Medication info

Tracipen Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
미래바이오제약(주)
Appearance
Light yellow, oblong, film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 200711202 · Notified 2007.10.09

This product's status changed to Expired on 2024.04.01. 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 and older and adults, the dosage is adjusted based on the patient's level of pain and treatment response. It is recommended to start with a dosage of 2 tablets, with subsequent dosing intervals being at least 6 hours apart, and not exceeding 8 tablets per day. The effective minimum dose should be administered for the shortest duration possible. Avoid administering this medication for extended periods unnecessarily; if long-term use is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continued use of this medication. Elderly patients Normal adult doses should be administered. However, for patients over 75 years old receiving tramadol orally, the half-life of tramadol increases by 17%, so the medication should be administered at intervals of at least 6 hours. Patients with renal impairment For moderate renal impairment (creatinine clearance 10-30ml/min), the dosing interval should be extended to 12 hours. Severe renal impairment (creatinine clearance less than 10ml/min) is not recommended for dosing. Tramadol is eliminated very slowly through hemodialysis and filtration; therefore, it is not necessary to re-administer this medication after dialysis to maintain analgesic effect. Patients with liver impairment Consideration should be given to extending the dosing interval for moderate liver impairment. This medication should not be given to patients with severe liver impairment.
Child dose
There is no separate dosage for children as it applies to children aged 12 and older and adults.

Ingredients

Manufacturer
미래바이오제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • 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 aged 12 and older and adults, the dosage is adjusted based on the patient's level of pain and treatment response. It is recommended to start with a dosage of 2 tablets, with subsequent dosing intervals being at least 6 hours apart, and not exceeding 8 tablets per day. The effective minimum dose should be administered for the shortest duration possible. Avoid administering this medication for extended periods unnecessarily; if long-term use is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continued use of this medication. Elderly patients Normal adult doses should be administered. However, for patients over 75 years old receiving tramadol orally, the half-life of tramadol increases by 17%, so the medication should be administered at intervals of at least 6 hours. Patients with renal impairment For moderate renal impairment (creatinine clearance 10-30ml/min), the dosing interval should be extended to 12 hours. Severe renal impairment (creatinine clearance less than 10ml/min) is not recommended for dosing. Tramadol is eliminated very slowly through hemodialysis and filtration; therefore, it is not necessary to re-administer this medication after dialysis to maintain analgesic effect. Patients with liver impairment Consideration should be given to extending the dosing interval for moderate liver impairment. This medication should not be given to patients with severe liver impairment.

Child dose

There is no separate dosage for children as it applies to children aged 12 and older and adults.

Precautions

This medication should be discussed with a doctor or pharmacist before use by individuals who regularly consume three or more alcoholic drinks per day, as taking it with alcohol may cause liver damage. If any unusual reactions such as rashes or itching occur during the use of this medication, it should be stopped immediately, and a doctor's appointment should be made, as serious skin allergic reactions may occur. This medication can induce seizures, so it should be used cautiously in patients with a history of seizures or who are at a high risk of seizures. Care should be taken to not exceed the recommended dosage, and it must be used carefully with specific medications that can increase seizure risk. Severe allergic reactions can occur rarely while taking this medication, so if symptoms such as difficulty breathing or severe hives develop, medical attention should be sought immediately. Patients with acute and severe bronchial asthma are at risk of worsening breathing difficulties when taking this medication; therefore, it should be consumed in a medical facility with personnel present. Taking this medication with central nervous system depressants or alcohol can result in severe drowsiness, respiratory depression, and coma. Therefore, its combined use should be avoided, or if necessary, it should be used at the minimum dose for as short a duration as possible. Patients with head injuries or increased intracranial pressure should be careful, as respiratory depression from this medication may worsen their symptoms. This medication can cause psychological and physical dependence, so long-term use requires careful monitoring for dependency. Patients with liver impairment may experience liver damage due to the ingredients of this medication; therefore, a doctor should be consulted before use. Some patients may metabolize this medication rapidly, leading to unexpectedly severe side effects. Adjustment of the dosage may be necessary based on genetic test results or individual conditions. This medication should not be administered to children under 12 years or adolescents under 18 who have undergone tonsillectomy or adenoidectomy. Patients with sleep apnea or hypoxia should carefully monitor changes in symptoms, as they may worsen after taking this medication. Elderly patients or those at risk of hyponatremia may experience hyponatremia during the use of this medication, necessitating symptom monitoring. This medication should not be used in patients with hypersensitivity to its ingredients, those with central nervous system drug abuse, severe respiratory depression, head trauma patients, or those taking MAO inhibitors. Abrupt discontinuation while taking this medication can lead to withdrawal symptoms, so it should be tapered gradually under a doctor's direction. Drowsiness or dizziness may occur while driving or operating machinery, so caution is required. In case of overdose, severe respiratory depression, seizures, and liver damage may occur, necessitating immediate emergency treatment. This medication must be stored in a secure place out of reach of children to prevent misuse or abuse.

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, peeling skin, pain in mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and very severe headaches, thunderclap headaches, seizures, altered 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
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors
  • paresthesia

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 or moisture exposure. It is also recommended to store it at room temperature between 1°C and 30°C, avoiding extremely hot or cold places.

Appearance and packaging

Appearance

Light yellow, oblong, 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

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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.