Medication info
Acetadol Tablets

Acetadol Tablets

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
(주)오스코리아제약
Appearance
Pale yellow to yellow oblong film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201504763 · Approved 2015.07.10 · Insurance code 629700710

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: Dosage should be adjusted based on the severity of the patient’s pain and treatment response. A starting dosage of 2 tablets is recommended, thereafter the dosing interval should be at least 6 hours, not exceeding 8 tablets per day. The lowest effective dose should be administered for the shortest duration possible. Avoid long-term use of this medication unless necessary for conditions and severity of the disease, and conduct regular monitoring to determine the need for continued use of this medication. Elderly Administer the usual adult dose. However, in elderly patients over 75 years of age, the elimination half-life of tramadol may increase by 17%; therefore, administer this medication at intervals of at least 6 hours. Patients with renal impairment For moderate renal impairment (creatinine clearance 10-30 mL/min), extend the dosing interval to 12 hours. Tramadol is not recommended for severe renal impairment (creatinine clearance less than 10 mL/min). Tramadol is removed very slowly during blood dialysis and filtering; hence, there is no need to re-administer this medication after dialysis to maintain analgesic effect. Patients with hepatic impairment In patients with moderate hepatic impairment, it is recommended to consider extending the dosing interval carefully. For severe hepatic impairment, it is not recommended to administer this medication.
Child dose
This medication is applicable for children aged 12 and older and for adults, therefore no separate dosage for children is mentioned.

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate acute pain
  • Severe acute pain
  • Moderate chronic pain
  • Severe 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 aged 12 and older and adults: Dosage should be adjusted based on the severity of the patient’s pain and treatment response. A starting dosage of 2 tablets is recommended, thereafter the dosing interval should be at least 6 hours, not exceeding 8 tablets per day. The lowest effective dose should be administered for the shortest duration possible. Avoid long-term use of this medication unless necessary for conditions and severity of the disease, and conduct regular monitoring to determine the need for continued use of this medication. Elderly Administer the usual adult dose. However, in elderly patients over 75 years of age, the elimination half-life of tramadol may increase by 17%; therefore, administer this medication at intervals of at least 6 hours. Patients with renal impairment For moderate renal impairment (creatinine clearance 10-30 mL/min), extend the dosing interval to 12 hours. Tramadol is not recommended for severe renal impairment (creatinine clearance less than 10 mL/min). Tramadol is removed very slowly during blood dialysis and filtering; hence, there is no need to re-administer this medication after dialysis to maintain analgesic effect. Patients with hepatic impairment In patients with moderate hepatic impairment, it is recommended to consider extending the dosing interval carefully. For severe hepatic impairment, it is not recommended to administer this medication.

Child dose

This medication is applicable for children aged 12 and older and for adults, therefore no separate dosage for children is mentioned.

Precautions

This medication can put extra strain on the liver, so individuals consuming more than three alcoholic beverages per day should consult a doctor or pharmacist before taking it. If a sudden rash, blisters, or severe allergic reactions occur while taking this medication, stop immediately and inform healthcare personnel. Those at risk of seizures need to be cautious when taking this medication, especially when used in conjunction with certain antidepressants or opioid analgesics, as the risk of seizures may increase. In patients with severe respiratory diseases, this medication may suppress breathing, so it should be administered in a facility equipped for such cases. Taking this medication with alcohol or sedatives can lead to severe drowsiness, respiratory suppression, or coma, so concomitant use should be avoided. Patients with head injuries or increased intracranial pressure may experience worsening symptoms while taking this medication, necessitating caution. This medication may cause physical and psychological dependence; therefore, it should be taken strictly according to a doctor's instructions when used for long periods. Patients with impaired liver function or liver disease must consult healthcare providers before using this medication. Patients with specific genotypes may produce excessive amounts of the active metabolite, leading to severe respiratory suppression; in such cases, dosage adjustment or alternate medications may be necessary. This medication should not be used in children under 12 years old or in adolescents under 18 years old who have undergone tonsillectomy and adenoidectomy. Patients with sleep apnea or hypoxia must continually monitor for symptoms worsening while taking this medication, and may need to reduce or discontinue the dosage if necessary. This medication can cause hyponatremia; therefore, elderly patients or those with related risk factors should periodically check their serum sodium levels. Drowsiness or dizziness may occur; caution is necessary when driving or operating machinery. Overdosing on this medication can lead to severe respiratory suppression or liver damage; therefore, adhere to recommended dosages and avoid overdose. Due to numerous drug interactions, especially with MAO inhibitors, antidepressants, central nervous system depressants, and warfarin, inform healthcare personnel if you are taking any such medications. Pregnant or breastfeeding women should consult a doctor before using this medication, as it may be transmitted through breast milk and could pose risks to the baby. Elderly patients may have reduced liver, kidney, and heart function and often take multiple medications, so closer observation is needed while administering this medication. This medication should be stored in a safe place out of reach of children to prevent misuse or accidents.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Loss of appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • itching
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory loss
  • tremors
  • sensation

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

Storage

This medication should be stored in a sealed container that is well-ventilated and kept in a cool place at room temperature below 25 degrees Celsius. Storing it this way will help maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

Pale yellow to yellow oblong film-coated tablets

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.