Medication info
Hutradol Semi Tablet

Hutradol Semi Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›18.75mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Light yellow oblong film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 200712587 · Notified 2007.11.19 · Insurance code 670604310

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: Adjust the dosage based on the degree of pain and therapeutic response. It is recommended to administer an initial dose of 4 tablets, thereafter maintaining a dosing interval of at least 6 hours, but not to exceed 16 tablets per day. Administer the lowest effective dose for the shortest duration necessary. Avoid the long-term use of this medication without indication, and if long-term treatment is required due to the nature and severity of the disease, regular monitoring should be conducted to determine if continual administration of this medication is warranted. Elderly patients: Administer the usual adult dose. However, in patients over 75 years of age, the elimination half-life of tramadol increased by 17% when taken orally, 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. Administration is not recommended for severely impaired renal patients (creatinine clearance of less than 10 mL/min). Tramadol is eliminated very slowly during hemodialysis and filtration; therefore, there is no need for re-administration post-dialysis to maintain analgesic effect. Liver impairment: Consider extending the dosing interval cautiously for patients with moderate liver impairment. Do not administer this medication to severely impaired liver patients.
Child dose
Children aged 12 and older and adults: Adjust the dosage based on the degree of pain and therapeutic response. It is recommended to administer an initial dose of 4 tablets, thereafter maintaining a dosing interval of at least 6 hours, but not to exceed 16 tablets per day.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute and 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: Adjust the dosage based on the degree of pain and therapeutic response. It is recommended to administer an initial dose of 4 tablets, thereafter maintaining a dosing interval of at least 6 hours, but not to exceed 16 tablets per day. Administer the lowest effective dose for the shortest duration necessary. Avoid the long-term use of this medication without indication, and if long-term treatment is required due to the nature and severity of the disease, regular monitoring should be conducted to determine if continual administration of this medication is warranted. Elderly patients: Administer the usual adult dose. However, in patients over 75 years of age, the elimination half-life of tramadol increased by 17% when taken orally, 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. Administration is not recommended for severely impaired renal patients (creatinine clearance of less than 10 mL/min). Tramadol is eliminated very slowly during hemodialysis and filtration; therefore, there is no need for re-administration post-dialysis to maintain analgesic effect. Liver impairment: Consider extending the dosing interval cautiously for patients with moderate liver impairment. Do not administer this medication to severely impaired liver patients.

Child dose

Children aged 12 and older and adults: Adjust the dosage based on the degree of pain and therapeutic response. It is recommended to administer an initial dose of 4 tablets, thereafter maintaining a dosing interval of at least 6 hours, but not to exceed 16 tablets per day.

Precautions

This medication can burden the liver; therefore, individuals who consistently consume alcohol in excess of a certain amount daily must consult a physician or pharmacist before taking it. If skin rashes or allergic reactions occur during use, discontinue immediately and seek medical attention. Care should be taken when used in combination with certain antidepressants or other central nervous system drugs due to the risk of seizures. This medication can occasionally cause severe allergic reactions; thus, if symptoms such as difficulty breathing or hives occur, immediate medical attention should be sought. Patients with severe respiratory diseases may experience life-threatening respiratory depression when taking this medication, so it should be administered under the supervision of healthcare professionals. Avoid taking it with alcohol or sedatives, as this may lead to severe drowsiness or respiratory depression, which are dangerous side effects. Patients with head injuries or elevated intracranial pressure need to be cautious as the respiratory depressing effects of this drug can exacerbate their symptoms. This medication may cause physical and psychological dependence, so usage should adhere to a physician’s guidance if taken long-term. Patients with poor liver function must consult a physician before taking this medication and avoid exceeding the recommended daily dose. Patients with certain genetic metabolic disorders may experience rapid metabolism of this drug’s components in the body, leading to severe side effects, so consulting a physician before use is necessary. This medication is not to be administered to children under 12 years of age or individuals under 18 years who have undergone tonsillectomy or adenoidectomy. This medication may induce sleep apnea or hypoxemia, so if such symptoms are suspected, immediate consultation with healthcare providers is advised. Elderly patients or those at risk for hyponatremia should closely monitor for symptoms of hyponatremia while taking this medication. This medication is contraindicated for patients with specific conditions or those taking certain medications; always inform the doctor of current medications and health status before use. Drowsiness or dizziness may occur during use, so caution is advised when driving or operating dangerous machinery. Overdose may result in serious respiratory depression or liver damage, so adherence to prescribed doses and timing is essential. Avoid alcohol consumption while taking this medication and refrain from taking other analgesics or central nervous system depressants concurrently. Discontinuation should not be abrupt as withdrawal symptoms may occur; taper off gradually per physician’s instructions. If any adverse reactions or discomfort occur during use, consult healthcare providers immediately to receive appropriate guidance.

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, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanying respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision abnormalities, paralysis, urination issues

Mild side effects

  • Reduced 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
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disorders
  • confusion
  • spatial disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremor
  • sensory deficit

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

Storage

Store this medication in a sealed container to prevent air ingress, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and prevent degradation.

Appearance and packaging

Appearance

Light yellow oblong film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle, 500 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.