Medication info
Traplem Tablet

Traplem Tablet

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

MFDS item code 201310583 · Approved 2013.12.08 · Insurance code 622801730

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. A initial dose of 2 tablets is recommended, and thereafter the interval between doses should be at least 6 hours, but not exceeding 8 tablets per day. Administer the effective minimum dose for the shortest duration necessary. Avoid prolonged use of this medication unnecessarily; if prolonged treatment is required due to the nature and severity of the disease, regular monitoring should be conducted to determine whether continued use of this medication is warranted. Elderly Administer the usual adult dosage. However, for elderly patients over 75 years old, the half-life of tramadol may increase by 17% when taken orally, so doses should be administered at intervals of at least 6 hours. Renal impairment For moderate renal impairment (creatinine clearance 10-30 ml/min), the dosing interval should be extended to 12 hours. Tramadol is not recommended for severe renal impairment (creatinine clearance less than 10 ml/min). Tramadol is removed very slowly during hemodialysis and filtration, thus, there is no need to re-administer this medication after dialysis to maintain analgesic effects. Liver impairment For moderate liver impairment, careful consideration should be given to extending the dosing interval. This medication should not be administered to patients with severe liver impairment.
Child dose
Children aged 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. A initial dose of 2 tablets is recommended, and thereafter the interval between doses should be at least 6 hours, but not exceeding 8 tablets per day.

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate pain
  • severe pain
  • acute pain
  • chronic pain
View approved original text

This medication is used to relieve moderate to severe acute or chronic pain.

How to take

Adult dose

Children aged 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. A initial dose of 2 tablets is recommended, and thereafter the interval between doses should be at least 6 hours, but not exceeding 8 tablets per day. Administer the effective minimum dose for the shortest duration necessary. Avoid prolonged use of this medication unnecessarily; if prolonged treatment is required due to the nature and severity of the disease, regular monitoring should be conducted to determine whether continued use of this medication is warranted. Elderly Administer the usual adult dosage. However, for elderly patients over 75 years old, the half-life of tramadol may increase by 17% when taken orally, so doses should be administered at intervals of at least 6 hours. Renal impairment For moderate renal impairment (creatinine clearance 10-30 ml/min), the dosing interval should be extended to 12 hours. Tramadol is not recommended for severe renal impairment (creatinine clearance less than 10 ml/min). Tramadol is removed very slowly during hemodialysis and filtration, thus, there is no need to re-administer this medication after dialysis to maintain analgesic effects. Liver impairment For moderate liver impairment, careful consideration should be given to extending the dosing interval. This medication should not be administered to patients with severe liver impairment.

Child dose

Children aged 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. A initial dose of 2 tablets is recommended, and thereafter the interval between doses should be at least 6 hours, but not exceeding 8 tablets per day.

Precautions

This medication can cause liver damage if taken regularly by individuals who consume more than three alcoholic drinks per day, so it is essential to consult a physician or pharmacist. If severe skin rashes or symptoms like pus-filled blisters appear while taking this medication, discontinue use immediately and consult a doctor. The ingredients in this medication can trigger seizures, so patients with a history of seizures or those at high risk for seizures should take this drug with caution. Patients with severe respiratory diseases should only use this medication in a facility equipped with appropriate medical equipment due to the risk of respiratory depression. Taking this medication with alcohol or central nervous system depressants can lead to severe drowsiness, respiratory depression, or coma, so extreme caution is warranted. Patients with brain injury or increased intracranial pressure may experience worsened symptoms while taking this medication. This medication can cause psychological and physical dependence, so caution is required when used for an extended period. Patients with liver impairments must consult a physician before using this medication and should avoid taking it with other acetaminophen-containing products. Individuals who metabolize this drug fast due to genetic factors are at higher risk for serious side effects like respiratory depression, and should follow a doctor's instructions closely. Children under 12 years of age and adolescents under 18 who have undergone tonsillectomy or adenoidectomy should not take this medication. This drug can worsen conditions like sleep apnea or hypoxia, so if such symptoms occur, dosage adjustments must be made in consultation with a doctor. Elderly patients or those taking specific medications who are at risk of hyponatremia should be carefully monitored for symptoms during the course of this medication. Patients with hypersensitivity to this medication or those with central nervous system drug addiction, severe respiratory depression, head injury, or those on MAO inhibitors should not take this medication. Pregnant or breastfeeding women should consult a physician before taking this medication, and it is safest to avoid using it while breastfeeding. Drowsiness or dizziness may occur while taking this medication, and caution is necessary when driving or operating machinery. Overdose can lead to serious side effects such as respiratory depression, seizures, and liver damage, so the prescribed dosage should be strictly adhered to, and in the case of an overdose, immediate medical attention is required. This medication should be stored in a safe place out of the reach of children to prevent misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, cough and fever associated respiratory abnormalities, jaundice, extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly reduced urine output

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
  • hypoglycemia
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • reduced libido
  • sleep disorders
  • confusion
  • orientation disorder
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucination
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors
  • sensory disturbance

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

Storage

This medication should be stored in a well-closed container that is not exposed to air and kept at a temperature between 1 and 30 degrees Celsius to maintain its effectiveness and prevent degradation.

Appearance and packaging

Appearance

Light yellow rectangular film-coated tablets

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.