Medication info
Artinolsest Semi Tablet

Artinolsest Semi Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›18.75mg / 1 tabletAcetaminophen›162.5mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
Pale yellow oblong film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 200712647 · Notified 2007.11.20 · Insurance code 698500760

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 based on the level of pain and response to treatment. A starting dose of 4 tablets is recommended, and the interval between doses should be at least 6 hours, but not exceeding 16 tablets in a day. The effective minimum dose should be administered for the shortest duration possible. Do not administer this medication for longer than necessary, and if long-term administration is required due to the nature and severity of the disease, regular monitoring should be conducted to determine whether to continue this medication. Elderly Administer the standard adult dose, but for elderly patients over 75 years of age, oral administration of tramadol has shown a 17% increase in elimination half-life, so doses should be administered at least 6 hours apart. Patients with renal impairment For moderate renal impairment patients (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. It is not recommended to administer to patients with severe renal impairment (creatinine clearance of less than 10 ml/min). Tramadol is very slowly removed during blood dialysis and filtration, so it is not necessary to re-administer this medication after dialysis to maintain analgesic effects. Patients with hepatic impairment For moderate hepatic impairment patients, carefully consider extending the dosing interval. This medication should not be administered to patients with severe hepatic impairment.
Child dose
Children aged 12 years and older and adults: The dosage should be adjusted based on the level of pain and response to treatment. A starting dose of 4 tablets is recommended, and the interval between doses should be at least 6 hours, but not exceeding 16 tablets in a day.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute pain
  • moderate to severe 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

Children aged 12 years and older and adults: The dosage should be adjusted based on the level of pain and response to treatment. A starting dose of 4 tablets is recommended, and the interval between doses should be at least 6 hours, but not exceeding 16 tablets in a day. The effective minimum dose should be administered for the shortest duration possible. Do not administer this medication for longer than necessary, and if long-term administration is required due to the nature and severity of the disease, regular monitoring should be conducted to determine whether to continue this medication. Elderly Administer the standard adult dose, but for elderly patients over 75 years of age, oral administration of tramadol has shown a 17% increase in elimination half-life, so doses should be administered at least 6 hours apart. Patients with renal impairment For moderate renal impairment patients (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. It is not recommended to administer to patients with severe renal impairment (creatinine clearance of less than 10 ml/min). Tramadol is very slowly removed during blood dialysis and filtration, so it is not necessary to re-administer this medication after dialysis to maintain analgesic effects. Patients with hepatic impairment For moderate hepatic impairment patients, carefully consider extending the dosing interval. This medication should not be administered to patients with severe hepatic impairment.

Child dose

Children aged 12 years and older and adults: The dosage should be adjusted based on the level of pain and response to treatment. A starting dose of 4 tablets is recommended, and the interval between doses should be at least 6 hours, but not exceeding 16 tablets in a day.

Precautions

This medication can put a strain on the liver, so anyone who regularly consumes more than three drinks a day should consult a physician or pharmacist before taking it. If severe rash or allergic reactions occur while taking this medication, administration must be stopped immediately, and medical consultation is necessary. The active ingredient tramadol can cause seizures, so patients with a history of seizures or those at risk of seizures need to take caution. Additionally, taking tramadol with certain antidepressants, opioid analgesics, etc., may increase the risk of seizures, so it should be discussed with a doctor. Those with severe respiratory diseases may have difficulty breathing while taking this medication, so it is safer to take it in a place equipped with medical equipment. Taking this medication with alcohol or central nervous system depressants can lead to severe drowsiness or respiratory depression, so co-administration should be avoided. Patients with head injuries or brain diseases should be cautious as this medication may worsen confusion or respiratory problems. This medication can cause physical and psychological dependence with long-term use, so the administration period and dosage should strictly follow the doctor's instructions. Patients with impaired liver or kidney function must consult a physician before taking this medication and be careful not to exceed the recommended dosage. Particularly, this medication should not be administered to children under 12 years of age or adolescents under 18 years of age who have undergone tonsillectomy. Pregnant or breastfeeding women should consult a physician before taking this medication as it may be risky for the fetus or newborn. Drowsiness or dizziness may occur while taking this medication, so caution is required when driving or operating machinery. In case of overdose, severe respiratory depression, seizures, liver damage, etc., may occur, so it is important to adhere strictly to the prescribed dosing, and one should visit a medical institution immediately if any abnormal symptoms appear. This medication should be stored in a safe place out of reach of children and managed in a way to prevent drug abuse and ensure it is not easily accessible to others.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath, or difficulty breathing, asthma attacks, abnormal breathing accompanied by coughing and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, decreased 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
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disorders
  • confusion
  • directional sense disorder
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremor
  • sensations

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

Storage

This medication should be stored in a sealed container to prevent air from entering and kept at a temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 500 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

No questions yet.

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.