Medication info

Acetamadol Tablets

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
(주)알피바이오
Appearance
Pale yellow oblong film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201601861 · Approved 2016.03.23

This product's status changed to Approval withdrawn on 2025.02.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 and older and adults: The dosage should be adjusted based on the severity of the pain and the patient's response to treatment. A starting dose of 2 tablets is recommended, followed by doses at intervals of at least 6 hours, not exceeding 8 tablets in one day. The lowest effective dose should be administered for the shortest duration possible. Avoid prolonged use of this medicine beyond necessary, and if prolonged treatment is required due to the nature and severity of the illness, regular monitoring should be conducted to ascertain the need for continued treatment with this medicine. Elderly Generally administer the standard adult dosage. However, it should be noted that for elderly patients over 75 years of age taking tramadol orally, the elimination half-life of tramadol is increased by 17%, hence it should be dosed at intervals of at least 6 hours. Renal Impairment For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), the dosing interval should be extended to 12 hours. For patients with severe renal impairment (creatinine clearance of less than 10 mL/min), it is not recommended to administer this medicine. Tramadol is eliminated very slowly during hemodialysis and filtration, thus it is not necessary to re-administer this medicine post-dialysis to maintain analgesic effect. Hepatic Impairment For patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. For patients with severe hepatic impairment, administration of this medicine is not recommended.
Child dose
Children aged 12 and older and adults: The dosage should be adjusted based on the severity of the pain and the patient's response to treatment. A starting dose of 2 tablets is recommended, followed by doses at intervals of at least 6 hours, not exceeding 8 tablets in one day.

Ingredients

Manufacturer
(주)알피바이오

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medicine is used to relieve acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

Children aged 12 and older and adults: The dosage should be adjusted based on the severity of the pain and the patient's response to treatment. A starting dose of 2 tablets is recommended, followed by doses at intervals of at least 6 hours, not exceeding 8 tablets in one day. The lowest effective dose should be administered for the shortest duration possible. Avoid prolonged use of this medicine beyond necessary, and if prolonged treatment is required due to the nature and severity of the illness, regular monitoring should be conducted to ascertain the need for continued treatment with this medicine. Elderly Generally administer the standard adult dosage. However, it should be noted that for elderly patients over 75 years of age taking tramadol orally, the elimination half-life of tramadol is increased by 17%, hence it should be dosed at intervals of at least 6 hours. Renal Impairment For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), the dosing interval should be extended to 12 hours. For patients with severe renal impairment (creatinine clearance of less than 10 mL/min), it is not recommended to administer this medicine. Tramadol is eliminated very slowly during hemodialysis and filtration, thus it is not necessary to re-administer this medicine post-dialysis to maintain analgesic effect. Hepatic Impairment For patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. For patients with severe hepatic impairment, administration of this medicine is not recommended.

Child dose

Children aged 12 and older and adults: The dosage should be adjusted based on the severity of the pain and the patient's response to treatment. A starting dose of 2 tablets is recommended, followed by doses at intervals of at least 6 hours, not exceeding 8 tablets in one day.

Precautions

This medicine may put a burden on the liver, so it is essential that individuals who consume more than three alcoholic drinks daily consult with a doctor or pharmacist before taking it. If you experience unusual reactions such as skin rash or itching while taking this medicine, it is important to stop taking it immediately and notify your healthcare provider. This medicine carries a risk of seizures, so patients with a history of seizures or at high risk for seizures should use it cautiously. Patients with severe respiratory depression or asthma may experience worsened breathing issues while taking this medicine; therefore, special caution is needed. This medicine can affect the central nervous system, and taking it with alcohol or sedatives may increase the risk of drowsiness or respiratory depression, so co-administration should be avoided. Patients with head injuries or brain diseases should be cautious as taking this medicine may pose risks of elevated intracranial pressure or altered consciousness. This medicine may cause psychological and physical dependence, so careful monitoring of dependence is required with long-term use. Patients with impaired liver function should consult a physician before taking this medicine and be careful not to exceed the recommended dose. Children under 12 years old and adolescents under 18 who have undergone tonsillectomy and adenoidectomy should not take this medicine. Pregnant or breastfeeding women should consult a physician before taking this medicine as it may affect the fetus or newborn. This medicine may cause drowsiness or dizziness while driving or operating machinery, so caution is needed when engaging in such activities. In cases of overdose, serious side effects such as respiratory depression, seizures, or liver damage may occur, making it imperative to strictly adhere to the dosing regimen and visit a healthcare facility immediately if abnormal symptoms arise. This medicine should be stored out of reach of children to prevent accidental ingestion, and it should be kept secure to prevent unauthorized use by others.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, desquamation of skin, pain in oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attack, abnormal breathing accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision problems, paralysis, urination

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
  • anxiety
  • neuroexcitation
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • altered sense of direction
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory loss
  • tremors
  • paresthesia
  • attention

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

Storage

This medicine should be stored in a sealed container to prevent air or moisture from entering, and kept in a cool place below room temperature (25 degrees Celsius). Doing so will help maintain the drug's effectiveness over 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

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.