Medication info
Traspensemi Tablet (Tramadol, Acetaminophen)

Traspensemi Tablet (Tramadol, Acetaminophen)

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›18.75mg / 1 tabletAcetaminophen›162.5mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Pale yellow, rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200804519 · Notified 2008.04.23 · Insurance code 643504230

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children over 12 years and adults: The dosage should be adjusted according to the patient's level of pain and response to treatment. An initial dose of 4 tablets is recommended, and thereafter the dosing interval should be at least 6 hours, with a maximum of 16 tablets per day. The lowest effective dose should be given for the shortest duration possible. Avoid prolonged use beyond medical necessity, and if long-term administration is needed due to the nature and severity of the condition, regular monitoring should be conducted to evaluate the continued use of this medication. Elderly The standard adult dosage should be administered. However, when tramadol is given orally to elderly patients over 75 years of age, the elimination half-life of tramadol may increase by 17%; thus, administer this medication at intervals of at least 6 hours. Renal Insufficiency Patients For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. Severe renal impairment patients (creatinine clearance less than 10 ml/min) are not recommended to take this medication. Tramadol is eliminated very slowly during hemodialysis and filtration, and therefore, re-dosing is not necessary after dialysis to maintain the analgesic effect. Hepatic Insufficiency Patients For patients with moderate hepatic impairment, carefully consider extending the dosing interval. For patients with severe hepatic impairment, this medication should not be administered.
Child dose
Children over 12 years and adults: The dosage should be adjusted according to the patient's level of pain and response to treatment. An initial dose of 4 tablets is recommended, and thereafter the dosing interval should be at least 6 hours, with a maximum of 16 tablets per day.

Ingredients

Manufacturer
한미약품(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 over 12 years and adults: The dosage should be adjusted according to the patient's level of pain and response to treatment. An initial dose of 4 tablets is recommended, and thereafter the dosing interval should be at least 6 hours, with a maximum of 16 tablets per day. The lowest effective dose should be given for the shortest duration possible. Avoid prolonged use beyond medical necessity, and if long-term administration is needed due to the nature and severity of the condition, regular monitoring should be conducted to evaluate the continued use of this medication. Elderly The standard adult dosage should be administered. However, when tramadol is given orally to elderly patients over 75 years of age, the elimination half-life of tramadol may increase by 17%; thus, administer this medication at intervals of at least 6 hours. Renal Insufficiency Patients For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. Severe renal impairment patients (creatinine clearance less than 10 ml/min) are not recommended to take this medication. Tramadol is eliminated very slowly during hemodialysis and filtration, and therefore, re-dosing is not necessary after dialysis to maintain the analgesic effect. Hepatic Insufficiency Patients For patients with moderate hepatic impairment, carefully consider extending the dosing interval. For patients with severe hepatic impairment, this medication should not be administered.

Child dose

Children over 12 years and adults: The dosage should be adjusted according to the patient's level of pain and response to treatment. An initial dose of 4 tablets is recommended, and thereafter the dosing interval should be at least 6 hours, with a maximum of 16 tablets per day.

Precautions

This medication can put strain on the liver, so individuals who consume alcohol in larger quantities daily should consult a doctor or pharmacist before taking it. The acetaminophen component can rarely cause severe skin rashes or allergic reactions, so if a rash or hypersensitivity reaction occurs, the medication should be discontinued immediately. The tramadol component carries a risk of seizures; hence, patients with a history of seizures or who are at high risk for seizures should use caution, as the risk of seizures may increase when taken with certain antidepressants or other medications. This medication can be dangerous for patients with severe respiratory depression or severe bronchial asthma; thus, such patients should be treated in a well-equipped healthcare setting. Taking this medication with alcohol or central nervous system depressants can increase the risk of severe drowsiness, respiratory depression, and coma, so caution is advised when combining medications. Patients with elevated intracranial pressure or head injury should use this medication cautiously as respiratory depression may further increase intracranial pressure. This medication can cause psychological and physical dependence, so its use should be closely monitored for dependence when used long-term. The acetaminophen component can cause severe liver damage in cases of overdose; therefore, it should not be taken with other medications containing acetaminophen, and patients with impaired liver function should consult a physician prior to taking it. Some patients may metabolize this medication quickly, leading to increased blood levels of the active substance and a higher risk of respiratory depression; in such cases, alternative medications or dosage adjustments may be necessary. This medication should not be administered to children under 12 years of age or adolescents under 18 after certain surgeries, and caution is required for patients with sleep apnea. This medication can cause hyponatremia, so patients, especially elderly individuals or those at risk of hyponatremia, should closely monitor for symptoms. This medication can interact with certain drugs, increasing the risk of side effects such as seizures or serotonin syndrome, so patients must inform healthcare providers when taking other medications. Pregnant or nursing women should only use this medication under the supervision of a doctor, as it may affect the fetus or newborn. This medication can cause drowsiness or dizziness, so caution should be exercised when driving or operating machinery. In cases of overdose, severe respiratory depression, seizures, and liver damage can occur, so the dosage should be strictly followed; if an overdose is suspected, seek medical attention immediately. This medication should be kept out of reach of children to prevent accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, abnormal breathing with cough and fever, jaundice (yellowing of skin or eyes), extreme drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, vision disturbances, paralysis, urination.

Mild side effects

  • Loss of appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • gas
  • itching
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbance
  • confusion
  • altered sense of direction
  • agitation
  • abnormal dreams
  • substance abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremors
  • sensory imbalance.

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

Storage

Store this medication in a tightly closed container to prevent exposure to air and moisture, preferably in a cool place at room temperature (below 25 degrees).

Appearance and packaging

Appearance

Pale yellow, rectangular 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.