Medication info
Hutradol Tablets

Hutradol Tablets

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Light yellow, rectangular film-coated tablet
Packaging
For domestic use: 30 tablets/bottle, 300 tablets/bottle, for export: 100 tablets (10 tablets/PTP × 10)
Approval status
Active

MFDS item code 200712588 · Notified 2007.11.19 · Insurance code 670604320

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 according to the severity of the patient's pain and response to treatment. It is recommended to administer 2 tablets as an initial dose, and subsequent doses should be spaced at least 6 hours apart, not exceeding 8 tablets per day. Administer the effective lowest dose for the shortest duration possible. Avoid administering this medication for longer than necessary, and if long-term administration is required due to the nature and severity of the disease, regular monitoring should be implemented to assess the continuation of this medication. Elderly: Usual adult doses should be administered. However, the elimination half-life of tramadol increases by 17% in elderly patients over 75, so this medication should be administered at intervals of at least 6 hours. Patients with renal impairment: In 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 of less than 10 ml/min). Tramadol is very slowly removed during dialysis and filtration, so there is no need to re-administer it after dialysis to maintain analgesic effects. Patients with hepatic impairment: In patients with moderate hepatic impairment, consider extending the dosing interval. This medication should not be administered to patients with severe hepatic impairment.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

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

How to take

Adult dose

Children over 12 years and adults: The dosage should be adjusted according to the severity of the patient's pain and response to treatment. It is recommended to administer 2 tablets as an initial dose, and subsequent doses should be spaced at least 6 hours apart, not exceeding 8 tablets per day. Administer the effective lowest dose for the shortest duration possible. Avoid administering this medication for longer than necessary, and if long-term administration is required due to the nature and severity of the disease, regular monitoring should be implemented to assess the continuation of this medication. Elderly: Usual adult doses should be administered. However, the elimination half-life of tramadol increases by 17% in elderly patients over 75, so this medication should be administered at intervals of at least 6 hours. Patients with renal impairment: In 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 of less than 10 ml/min). Tramadol is very slowly removed during dialysis and filtration, so there is no need to re-administer it after dialysis to maintain analgesic effects. Patients with hepatic impairment: In patients with moderate hepatic impairment, consider extending the dosing interval. This medication should not be administered to patients with severe hepatic impairment.

Precautions

This medication may put a strain on the liver, so individuals who regularly consume more than three glasses of alcohol per day should consult a doctor or pharmacist before taking it. If any rash or allergic reaction occurs during treatment, discontinue use immediately and inform medical personnel. The ingredients in this medication may increase the risk of seizures, so patients with a history of seizures or a high risk of seizures should use it cautiously, and caution is also required when combining it with certain antidepressants or other medications. Rarely, serious allergic reactions can occur, so if symptoms such as difficulty breathing or severe swelling appear, immediate emergency treatment should be sought. Patients with acute and severe bronchial asthma are at risk of severe respiratory suppression when using this medication, so it should only be administered in an environment where medical personnel can monitor. Taking this medication with alcohol or other central nervous system depressants may result in severe drowsiness, respiratory suppression, or coma, so co-administration should be avoided or done with extreme caution. Patients with head injuries or elevated intracranial pressure may experience worsening symptoms while taking this medication, so caution is necessary. This medication can lead to psychological and physical dependence, so long-term use should be managed in consultation with medical personnel regarding potential dependence. Patients with impaired liver function must consult a doctor before taking this medication, and due to the acetaminophen component, liver damage can occur, so do not exceed the recommended dosage. Patients with certain genotypes metabolize this medication faster, increasing the risk of severe respiratory suppression, so alternative medications or dosage adjustments may be necessary. It is safest not to administer this medication to children under 12 years old and adolescents under 18 who have undergone tonsillectomy or adenoidectomy. Patients with sleep apnea or hypoxemia may experience worsening symptoms when taking this medication, so continuous monitoring and dosage adjustments as needed are required. Elderly patients or those at risk of hyponatremia should carefully monitor symptoms of hyponatremia while taking this medication. This medication may interact with certain drugs, so if other medications are being taken, it is important to inform a doctor or pharmacist before use. Pregnant or breastfeeding women should consult medical personnel before using this medication, as it may transfer into breast milk and affect the baby. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating machinery. In the event of overdose, there is a risk of severe respiratory suppression or liver damage, so it is important to adhere to the prescribed dosage and not exceed it. This medication should be kept in a safe place out of reach of children, and care should be taken to prevent abuse or accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling of the skin, pain in the mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and 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

  • 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
  • hypersensitivity
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremor

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

Storage

This medication should be stored in a sealed container to prevent air and moisture from entering, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way will maintain the effectiveness of the medication and ensure its safe use.

Appearance and packaging

Appearance

Light yellow, rectangular film-coated tablet

Package unit

For domestic use: 30 tablets/bottle, 300 tablets/bottle, for export: 100 tablets (10 tablets/PTP × 10)

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.