Medication info
Exetra Tablet

Exetra Tablet

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

MFDS item code 200709609 · Notified 2007.08.20 · Insurance code 653802140

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
Children and adults aged 12 years and older: The dosage should be adjusted according to the level of pain and response to treatment. The initial recommended dose is 2 tablets, and subsequent administration intervals should be at least 6 hours apart, not exceeding 8 tablets in a day. The effective lowest dosage should be administered for the shortest duration possible. Avoid administering this medication for longer than necessary, especially when the characteristics and severity of the disease require longer-term use; regular monitoring should be implemented to confirm the need for continued use of this medication. Elderly Administer the usual adult dosage. However, for elderly patients aged 75 and older, the half-life of tramadol increases by 17% when taken orally, so the dosage should be administered with intervals of at least 6 hours. Patients with renal impairment For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), administration intervals should be extended to 12 hours. For patients with severe renal impairment (creatinine clearance of less than 10 ml/min), administration is not recommended. Tramadol is removed very slowly during blood dialysis and filtration, therefore it is not necessary to re-administer this medication after dialysis to maintain analgesic effect. Patients with hepatic impairment For patients with moderate hepatic impairment, careful consideration should be given to extending administration intervals. This medication should not be administered to patients with severe hepatic impairment.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate pain
  • severe pain
  • acute pain
  • chronic pain
View approved original text

This medication is used to relieve acute or chronic pain that ranges from moderate to severe.

How to take

Adult dose

Children and adults aged 12 years and older: The dosage should be adjusted according to the level of pain and response to treatment. The initial recommended dose is 2 tablets, and subsequent administration intervals should be at least 6 hours apart, not exceeding 8 tablets in a day. The effective lowest dosage should be administered for the shortest duration possible. Avoid administering this medication for longer than necessary, especially when the characteristics and severity of the disease require longer-term use; regular monitoring should be implemented to confirm the need for continued use of this medication. Elderly Administer the usual adult dosage. However, for elderly patients aged 75 and older, the half-life of tramadol increases by 17% when taken orally, so the dosage should be administered with intervals of at least 6 hours. Patients with renal impairment For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), administration intervals should be extended to 12 hours. For patients with severe renal impairment (creatinine clearance of less than 10 ml/min), administration is not recommended. Tramadol is removed very slowly during blood dialysis and filtration, therefore it is not necessary to re-administer this medication after dialysis to maintain analgesic effect. Patients with hepatic impairment For patients with moderate hepatic impairment, careful consideration should be given to extending administration intervals. This medication should not be administered to patients with severe hepatic impairment.

Precautions

This medication may burden the liver, so individuals who regularly consume more than three alcoholic drinks per day should consult a doctor or pharmacist before use. If any unusual reactions such as skin rashes or itching occur while taking this medication, treatment should be stopped immediately and a doctor's advice should be sought. The tramadol component in this medication can cause seizures, so patients with a history of seizures or those at high risk should take it with caution. Additionally, serious allergic reactions or anaphylaxis may occur during use, so if abnormal symptoms appear, immediate medical attention is necessary. Patients with acute and severe bronchial asthma may experience difficulty in breathing, thus administration should occur in a specialized facility. Taking this medication with alcohol, benzodiazepines, or other central nervous system depressants can cause severe drowsiness, respiratory depression, and coma, so concurrent use should be avoided or done very cautiously. Patients with head injuries or elevated intracranial pressure may have worsening symptoms due to respiratory depression from this medication and should be cautious. This medication may cause physical and psychological dependence, so long-term use should follow strict dosage and duration management as per a doctor's instructions. Patients with impaired liver function should definitely consult a doctor before use, and care should be taken to ensure the total daily dosage does not exceed 4,000 mg if using other acetaminophen products. Especially for patients with reduced liver and kidney function, and those who are ultra-rapid metabolizers of CYP2D6, the effects and side effects of this medication can be more severe, thus consulting medical personnel before use is necessary. This medication is not to be administered to children under 12 or adolescents under 18 who have undergone tonsillectomy or adenoidectomy, and teenagers aged 12 to 18 should avoid use if there are special risk factors. This medication may cause sleep apnea and hypoxemia, so careful observation of sleep-related symptoms is necessary. There is a risk of hyponatremia during use, so especially elderly patients or those at risk of hyponatremia should periodically check for symptoms. This medication may interact with certain other drugs, so if currently taking any medications, it is essential to inform healthcare personnel, particularly when used with MAO inhibitors, antidepressants, anticonvulsants, warfarin, and central nervous system depressants. Women who are pregnant or may become pregnant must consult a doctor before use, and while breastfeeding, it is safer not to take this medication. This medication can cause drowsiness or dizziness, so caution is advised while driving or operating machinery. In the case of overdose, serious respiratory depression, seizures, and liver damage can occur, so prescribed dosages and times must be strictly followed, and if overdose is suspected, immediate emergency treatment is required. This medication should be stored in a safe place out of reach of children, and careful management is necessary to prevent drug misuse and accidental ingestion.

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, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination problems

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • discomfort in the abdomen
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremor

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

Storage

This medication should be stored in a tightly sealed container that allows for good air circulation, and it is recommended that it be kept at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and ensures safe use.

Appearance and packaging

Appearance

Pale yellow rectangular 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

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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.