Medication info
Tranopen Tablet

Tranopen Tablet

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

MFDS item code 200705594 · Notified 2007.05.16 · Insurance code 648503740

Summary

Main use
Moderate to severe acute and chronic pain relief
Who takes it
Adults · Children
Adult dose
Children older than 12 years and adults: Dosage should be adjusted based on the severity of the patient's pain and therapeutic response. An initial dose of 2 tablets is recommended, with subsequent dosing intervals of at least 6 hours apart, not exceeding 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Do not administer this medication for longer than necessary, and in cases requiring prolonged administration due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continued necessity of this medication. Elderly patients: Administer the usual adult dose. However, for those over 75 years old, the elimination half-life of tramadol increases by 17% when taken orally, so administer this medication with intervals of at least 6 hours. Renal impairment: For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. Patients with severe renal impairment (creatinine clearance below 10 mL/min) should not receive this medication. Tramadol is removed very slowly by dialysis and filtration, thus, there's no need to re-administer this medication after dialysis to maintain analgesic effects. Liver impairment: For patients with moderate liver impairment, carefully consider extending the dosing interval. Do not administer this medication to patients with severe liver impairment.
Child dose
Children older than 12 years and adults: Dosage should be adjusted based on the severity of the patient's pain and therapeutic response. An initial dose of 2 tablets is recommended, with subsequent dosing intervals of at least 6 hours apart, limiting to a maximum of 8 tablets per day.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Moderate to severe acute and chronic pain relief

  • 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.

How to take

Adult dose

Children older than 12 years and adults: Dosage should be adjusted based on the severity of the patient's pain and therapeutic response. An initial dose of 2 tablets is recommended, with subsequent dosing intervals of at least 6 hours apart, not exceeding 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Do not administer this medication for longer than necessary, and in cases requiring prolonged administration due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continued necessity of this medication. Elderly patients: Administer the usual adult dose. However, for those over 75 years old, the elimination half-life of tramadol increases by 17% when taken orally, so administer this medication with intervals of at least 6 hours. Renal impairment: For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. Patients with severe renal impairment (creatinine clearance below 10 mL/min) should not receive this medication. Tramadol is removed very slowly by dialysis and filtration, thus, there's no need to re-administer this medication after dialysis to maintain analgesic effects. Liver impairment: For patients with moderate liver impairment, carefully consider extending the dosing interval. Do not administer this medication to patients with severe liver impairment.

Child dose

Children older than 12 years and adults: Dosage should be adjusted based on the severity of the patient's pain and therapeutic response. An initial dose of 2 tablets is recommended, with subsequent dosing intervals of at least 6 hours apart, limiting to a maximum of 8 tablets per day.

Precautions

This medication can cause liver damage if taken by those who regularly consume more than three alcoholic drinks a day, so it is essential to consult with a doctor or pharmacist. If a rash or hypersensitivity reaction occurs while taking this medication, discontinue use immediately and consult a healthcare professional. This can be a very rare but serious skin reaction. The tramadol component of this medication can increase the risk of seizures if taken in excess of the recommended dose, and the risk may be heightened if taken in conjunction with certain antidepressants or other central nervous system medications. Rarely, a severe allergic reaction may occur; if symptoms such as difficulty breathing or hives appear, seek emergency treatment immediately. Patients with acute bronchial asthma are at risk of respiratory depression while taking this medication, so it must be taken in an environment equipped with medical equipment. Combining this medication with alcohol or benzodiazepines can lead to severe drowsiness, respiratory depression, or coma, so such combinations should be avoided. Patients with elevated intracranial pressure or head injuries should be cautious while taking this medication, as symptoms of increased brain pressure and respiratory depression may worsen. The tramadol component may induce psychological and physical dependence, thus careful observation for dependency is necessary during long-term use. The acetaminophen component may put strain on the liver, so patients with poor liver function should consult a doctor before taking it and should be careful not to exceed the maximum daily dose. This medication may have varying metabolic rates based on the CYP2D6 genotype, potentially increasing the risk of serious side effects such as respiratory depression in certain patients, requiring monitoring based on genotype. This medication should not be administered to children under 12 years of age or to children under 18 years of age who have undergone tonsillectomy or adenoidectomy, and careful consideration should be given to adolescents aged 12 to 18 years regarding its use. This medication may induce sleep apnea and hypoxia; therefore, patients with related symptoms should continuously assess their condition during treatment. Elderly patients or those at risk for hyponatremia should periodically check their blood sodium levels while taking this medication. This medication may interact with certain drugs; therefore, it is crucial to inform healthcare professionals if the patient is taking other medications, especially if combining with MAO inhibitors, antidepressants, antibiotics, antifungals, warfarin, etc. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, as it may affect the fetus or newborn. This medication can cause drowsiness or dizziness, necessitating caution when driving or operating machinery, and the risk further increases when combined with alcohol or other central nervous system depressants. In cases of overdose, severe respiratory depression, seizures, or liver damage may occur; therefore, strictly adhere to the prescribed dosage and seek emergency treatment immediately in the event of an overdose. This medication should be kept out of reach of children to prevent accidental ingestion, and due to the risk of drug abuse and dependence, it should be taken according to a doctor's instructions.

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, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound drowsiness, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary issues

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitability
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • lethargy
  • sensory loss
  • tremors
  • sensory disturbances

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 and is best kept at room temperature below 25 degrees Celsius. Proper storage helps maintain the integrity of the drug and prolong its effectiveness.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

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

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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.