Medication info
Acetsem Tablet

Acetsem Tablet

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

MFDS item code 201908574 · Approved 2019.12.20 · Insurance code 649104730

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
Children over 12 years and adults: The dosage should be adjusted based on the patient's level of pain and response to treatment. Initially, 4 tablets are recommended, and thereafter the dosing interval should be at least 6 hours, but not exceeding 16 tablets per day. Administer the lowest effective dose for the shortest duration possible. Avoid prolonged administration of this medication unless required due to the characteristics and severity of the illness, in which case regular monitoring should be conducted to confirm the continuation of this medication. Elderly Administer typical adult doses. However, the half-life of tramadol increased by 17% in elderly individuals over 75 years old; therefore, dosing should be spaced at least 6 hours apart. Renal impairment For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. This medication is not recommended for patients with severe renal impairment (creatinine clearance below 10 ml/min). Tramadol is removed very slowly during dialysis and filtration, hence it is unnecessary to readminister this medication for pain relief after dialysis. Hepatic impairment For patients with moderate hepatic impairment, consider extending the dosing interval cautiously. This medication should not be administered to patients with severe hepatic impairment.

Ingredients

Manufacturer
한국휴텍스제약(주)

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

Children over 12 years and adults: The dosage should be adjusted based on the patient's level of pain and response to treatment. Initially, 4 tablets are recommended, and thereafter the dosing interval should be at least 6 hours, but not exceeding 16 tablets per day. Administer the lowest effective dose for the shortest duration possible. Avoid prolonged administration of this medication unless required due to the characteristics and severity of the illness, in which case regular monitoring should be conducted to confirm the continuation of this medication. Elderly Administer typical adult doses. However, the half-life of tramadol increased by 17% in elderly individuals over 75 years old; therefore, dosing should be spaced at least 6 hours apart. Renal impairment For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. This medication is not recommended for patients with severe renal impairment (creatinine clearance below 10 ml/min). Tramadol is removed very slowly during dialysis and filtration, hence it is unnecessary to readminister this medication for pain relief after dialysis. Hepatic impairment For patients with moderate hepatic impairment, consider extending the dosing interval cautiously. This medication should not be administered to patients with severe hepatic impairment.

Precautions

This medication may affect liver function; individuals who consume three or more alcoholic beverages daily should consult a doctor or pharmacist before use. If a rash or allergic reaction occurs during the use of this medication, it should be discontinued immediately and medical advice should be sought. The ingredients in this medication can cause seizures, so those with a history of seizures or those at high risk of seizures should use it carefully. In patients with severe respiratory diseases, this medication may risk respiratory depression, so it should only be administered in a facility with appropriate equipment for severe bronchial asthma patients. Taking this medication with alcohol or central nervous system depressants can lead to severe sedation or respiratory depression, so avoid co-administration or follow medical advice. Patients with head injuries or brain disorders need to be careful as this medication may increase intracranial pressure. This medication poses a higher risk of respiratory depression in patients who metabolize specific enzymes rapidly, requiring dose adjustment and close monitoring. This medication should not be administered to children under 12 years old or adolescents under 18 years old who have undergone certain surgeries. Patients with sleep apnea or hypoxemia should regularly monitor for symptom deterioration while taking this medication. This medication can cause hyponatremia, therefore elderly patients or those with risk factors should periodically check their serum sodium levels. Do not exceed the recommended dosage during administration, and be cautious not to take other acetaminophen or tramadol preparations simultaneously. This medication can cause dependence similar to narcotic analgesics, so be vigilant for dependence and abuse potential during long-term use. Abrupt discontinuation of this medication can result in withdrawal symptoms, so gradually tapering off under a doctor's guidance is safer. If seizures or severe allergic symptoms occur while taking this medication, consult medical professionals immediately. There are numerous interactions with other medications, so inform medical professionals of any other drugs being taken, especially antidepressants, anticonvulsants, antibiotics, and anticoagulants. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and it is safer to avoid taking it while breastfeeding. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating machinery. In case of overdose, severe respiratory depression, seizures, liver damage, etc., may occur, therefore adherence to the prescribed dosage is essential, and in case of suspected overdose, seek emergency measures immediately. Store in a safe place out of reach of children, and take care to prevent drug misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain of the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headaches, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Loss of appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
Show 29 more
  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disturbances of spatial awareness
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucination
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremors
  • sensory abnormality

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 air or moisture from entering and is best kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage can maintain the medication's effectiveness and prevent degradation.

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.

Related searches

Search tags

Suggested searches

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.