Medication info
Acetram Semi Tablet

Acetram Semi Tablet

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

MFDS item code 200804633 · Notified 2008.04.25 · Insurance code 643102330

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 recommended initial dose is 4 tablets, with subsequent dosing intervals of at least 6 hours; do not exceed 16 tablets per day. Administer the effective lowest dose for the shortest duration possible. Avoid prolonged use of this medication beyond what is necessary, and if long-term administration is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the need for continued administration of this medication. Elderly Dose as usual for adults. However, in elderly patients over 75 years, oral administration of tramadol increases the half-life by 17%, thus the medication should be administered at intervals of at least 6 hours. Renal impairment For moderately impaired renal patients (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. For severely impaired renal patients (creatinine clearance of less than 10 ml/min), the use of this medication is not recommended. Tramadol is eliminated very slowly during hemodialysis and filtration, so there is no need to re-administer this medication after dialysis to maintain analgesic effects. Liver impairment For moderately impaired liver patients, careful consideration should be given to extending the dosing interval. For severely impaired liver patients, the administration of this medication should be avoided.
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 recommended initial dose is 4 tablets, with subsequent dosing intervals of at least 6 hours.

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medication is used to alleviate 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 according to the patient's level of pain and therapeutic response. A recommended initial dose is 4 tablets, with subsequent dosing intervals of at least 6 hours; do not exceed 16 tablets per day. Administer the effective lowest dose for the shortest duration possible. Avoid prolonged use of this medication beyond what is necessary, and if long-term administration is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the need for continued administration of this medication. Elderly Dose as usual for adults. However, in elderly patients over 75 years, oral administration of tramadol increases the half-life by 17%, thus the medication should be administered at intervals of at least 6 hours. Renal impairment For moderately impaired renal patients (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. For severely impaired renal patients (creatinine clearance of less than 10 ml/min), the use of this medication is not recommended. Tramadol is eliminated very slowly during hemodialysis and filtration, so there is no need to re-administer this medication after dialysis to maintain analgesic effects. Liver impairment For moderately impaired liver patients, careful consideration should be given to extending the dosing interval. For severely impaired liver patients, the administration of this medication should be avoided.

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 recommended initial dose is 4 tablets, with subsequent dosing intervals of at least 6 hours.

Precautions

This medication may place a burden on the liver, so individuals who consume alcohol in amounts exceeding the prescribed daily limit must consult a doctor or pharmacist before taking this medication. Special caution is warranted for patients with impaired liver function. Rarely, severe skin reactions may occur when taking this medication. If a skin rash or hypersensitivity reaction develops, discontinue use immediately and consult a healthcare professional. One of the ingredients in this medication may increase the risk of seizures, so patients with a history of seizures or those at risk for seizures should consult a doctor prior to use. Additionally, the risk of seizures may increase when taken with certain antidepressants or other central nervous system medications. Patients with severe respiratory diseases, especially those with acute and severe bronchial asthma, may face a risk of respiratory depression when taking this medication; hence, it should only be administered in a medically equipped environment. This medication may affect the central nervous system, and severe sedation or respiratory depression may occur when taken with alcohol or benzodiazepine medications. Therefore, caution is required when using such medications together, and it should be strictly under a doctor's guidance. Patients with elevated intracranial pressure or head injury may experience an exacerbation of symptoms when taking this medication, requiring careful monitoring. This medication has the potential to cause dependence, so long-term use necessitates monitoring by healthcare professionals for risks of dependency and abuse. This medication is not to be administered to children under 12 years of age and to adolescents under 18 years of age after certain surgeries; for children and adolescents at high risk of respiratory depression, avoid use. Drowsiness or dizziness may occur during use, so caution is advised when driving or operating machinery. Dosage must be strictly followed, and caution should be exercised to avoid concurrent use with other medications that contain similar components. Overdose may lead to liver damage, severe respiratory depression, seizures, and requires immediate medical attention. Pregnant or breastfeeding women should consult a doctor before taking this medication, especially nursing mothers who are advised not to take it.

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 high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue throughout the body, sudden and very severe headaches, lightning-strike headache, seizures, confusion of consciousness, vision abnormalities, paralysis, urination issues.

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbance
  • confusion
  • direction sense disorder
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremors
  • sensory disturbances.

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 exposure to air or moisture. It is also recommended to keep it in a cool place below 25 degrees Celsius and avoid direct sunlight.

Appearance and packaging

Appearance

Pale yellow, oval 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

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.