Medication info

Hurexone Tablets (Naltrexone Hydrochloride)

Prescription medicationTabletOral · Intravenous injection · Subcutaneous injectionExpired
Ingredient · strength
Naltrexone Hydrochloride›25mg / 1 tablet
Manufacturer / importer
Huons Co., Ltd.
Appearance
Pale yellow oblong film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201507398 · Approved 2015.10.27

This product's status changed to Expired on 2025.10.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of alcohol dependence and inhibition of the effects of exogenous opioids
Who uses it
Adults
Adult dosage
Treatment with naltrexone hydrochloride may be initiated only if the physician determines that the patient has not used opioids within 7 ∼ 10 days before treatment. If opioid dependence is suspected, a naloxone challenge test should be performed. 1. Treatment of alcohol dependence Adults: Administer 50 mg of naltrexone hydrochloride orally once daily. There are placebo-controlled studies in which this dose was administered for up to 12 weeks, but other doses or treatment durations were not evaluated in these studies. 2. Blocking the effects of exogenous opioids 1) Treatment should be initiated after a urine test confirms that the patient has not used opioids for at least 7 ∼ 10 days before treatment. 2) If opioid dependence is suspected, perform the following naloxone challenge test. If opioid withdrawal symptoms continue to be observed during the test, this medicine should not be administered. However, the naloxone challenge test may be repeated after 24 hours. 3) Treatment should be initiated cautiously, with the dose gradually increased. The initial dose is 25 mg. After observation for one hour, if no withdrawal symptoms occur, the remainder of the daily dose (25 mg) may be administered, for a total daily dose of 50 mg. 4) Administration of 50 mg once daily can adequately block the effects of intravenously administered narcotics (this dose blocks the effects of 25 mg of intravenously administered heroin). To improve patient adherence to medication, the dosing schedule may be adjusted as follows: ○ 50 mg daily on weekdays and 100 mg on Saturday ○ 100 mg every 2 days ○ 150 mg every 3 days However, doses exceeding 50 mg at a time may increase the risk of hepatocellular injury; such regimens should be used only when the benefits of improved medication adherence outweigh the risk of hepatotoxicity. Administration of more than 150 mg at one time is also not recommended because it may increase the likelihood of adverse reactions. <Naloxone challenge test> 1. Test procedure 1) Intravenous challenge test Draw 0.8 mg of naloxone into a sterile syringe. Inject 0.2 mg of naloxone and observe for signs or symptoms of withdrawal for approximately 30 seconds while the needle remains in the patient's vein. If no withdrawal symptoms occur, inject the remaining 0.6 mg and observe the patient's condition for 20 minutes for the onset of withdrawal symptoms. 2) Subcutaneous challenge test Inject 0.8 mg of naloxone subcutaneously and observe the patient's condition for approximately 20 minutes for signs or symptoms of withdrawal. 3. Interpretation of results If none of the above symptoms or signs are present, initiate treatment with this medicine. If they are present, defer treatment with this medicine and repeat the naloxone challenge test after 24 hours.

Ingredients

Manufacturer
Huons Co., Ltd.

Efficacy & effects

Treatment of alcohol dependence and inhibition of the effects of exogenous opioids

  • Alcohol dependence
  • effects of exogenous opioids
View approved original text

This medication is used in conjunction with an appropriate management program to assist in the treatment of alcohol dependence and to block the effects of exogenous opioids.

Dosage and Administration

Adult dosage

Treatment with naltrexone hydrochloride may be initiated only if the physician determines that the patient has not used opioids within 7 ∼ 10 days before treatment. If opioid dependence is suspected, a naloxone challenge test should be performed. 1. Treatment of alcohol dependence Adults: Administer 50 mg of naltrexone hydrochloride orally once daily. There are placebo-controlled studies in which this dose was administered for up to 12 weeks, but other doses or treatment durations were not evaluated in these studies. 2. Blocking the effects of exogenous opioids 1) Treatment should be initiated after a urine test confirms that the patient has not used opioids for at least 7 ∼ 10 days before treatment. 2) If opioid dependence is suspected, perform the following naloxone challenge test. If opioid withdrawal symptoms continue to be observed during the test, this medicine should not be administered. However, the naloxone challenge test may be repeated after 24 hours. 3) Treatment should be initiated cautiously, with the dose gradually increased. The initial dose is 25 mg. After observation for one hour, if no withdrawal symptoms occur, the remainder of the daily dose (25 mg) may be administered, for a total daily dose of 50 mg. 4) Administration of 50 mg once daily can adequately block the effects of intravenously administered narcotics (this dose blocks the effects of 25 mg of intravenously administered heroin). To improve patient adherence to medication, the dosing schedule may be adjusted as follows: ○ 50 mg daily on weekdays and 100 mg on Saturday ○ 100 mg every 2 days ○ 150 mg every 3 days However, doses exceeding 50 mg at a time may increase the risk of hepatocellular injury; such regimens should be used only when the benefits of improved medication adherence outweigh the risk of hepatotoxicity. Administration of more than 150 mg at one time is also not recommended because it may increase the likelihood of adverse reactions. <Naloxone challenge test> 1. Test procedure 1) Intravenous challenge test Draw 0.8 mg of naloxone into a sterile syringe. Inject 0.2 mg of naloxone and observe for signs or symptoms of withdrawal for approximately 30 seconds while the needle remains in the patient's vein. If no withdrawal symptoms occur, inject the remaining 0.6 mg and observe the patient's condition for 20 minutes for the onset of withdrawal symptoms. 2) Subcutaneous challenge test Inject 0.8 mg of naloxone subcutaneously and observe the patient's condition for approximately 20 minutes for signs or symptoms of withdrawal. 3. Interpretation of results If none of the above symptoms or signs are present, initiate treatment with this medicine. If they are present, defer treatment with this medicine and repeat the naloxone challenge test after 24 hours.

