Medication info
Artinorset Tablet

Artinorset Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
Pale yellow rectangular film-coated tablet
Packaging
[For domestic use] 30 tablets/bottle, 500 tablets/bottle [For export] 100 tablets (10 tablets/PTPX10)
Approval status
Active

MFDS item code 200712648 · Notified 2007.11.20 · Insurance code 698500770

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children over 12 and adults: The dosage should be adjusted according to the patient's level of pain and response to treatment. An initial dosage of 2 tablets is recommended, after which the interval between doses should be at least 6 hours, ensuring that the total daily dosage does not exceed 8 tablets. The effective lowest dosage should be used for the shortest duration possible. Care should be taken not to administer this medication for longer than necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to assess the need for continued administration of this medication. Elderly Administer the standard adult dosage. However, in patients over 75 years of age, the elimination half-life of tramadol is increased by 17% when taken orally, thus it should be administered at minimum intervals of 6 hours. Patients with renal impairment In moderate renal impairment patients (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. In severe renal impairment patients (creatinine clearance less than 10 ml/min), administration of this medication is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, so there is no need to readminister this medication after dialysis to maintain analgesic effects. Patients with hepatic impairment In patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. In severe hepatic impairment patients, this medication should not be administered.
Child dose
The same dosage as for children over 12 years and adults.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medication is used for the relief of acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

For children over 12 and adults: The dosage should be adjusted according to the patient's level of pain and response to treatment. An initial dosage of 2 tablets is recommended, after which the interval between doses should be at least 6 hours, ensuring that the total daily dosage does not exceed 8 tablets. The effective lowest dosage should be used for the shortest duration possible. Care should be taken not to administer this medication for longer than necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to assess the need for continued administration of this medication. Elderly Administer the standard adult dosage. However, in patients over 75 years of age, the elimination half-life of tramadol is increased by 17% when taken orally, thus it should be administered at minimum intervals of 6 hours. Patients with renal impairment In moderate renal impairment patients (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. In severe renal impairment patients (creatinine clearance less than 10 ml/min), administration of this medication is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, so there is no need to readminister this medication after dialysis to maintain analgesic effects. Patients with hepatic impairment In patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. In severe hepatic impairment patients, this medication should not be administered.

Child dose

The same dosage as for children over 12 years and adults.

Precautions

This medication can put a strain on the liver, so individuals who regularly consume more than three glasses of alcohol per day should consult a doctor or pharmacist before use. If you experience severe skin rashes or allergic reactions while taking this medication, you should immediately discontinue use and inform your healthcare provider. The ingredients in this medication can trigger seizures, so patients with a history of seizures or high seizure risk should use caution when taking this medication. Particularly, patients with brain injuries or high intracranial pressure should be cautious as this medication can exacerbate respiratory depression and increase intracranial pressure. If this medication is taken in conjunction with central nervous system depressants, the risk of severe drowsiness or respiratory depression increases, so caution is advised with co-administration. Patients with poor liver function should consult a doctor before taking this medication and should not exceed the recommended dosage due to the risk of liver damage. This medication is not to be used in children under the age of 12 or in adolescents under 18 who have undergone tonsillectomy or adenoidectomy. Women who are pregnant or may become pregnant should consult with healthcare providers before taking this medication, and nursing mothers should avoid taking this medication as it may be passed to the infant through breast milk. Drowsiness or dizziness may occur while taking this medication, so care should be taken when driving or operating machinery. Overdosing may result in serious respiratory depression, seizures, and liver damage, so it is important to adhere to the prescribed dosage and administration schedule. Care should be taken not to take this medication concurrently with other pain relievers or medications that contain acetaminophen. Abruptly stopping this medication may cause withdrawal symptoms such as anxiety, insomnia, and cold sweats, so doses should be reduced gradually according to physician's instructions. There are other medications that may increase risks when taken with this medication, so you need to inform your healthcare provider of all medications you are currently taking. This medication should be stored in a safe place out of reach of children, and precautions should be taken to prevent misuse or accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, mucosal pain in the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, abnormal breathing accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision abnormalities, paralysis, difficulty urinating

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • discomfort in the abdomen
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • directional perception disorder
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory loss
  • tremor
  • sensory abnormality
  • attention issues

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 the entry of air or moisture. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius, and it is best to avoid excessively hot or cold places.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

Package unit

[For domestic use] 30 tablets/bottle, 500 tablets/bottle [For export] 100 tablets (10 tablets/PTPX10)

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.