication may put stress on the liver; therefore, individuals who regularly consume more than three alcoholic beverages a day must consult a doctor or pharmacist. If skin rash, itching, or red spots occur during the use of this medication, stop taking it immediately and consult a doctor. Tramadol, one of the active ingredients in this medication, may increase the risk of seizures if taken in excess of the recommended dose or in conjunction with certain medications, so caution is necessary. Particularly when used with selective serotonin reuptake inhibitors, tricyclic antidepressants, narcotics, etc., the risk of seizures is increased, and consultation with healthcare professionals is essential. Patients with severe respiratory diseases or acute bronchial asthma may experience difficulty breathing while taking this medication, and it should be administered in a hospital under appropriate equipment and monitoring. Taking this medication with alcohol or benzodiazepines can lead to severe drowsiness, respiratory depression, or coma, so this combination should be avoided. Patients with head injuries or elevated intracranial pressure should exercise caution as respiratory depression from this medication may further increase intracranial pressure. This medication can lead to psychological and physical dependence, so dependency should be regularly checked with prolonged use. Patients with poor liver function must consult a doctor before taking this medication, and care should be taken to not exceed a total of 4,000mg of acetaminophen per day if taking other acetaminophen products. Patients with high activity of the enzyme CYP2D6 may metabolize this medication's components quickly, leading to an increased risk of respiratory depression, thus requiring dosage adjustment and monitoring. This medication should not be administered to children under 12 years or adolescents under 18 years who have had tonsillectomies or adenoidectomies. Patients with sleep apnea or hypoxia may experience worsening symptoms after taking this medication, so careful observation of symptom changes is necessary. Electrolyte imbalances such as hyponatremia may occur during the use of this medication, and regular testing is especially needed for the elderly or patients with risk factors. Before taking this medication, individuals who are allergic to its components or who have central nervous system drug addiction, severe respiratory depression, head injury, or severe liver, kidney, or heart diseases should not use it. Pregnant or breastfeeding women should consult a doctor before using this medication due to potential risks to the fetus or newborn. This medication may cause drowsiness or dizziness, requiring caution during driving or operating machinery. In case of overdose, respiratory depression, seizures, heart problems, etc., may occur, and immediate emergency treatment is necessary, along with possible therapy to protect the liver. This medication may interact with several drugs; if you are currently taking any medications, be sure to inform your healthcare provider, especially when combining with MAO inhibitors, serotonin acting drugs, and medications related to CYP3A4 and CYP2D6.

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 peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and extremely severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urine

Mild side effects

  • Reduced appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
Show 29 more
  • diarrhea
  • dyspepsia
  • abdominal pain
  • discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucination
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremors
  • sensation

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

Storage

This medication should be stored in a sealed container to prevent air and moisture from entering. It is also recommended to avoid direct sunlight and to keep it at room temperature below 25 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablets

Package unit

30 tablets/bottle, 300 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.