Precautions

This medication can cause hepatocyte damage in cases of overdose, so the recommended dosage must be strictly followed. Patients with impaired liver function or at risk of liver damage should be particularly cautious; if acute hepatitis symptoms appear, use should be discontinued immediately and medical attention should be sought. This medication should not be used by patients taking opioid analgesics, those with opioid dependence, or those experiencing acute opioid withdrawal symptoms. Additionally, it should not be administered to individuals with hypersensitivity to this medication, severe impairment of liver and kidney function, children and adolescents under 18 years of age, the elderly, pregnant women, or nursing mothers. Patients with active liver disease or those allergic to the dyes included in this medication should use it cautiously. Since this medication acts as an opioid receptor blocker, patients taking opioid medications must inform their physician that they are on this medication, and special attention must be given regarding dosage and administration if opioid analgesics are required. Attempting to overcome the action of this medication by suddenly using a large amount of opioid drugs can lead to severe respiratory depression or life-threatening situations, so this must never be attempted. Regular liver function tests should be performed while on this medication, and if symptoms such as abdominal pain or jaundice appear, immediate consultation with a physician is necessary. Furthermore, this medication has the potential for drug interactions, so always consult with a healthcare professional when taking other medications. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication, and it is also advisable to avoid use in children and the elderly for safety reasons. This medication must be taken strictly according to a doctor's prescription and instructions, and should be stored in a safe place out of reach of children.

Side effects

  • Liver cell damage
  • elevated liver enzymes
  • headache
  • irritability
  • insomnia
  • anxiety
  • depression
  • suicidal thoughts
  • suicide attempts
  • fatigue
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  • dizziness
  • tremor
  • nausea
  • vomiting
  • paranoia
  • confusion
  • disorientation
  • hallucinations
  • nightmares
  • bad dreams
  • sensory loss
  • hypersensitivity
  • blurred vision
  • burning sensation
  • photo-sensitivity
  • edema
  • pain
  • tension-type ear congestion
  • tinnitus
  • abdominal pain
  • abdominal cramps
  • decreased appetite
  • diarrhea
  • constipation
  • excessive gas
  • hemorrhoids
  • ulcers
  • nasal bleeding
  • phlebitis
  • increased blood pressure
  • non-specific ECG changes
  • palpitations
  • tachycardia
  • congestion
  • itching
  • rhinitis
  • sneezing
  • sore throat
  • excessive mucus production
  • venous problems
  • dyspnea
  • hoarseness
  • cough
  • shortness of breath
  • joint pain
  • muscle pain
  • shoulder pain
  • leg pain
  • knee pain
  • tremors
  • twisting
  • delayed ejaculation
  • sexual dysfunction
  • frequent urination
  • difficulty urinating
  • decreased libido
  • skin rash
  • oily skin
  • acne
  • athlete's foot
  • genital herpes
  • alopecia
  • decreased energy
  • increased thirst
  • increased energy
  • coldness
  • increased appetite
  • weight loss
  • weight gain
  • yawning
  • drowsiness
  • fever
  • dry mouth
  • head rush
  • groin pain
  • scrotal swelling
  • flank pain
  • cold extremities
  • sudden seizures
  • lethargy
  • exhaustion
  • drowsiness

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

Storage

This medication is sensitive to light, so it must be stored in a container that blocks light. Additionally, it is important to maintain a room temperature between 1 to 30 degrees Celsius when storing the medication, as this helps to preserve its efficacy and prevent degradation.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablets

Package unit

30 tablets/bottle, 100 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.