Medication info
Tramax Semi Tablet

Tramax Semi Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›18.75mg / 1 tabletAcetaminophen›162.5mg / 1 tablet
Manufacturer / importer
(주)라이트팜텍
Appearance
Pale yellow oblong film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201902624 · Approved 2019.04.25 · Insurance code 690300920

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
For children over 12 years and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. An initial dose of 4 tablets is recommended, followed by a minimum dosing interval of 6 hours, ensuring not to exceed 16 tablets in a day. The valid minimum dose should be administered for the shortest possible duration. Avoid taking this medication longer than necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continuation of this medication. Elderly patients Standard adult dosage should be administered. However, in individuals over 75 years, the oral clearance half-life of tramadol increases by 17%, so dosing should be spaced at least 6 hours apart. Patients with renal impairment For patients with moderate renal impairment (creatinine clearance between 10-30 ml/min), extend the dosing interval to 12 hours. For patients with severe renal impairment (creatinine clearance below 10 ml/min), administration is not recommended. Tramadol is removed very slowly during dialysis and filtration, so there is no need to re-administer the medication after dialysis to maintain analgesic effects. Patients with liver failure For patients with moderate liver failure, it is advised to carefully consider extending the dosing interval. Administration is not advisable for patients with severe liver failure.

Ingredients

Manufacturer
(주)라이트팜텍

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 over 12 years and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. An initial dose of 4 tablets is recommended, followed by a minimum dosing interval of 6 hours, ensuring not to exceed 16 tablets in a day. The valid minimum dose should be administered for the shortest possible duration. Avoid taking this medication longer than necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continuation of this medication. Elderly patients Standard adult dosage should be administered. However, in individuals over 75 years, the oral clearance half-life of tramadol increases by 17%, so dosing should be spaced at least 6 hours apart. Patients with renal impairment For patients with moderate renal impairment (creatinine clearance between 10-30 ml/min), extend the dosing interval to 12 hours. For patients with severe renal impairment (creatinine clearance below 10 ml/min), administration is not recommended. Tramadol is removed very slowly during dialysis and filtration, so there is no need to re-administer the medication after dialysis to maintain analgesic effects. Patients with liver failure For patients with moderate liver failure, it is advised to carefully consider extending the dosing interval. Administration is not advisable for patients with severe liver failure.

Precautions

This medication may put stress on the liver, so individuals who consume alcohol above a certain amount daily should consult a physician or pharmacist before taking it. Rarely, severe allergic reactions may occur, so if symptoms such as skin rash or itching develop, discontinue use immediately and consult medical personnel. The ingredients in this medication may induce seizures, so patients with a history of seizures or those at high risk of seizures should take caution. The risk of seizures may also increase when taken with certain antidepressants or other drugs. Rarely, serious allergic reactions such as anaphylaxis may occur, so in case of sudden difficulty breathing, hives, or facial swelling, immediate emergency assistance should be sought. Patients with asthma or severe respiratory diseases may find it more difficult to breathe while taking this medication, so it should be taken in a medically prepared environment. Taking this medication in conjunction with alcohol or other central nervous system depressants may lead to severe drowsiness, respiratory depression, or coma, so co-administration should be avoided. Patients with head injuries or brain diseases should be cautious as respiratory depression from this medication may increase intracranial pressure. This medication can cause physical and psychological dependency, so when taken long-term, the duration and dosage should be adjusted under a physician's guidance. Patients with impaired liver function should always consult a physician before taking this medication, and taking it with other acetaminophen products may increase the risk of liver damage. Individuals with a genetic predisposition for rapid metabolism of this medication may experience stronger effects or a heightened risk of respiratory depression, necessitating special caution. This medication should not be administered to children under 12 years or adolescents under 18 years after certain surgeries, nor should it be given to children with sleep apnea. This medication may induce sleep apnea and hypoxia, so symptoms should be regularly monitored during use. Elderly patients or those at risk for hyponatremia should be carefully observed for symptoms of hyponatremia while taking this medication. This medication has many interactions with specific drugs, so if you are taking other medications, you must inform your doctor or pharmacist, especially when co-administering MAO inhibitors, antidepressants, antibiotics, and anticoagulants. Women who are pregnant or may become pregnant should consult a doctor before taking this medication, and nursing women are advised to avoid its use. This medication can cause drowsiness or dizziness, so caution should be taken when driving or operating machinery requiring concentration. In the event of overdose, serious respiratory depression, seizures, liver damage, and other complications may occur, so adhere to the prescribed dosage, and seek immediate emergency care in case of overdose. This medication should be stored out of reach of children to prevent accidental ingestion or misuse.

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, peeling skin, pain in the mucous membranes of the mouth/eyes, wheezing or difficulty breathing, asthma attacks, abnormal breathing accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urinary problems

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 misuse
  • hallucinations
  • withdrawal symptoms
  • migraine
  • somnolence
  • sensory impairment
  • tremors
  • sensory loss

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

Storage

Store this medication in a sealed container to prevent air or moisture from entering and keep it at a temperature between 1 degree and 30 degrees Celsius for safe storage. Storing it this way will help maintain the drug's efficacy for a longer period.

Appearance and packaging

Appearance

Pale yellow oblong 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.